U.S. patent application number 17/197134 was filed with the patent office on 2021-06-24 for method and system for testing a sample.
This patent application is currently assigned to Boehringer Ingelheim Vetmedica GmbH. The applicant listed for this patent is Boehringer Ingelheim Vetmedica GmbH. Invention is credited to Heinz SCHOEDER, Kai Wuerz.
Application Number | 20210190804 17/197134 |
Document ID | / |
Family ID | 1000005444480 |
Filed Date | 2021-06-24 |
United States Patent
Application |
20210190804 |
Kind Code |
A1 |
SCHOEDER; Heinz ; et
al. |
June 24, 2021 |
METHOD AND SYSTEM FOR TESTING A SAMPLE
Abstract
An analysis system and a method for testing a biological sample
are proposed, wherein certain pieces of at least two different
pieces of control information are selected and/or used to carry out
the test using a cartridge and/or certain pieces of at least two
different pieces of evaluation information are selected and/or used
to evaluate the measurement results determined by the test.
Inventors: |
SCHOEDER; Heinz;
(Isernhagen, DE) ; Wuerz; Kai; (Mainz,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boehringer Ingelheim Vetmedica GmbH |
Ingelheim am Rhein |
|
DE |
|
|
Assignee: |
Boehringer Ingelheim Vetmedica
GmbH
Ingelheim am Rhein
DE
|
Family ID: |
1000005444480 |
Appl. No.: |
17/197134 |
Filed: |
March 10, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15725362 |
Oct 5, 2017 |
10976329 |
|
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17197134 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B01L 2400/0457 20130101;
B01L 2400/0487 20130101; G01N 2035/00851 20130101; G01N 35/00871
20130101; B01L 7/52 20130101; B01L 2200/028 20130101; B01L 2300/023
20130101; B01L 3/545 20130101; B01L 3/502 20130101; G01N 35/00732
20130101; G01N 2035/00881 20130101; G01N 35/00029 20130101; B01L
2200/143 20130101; B01L 2200/0621 20130101; G01N 2035/00811
20130101; B01L 2300/022 20130101; B01L 2300/021 20130101; B01L
3/502715 20130101; B01L 2300/0816 20130101 |
International
Class: |
G01N 35/00 20060101
G01N035/00; B01L 3/00 20060101 B01L003/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 7, 2016 |
EP |
16 020 387.3 |
Claims
1. A method of using an analysis system for testing a sample
received in a cartridge, the method comprising the steps of:
carrying out testing of the sample using the cartridge received in
the analysis device, and determining measurement results from said
testing of the sample, providing at least two different pieces of
evaluation information for carrying out different evaluations of
said measurement results, and selecting or using at least one piece
of said pieces of evaluation information for evaluating the
measurement results determined by the testing of the sample.
2. The method according to claim 1, wherein the different pieces of
evaluation information are provided in a database, wherein the
method further comprises unblocking only certain of said pieces of
evaluation information and using said certain of said unblocked
pieces of evaluation information for at least one of selection,
retrieval or evaluation of the measurement results.
3. The method according to claim 1, wherein the different pieces of
evaluation information are provided in a database, wherein the
method further comprising blocking of only certain of said pieces
of evaluation information, thus preventing said certain blocked
pieces of evaluation information from being at least one of
selected, retrieved or used for evaluation.
4. The method according to claim 2, wherein measurement results
from the same test on the sample carried out using the cartridge
are evaluated using the selected one of the unblocked pieces of
evaluation information or that measurement results from different
tests on the sample carried out using the same cartridge are
evaluated using the selected one of the unblocked different pieces
of evaluation information.
5. The method according to claim 1, wherein a cartridge identifier
of the cartridge is determined and, depending on the cartridge
identifier, pieces of evaluation information for use in the
evaluation of measurement results from the test are blocked or
unblocked.
6. The method according to claim 1, wherein the selected piece of
evaluation information is retrieved using an operating instrument
of the analysis system.
7. The method according to claim 6, wherein the evaluation
information comprises instructions forming or replacing a module of
the operating instrument, as a result of which the behavior of the
operating instrument is changed.
8. The method according to claim 7, wherein the instructions are
commands, machine code, pre-compiled source code or source
code.
9. The method according to claim 7, wherein the instructions are
provided in a replaceable plugin unit.
10. The method according to claim 1, wherein the measurement
results are analyzed in different manners using different pieces of
said evaluation information, respectively, in order to determine
different characteristic values or to detect different
diseases.
11. The method according to claim 1, wherein the measurement
results are evaluated such that the presence of certain amino-acid
sequences, proteins and/or diseases is/are determined and/or
output.
12. An analysis system for testing a sample, comprising: at least
one cartridge for receiving a sample and configured for performing
of a test on the sample, the at least one cartridge having an
identifier for identifying the particular cartridge, means for
reading out said identifier for use in retrieving evaluation
information for performing a particular evaluation of measurement
results determined by said test, a data base containing at least
two different pieces of evaluation information that correspond to
different evaluations performable with the measurement results, the
pieces of evaluation information being selectable based on the
identifier read out by said means for reading, an analysis device
for receiving the at least one cartridge and subsequently
determining the measurement results by carrying out testing using a
received cartridge, an operating instrument for controlling
performing of the particular evaluation, and means for at least one
of: unblocking only certain of said pieces of evaluation
information in said data base for enabling selection or retrieval
thereof for control as to which of the different evaluations is
performable with the measurement results using only the unblocked
pieces of evaluation information; or blocking at least one of said
different pieces of evaluation information in said data base for
preventing the blocked evaluation information from being selected
or retrieved for control as to which of the different evaluations
is performable with the measurement results.
13. Analysis system according to claim 12, wherein each of the
different pieces of evaluation information comprises respective
instructions which can form or replace a module of the operating
instrument, which module can be implemented by the operating
instrument, as a result of which the behavior of the operating
instrument is changeable.
14. Analysis system according to claim 13, wherein the instructions
are commands, machine code, pre-compiled source code or source
code.
15. Analysis system according to claim 13, wherein the instructions
are provided in a replaceable plugin unit.
16. An analysis system for testing a sample, comprising: at least
one cartridge for receiving a sample and configured for performing
of a test on the sample, the at least one cartridge having an
identifier for identifying the particular cartridge, means for
reading out said identifier for use in retrieving evaluation
information for performing a particular evaluation of measurement
results determined by said test, a data base containing at least
two different pieces of evaluation information that correspond to
different evaluations performable with the measurement results, the
pieces of evaluation information being selectable based on the
identifier read out by said means for reading, an analysis device
for receiving the at least one cartridge and subsequently
determining the measurement results by carrying out testing using a
received cartridge, and an operating instrument for controlling
performing of the particular evaluation, wherein each of the
different pieces of evaluation information comprises respective
instructions which can form or replace a module of the operating
instrument, which module can be implemented by the operating
instrument, as a result of which the behavior of the operating
instrument is changeable.
17. Analysis system according to claim 16, wherein the instructions
are commands, machine code, pre-compiled source code or source
code.
18. Analysis system according to claim 16, wherein the instructions
are provided in a replaceable plugin unit.
19. A method for testing a sample by means of an analysis system,
comprising a cartridge for receiving the sample, an analysis device
for receiving the cartridge and subsequently carrying out a test
using the received cartridge, the cartridge being configured to
separately carry out different tests on the sample, for which the
sample is conveyed and/or treated in different manners specific to
the respective tests, the method comprising: providing at least two
different pieces of control information that correspond to the
different tests, wherein each of the different pieces of control
information comprises respective instructions, selecting at least
one piece or certain pieces of said control information for
respectively carrying out at least one of the different tests on
the sample using the cartridge, and using the instructions of said
piece or pieces of control information for changing the behavior of
the analysis device, the instructions forming or replacing a module
of the analysis device.
20. The method according to claim 19, wherein the instructions are
provided as commands, machine code, pre-compiled source code or
source code.
21. The method according to claim 19, wherein the instructions are
provided in a replaceable plugin unit.
22. An analysis system for testing a sample, comprising: at least
one cartridge for receiving a sample and configured to separately
carry out different tests on the sample, for which the sample is
conveyed and/or treated in different manners specific to the
respective tests, a data base containing at least two pieces of
control information that correspond to different tests performable
with the at least one cartridge, at least one piece or certain
pieces of said control information being selectable for carrying
out at least one of the different tests, an analysis device for
receiving the at least one cartridge and subsequently carrying out
at least one of the different tests using the received cartridge,
wherein the analysis device is configured to be controlled using at
least one of the pieces of control information such that the sample
is conveyed and/or treated within the cartridge in a manner
specific to the test corresponding to the at least one piece of
control information, and wherein each of the different pieces of
control information comprises respective instructions which can
form or replace a module of the analysis device, which module can
be implemented by the analysis device, and as a result of which the
behavior of the analysis device is changeable.
23. The analysis system according to claim 22, wherein the
instructions are commands, machine code, pre-compiled source code
or source code.
24. The analysis system according to claim 22, wherein the
instructions are provided in a replaceable plugin unit.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a Division of U.S. patent
application Ser. No. 15/725,362 filed Oct. 5, 2017, which claims
the benefit of priority to European Patent Application No.
16020387.3 filed Oct. 7, 2016, the contents of which are
incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention relates to a method and system for
testing a sample.
[0003] Preferably, the present invention deals with analyzing and
testing a sample, in particular from a human or animal,
particularly preferably for analytics and diagnostics, for example
with regard to the presence of diseases and/or pathogens and/or for
determining blood counts, antibodies, hormones, steroids or the
like. Therefore, the present invention is in particular within the
field of bioanalytics. A food sample, environmental sample or
another sample may optionally also be tested, in particular for
environmental analytics or food safety and/or for detecting other
substances.
[0004] Preferably, by means of the present invention, at least one
analyte (target analyte) of a sample can be determined, identified
or detected. In particular, the sample can be tested for
qualitatively or quantitatively determining at least one analyte,
for example, in order for it to be possible to detect or identify a
disease and/or pathogen.
[0005] Within the meaning of the present invention, analytes are in
particular nucleic-acid sequences, in particular DNA sequences
and/or RNA sequences, and/or proteins, in particular antigens
and/or antibodies. In particular, by means of the present
invention, nucleic-acid sequences can be determined, identified or
detected as analytes of a sample, and/or proteins can be
determined, identified or detected as analytes of the sample. More
particularly preferably, the present invention deals with systems,
devices and other apparatus for carrying out a nucleic-acid assay
for detecting or identifying a nucleic-acid sequence and/or a
protein assay for detecting or identifying a protein.
[0006] The present invention deals in particular with what are
known as point-of-care systems, i.e., in particular with mobile
systems, devices and other apparatus, and deals with methods for
carrying out tests on a sample at the sampling site and/or
independently and/or away from a central laboratory or the like.
Preferably, point-of-care systems can be operated autonomously
and/or independently of a mains network for supplying electrical
power.
DESCRIPTION OF RELATED ART
[0007] U.S. Pat. No. 5,096,669 discloses a point-of-care system for
testing a biological sample, in particular a blood sample. The
system comprises a single-use cartridge and an analysis device.
Once the sample has been received, the cartridge is inserted into
the analysis device in order to carry out the test. The cartridge
comprises a microfluidic system and a sensor apparatus comprising
electrodes, which apparatus is calibrated by means of a calibration
liquid and is then used to test the sample.
[0008] Furthermore, International Patent Application Publication WO
2006/125767 A1 and corresponding U.S. Pat. No. 9,110,044 B2
disclose a point-of-care system for integrated and automated DNA or
protein analysis, comprising a single-use cartridge and an analysis
device for fully automatically processing and evaluating
molecular-diagnostic analyses using the single-use cartridge. The
cartridge is designed to receive a sample, in particular blood, and
in particular allows cell disruption, PCR and detection of PCR
amplification products, which are bonded to capture molecules and
provided with a label enzyme, in order for it to be possible to
detect bonded PCR amplification products or nucleic sequences as
target analytes in what is known as a redox cycling process.
[0009] U.S. Pat. No. 8,580,569 B2 discloses a feedback control in
microfluidic systems. The control of fluids involves the use of
feedback from one or more processes or events taking place in the
microfluidic system. For instance, a detector may detect one or
more fluids at a measurement zone and, using this data, a control
system may determine whether to modulate subsequent fluid flow in
the microfluidic system. However, there is no hint how to achieve a
more flexible use. Moreover, there is no hint regarding any
particular evaluation procedures.
[0010] U.S. Pat. No. 9,810,704 B2 discloses systems and methods for
multi-analysis and sample processing. A device may be provided,
capable of receiving the sample, and performing one or more of a
sample preparation, sample assay, and detection step. The device
may be capable of performing multiple assays. A cartridge may be a
universal cartridge that can be configured for the same selection
of tests. However, there is no hint regarding whether specific
tests can be selected or how the universal cartridge is used.
Moreover, there is no hint regarding any particular evaluation
procedures.
[0011] U.S. Pat. No. 6,709,869 B2 discloses devices and methods for
using centripetal acceleration to drive fluid movement in a
microfluidics system. The invention provides a microsystem platform
and a micromanipulation device for manipulating the platform that
utilizes the centripetal force resulting from rotation of the
platform to motivate fluid movement through micro-channels. The
microsystem platforms are optionally provided having system
informatics and data acquisition, analysis and storage and
retrieval informatics encoded on the surface of the disk opposite
to the surface containing the fluidic components. The platform
comprises multiple similar devices. It can be selected to run an
exhaustive or limited set of diagnostics. However, as there is no
hint how to do this and whether identical tests are selectable.
Further, there is no hint regarding evaluation handling apparent.
The extent of detail and a method of reporting can be selected,
however, this does not mean that an evaluation of measurement
results was conducted or influenced.
SUMMARY OF THE INVENTION
[0012] Point-of-care systems are generally specifically designed
for a particular test, in order to thus provide a compact and
therefore transportable form.
[0013] The problem addressed by the present invention is to provide
a method for testing an in particular biological sample, a computer
program product and an analysis system, it being possible to
achieve a high level of flexibility and reliability.
[0014] This problem is solved by a method and system according to
the invention as described herein.
[0015] The present invention relates to the testing of an in
particular biological sample using an analysis system. For this
purpose, the analysis system preferably comprises a cartridge for
receiving the sample. Furthermore, the analysis system preferably
comprises an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge.
The present invention is particularly advantageous in this regard;
however, it may also be used for other analysis systems,
substantially or in part. In the following, however, the invention
is always explained on the basis of the preferred analysis
system.
[0016] For the test supported by the cartridge, the cartridge
preferably comprises a sensor apparatus and a fluid system
comprising channels for preparing, treating and/or conveying the
sample to a sensor apparatus. The test therefore preferably takes
place at least substantially or exclusively within the
cartridge.
[0017] According to one aspect of the present invention, the
cartridge supports different tests on the sample, which can also be
carried out separately. For this purpose, the sample is conveyed
and/or prepared within the cartridge in different ways that are
specific to the respective tests.
[0018] Using other words, the cartridge preferably supports
different tests on the sample meaning that the cartridge is
configured such that the sample can be treated differently inside
the cartridge such that different test procedures and test results
can be obtained. In particular, the cartridge supports different
tests by the cartridge being configured such that different assays
are enabled due to the construction of the cartridge such that
different substances or ingredients of the sample can be detected
by means of the cartridge. For that purpose, the sample can be
treated differently in or by means of the cartridge for performing
the different assays and detecting of different substances or
ingredients.
[0019] It may thus be provided that the sample is conveyed on
different paths formed by channels of the fluid system and/or in
different directions and/or differently in another manner. This
means that different tests can be carried out. Alternatively, or
additionally, the sample is prepared or treated differently, in
particular heat-treated differently and/or brought into contact
with different reagents. For this purpose, the sample is preferably
always transported from a receptacle towards the sensor apparatus
as a result, in order to use the sensor apparatus to determine, at
this point, specific measured values for the sample that can be
evaluated or analyzed subsequently.
[0020] Preferably, the same cartridge supports the tests on the
sample, which can also be carried out separately. For this purpose,
the cartridge is preferably designed, in particular by means of
valves and/or by supporting different transport and/or pump
directions, to convey, to treat and/or to prepare the sample in
different manners and/or on different paths. In particular, the
cartridge comprises corresponding reagents for carrying out
different tests, comprises one or more different cavities,
preferably having different functions, and/or comprises a bypass,
in order to bypass portions of the fluid system depending on the
selected test.
[0021] For example, the cartridge is designed to prepare different
components of the sample in different manners in the different
tests, in particular by means of different mixing processes, heat
treatments and/or by carrying out different reactions.
[0022] In particular, on the one hand, the cartridge can support a
test in which a PCR is carried out, the sample being or being able
to be temperature-controlled in a region provided or designed
therefor. On the other hand, in another test a PCR is not carried
out and/or the sample is guided past or bypasses a
temperature-control region. Alternatively, or additionally, the
sample can also be transported through the temperature-control
region without temperature-control taking place. In this manner or
in another manner, the sample can be prepared and/or treated
differently.
[0023] In order to carry out the different tests, corresponding
pieces of control information are preferably provided for the
respective tests. The pieces of control information can be stored
in a database and/or can be retrieved from a database.
[0024] Therefore, preferably at least two, in particular different,
pieces of control information are provided which correspond to the
different tests, in particular different tests on the same sample
and/or using the same analysis system, the same analysis device
and/or the same cartridge. Preferably, using the different tests,
different measurement results can be determined and/or different
analytes can be detected, in particular measured, when the same
sample is used.
[0025] Providing a piece of control information preferably means
that said piece of control information is made available such that
said piece of control information can be provided to and/or used by
the analysis device for performing the test or test sequence. In
particular, the pieces of control information are stored and can be
received or retrieved on demand. However, there are different
measures known in the art to provide pieces of control information
as well.
[0026] A piece of control information preferably corresponds to a
test in the sense of the present invention preferably if or when
said piece of control information is configured to be used for
controlling a test, test sequence, test procedure or test process.
Thus, different pieces of control information in the sense of the
present invention preferably correspond to different tests, test
sequences, test procedures or test processes if the pieces of
control information are different in comparison to each other and,
respectively, are configured to be used for controlling different
tests, test procedures, test sequences or test processes, which in
particular are supported by the same cartridge.
[0027] Accordingly, it is preferred that the different pieces of
control information are configured, in particular containing
instructions, parameters or the like, to perform different tests,
test sequences, test procedures or test processes the cartridge
supports, i.e., the cartridge is configured for said different
tests, test sequences, test procedures or test processes to be
carried out--preferably by treating the sample differently,
transporting the sample differently, mixing it with different
substances, heating it differently, performing different reactions
with it or the like.
[0028] The (different) pieces of control information are preferably
designed to be interpreted by the analysis device, whereupon
actuators of the analysis device are controlled in the manner
specified by the (respective) pieces of control information such
that the test is carried out (differently), the sample preferably
being conveyed and/or prepared in a specific (different)
manner.
[0029] Preferably, at least one piece of the control information is
or can be selected for carrying out the test using the cartridge.
Subsequently, the selected test can be carried out using the
analysis system and/or the analysis device and/or the cartridge on
the basis of this selected piece of control information. The
analysis system therefore preferably supports a selection process
between a plurality of possible tests which are supported by the
analysis system, the analysis device and/or the cartridge,
preferably by selecting the (desired) piece of control
information.
[0030] Particularly preferably, the analysis device can be
controlled using the selected piece of control information. In this
respect, the analysis device can preferably be controlled using the
selected piece of control information such that the sample is
conveyed within the cartridge in a specific manner which
corresponds to the selected piece of control information or test.
In particular, it is therefore provided that different tests or
pieces of control information corresponding thereto are or can be
selected and, on the basis of the selected piece of control
information, the test corresponding thereto is carried out by the
sample being conveyed in the cartridge on the basis of the piece of
control information and/or being conveyed within the cartridge in
the manner specific to the selected test.
[0031] By it being possible to select the piece of control
information, it is simply and effectively made possible to carry
out different tests using the same analysis system, and optionally
using the same cartridge. For example, a cartridge can support both
a nucleic-acid assay and a protein assay and, by selecting the
piece of control information specific to one of these tests, the
analysis device can be controlled such that, using the cartridge,
the selected test and/or the test defined by or corresponding to
the selected piece of control information is carried out on the
sample received in the cartridge. Here, the sample is preferably
correspondingly conveyed and/or treated within the cartridge, in
order to then be analyzed using the sensor apparatus. Therefore,
the present invention allows for a convenient and flexible
test.
[0032] In another aspect of the present invention, which can also
be implemented independently, it is provided that measurement
results are determined by carrying out the test using the sensor
apparatus of the cartridge. For this purpose, it is in particular
provided that the sample, which has preferably been prepared, is
fed to the sensor apparatus and sample-specific measurement results
are determined, in particular measured, or can be determined, in
particular can be measured, by the sensor apparatus.
[0033] Different pieces of evaluation information are preferably
provided in order to evaluate the measurement results in different
manners, in particular in order to obtain different evaluation
results, such as characteristic values, indicators or the like.
[0034] Providing a piece of evaluation information preferably means
that said piece of evaluation information is available such that
said piece of evaluation information can be provided to and/or used
for performing the evaluation. In particular, the pieces of
evaluation information are stored and can be received or retrieved
on demand. However, there are different measures known in the art
to provide pieces of evaluation information as well.
[0035] A piece of evaluation information preferably corresponds to
an evaluation in the sense of the present invention preferably if
or when said piece of evaluation information is configured to be
used for evaluating a measurement result. Said measurement result
preferably is a result or outcome of the test, test sequence, test
procedure or test process. The measurement result preferably is
indicative of a property of the sample, in particular of an analyte
contained in the sample.
[0036] Different pieces of evaluation information in the sense of
the present invention preferably correspond to different
evaluations of the same measurement result or of different
measurement results, preferably determined using the same
cartridge. The pieces of evaluation information are different in
comparison to each other and, respectively, are configured to be
used for evaluating said measurement results differently.
[0037] The measurement results preferably are either the outcome
from the same test, test sequence, test procedure or test process
or the outcome from one or more tests, test sequences, test
procedures or test processes carried out using the same
cartridge.
[0038] Accordingly, it is preferred that the different pieces of
evaluation information are configured, in particular containing
instructions, parameters or the like, to perform evaluation of
measurement results differently--preferably by processing,
computing or calculating based on the measurement results one or
more evaluation results, in particular wherein different types
and/or concentrations and/or (absolute) quantities of one, and
particularly preferably more than one, analyte is or are
determined.
[0039] Preferably, at least two different pieces of evaluation
information are provided for carrying out different evaluations of
the measurement results. In order to carry out the different
evaluations of the measurement results, at least one piece of the
evaluation information is selected and/or used for evaluating the
measurement results determined by the test on the sample.
[0040] For example, it is possible for different characteristic
values, indicators or the like to be determined using the
measurement results from the same test. This is, however, often
associated with computational effort and waiting time. However, by
selecting particular evaluations or pieces of evaluation
information corresponding thereto from the entirety of all the
evaluations that are possible with the measurement results or that
are supported, the present invention makes it possible to carry out
only those particular evaluations target-oriented, and to therefore
obtain only those corresponding results, that are required at that
particular time. In addition, it is possible to evaluate the
measurement results in stages. Therefore, it is possible, initially
using a first piece of evaluation information, to carry out a first
evaluation of the measurement results and, if required, in a second
step, to evaluate the same measurement results in another manner
using another piece or different pieces of evaluation information,
in order to obtain additional or different evaluation results.
[0041] "The same measurement results" are preferably measurement
results from the same test and/or from the same sample and/or
obtained using the same sensor apparatus. This does not exclude the
same measurement results being or comprising a set of results, in
particular a plurality of individual measured values. It is
possible for the same measurement results to comprise different
sub-results and, in the different evaluations, for the same results
or sub-results to be evaluated using preferably different methods,
or for different sub-results to be evaluated using the same or
different methods.
[0042] The cartridge preferably comprises a sensor apparatus, which
tests the sample in such a way that measurement results which are
generated by the sensor apparatus during sample testing can be
evaluated in different manners.
[0043] The sensor apparatus or a sensor array thereof preferably
comprises multiple sensor fields and/or electrodes for specifically
bonding and/or detecting one or more analytes to be detected or
measured. Further, the sensor apparatus preferably is configured
for electrical or electrochemical detection of analytes of the
sample.
[0044] Alternatively, or additionally, the sensor apparatus and/or
the sensor device can be configured for detecting or measuring
other or further analytes compounds, material characteristics, or
the like without specific bonding and/or by means of optical
measurement, impedance measurement, capacitance measurement,
spectrometric measurement, mass spectrometric measurement, or
tomography, like Magnetic Resonance Tomography (MRT). In this
regard, the sensor apparatus, thus, can be formed by an arrangement
enabling such measurement. In particular, the sensor apparatus or
cartridge or any other sample carrier of the analysis device or
system can comprise or form a cavity having a window for said
optical measurement. The optical sensor or the sensor apparatus,
such as a spectrometer, can be realized independently of the
cartridge and/or can form part of the analysis device.
[0045] In the following, the present invention is explained based
primarily on the sensor apparatus having multiple sensor fields
and/or being or comprising a chip having electrodes for
electrochemical detection. However, unless stated or conductible
unambiguously to the contrary, it is to be understood that
measurement results alternatively or additionally can be achieved
by or can be the outcome of one or more of the above mentioned
measurement techniques even if not mentioned explicitly.
[0046] The sensor apparatus may comprise a plurality of sensor
fields, different tests being able to be carried out on the sample
with said sensor fields. Accordingly, the different pieces of
evaluation information may comprise instructions on choosing or
selecting certain sensor fields, and therefore only certain sensor
fields are evaluated and other sensor fields are disregarded.
Alternatively, or additionally, the (different) pieces of
evaluation information may, however, also contain instructions
regarding the manner in which to evaluate measurement results from
the same sensor fields in different ways, in order to thereby
generate different evaluation results.
[0047] The piece/pieces of control information and/or evaluation
information is/are particularly preferably selected by an operating
instrument that is in particular designed to be separated and/or
disconnected from the analysis device or is separable or
disconnectable from the analysis device, in particular with respect
to a data connection and/or physically. The different pieces of
control information and/or evaluation information can be stored on
the operating instrument for selection. Alternatively, or
additionally, the different pieces of control information and/or
evaluation information are stored in an external database, to which
the control instrument is or can be connected by a data
connection.
[0048] Particular pieces of control information and/or evaluation
information can be selected using the operating instrument. For
this purpose, a selection of possible pieces of control information
and/or evaluation information can be output by the operating
instrument, in particular an output apparatus, and can be displayed
for selection. A selection can then be made by the operating
instrument, in particular by means of an input apparatus
thereof.
[0049] Subsequently or as a result, the (selected) piece/pieces of
control information and/or evaluation information can be retrieved
from the database. The piece/pieces of control information is/are
preferably transmitted to the analysis device in order to carry out
the test. The piece/pieces of evaluation information is/are
preferably used by the operating instrument to evaluate measurement
results received from the analysis device.
[0050] Another aspect of the present invention, which can also be
implemented independently, relates to a computer program product
comprising program code means which, when executed, for example by
a processor, computer, microcontroller or one or more other data
processing apparatus for executing the program code means, in
particular of the operating instrument and/or of the analysis
device, cause the method steps or the method according to the
present invention to be carried out. The computer program product
preferably is a non-transitory computer-readable media.
[0051] Another aspect of the present invention, which can also be
implemented independently, relates to an analysis system, which is
designed to carry out the method.
[0052] Here, the analysis system, in particular the cartridge
thereof, supports different tests on the sample, which can also be
carried out separately, the sample being conveyed, treated and/or
prepared for the different tests within the cartridge in different
manners that are specific to the respective tests.
[0053] Furthermore, at least two different pieces of control
information are provided that correspond to the different tests. At
least one piece or certain pieces of the control information can be
selected for carrying out the test using the cartridge.
Furthermore, the analysis device can be controlled using the
selected piece of control information, and therefore the sample is
conveyed, treated and/or prepared within the cartridge in the
manner that is specific to the test corresponding to the selected
piece of control information.
[0054] Alternatively, or additionally, measurement results can be
determined using the sensor apparatus of the cartridge by means of
the test, and at least two different pieces of evaluation
information are provided for carrying out different evaluations of
the measurement results. It is provided here that at least one
piece of the evaluation information can be selected for evaluating
the measurement results that are determined by the test on the
sample.
[0055] The term "piece of control information" is preferably
understood to mean one or more data sets, files or other units that
correspond to the control of a preferably complete test sequence.
For this purpose, the piece of control information and/or data
sets, files or other units in particular comprises parameters
and/or instructions for controlling the (entire) test. If reference
is being made to different pieces of control information, these are
particularly preferably different data sets, files or other units
that are preferably designed to carry out different (complete)
tests. Selecting particular pieces of control information therefore
preferably corresponds to selecting one or more of the different
data sets, files or other units. If required, the term "piece of
control information" or "pieces of control information" can
therefore be substituted with one or more of the terms or the
expression "data sets, files and/or other units comprising one or
more pieces of control information".
[0056] The term "test" as used herein preferably means a test
procedure and/or performing an assay, in particular one, several or
all steps for performing an assay to determine one or more analytes
of a sample. The steps are preferably realized by or within the
analysis system, analysis device and/or cartridge.
[0057] An "assay" according to the present invention is preferably
an investigative procedure for qualitatively and/or quantitatively
measuring, detecting and/or identifying the presence, amount,
and/or functional activity of a target entity or analyte of the
sample. The analyte can, e.g., be a drug, a biological, chemical
and/or biochemical substance, and/or a cell in an organism or
organic sample. In particular, the analyte can be a molecule, a
nucleic-acid sequence, a DNA, an RNA and/or a protein.
[0058] Preferably, the assay according to the present invention is
a nucleic-acid assay for detecting or identifying a nucleic-acid
sequence and/or a protein assay for detecting or identifying a
protein.
[0059] An assay, test or test procedure according to the present
invention accordingly preferably covers at least one of:
controlling actuators of the analysis device like a pump drive,
temperature control apparatus, and valve actuators; acting on the
cartridge or sample; treating the sample; preparing the sample;
performing one or more mixing processes and/or reactions with the
sample; conveying the sample; and measuring one or more properties
of the sample, particularly with the sensor apparatus of the
cartridge.
[0060] An assay, test or test procedure according to the present
invention preferably starts or begins with the analysis device
acting on and/or controlling processes on the cartridge and/or the
sample. In particular, a test starts or begins with actuators
acting on the cartridge. For example, a test can start with
conveying the sample within the cartridge.
[0061] Methods and/or steps performed before insertion or receiving
of the cartridge into/by the analysis device and/or before
conveying, treating and/or preparing the sample within said
cartridge are preferably not part of an assay, test or test
procedure according to the present invention.
[0062] The "piece of control information", thus, preferably is
configured to carry out such an assay, test or test procedure or to
enable the analysis system or the analysis device to carry out such
an assay, test or test procedure. Preferably, said piece of control
information is configured to control or to define a control
sequence or to be used by the analysis device to carry out said
assay, test or test procedure. A "piece of control information",
thus, preferably has instructions being configured for controlling
the assay, test or test procedure. In particular, the piece of
control information is configured to control an assay, test or test
procedure by defining steps or parameters of steps including
controlling and/or feedback controlling actuators like the pump
drive, the temperature control apparatus and valve actuators.
[0063] The term "piece of evaluation information" is preferably
understood to mean one or more data sets, files or other units that
are provided and suitable for evaluating measurement results,
preferably from the sensor arrangement. For this purpose, the piece
of evaluation information and/or data sets, files or other units in
particular comprise instructions, algorithms, assignment means
and/or parameters for carrying out the evaluation, in particular by
means of computational operations, for example using a processor or
controller.
[0064] If herein reference is made to different pieces of
evaluation information, these are particularly preferably different
data sets, files or other units that are preferably designed to
carry out different evaluation processes. Selecting particular
pieces of evaluation information therefore preferably corresponds
to selecting one or more of the different data sets, files or other
units. If required, the term "piece of evaluation information" or
"pieces of evaluation information" can therefore be substituted
with one or more of the terms or the expression "data sets, files
and/or other units comprising one or more pieces of evaluation
information".
[0065] The term "analysis device" is preferably understood to mean
an instrument which is in particular mobile, can be used on site,
is supplied with energy by an internal energy storage means and/or
is autonomous, and is designed to chemically, biologically and/or
physically test and/or analyze a sample or a component thereof,
preferably in and/or by means of a cartridge. In particular, the
analysis device controls the pretreatment and/or testing of the
sample in the cartridge. For this purpose, the analysis device can
act on the cartridge, in particular such that the sample is
conveyed, temperature-controlled and/or measured in the
cartridge.
[0066] The term "cartridge" is preferably understood to mean a
structural apparatus or unit designed to receive, to store, to
physically, chemically and/or biologically treat and/or prepare
and/or to measure a sample, preferably in order to make it possible
to detect, identify or determine at least one analyte, in
particular a protein and/or a nucleic-acid sequence, of the
sample.
[0067] A cartridge within the meaning of the present invention
preferably comprises a fluid system having a plurality of channels,
cavities and/or valves for controlling the flow through the
channels and/or cavities.
[0068] In particular, within the meaning of the present invention,
a cartridge is designed to be at least substantially planar, flat
and/or card-like, in particular is designed as a (micro)fluidic
card and/or is designed as a main body or container that can
preferably be closed and/or said cartridge can be inserted and/or
plugged into a proposed analysis device when it contains the
sample.
[0069] The term "operating instrument" is preferably understood to
mean an apparatus by means of which the analysis device can be
controlled, pieces of control information can be transmitted to the
analysis device, and/or measurement results can be received from
the analysis device and/or measurement results can be evaluated.
Preferably, the operating instrument is or forms a user interface
for controlling the test and/or the evaluation or outputting of
measurement results.
[0070] The operating instrument can alternatively be called
operator control instrument. The operating instrument preferably is
configured to be operated by an operator (user) for controlling, in
particular of the analysis device, the test and/or the evaluation.
Thus, the operating instrument is or comprises a user interface for
input of commands and transfer of pieces of control information to
the analysis device.
[0071] The operating instrument preferably comprises an input
apparatus for controlling the analysis device, for controlling data
transmission and/or for controlling the evaluation of measurement
results. Alternatively, or additionally, the operating instrument
comprises an output apparatus for outputting, in particular
displaying, information or pieces of information, in particular
(pieces of) status information, operating elements and/or results.
The operating instrument preferably comprises a processor,
microcontroller and/or memory for executing a computer program
product for data transmission, for control and/or for evaluating
measurement results.
[0072] Particularly preferably, the operating instrument is a
mobile terminal device, in particular for a radio and/or mobile
network, such as a smartphone, tablet computer, mobile telephone or
the like. The operating instrument can preferably be operated
independently from a power network, using a power storage means, in
particular a (rechargeable) battery, and in a mobile manner,
autonomously of and/or independently from further components of the
analysis system, in particular the analysis device. The operating
instrument preferably comprises one or more interfaces for wireless
data communications, in particular a WPAN communication interface,
a WLAN communication interface, a near-field communication
interface, an optical communication interface such as a camera,
and/or a mobile radio interface.
[0073] According to one aspect of the present invention, at least
one piece or certain pieces of the control information is/are
selected for carrying out the test. Alternatively, or additionally,
at least one piece or certain pieces of the evaluation information
is/are selected for carrying out the evaluation.
[0074] The analysis device can be provided with the selected piece
of control information and the analysis device can perform the
test, test procedure, test process or test sequence as defined by
the selected piece of control information, in particular to carry
out the steps with the analysis system to prepare, treat and/or
convey the sample according to said selected piece of control
information.
[0075] The selected piece of evaluation information preferably is
intended to be used for the evaluation of the measurement results
obtained with the test, test procedure, test process or test
sequence, in particular for conducting it or for controlling the
analysis system, in particular the operating instrument, to carry
out the evaluation as defined by the selected piece of evaluation
information.
[0076] Thus, the operating instrument can be provided with the
selected piece of evaluation information and the operating
instrument can perform the evaluation as defined by the selected
piece of evaluation information, in particular can carry out the
steps with the analysis system to compute or calculate according to
said selected piece of control evaluation results like presence
and/or concentration of one or multiple analytes from the
measurement results.
[0077] In the following, the term "piece of information" is used to
abbreviate the term "piece of control information and/or piece of
evaluation information". Further, the term "piece of information"
might cover different pieces of information like "piece of
calibration information". Thus, the term "piece of information"
might be replaced accordingly.
[0078] Selecting a piece of information (i.e., control or
evaluation information) preferably means or selection preferably is
conducted or covers that said piece of information is identified
among further pieces of information.
[0079] Preferably, a piece of information by selecting is marked,
for example using a flag. Alternatively, or additionally, selecting
a piece of information means or covers generating and/or receiving
a command, in particular a user command which can be initiated by a
user, transmitting the command, and/or using the command
corresponding to or identifying said piece of information. Using
this command, the piece of information can be retrieved, caused to
be transmitted, and/or used to perform the test, test sequence,
test procedure or test process or the evaluation.
[0080] However, according to one aspect of the present invention,
executing this command, retrieving the piece of information,
transmitting the piece of information, and/or using the piece of
information preferably is enabled and/or conducted only under
certain conditions, in particular, a verification and/or
unblocking.
[0081] Preferably there are blocked and unblocked pieces of
information provided, in particular stored in a database, and the
system is configured that only the unblocked pieces of information
are enabled, i.e., can be retrieved, transmitted, and/or used to
perform the test, test sequence, test procedure or test process or
evaluation.
[0082] The system further is preferably configured to disable,
i.e., prevent retrieval of pieces of information, transmission of
pieces of information and/or performing the test, test sequence,
test procedure or test or evaluation process with pieces of
information when said pieces of information are blocked. That is,
blocked pieces of information are disabled for retrieval and/or use
by the analysis system, while unblocked pieces of information are
enabled to be retrieved and/or used.
[0083] Preferably, different pieces of information are stored in a
database for the same cartridge and/or measurement results. In
other words, different pieces of control information, which are
configured to perform different tests, test sequences, test
procedures or test processes using the same cartridge or different
pieces of evaluation information which are configured to perform
different evaluations of the same measurement results, are stored
in the database.
[0084] Preferably, only certain ones of said pieces of information
stored in the database is or are enabled for retrieval provided
that the certain piece or pieces of information is/are compatible
and/or unblocked for a specific cartridge.
[0085] Alternatively, or additionally, the analysis system,
analysis device and/or operating instrument uses only the certain
pieces of information being enabled provided that the certain
pieces of information are unblocked and/or compatible to the
cartridge and/or measurement results. That is, preferably only
those pieces of information can be or are unblocked or unblockable
that are compatible with a specific cartridge or specific
measurement results, in particular measurement results of a
specific test using a specific cartridge.
[0086] Alternatively, or additionally, only certain ones of the
pieces of information stored in the database is or are enabled for
retrieval provided that a user, the operating instrument, the
analysis device and/or analysis system has a permission for the
certain piece or pieces of information. This permission can be
represented by a status or data like a flag or identifier of or
stored in the database or the piece of information.
[0087] Particularly preferably, only certain pieces of information
stored in the database is or are enabled for retrieval provided
that said certain ones of said certain pieces of information are
compatible with the cartridge and/or measurement results as well as
provided that a user, the operating instrument, the analysis device
and/or analysis system has a permission for the certain piece or
pieces of information. Each can be checked, preferably by the
database, before or in order to unblock a certain piece of
information.
[0088] According to this aspect, there are multiple pieces of
control information being stored in a data base and being
configured to control different tests, test sequences, test
processes or test procedures using the same cartridge. Some of
those stored pieces of control information are unblocked and, thus,
enabled for retrieval and/or to be used by the analysis device to
perform the test this piece of control information defines.
[0089] On the other hand, different of said multiple pieces of
control information being generally compatible with the same
cartridge and being stored in said data base as well, are blocked
and, thus, are prevented from being retrieved and/or used for a
test, test sequence, test procedure or test process.
[0090] Alternatively, or additionally, there are multiple pieces of
evaluation information being stored in a/the database and being
configured to define different evaluations/evaluation procedures
using the same measurement results. Some of those stored pieces of
evaluation information are unblocked and, thus, enabled for
retrieval and/or to be used to perform the evaluation this piece of
control information defines.
[0091] On the other hand, different pieces of evaluation
information being generally compatible with the same measurement
results and being stored in said database as well, are blocked and,
thus, are prevented from being retrieved and/or used for an
evaluation.
[0092] Pieces of information preferably are enabled for retrieval
according to the present invention when said pieces of information
are made available to be downloaded from the database, preferably
to be used for controlling a test, test sequence, test process or
test procedure and/or evaluation as defined by this piece of
information.
[0093] Using only certain pieces of information being enabled in
the sense of the present invention preferably means that the
analysis system or one or more of its components like the database,
the analysis device or the operating instrument is or are
configured to conduct a test, test sequence, test process or test
procedure or evaluation as defined by this piece of information
only under the condition that it is enabled/unblocked.
[0094] Enabled or enabled for retrieval preferably means that it is
not disabled or blocked. With other words, enabled means that
retrieval and/or use of a certain piece of information is supported
by the analysis system, i.e., the analysis system is configured to
directly use enabled certain pieces of information for controlling
a test, test sequence, test procedure or test process or for
evaluation of measurement results.
[0095] Pieces of control information generally can be blocked and
unblocked for a specific cartridge. This preferably means that
certain pieces of control information can be blocked, i.e.,
prevented to be retrieved and/or to be used for a test, test
process, test procedure or test sequence. On the other hand,
different pieces of control information can be unblocked in the
sense that retrieval or use for a test, test sequence, test process
or test procedure is enabled.
[0096] Pieces of evaluation information generally can be blocked
and unblocked for a measurement result and/or cartridge. This
preferably means that certain pieces of evaluation information can
be blocked, i.e., prevented to be retrieved and/or to be used for
evaluation. On the other hand, different pieces of evaluation
information can be unblocked in the sense that retrieval or use for
a test, test sequence, test process or test procedure is
enabled.
[0097] The status "blocked" and "unblocked" can be realized or
indicated by a flag or data assigned to the respective piece of
information. Means can be provided by or within the analysis system
to change the status that a certain piece of information is blocked
or unblocked. As soon as a certain piece of information is
unblocked--meaning changed from a blocked status to an unblocked
status, retrieval and use of it is enabled.
[0098] Blocking and unblocking, for example, can be realized by a
verification process. In particular, the status can change from
blocked to unblocked depending on confirmation of an identification
and/or of an entitlement.
[0099] Said entitlement can be a flag or data assigned to a user or
his verification means like an identification. Alternatively, or
additionally, said entitlement can be, relate to, correspond to or
depend on a specific cartridge or cartridge identifier or cartridge
identification.
[0100] The blocking or unblocking can depend or the analysis system
can be configured to control or change blocking or unblocking
depending on both, a cartridge and user identification.
[0101] Alternatively, or additionally, blocking or unblocking can
depend on or controlled under the condition that a cartridge has
specific properties and/or specific properties related to said
cartridge identify an entitlement to use a specific piece of
information which, accordingly, is unblocked.
[0102] This entitlement, blocking and/or unblocking preferably can
be changed or amended. For example, a user input, in particular via
the operating instrument, can automatically unblock a certain piece
of control information. A password, biometric or operating device
verification might be a condition for unblocking.
[0103] The analysis system can be configured to conduct unblocking
only under other and/or further conditions like compatibility of a
specific piece of control information to a specific or identified
cartridge, and/or further or different boundary conditions like
payment information. In particular, unblocking automatically
results in update of an account, in particular of a payment or
debit account, or in another payment or debit process or the system
is configured or a method is realized that this is a precondition
for or result caused by or coming along with unblocking.
[0104] The above-mentioned aspects and features of the present
invention and the aspects and features of the present invention
that will become apparent from the claims and the following
description can in principle be implemented independently from one
another, but also in any combination or order.
[0105] Other aspects, advantages, features and properties of the
present invention will become apparent from the following
description of a preferred embodiment with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0106] FIG. 1 is a schematic view of a proposed analysis system
and/or analysis device comprising a proposed cartridge received
therein;
[0107] FIG. 2 is a schematic view of the cartridge;
[0108] FIG. 3 is a schematic view of the analysis system; and
[0109] FIG. 4 shows a schematic sequence using the analysis
system.
DETAILED DESCRIPTION OF THE INVENTION
[0110] In the figures, which are only schematic and sometimes not
to scale, the same reference signs are used for the same or similar
parts and components, corresponding or comparable properties and
advantages being achieved even if these are not repeatedly
described.
[0111] FIG. 1 is a highly schematic view of a proposed analysis
system 1 and analysis device 200 for testing an in particular
biological sample P, preferably by means of or in an apparatus or
cartridge 100.
[0112] FIG. 2 is a schematic view of a preferred embodiment of the
proposed apparatus or cartridge 100 for testing the sample P. The
apparatus or cartridge 100 in particular forms a handheld unit, and
in the following is merely referred to as a cartridge.
[0113] The term "sample" is preferably understood to mean the
sample material to be tested, which is in particular taken from a
human or animal. In particular, within the meaning of the present
invention, a sample is a fluid, such as saliva, blood, urine or
another liquid, preferably from a human or animal, or a component
thereof. Within the meaning of the present invention, a sample may
be pretreated or prepared if necessary, or may come directly from a
human or animal or the like, for example. A food sample,
environmental sample or another sample may optionally also be
tested, in particular for environmental analytics, food safety
and/or for detecting other substances, preferably natural
substances, but also biological or chemical warfare agents, poisons
or the like.
[0114] Preferably, the analysis system 1 and/or analysis device 200
controls the testing of the sample P in particular in or on the
cartridge 100 and/or is used to evaluate the testing and/or to
collect, to process and/or to store measured values from the
test.
[0115] The analysis system 1 preferably comprises one or more
cartridges 100 for receiving the sample P.
[0116] The analysis system 1 preferably comprises the analysis
device 200 for receiving the cartridge 100 and subsequently
carrying out the test using the received cartridge 100.
[0117] By means of the proposed analysis system 1, analysis device
200 and/or cartridge 100 and/or using the proposed method for
testing the sample P, preferably an analyte A of the sample P, in
particular a (certain) nucleic-acid sequence and/or a (certain)
protein, or particularly preferably a plurality of analytes A of
the sample P, can be determined, identified or detected. Said
analytes A are in particular detected, identified and/or measured
not only qualitatively, but particularly preferably also
quantitatively.
[0118] Therefore, the sample P can in particular be tested for
qualitatively or quantitatively determining at least one analyte A,
for example in order for it to be possible to detect a disease
and/or pathogen or to determine other values, which are important
for diagnostics, for example.
[0119] Particularly preferably, a molecular-biological test is made
possible by means of the analysis system 1 and/or analysis device
200 and/or by means of the cartridge 100.
[0120] Particularly preferably, a nucleic-acid assay for detecting
a nucleic-acid sequence, in particular a DNA sequence and/or RNA
sequence, and/or a protein assay for detecting a protein, in
particular an antigen and/or antibody, are made possible or are
carried out.
[0121] Preferably, the sample P or individual components of the
sample P or analyte A can be amplified if necessary, in particular
by means of PCR, and tested, identified or detected in the analysis
system 1, analysis device 200 and/or in the cartridge 100, and/or
for the purpose of carrying out the nucleic-acid assay. Preferably,
amplification products of the analyte A or analytes A are thus
produced.
[0122] In the following, further details are first given on a
preferred construction of the cartridge 100, with features of the
cartridge 100 preferably also directly representing features of the
analysis system 1, in particular even without any further explicit
explanation.
[0123] The cartridge 100 is preferably at least substantially
planar, flat, plate-shaped and/or card-like.
[0124] The cartridge 100 preferably comprises an in particular at
least substantially planar, flat, plate-shaped and/or card-like
main body or support 101, the main body or support 101 in
particular being made of and/or injection-molded from plastics
material, particularly preferably polypropylene.
[0125] The cartridge 100 preferably comprises at least one film or
cover 102 for covering the main body 101 and/or cavities and/or
channels formed therein at least in part, in particular on the
front, and/or for forming valves or the like, as shown by dashed
lines in FIG. 2.
[0126] The analysis system 1 or cartridge 100 or the main body 101
thereof, in particular together with the cover 102, preferably
forms and/or comprises a fluidic system 103, referred to in the
following as the fluid system 103.
[0127] The cartridge 100, the main body 101 and/or the fluid system
103 are preferably at least substantially vertically oriented in
the operating position and/or during the test, in particular in the
analysis device 200, as shown schematically in FIG. 1. In
particular, the main plane or surface extension of the cartridge
100 thus extends at least substantially vertically in the operating
position.
[0128] The cartridge 100 and/or the fluid system 103 preferably
comprises a plurality of cavities, in particular at least one
receiving cavity 104, at least one metering cavity 105, at least
one intermediate cavity 106A-G, at least one mixing cavity 107, at
least one storage cavity 108, at least one reaction cavity 109A-C,
at least one intermediate temperature-control cavity 110 and/or at
least one collection cavity 111, as shown in FIG. 1 and FIG. 2.
[0129] The cartridge 100 and/or the fluid system 103 also
preferably comprises at least one pump apparatus 112 and/or at
least one sensor arrangement or sensor apparatus 113.
[0130] Some, most or all of the cavities are preferably formed by
chambers and/or channels or other depressions in the cartridge 100
and/or the main body 101, and particularly preferably are covered
or closed by the cover 102. However, other structural solutions are
also possible.
[0131] In the example shown, the cartridge 100 or the fluid system
103 preferably comprises two metering cavities 105, a plurality of
intermediate cavities 106A to 106G, a plurality of storage cavities
108A to 108E and/or a plurality of reaction cavities 109A-C, which
can preferably be loaded separately from one another, in particular
a first reaction cavity 109A, a second reaction cavity 109B and an
optional third reaction cavity 109C, as can be seen in FIG. 2.
[0132] The reaction cavity/cavities 109A-C is/are used in
particular to carry out an amplification reaction, in particular
PCR, or several, preferably different, amplification reactions, in
particular PCRs. It is preferable to carry out several, preferably
different, PCRs, i.e., PCRs having different primer combinations or
primer pairs, in parallel and/or independently and/or in different
reaction cavities 109A-C.
[0133] To carry out the nucleic-acid assay, preferably nucleic-acid
sequences, as analytes A of the sample P, are amplified in the
reaction cavity/cavities 109A-C by means of an amplification
reaction, in particular in order to produce amplification products
for the subsequent detection in the sensor arrangement or sensor
apparatus 113.
[0134] Within the meaning of the present invention, amplification
reactions are in particular molecular-biological reactions in which
an analyte A, in particular a nucleic-acid sequence, is
amplified/copied and/or in which amplification products, in
particular nucleic-acid products, of an analyte A are produced.
Particularly preferably, PCRs are amplification reactions within
the meaning of the present invention.
[0135] "PCR" stands for polymerase chain reaction and is a
molecular-biological method by means of which certain analytes A,
in particular portions of RNA or RNA sequences or DNA or DNA
sequences, of a sample P are amplified, preferably in several
cycles, using polymerases or enzymes, in particular in order to
then test and/or detect the amplification products or nucleic-acid
products. If RNA is intended to be tested and/or amplified, before
the PCR is carried out, a cDNA is produced starting from the RNA,
in particular using reverse transcriptase. The cDNA is used as a
template for the subsequent PCR.
[0136] Preferably, during a PCR, a sample P is first denatured by
the addition of heat in order to separate the strands of DNA or
cDNA. Preferably, primers or nucleotides are then deposited on the
separated single strands of DNA or cDNA, and a desired DNA or cDNA
sequence is replicated by means of polymerase and/or the missing
strand is replaced by means of polymerase. This process is
preferably repeated in a plurality of cycles until the desired
quantity of the DNA or cDNA sequence is available.
[0137] For the PCR, marker primers are preferably used, i.e.,
primers which (additionally) produce a marker or a label, in
particular biotin, on the amplified analyte A or amplification
product. This allows or facilitates detection. Preferably, the
primers used are biotinylated and/or comprise or form in particular
covalently bonded biotin as the label.
[0138] The amplification products and/or other portions of the
sample P produced in the one or more reaction cavities 109A-C can
be conducted or fed to the connected sensor arrangement or sensor
apparatus 113, in particular by means of the pump apparatus
112.
[0139] The sensor apparatus 113 is used in particular for
detecting, particularly preferably qualitatively and/or
quantitatively determining, the analyte A or analytes A of the
sample P, in this case particularly preferably the nucleic-acid
sequences and/or proteins as the analytes A. Alternatively, or
additionally, however, other values may also be collected or
determined.
[0140] As already explained at the outset, in particular
nucleic-acid sequences, preferably DNA sequences and/or RNA
sequences, and/or proteins, in particular antigens and/or
antibodies, are preferably qualitatively and/or quantitatively
determined as analytes A of the sample P. In the following,
however, a distinction is not made between nucleic-acid sequences
and proteins, or between the nucleic-acid assay for detecting
nucleic-acid sequences and the protein assay for detecting
proteins.
[0141] In particular, the pump apparatus 112 comprises or forms a
tube-like or bead-like raised portion, in particular by means of
the film or cover 102, particularly preferably on the back of the
cartridge 100, as shown schematically in FIG. 1.
[0142] The cartridge 100, the main body 101 and/or the fluid system
103 preferably comprise a plurality of channels 114 and/or valves
115A, 115B, as shown in FIG. 2.
[0143] By means of the channels 114 and/or valves 115A, 115B, the
cavities 104 to 111, the pump apparatus 112 and/or the sensor
arrangement and/or sensor apparatus 113 can be temporarily and/or
permanently fluidically interconnected and/or fluidically separated
from one another, as required and/or optionally or selectively, in
particular such that they are controlled by the analysis system 1
or the analysis device 200.
[0144] The cavities 104 to 111 are preferably each fluidically
linked or interconnected by a plurality of channels 114.
Particularly preferably, each cavity is linked or connected by at
least two associated channels 114, in order to make it possible for
fluid to fill, flow through and/or drain from the respective
cavities as required.
[0145] The fluid transport or the fluid system 103 is preferably
not based on capillary forces, or is not exclusively based on said
forces, but in particular is essentially based on the effects of
gravity and/or pumping forces and/or compressive forces and/or
suction forces that arise, which are particularly preferably
generated by the pump or pump apparatus 112. In this case, the
flows of fluid or the fluid transport and the metering are
controlled by accordingly opening and closing the valves 115A, 115B
and/or by accordingly operating the pump or pump apparatus 112, in
particular by means of a pump drive 202 of the analysis device
200.
[0146] Preferably, each of the cavities 104 to 110 has an inlet at
the top and an outlet at the bottom in the operating position.
Therefore, if required, only liquid from the respective cavities
can be removed via the outlet.
[0147] In the operating position, the liquids from the respective
cavities are preferably removed, in particular drawn out, via the
outlet that is at the bottom in each case, it preferably being
possible for gas or air to flow and/or be pumped into the
respective cavities via the inlet that is in particular at the top.
In particular, relevant vacuums in the cavities can thus be
prevented or at least minimized when conveying the liquids.
[0148] In particular, the cavities, particularly preferably the
storage cavity/cavities 108, the mixing cavity 107 and/or the
receiving cavity 104, are each dimensioned and/or oriented in the
normal operating position such that, when said cavities are filled
with liquid, bubbles of gas or air that may potentially form rise
upwards in the operating position, such that the liquid collects
above the outlet without bubbles. However, other solutions are also
possible here.
[0149] The receiving cavity 104 preferably comprises a connection
104A for introducing the sample P. In particular, the sample P may
for example be introduced into the receiving cavity 104 and/or
cartridge 100 via the connection 104A by means of a pipette,
syringe or other instrument.
[0150] The receiving cavity 104 preferably comprises an inlet 104B,
an outlet 104C and an optional intermediate connection 104D, it
preferably being possible for the sample P or a portion thereof to
be removed and/or conveyed further via the outlet 104C and/or the
optional intermediate connection 104D. Gas, air or another fluid
can flow in and/or be pumped in via the inlet 104B, as already
explained.
[0151] Preferably, the sample P or a portion thereof can be
removed, optionally and/or depending on the assay to be carried
out, via the outlet 104C or the optional intermediate connection
104D of the receiving cavity 104. In particular, a supernatant of
the sample P, such as blood plasma or blood serum, can be conducted
away or removed via the optional intermediate connection 104D, in
particular for carrying out the protein assay.
[0152] Preferably, at least one valve 115A, 115B is assigned to
each cavity, the pump apparatus 112 and/or the sensor apparatus 113
and/or is arranged upstream of the respective inlets and/or
downstream of the respective outlets.
[0153] Preferably, the cavities 104 to 111 or sequences of cavities
104 to 111, through which fluid flows in series or in succession
for example, can be selectively released and/or fluid can
selectively flow therethrough by the assigned valves 115A, 115B
being actuated, and/or said cavities can be fluidically connected
to the fluid system 103 and/or to other cavities.
[0154] In particular, the valves 115A, 115B are formed by the main
body 101 and the film or cover 102 and/or are formed in another
manner, for example by additional layers, depressions or the
like.
[0155] Particularly preferably, one or more valves 115A are
provided which are preferably tightly closed initially or in the
storage state, particularly preferably in order to seal liquids or
liquid reagents F, located in the storage cavities 108, and/or the
fluid system 103 from the open receiving cavity 104 in a
storage-stable manner.
[0156] Preferably, an initially closed valve 115A is arranged
upstream and downstream of each storage cavity 108. Said valves are
preferably only opened, in particular automatically, when the
cartridge 100 is actually being used and/or while inserting the
cartridge 100 into the analysis device 200 and/or for carrying out
the assay.
[0157] A plurality of valves 115A, in particular three valves in
this case, are preferably assigned to the receiving cavity 104, in
particular if the intermediate connection 104D is provided in
addition to the inlet 104B and the outlet 104C. Depending on the
use, in addition to the valve 115A at the inlet 104B, then
preferably only the valve 115A either at the outlet 104C or at the
intermediate connection 104D is opened.
[0158] The valves 115A assigned to the receiving cavity 104 seal
the fluid system 103 and/or the cartridge 100 in particular
fluidically and/or in a gas-tight manner until the sample P is
inserted and the receiving cavity 104 or a connection 104A of the
receiving cavity 104 is closed.
[0159] As an alternative or in addition to the valves 115A (which
are initially closed), one or more valves 115B are preferably
provided which are not closed in a storage-stable manner and/or
which are open initially and/or which can be closed by actuation.
These valves are used in particular to control the flows of fluid
during the test.
[0160] The cartridge 100 is preferably designed as a microfluidic
card and/or the fluid system 103 is preferably designed as a
microfluidic system. In the present invention, the term
"microfluidic" is preferably understood to mean that the respective
volumes of individual cavities, some of the cavities or all of the
cavities 104 to 111 and/or channels 114 are, separately or
cumulatively, less than 5 ml or 2 ml, particularly preferably less
than 1 ml or 800 .mu.l, in particular less than 600 .mu.l or 300
.mu.l, more particularly preferably less than 200 .mu.l or 100
.mu.l.
[0161] Particularly preferably, a sample P having a maximum volume
of 5 ml, 2 ml or 1 ml can be introduced into the cartridge 100
and/or the fluid system 103, in particular the receiving cavity
104.
[0162] Reagents and liquids which are preferably introduced or
provided before the test in liquid form as liquids or liquid
reagents F and/or in dry form as dry reagents S are required for
testing the sample P, as shown in the schematic view according to
FIG. 2 by reference signs F1 to F5 and S1 to S10.
[0163] Furthermore, other liquids F, in particular in the form of a
wash buffer, solvent for dry reagents S and/or a substrate, for
example in order to form detection molecules and/or a redox system,
are also preferably required for the test, the detection process
and/or for other purposes, and are in particular provided in the
cartridge 100, i.e., are likewise introduced before use, in
particular before delivery. At some points in the following, a
distinction is not made between liquid reagents and other liquids,
and therefore the respective explanations are accordingly also
mutually applicable.
[0164] The analysis system 1 or the cartridge 100 preferably
contains all the reagents and liquids required for pre-treating the
sample P and/or for carrying out the test or assay, in particular
for carrying out one or more amplification reactions or PCRs, and
therefore, particularly preferably, it is only necessary to receive
the optionally pretreated sample P.
[0165] The cartridge 100 or the fluid system 103 preferably
comprises a bypass 114A that can optionally be used, in order for
it to be possible, if necessary, to conduct or convey the sample P
or components thereof past the reaction cavities 109A-C and/or, by
bypassing the optional intermediate temperature-control cavity 110,
also directly to the sensor apparatus 113.
[0166] The cartridge 100, the fluid system 103 and/or the channels
114 preferably comprise sensor portions 116 or other apparatus for
detecting liquid fronts and/or flows of fluid.
[0167] It is noted that various components, such as the channels
114, the valves 115A, 115B, in particular the valves 115A that are
initially closed and the valves 115B that are initially open, and
the sensor portions 116 in FIG. 2 are, for reasons of clarity, only
labelled in some cases, but the same symbols are used in FIG. 2 for
each of these components.
[0168] The collection cavity 111 is preferably used for receiving
excess or used reagents and liquids and volumes of the sample,
and/or for providing gas or air in order to empty individual
cavities and/or channels.
[0169] In particular, the collection cavity 111 can optionally be
connected to individual cavities and channels or other apparatus
fluidically in order to remove reagents and liquids from said
cavities, channels or other apparatus and/or to replace said
reagents and liquids with gas or air. The collection cavity 111 is
preferably given appropriate large dimensions.
[0170] Once the sample P has been introduced into the receiving
cavity 104 and the connection 104A has been closed, the cartridge
100 can be inserted into and/or received in the proposed analysis
device 200 in order to test the sample P, as shown in FIG. 1.
Alternatively, the sample P could also be fed in later.
[0171] FIG. 1 shows the analysis system 1 in a ready-to-use state
for carrying out a test or assay on the sample P received in the
cartridge 100. In this state, the cartridge 100 is therefore linked
to, received by and/or inserted into the analysis device 200.
[0172] In the following, some features and aspects of the analysis
device 200 are first explained in greater detail, in particular on
the basis of FIG. 1. The features and aspects relating to said
device are preferably also directly features and aspects of the
proposed analysis system 1, in particular even without any further
explicit explanation.
[0173] The analysis system 1 or analysis device 200 preferably
comprises a mount or receptacle 201 for mounting and/or receiving
the cartridge 100.
[0174] Preferably, the cartridge 100 is fluidically, in particular
hydraulically, separated or isolated from the analysis device 200.
In particular, the cartridge 100 forms a preferably independent and
in particular closed or sealed fluidic or hydraulic system 103 for
the sample P and the reagents and other liquids. In this way, the
analysis device 200 does not come into direct contact with the
sample P and can in particular be reused for another test without
being disinfected and/or cleaned first.
[0175] It is however provided that the analysis device 200 can be
connected or coupled mechanically, electrically, thermally and/or
pneumatically to the cartridge 100.
[0176] In particular, the analysis device 200 is designed to have a
mechanical effect, in particular for actuating the pump apparatus
112 and/or the valves 115A, 115B, and/or to have a thermal effect,
in particular for temperature-controlling the reaction
cavity/cavities 109A-C and/or the intermediate temperature-control
cavity 110.
[0177] In addition, the analysis device 200 can preferably be
pneumatically connected to the cartridge 100, in particular in
order to actuate individual apparatus, and/or can be electrically
connected to the cartridge 100, in particular in order to collect
and/or transmit measured values, for example from the sensor
apparatus 113 and/or sensor portions 116.
[0178] The analysis system 1 or analysis device 200 preferably
comprises a pump drive 202, the pump drive 202 in particular being
designed for mechanically actuating the pump apparatus 112.
[0179] Preferably, a head of the pump drive 202 can be rotated in
order to rotationally axially depress the preferably bead-like
raised portion of the pump apparatus 112. Particularly preferably,
the pump drive 202 and pump apparatus 112 together form a pump, in
particular in the manner of a hose pump or peristaltic pump and/or
a metering pump, for the fluid system 103 and/or the cartridge
100.
[0180] Particularly preferably, the pump is constructed as
described in German Patent DE 10 2011 015 184 B4 and corresponding
U.S. Pat. No. 8,950,424. However, other structural solutions are
also possible.
[0181] Preferably, the capacity and/or discharge rate of the pump
can be controlled and/or the conveying direction of the pump and/or
pump drive 202 can be switched. Preferably, fluid can thus be
pumped forwards or backwards as desired.
[0182] The analysis system 1 or analysis device 200 preferably
comprises a connection apparatus 203 for in particular electrically
and/or thermally connecting the cartridge 100 and/or the sensor
arrangement or sensor apparatus 113.
[0183] As shown in FIG. 1, the connection apparatus 203 preferably
comprises a plurality of electrical contact elements 203A, the
cartridge 100, in particular the sensor arrangement or sensor
apparatus 113, preferably being electrically connected or
connectable to the analysis device 200 by the contact elements
203A.
[0184] The analysis system 1 or analysis device 200 preferably
comprises one or more temperature-control apparatus for
temperature-controlling the cartridge 100 and/or having a thermal
effect on the cartridge 100, in particular for heating and/or
cooling, the temperature-control apparatus(es) (each) preferably
comprising or being formed by a heating resistor or a Peltier
element.
[0185] Individual temperature-control apparatus, some of these
apparatus or all of these apparatus can preferably be positioned
against or abutted on the cartridge 100, the main body 101, the
cover 102, the sensor arrangement, sensor apparatus 113 and/or
individual cavities and/or can be thermally coupled thereto and/or
can be integrated therein and/or in particular can be operated or
controlled electrically by the analysis device 200. In the example
shown, in particular the temperature-control apparatus 204A-C are
provided.
[0186] Preferably, the temperature-control apparatus, referred to
in the following as the reaction temperature-control apparatus
204A, is assigned to one of the reaction cavities 109A-C or to a
plurality of reaction cavities 109A-C, in particular in order for
it to be possible to carry out one or more amplification reactions
therein.
[0187] The reaction cavities 109A-C are preferably
temperature-controlled simultaneously and/or uniformly, in
particular by means of one common reaction temperature-control
apparatus 204A or two reaction temperature-control apparatus
204A.
[0188] More particularly preferably, the reaction cavity/cavities
109A-C can be temperature-controlled from two different sides
and/or by means of two or the reaction temperature-control
apparatus 204A that are preferably arranged on opposite sides.
[0189] Alternatively, each reaction cavity 109A-C can be
temperature-controlled independently and/or individually.
[0190] The temperature-control apparatus, referred to in the
following as the intermediate temperature-control apparatus 204B,
is preferably assigned to the intermediate temperature-control
cavity 110 and/or is designed to (actively) temperature-control or
heat the intermediate temperature-control cavity 110 and/or a fluid
located therein, in particular the amplification products,
preferably to a preheat temperature.
[0191] The intermediate temperature-control cavity 110 and/or
intermediate temperature-control apparatus 204B is preferably
arranged upstream of or (immediately) before the sensor arrangement
or sensor apparatus 113, in particular in order for it to be
possible to temperature-control or preheat, in a desired manner,
fluids to be fed to the sensor arrangement or sensor apparatus 113,
in particular analytes A and/or amplification products,
particularly preferably immediately before said fluids are fed.
[0192] Particularly preferably, the intermediate
temperature-control cavity 110 or intermediate temperature-control
apparatus 204B is designed or provided to denature the sample P or
analytes A and/or the amplification products produced, and/or to
divide any double-stranded analytes A or amplification products
into single strands and/or to counteract premature bonding or
hybridizing of the amplification products, in particular by the
addition of heat.
[0193] Preferably, the analysis system 1, analysis device 200
and/or the cartridge 100 and/or one or each temperature-control
apparatus comprise/comprises a temperature detector and/or
temperature sensor (not shown), in particular in order to make it
possible to control and/or feedback control temperature.
[0194] One or more temperature sensors may for example be assigned
to the sensor portions 116 and/or to individual channel portions or
cavities, i.e., may be thermally coupled thereto.
[0195] The temperature-control apparatus 204C, referred to in the
following as the sensor temperature-control apparatus 204C, is in
particular assigned to the sensor apparatus 113 and/or is designed
to (actively) temperature-control or heat fluids located in or on
the sensor arrangement or sensor apparatus 113, in particular
analytes A and/or amplification products, reagents or the like, in
a desired manner, preferably to a hybridization temperature.
[0196] The sensor temperature-control apparatus 204C is preferably
planar and/or has a contact surface which is preferably rectangular
and/or corresponds to the dimensions of the sensor arrangement or
sensor apparatus 113, the contact surface allowing for heat
transfer between the sensor temperature-control apparatus 204C and
the sensor apparatus 113.
[0197] Preferably, the analysis device 200 comprises the sensor
temperature-control apparatus 204C. However, other structural
solutions are also possible in which the sensor temperature-control
apparatus 204C is integrated in the cartridge 100, in particular
the sensor arrangement or sensor apparatus 113.
[0198] Particularly preferably, the connection apparatus 203
comprises the sensor temperature-control apparatus 204C, and/or the
connection apparatus 203 together with the sensor
temperature-control apparatus 204C can be linked to, in particular
pressed against, the cartridge 100, in particular the sensor
arrangement or sensor apparatus 113.
[0199] More particularly preferably, the connection apparatus 203
and the sensor temperature-control apparatus 204C (together) can be
moved towards and/or relative to the cartridge 100, in particular
the sensor arrangement or sensor apparatus 113, and/or can be
positioned against said cartridge, preferably in order to both
electrically and thermally couple the analysis device 200 to the
cartridge 100, in particular the sensor arrangement or sensor
apparatus 113 or the support thereof.
[0200] Preferably, the sensor temperature-control apparatus 204C is
arranged centrally on the connection apparatus 203 or a support
thereof and/or is arranged between the contact elements 203A.
[0201] In particular, the contact elements 203A are arranged in an
edge region of the connection apparatus 203 or a support thereof or
are arranged around the sensor temperature-control apparatus 204C,
preferably such that the connection apparatus 203 is connected or
connectable to the sensor apparatus 113 thermally in the center and
electrically on the outside or in the edge region. However, other
solutions are also possible here.
[0202] The analysis system 1 or analysis device 200 preferably
comprises one or more valve actuators 205A, B for actuating the
valves 115A, 115B. Particularly preferably, different (types or
groups of) valve actuators 205A and 205B are provided which are
assigned to the different (types or groups of) valves 115A and 115B
for actuating each of said valves, respectively.
[0203] The analysis system 1 or analysis device 200 preferably
comprises a control apparatus 207 for controlling the sequence of a
test or assay and/or for collecting, evaluating and/or outputting
or providing measured values or measurement results 713, in
particular from the sensor apparatus 113, and/or test results
and/or other data or values.
[0204] The control apparatus 207 preferably comprises an internal
clock or time base by means of which the sequence of the test is or
can be controlled and/or by means of which test steps that follow
temporally one another or that extend over time are controlled or
can be controlled by the control apparatus 207.
[0205] The control apparatus 207 preferably controls or is designed
to control actuators of the analysis device 200 for acting on the
cartridge 100 in order to carry out the test. The actuators are in
particular the pump drive 202, the temperature-control apparatus
204 and/or the valve actuators 205A, B.
[0206] The analysis system 1 or analysis device 200 preferably
comprises one or more sensors 206A-H. In particular, fluid sensors
206A are designed or provided to detect liquid fronts and/or flows
of fluid in the fluid system 103. Particularly preferably, the
fluid sensors 206A are designed to measure or detect, for example
optically and/or capacitively, a liquid front and/or the presence,
the speed, the mass flow rate/volume flow rate, the temperature
and/or another value of a fluid in a channel and/or a cavity, in
particular in a respectively assigned sensor portion 116, which is
in particular formed by a planar and/or widened channel portion of
the fluid system 103.
[0207] The fluid sensor 206A preferably measures a fluid entering
or leaving the sensor portion 116 and/or a content change or fluid
change in the sensor portion 116, and in the process generates a
measurement result 706A that corresponds to the fluid entering, the
fluid leaving, the content change and/or the fluid change in the
sensor portion 116. This measurement result 706A from the fluid
sensor 206A can be retrieved by the control apparatus 207 and/or
transmitted to the control apparatus 207. The control apparatus 207
controls or is designed to control the test and/or the actuators,
preferably using or taking into account the measurement result 706A
from the fluid sensor 206A. In particular, when a content change,
an entering fluid, a leaving fluid and/or a fluid change is
detected in the sensor portion 116, in particular when a liquid
front is detected, the control apparatus 207 influences a program
sequence. In this case, for example a check can be carried out or a
subsequent step of the test can be controlled, in particular by
activating the actuators in a particular and/or differing
manner.
[0208] Particularly preferably, the sensor portions 116 are each
oriented and/or incorporated in the fluid system 103 and/or fluid
flows against or through the sensor portions 116 such that, in the
operating position of the cartridge 100, fluid flows through the
sensor portions 116 in the vertical direction and/or from the
bottom to the top, or vice versa, in particular in order to make it
possible or easier to accurately detect liquid.
[0209] Alternatively, or additionally, the analysis device 200
preferably comprises one or more (different, other and/or further)
sensors 206B.
[0210] Preferably, the other sensor 206B is or comprises a pressure
sensor for determining the (relative) air pressure. The other
sensor 206B can generate a measurement result 706B, which
corresponds in particular to the air pressure. This measurement
result 706B can be retrieved by the control apparatus 207 and/or
transmitted to the control apparatus 207. The control apparatus 207
controls or is designed to control the test and/or the actuators,
preferably using or taking into account the measurement result 706B
from the other sensor 206B.
[0211] Alternatively, or additionally, one or more temperature
sensors 206C are provided for detecting the internal temperature
and/or the temperature in the interior space 212A of the analysis
device 200, in particular the temperature of an atmosphere in the
interior space 212A. Alternatively, or additionally, one or more
temperature sensors 206C are provided for detecting the ambient
temperature and/or the temperature of an atmosphere surrounding the
analysis device 200 and/or the temperature of one or more of the
temperature apparatus.
[0212] The temperature sensor 206C preferably measures a
temperature, in particular of the interior space 212A of the
analysis device 200, and in the process generates a measurement
result 706C that corresponds to the temperature, in particular of
the interior space 212A and/or atmosphere of or parts of the
interior space 212A. This measurement result 706C from the
temperature sensor 206C can be retrieved by the control apparatus
207 and/or transmitted to the control apparatus 207. The control
apparatus 207 controls or is designed to control the test and/or
the actuators, preferably using or taking into account the
measurement result 706C from the temperature sensor 206C.
[0213] The analysis device 200 preferably comprises a tilt sensor
206D for detecting the inclination and/or orientation of the
analysis device 200 and/or of the cartridge 100. The tilt sensor
206D is in particular designed and set up to determine the
inclination of the analysis device 200 and/or of the cartridge 100
that differs from that in an operating position.
[0214] The tilt sensor 206D preferably measures the inclination,
and in the process generates a measurement result 706D that
corresponds to the inclination of the analysis device 200 and/or of
the cartridge 100. This measurement result 706D from the tilt
sensor 206D can be retrieved by the control apparatus 207 and/or
transmitted to the control apparatus 207. The control apparatus 207
controls or is designed to control the test and/or the actuators,
preferably using or taking into account the measurement result 706D
from the tilt sensor 206D. In particular, if the inclination is too
great, the test is prevented, blocked or interrupted, and/or an
error is identified, processed, transmitted and/or signaled.
[0215] The analysis device 200 may comprise an acceleration sensor
206E. The acceleration sensor 206E is preferably designed to
determine an acceleration of the analysis device 200, in particular
an acceleration in the vertical and/or horizontal direction with
respect to the operating position.
[0216] The acceleration sensor 206E preferably measures the
acceleration, and in the process generates a measurement result
706E that corresponds to the acceleration of the analysis device
200 and/or of the cartridge 100. This measurement result 706E from
the acceleration sensor 206E can be retrieved by the control
apparatus 207 and/or transmitted to the control apparatus 207. The
control apparatus 207 controls or is designed to control the test
and/or the actuators, preferably using or taking into account the
measurement result 706E from the acceleration sensor 206E. In
particular, if the acceleration is too great, the test is
prevented, blocked or interrupted, and/or an error is identified,
processed, transmitted and/or signaled.
[0217] The analysis device 200 may comprise a humidity sensor 206F
for determining the (relative) atmospheric humidity and/or the dew
point of the atmosphere inside or in the interior space 212A and/or
outside the analysis device 200.
[0218] The humidity sensor 206F preferably measures the (relative)
atmospheric humidity and/or the dew point, and in the process
generates a measurement result 706F that corresponds to the
(relative) atmospheric humidity and/or the dew point of the
atmosphere in the analysis device 200 and/or the surroundings of
the analysis device 200. This measurement result 706F from the
humidity sensor 206F can be retrieved by the control apparatus 207
and/or transmitted to the control apparatus 207. The control
apparatus 207 controls or is designed to control the test and/or
the actuators, preferably using or taking into account the
measurement result 706F from the humidity sensor 206F. In
particular, if the (relative) atmospheric humidity is too high
and/or if the dew point is approached or reached, the test is
prevented, blocked or interrupted, and/or an error is identified,
processed, transmitted and/or signaled.
[0219] The analysis device 200 may comprise a position sensor 206G
for determining the position or location, for example by means of a
GPS sensor. The position sensor 206G is preferably designed to
determine the location of the analysis device 200 in space, in
particular on the Earth's surface, and/or to output the
geographical position, the location and/or the coordinates of the
analysis device 200.
[0220] The position sensor 206G preferably measures the position,
in particular the geographical position, of the analysis device
200, and in the process generates a measurement result 706G that
corresponds to the position or geographical position. This
measurement result 706G from the position sensor 206G can be
retrieved by the control apparatus 207 and/or transmitted to the
control apparatus 207. The control apparatus 207 controls or is
designed to control the test and/or the actuators, preferably using
or taking into account the measurement result 706G from the
position sensor 206G.
[0221] The analysis device 200 may comprise a cartridge sensor 206H
for determining or checking the position or alignment of the
cartridge 100 in or with respect to the analysis device 200. In
particular, the cartridge sensor 206H is designed to detect an
incorrect position of the cartridge 100 in the analysis device 200.
Alternatively, or additionally, the cartridge sensor 206H is
designed to detect and/or verify the correct and/or operating
position of the cartridge 100 in the analysis device 200.
[0222] The cartridge sensor 206H preferably measures the position
of the cartridge 100 in the analysis device 200, and in the process
generates a measurement result 706H that corresponds to the
position or alignment of the cartridge 100 in the analysis device
200. This measurement result 706H from the cartridge sensor 206H
can be retrieved by the control apparatus 207 and/or transmitted to
the control apparatus 207. The control apparatus 207 controls or is
designed to control the test and/or the actuators, preferably using
or taking into account the measurement result 706H from the
cartridge sensor 206H. In particular, if the cartridge 100 is
incorrectly positioned in the analysis device 200, the test is
prevented or blocked and/or the cartridge 100 is automatically
ejected from the analysis device 200 or the like. Alternatively, or
additionally, the test is enabled if it is detected that the
cartridge 100 is in the correct operating position in the analysis
device 200.
[0223] The control apparatus 207 preferably controls or feedback
controls the pump drive 202, the temperature-control apparatus 204
and/or the valve actuators 205, in particular taking into account
or depending on the desired test and/or measured values from the
sensor arrangement or sensor apparatus 113 and/or sensors
206A-H.
[0224] The flows of fluid are controlled in particular by
accordingly activating the pump or pump apparatus 112 and actuating
the valves 115A, 115B.
[0225] Particularly preferably, the pump drive 202 comprises a
stepper motor, or a drive calibrated in another way, such that
desired metering can be achieved, at least in principle, by means
of appropriate activation.
[0226] Additionally, or alternatively, the fluid sensors 206A are
used to detect liquid fronts or flows of fluid, in particular in
cooperation with the assigned sensor portions 116, in order to
achieve the desired fluidic sequence and the desired metering by
accordingly controlling the pump or pump apparatus 112 and
accordingly activating the valves 115A, 115B.
[0227] Optionally, the analysis system 1 or analysis device 200
comprises an input apparatus 208, such as a keyboard, a touch
screen or the like, and/or a display apparatus 209, such as a
screen.
[0228] The analysis system 1 or analysis device 200 preferably
comprises at least one interface 210, for example for controlling,
for communicating and/or for outputting measured data or test
results and/or for linking to other devices, such as a printer, an
external power supply or the like. This may in particular be a
wired or wireless interface 210.
[0229] The analysis system 1 or analysis device 200 preferably
comprises a power supply 211, preferably a battery or an
accumulator, which is in particular integrated and/or externally
connected or connectable.
[0230] Preferably, an integrated accumulator is provided as a power
supply 211 and can be (re)charged by an external charging device
(not shown) via a connection 211A and/or is interchangeable.
[0231] The analysis system 1 or analysis device 200 preferably
comprises a housing 212, all the components and/or some or all of
the apparatus preferably being integrated in the housing 212.
Particularly preferably, the cartridge 100 can be inserted or slid
into the housing 212, and/or can be received by the analysis device
200, through an opening 213 which can in particular be closed, such
as a slot or the like.
[0232] The analysis system 1 or analysis device 200 is preferably
portable or mobile. Particularly preferably, the analysis device
200 weighs less than 25 kg or 20 kg, particularly preferably less
than 15 kg or 10 kg, in particular less than 9 kg or 6 kg.
[0233] The fluidic, in particular pneumatic, coupling between the
cartridge 100 and the analysis device 200 will be explained in
greater detail in the following, it being possible for the
following aspects to be implemented independently from the
preceding aspects.
[0234] As already explained, the analysis device 200 can preferably
be pneumatically linked to the cartridge 100, in particular to the
sensor arrangement or sensor apparatus 113 and/or to the pump
apparatus 112.
[0235] Particularly preferably, the analysis device 200 is designed
to supply the cartridge 100, in particular the sensor arrangement
or sensor apparatus 113 and/or the pump apparatus 112, with a
working medium, in particular gas or air.
[0236] Preferably, the working medium can be compressed and/or
pressurized in the analysis device 200 or by means of the analysis
device 200.
[0237] Preferably, the analysis device 200 comprises a pressurized
gas supply 214 for this purpose, in particular a pressure generator
or compressor, preferably in order to compress and/or pressurize
the working medium.
[0238] The pressurized gas supply 214 is preferably integrated in
the analysis device 200 or the housing 212 and/or can be controlled
or feedback controlled by means of the control apparatus 207. The
pressurized gas supply 214 can also, at least in part, be formed on
or by the cartridge 100.
[0239] Preferably, the pressurized gas supply 214 is electrically
operated or can be operated by electrical power. In particular, the
pressurized gas supply 214 can be supplied with electrical power by
means of the power supply 211.
[0240] The analysis device 200 or pressurized gas supply 214 is
preferably designed to compress the working medium to a pressure of
more than 100 kPa, particularly preferably more than 150 kPa or 250
kPa, in particular more than 300 kPa or 350 kPa, and/or of less
than 1 MPa, particularly preferably less than 900 kPa or 800 kPa,
in particular less than 700 kPa and/or to feed said medium to the
cartridge 100 at said pressure.
[0241] Preferably, air can be drawn in, in particular from the
surroundings, as the working medium by means of the analysis device
200 or pressurized gas supply 214. In particular, the analysis
device 200 or pressurized gas supply 214 is designed to use the
surroundings as a reservoir for the working medium or the air.
However, other solutions are also possible here, in particular
those in which the analysis device 200 or pressurized gas supply
214 comprises a preferably closed or delimited reservoir, such as a
tank or container, comprising the working medium, and/or is
connected or connectable thereto.
[0242] Preferably, the analysis device 200 or pressurized gas
supply 214 comprises an inlet, the working medium in particular
being able to be drawn in and/or conducted in the pressurized gas
supply 214 via the inlet.
[0243] Preferably, the analysis device 200 or pressurized gas
supply 214 comprises a filter, the filter preferably being
integrated in the inlet and/or it preferably being possible for the
working medium to be filtered by means of the filter and/or it
preferably being possible for particles to be separated from the
working medium by means of the filter.
[0244] The filter is preferably designed as a micro filter or as a
fine particulate air filter. Preferably, particles having a
particle diameter of more than 10 .mu.m, particularly preferably
more than 8 .mu.m or 9 .mu.m, in particular more than 6 .mu.m or 7
.mu.m, more particularly preferably more than 4 .mu.m or 5 .mu.m,
can be separated by means of the filter, the particle diameter
preferably being the maximum or average diameter of the respective
particles. This ensures that the channels or lines in the cartridge
that convey the working medium do not become contaminated or
clogged and/or that no undesired pressure loss occurs.
[0245] The analysis device 200 or pressurized gas supply 214
preferably comprises a connection element 214A, in particular in
order to pneumatically connect the analysis device 200 and/or
pressurized gas supply 214 to the cartridge 100.
[0246] FIG. 3 is a schematic view of the proposed analysis system 1
for testing an in particular biological sample P, comprising the
analysis device 200 for receiving the cartridge 100 and
subsequently carrying out the test using the received cartridge
100, and an operating instrument 400 for the analysis device
200.
[0247] The operating instrument 400 is preferably designed to
control the analysis device 200. Alternatively, or additionally,
the operating instrument 400 can receive or retrieve (pieces of)
information, in particular (measurement) results such as measured
values, from the analysis device 200. In particular, the operating
instrument 400 is a mobile terminal device such as a smartphone, a
tablet or the like.
[0248] The operating instrument 400 is preferably implemented or
provided so as to be physically separated from the analysis device
200. The operating instrument 400 can preferably be separated
and/or disconnected from the analysis device 200 physically and/or
with respect to a data connection.
[0249] The operating instrument 400 can preferably be wirelessly
connected to the analysis device 200. A data connection DVA can
thus be established between the analysis device 200 and the
operating instrument 400. However, the data connection DVA can in
principle also be established in another manner, for example
wired.
[0250] It is preferable for the operating instrument 400 to also be
operational when separated or disconnected from the analysis device
200, in particular for carrying out evaluations or for other
purposes. Alternatively, or additionally, the analysis device 200
is also operational when separated or disconnected from the
operating instrument 400, in particular for continuing a test.
[0251] Particularly preferably, the operating instrument 400
comprises an interface 430 for establishing data connections DVA,
DVB, DVD.
[0252] The interface 430 and/or the operating instrument 400 in
particular comprises what is referred to as an analysis device
interface 431 that is designed to establish the preferably wireless
data connection DVA to the analysis device 200. This can, for
example, be a radio interface, WPAN interface, Bluetooth interface
and/or a Bluetooth module or the like.
[0253] The interface 210 of the analysis device 200 preferably
corresponds to the interface 430 and/or the analysis device
interface 431 of the operating instrument 400, in particular such
that the data connection DVA between the operating instrument 400
and the analysis device 200 can be established. The interface 210
of the analysis device 200 and the analysis device interface 431
preferably support the same data transmission method and/or radio
transmission method or radio standard, in particular WLAN or WPAN
methods such as Bluetooth, NFC, Zigbee or the like.
[0254] Particularly preferably, the interface 210 of the analysis
device 200 and the analysis device interface 431 make possible or
facilitate what is known as an ad-hoc connection. In this case, the
data connection DVA is established preferably automatically when
the devices, i.e., the operating instrument 400 and the analysis
device 200, are within range of one another. In other words, the
operating instrument 400 and the analysis device 200 each comprise
a wireless data interface 430, 210, respectively, which are
designed to jointly establish an ad-hoc data connection between the
operating instrument 400 and the analysis device 200, preferably
such that, when the operating instrument 400 and the analysis
device 200 approach one another in space, the data connection DVA
therebetween is automatically established and is preferably
displayed by means of the operating instrument 400.
[0255] The data connection DVA is preferably a point-to-point
connection. The data connection DVA connects the analysis device
200 to the operating instrument 400 preferably directly and/or
without any interposed networks. It is possible for the operating
instrument 400 to establish data connections DVA to different
analysis devices 200 simultaneously or in succession.
Alternatively, or additionally, it is possible for one analysis
device 200 to establish data connections DVA to a plurality of
operating instruments 400 simultaneously or in succession.
[0256] In order to control the test, it is preferable for precisely
one data connection DVA to be provided between the analysis device
200 to be controlled and the operating instrument 400 controlling
the analysis device 200, and/or for a piece or pieces of control
information 510 to be received and/or accepted or to be acceptable
and/or receivable and/or for measurement results 713 to be
transmitted or to be transmittable only via precisely one data
connection DVA between the analysis device 200 to be controlled and
the operating instrument 400 controlling the analysis device
200.
[0257] The analysis device 200 preferably comprises a receiver 210A
for, preferably wirelessly, receiving the piece/pieces of control
information 510 from the operating instrument 400. Preferably, the
interface 210 comprises the receiver 210A, via which signals, in
particular pieces of control information 510, are or can be
received from the operating instrument 400.
[0258] Alternatively, or additionally, the analysis device 200
and/or the interface 210 comprises a transmitter 210B, via which
data, in particular results such as measurement results 713 from
the sensor apparatus 113, are or can be sent, particularly
preferably to the operating instrument 400.
[0259] The interfaces 210, 431 preferably correspond to one another
such that they support the same data transmission standard and/or
radio standard, in particular Bluetooth, WLAN or the like. These
interfaces are particularly preferably interfaces 210, 431 which
make possible what is known as an ad-hoc connection, the data
connection DVA preferably being established automatically when the
devices, i.e., the operating instrument 400 and the analysis device
200, are within range of one another.
[0260] The analysis system 1 preferably further comprises a
database 500 or the database 500 is assigned to the analysis system
1. The database 500 is preferably an external database 500 that is
implemented or provided so as to be physically separated from the
operating instrument 400 and/or from the analysis device 200. In
principle, however, it is not impossible for the database 500 to be
provided or implemented such that it can be directly linked, in
particular to the operating instrument 400, or to be provided or
implemented by the operating instrument 400.
[0261] The operating instrument 400 can access the database 500 via
a data connection DVD. For this purpose, the operating instrument
400 and/or the interface 430 can comprise a database interface 432
by means of which the database 500 can be accessed, in particular
via a network N. The network N may be the Internet or another data
network. It is also preferable for the operating instrument 400 to
be able to establish the data connection DVD to the database 500
via a wireless interface, in particular WLAN, WPAN, mobile
communications or the like. However, in principle, other solutions
are also possible here.
[0262] Particularly preferably, the operating instrument 400
comprises different interfaces 430 that are independent of one
another for establishing data connections DVA, DVD to the analysis
device 200 and to the database 500, the analysis device 200 (as a
peripheral device of the operating instrument 400) being designed
to communicate exclusively with or via the operating instrument
400.
[0263] The analysis system 1, in particular the database 500,
preferably comprises pieces of control information 510 by means of
which the analysis device 200 can be controlled in order to carry
out a test.
[0264] The pieces of control information 510 preferably define the
actuation of the actuators of the analysis device 200 in a
particular manner, such that the sample P is tested in the
cartridge 100. In particular, actuators for carrying out the test
can be or are controlled using a piece or pieces of control
information 510 such that said actuators act on the cartridge 100
and/or the sample P. These actuators are in particular the pump
drive 202 and/or one or more temperature-control apparatus 204
and/or one or more valve actuators 205. The piece/pieces of control
information 510 preferably comprises/comprise parameters and/or
instructions for carrying out one or more steps of the method for
testing the sample P explained above.
[0265] Preferably, the analysis system 1 comprises pieces
calibration information 520 that can be stored in the database 500
and/or can be retrieved from the database 500. The pieces of
calibration information 520 are preferably capable of influencing
the test of the sample P, in particular depending on the specific
cartridge 100, on a cartridge batch of the specific cartridge 100
and/or on the specific test.
[0266] The pieces of calibration information 520 are in particular
default or basic settings, parameters and/or threshold values for
sensors such as the sensor apparatus 113 of the cartridge 100, for
one or more of the sensor(s) 206A-H of the analysis device 200
and/or for one or more of the actuators.
[0267] Pieces of calibration information 520 can be used in
addition to pieces of control information 510 for carrying out the
test, the pieces of calibration information 520 preferably
influencing or specifying the pieces of control information 510.
The pieces of calibration information 520 can be or can form the
pieces of control information 510 or a part of the pieces of
control information, even if this is not explicitly mentioned in
the following.
[0268] The analysis device 200 can be calibrated and/or configured
by pieces of calibration information 520 that can form part of the
pieces of control information 510 or can be provided separately.
For this purpose, the pieces of calibration information 520 can be
determined, retrieved and/or transmitted to the analysis device 200
by means of the operating instrument 400.
[0269] In one example, pieces of fluid sensor calibration
information 521 are provided which influences setting and/or
evaluation of the fluid sensor 206A. The pieces of fluid sensor
calibration information 521 are preferably dependent on the test to
be carried out, the phase of the test and/or expected effects of a
content change in a sensor portion 116 during the test sequence,
and/or contain various specifications which are dependent
thereon.
[0270] Alternatively, or additionally, pieces of tilt sensor
calibration information 524 can be provided, preferably comprising
one or more threshold values 525, in particular a start threshold
value 526 for blocking the start of a test if said threshold value
is exceeded, and/or an interruption threshold value 527 for
interrupting the test and/or for processing errors if said
threshold is exceeded.
[0271] Alternatively, or additionally, pieces of sensor arrangement
calibration information 528 can be provided, by means of which
properties of the sensor arrangement 113 or sensor apparatus 113
are or can be set. In particular, it is provided that the pieces of
sensor arrangement calibration information 528 are transmitted or
can be transmitted to the sensor arrangement 113 or sensor
apparatus 113 by the analysis device 200, and that the sensor
arrangement 113 or sensor apparatus 113 carries out or is designed
to carry out a measurement taking into account the pieces of sensor
arrangement calibration information 528.
[0272] The proposed analysis system 1 preferably comprises pieces
of evaluation information 530 which are stored in the database 500
and/or are retrievable or can be retrieved from the database 500.
The pieces of evaluation information 530 are preferably designed to
be able to interpret measurement results 713 that originate from
the cartridge 100, in particular from the sensor apparatus 113.
[0273] The pieces of control information 510 and/or evaluation
information 530 particularly preferably comprise instructions,
preferably in the form of an algorithm and/or for controlling a
process on or using a processor or controller. The instructions
preferably form a module that can be or is implemented by the
analysis device 200 and/or the operating instrument 400, as a
result of which the behavior of the analysis device 200 and/or the
operating instrument 400 can be or is changed.
[0274] The instructions are in particular commands, machine code,
pre-compiled source code or source code. The instructions
preferably form a module-like software component, in particular a
plugin. The instructions can be designed to form and/or to replace
a module of the operating instrument 400 and/or of the analysis
device 200. For this purpose, the pieces of control information 510
and/or the pieces of evaluation information 530 can comprise a
(software) interface for coupling or implementation by the control
apparatus 207 and/or an evaluation module 440 of the operating
instrument 400.
[0275] The piece/pieces of control information 510 particularly
preferably comprises/comprise or forms/form a module of the control
apparatus 207 that can be exchanged, preferably in terms of
software. This module preferably contains instructions such as
logic commands, loops and the like for controlling the test, in
particular in the form of a computer program or computer program
product to be executed by the analysis device 200 and/or the
control apparatus 207. The piece/pieces of control information 510
can be or form, in particular as a plugin, an exchangeable part of
the control apparatus 207.
[0276] An evaluation module 440 is preferably formed by the
operating instrument 400 or the operating instrument 400 comprises
the evaluation module 440. By means of the evaluation module 440,
measurement results 713 read out from the sensor apparatus 113 are
evaluated preferably using the piece/pieces of evaluation
information 530 retrieved from the database 500 and/or the
evaluation module 440 is designed for this purpose.
[0277] The piece/pieces of evaluation information 530 particularly
preferably comprises/comprise or forms/form a module of the
evaluation apparatus 440 that can be exchanged, preferably in terms
of software. This module preferably contains instructions such as
logic commands, loops and the like for controlling the evaluation
of measurement results 713, in particular in the form of a computer
program or computer program product to be executed by the operating
instrument 400 and/or the evaluation module 440. The piece/pieces
of evaluation information 530 can be or form, in particular as a
plugin, an exchangeable part of the evaluation module 440.
[0278] Alternatively, or additionally, the instructions can
comprise parameters for configuring the control apparatus 207
and/or the evaluation module 440. These parameters are preferably
provided in addition to the instructions, for example for the
analysis device 200, in the form of or comprising the pieces of
calibration information 520. Alternatively, the pieces of control
information 510 and/or pieces of evaluation information 530 can
however also merely comprise parameters and/or other information
for the control and/or evaluation.
[0279] The database 500 preferably comprises a results memory 550
in which results can be stored and/or saved.
[0280] Within the meaning of the present invention, the term
"database" should preferably be understood in a broad sense and
also incorporates multi-part databases in particular. Therefore, in
principle, the database 500 can be provided in different physical
units or at different locations and/or can be composed of a
plurality of sub-databases.
[0281] The operating instrument 400 can preferably be separated or
disconnected from the analysis device 200 with respect to a data
connection and/or physically. For this purpose, the analysis device
200 can initially be connected to the operating instrument 400 with
respect to a data connection by the data connection DVA being
established.
[0282] In order to control the test and/or the analysis device 200,
the operating instrument 400 can retrieve pieces of control
information 510 from the database 500 and transmit said pieces of
information to the analysis device 200 in unaltered or altered
form.
[0283] The operating instrument 400 is preferably designed to
evaluate measurement results 713 which can preferably be generated
by the sensor apparatus 113 of the cartridge 100 while the sample P
is being tested. For this purpose, it is provided that measurement
results 713 which can originate from a sensor apparatus 113 of the
cartridge 100 and/or which can be transmitted from the analysis
device 200 to the operating instrument 400, are or can be evaluated
in the operating instrument 400. For this purpose, the operating
instrument 400 can retrieve or receive the pieces of evaluation
information 530 from the database 500 and, using this pieces of
evaluation information 530, evaluate the measurement results 713,
in particular in the evaluation module 440 of the operating
instrument 400.
[0284] The operating instrument 400 preferably comprises a memory
450. The memory 450 can be used to store, at least temporarily,
pieces of control information 510, calibration information 520
and/or evaluation information 530, or the operating instrument 400
and the memory 450 can be designed for this purpose. Alternatively,
or additionally, evaluation results 740, that have been or can be
generated from the measurement results 713 by means of the
operating instrument 400, can be stored in the memory 450.
[0285] In one example, the operating instrument 400 comprises an
output apparatus 410, preferably an in particular touch-sensitive
screen or display 411 and/or a speaker 412. Alternatively, or
additionally, the operating instrument 400 comprises an input
apparatus 420, in particular a camera 421, a touchpad 422, a
microphone 423 and/or a keyboard 424.
[0286] The operating instrument 400 is preferably designed to
display an operating interface or a user interface via the output
apparatus 410, in particular the screen or display 411, or to
provide in another way operating elements for controlling the test
and/or the analysis device 200, and/or to output a status or other
(pieces of) information relating to the test. Alternatively, or
additionally, commands can be received via the input apparatus 420,
by means of which the operating instrument 400 starts, configures
and/or controls the test of the sample P in a manner corresponding
to the commands.
[0287] Preferably, the transmission of commands and/or (pieces of)
information to the analysis device 200 is triggered via the input
apparatus 420 or can be triggered by the input apparatus 420.
[0288] In particular, transmission of the piece/pieces of control
information 510 from the operating instrument 400 to the analysis
device 200 can be initiated or controlled via the input apparatus
420. Alternatively, or additionally, the analysis device 200 can be
controlled in order to receive the cartridge 100 and/or to start
the test, preferably using the piece/pieces of control information
510 and/or a command received via the input apparatus 420. The
operating instrument 400 is therefore preferably designed to
transmit to the analysis device 200 pieces of control information
510 for receiving or ejecting the cartridge 100. In this case, a
cartridge 100 can in particular be inserted only when the operating
instrument 400 is connected to the analysis device 200, whereupon
the operating instrument 400 can verify the cartridge 100 and can
eject said cartridge or block a test if an error, such as
incompatibility, is detected.
[0289] Alternatively, or additionally, the operating instrument 400
is designed to transmit pieces of control information 510 for
starting the test to the analysis device 200. The test is thus
preferably started only by a command originating from the operating
instrument 400. The analysis device 200 itself preferably does not
comprise a user interface for generating a start command or for
causing the test to start. This task is preferably reserved for the
operating instrument 400.
[0290] The cartridge 100 preferably comprises at least one
cartridge identifier 100C which corresponds to the cartridge 100
and/or to a batch with which the cartridge 100 is associated.
[0291] The cartridge identifier 100C is in particular a piece of
information that is specific to the relevant cartridge 100, is in
particular unique and/or is designed to uniquely identify the
cartridge 100, such as an identification code which is assigned to
the relevant cartridge 100 and makes it possible for said cartridge
to be identified in a preferably unique manner.
[0292] Alternatively, or additionally, the cartridge identifier
100C makes it possible to assign the cartridge 100 to a production
cycle and/or to a batch of particular cartridges 100. A batch is
preferably characterized in that cartridges 100 are produced in the
same continuous production cycle and/or are produced having the
same components, in particular having the same sensor apparatus 113
and/or the same reagents and the like. There is preferably a
plurality of batches which can differ from one another with regard
to production periods, batches of starting materials used and the
like, for example.
[0293] The cartridge identifier 100C can be stored and/or saved in
a memory means 100D of the cartridge 100. The memory means 100D can
be a barcode 124, an NFC tag and/or a memory which is provided in
the sensor apparatus 113, is connected to the sensor apparatus 113
or is assigned to the sensor apparatus 113, or another apparatus
for storing code or the like.
[0294] The cartridge identifiers 100C are preferably assigned to
the respective cartridges 100. In particular, the cartridge
identifier 100C is formed by the cartridge 100, connected thereto
and/or arranged thereon.
[0295] The analysis system 1 can comprise one or a plurality of
cartridges 100 which can each preferably be distinguished from one
another by means of at least one cartridge identifier 100C and/or
which are assigned to a batch.
[0296] The same cartridge 100 can comprise at least two cartridge
identifiers 100C that each correspond to the cartridge 100. The
cartridge identifiers 100C can preferably be read out by different
read-out methods, in particular optically, by radio, by a wired
connection or the like.
[0297] The respective cartridges 100 can comprise two different
memory means 100D having the same or corresponding cartridge
identifiers 100C. The memory means 100D are preferably independent
of one another and/or separated from one another physically. The
memory means 100D can preferably be read out in different ways, in
particular electronically and/or by an electronic connection on the
one hand, and wirelessly, in particular optically and/or by radio
on the other hand.
[0298] In the example shown, corresponding cartridge identifiers
100C are stored, saved or recorded both in a memory that can be
read out electronically, in particular of the sensor apparatus 113,
and in a memory that can be read out wirelessly, by radio or
optically, in particular the barcode 124. This makes it possible
for the cartridge identifier 100C or cartridge identifiers 100C
corresponding to the same cartridge 100 to be read out in different
ways.
[0299] This advantageously makes it possible to retrieve pieces of
control information 510, calibration information 520 and/or
evaluation information 530 from the database 500 independently,
disconnected or separately from the analysis device 200, preferably
by optically reading out the cartridge identifier 100C from the
cartridge 100. Alternatively, or additionally, a memory means 100D
of the cartridge 100 that can be read out electronically makes it
possible for the cartridge identifier 100C to be read out without
there being an optical connection to or visual contact with the
cartridge 100, for example when said cartridge is inserted into the
analysis device 200.
[0300] The at least two cartridge identifiers 100C can be the same
or, in one aspect of the present invention, which can also be
implemented independently, said cartridge identifiers 100C can be
different. In particular, it is possible and preferable for a
(first) cartridge identifier 100C to be individual or unique to the
cartridge 100, i.e., designed to uniquely identify the cartridge
100. A (different or second) cartridge identifier 100C is
preferably designed to assign the cartridge 100 to a batch of
cartridges 100. The at least two cartridge identifiers 100C
preferably correspond to one another. In particular, the cartridge
identifier 100C corresponding to the batch and/or the batch can be
identified using the cartridge identifier 100C that uniquely
identifies the cartridge 100. Preferably, both cartridge
identifiers 100 are read out and used, in particular in order to
determine and/or retrieve pieces of control information 510 and/or
evaluation information 530 on the one hand and in order to verify
said pieces of information on the other hand.
[0301] The respective cartridges 100 are preferably identified at
least twice or a cartridge identifier 100C is read out and used at
least twice, namely preferably once directly by the operating
instrument 400 in order to retrieve pieces of control information
510 and/or calibration information 520 and/or evaluation
information 530 and a second time by means of or via the analysis
device 200 in order to ensure that the test is carried out using
pieces of control information 510, calibration information 520
and/or evaluation information 530 that corresponds to the cartridge
100 and/or in order to ensure and/or verify that the pieces of
control information 510, calibration information 520 and/or
evaluation information 530 corresponds to the cartridge 100.
[0302] The proposed analysis system 1 preferably supports a
plurality of different tests. As a first option, it may be provided
that the analysis system 1 supports different cartridges 100, the
cartridges 100 each being designed to carry out one of the tests,
and the tests being different. Alternatively, or additionally, the
same cartridge 100 may, or may be able to, carry out different
tests.
[0303] Different tests differ in particular in that the sample P is
differently conveyed and/or treated within the cartridge 100. In a
cartridge 100 that supports different tests, for this purpose the
sample P can be transported on different paths and/or in different
directions within the fluid system 103 of the cartridge 100.
[0304] Alternatively, or additionally, different preparation steps
or treatments of the sample P that are supports by the cartridge
100 are carried out. The cartridge 100 preferably comprises (just)
one sensor apparatus for generating measurement results
corresponding to the sample P. In principle, however, a plurality
of different sensor apparatus 113 may also be provided on the same
cartridge 100 for the different tests.
[0305] If different cartridges 100 are provided or used for the
different tests, the sample P is preferably likewise conveyed
and/or treated in different manners within these different
cartridges 100. Here, different conveying paths, conveying
directions and/or treatments may necessarily result due to the
construction of the cartridges 100.
[0306] Alternatively, or additionally, different cartridges 100 may
in principle be constructed identically or similarly, the different
cartridges 100 being designed for different tests by different
reagents, wash buffers or the like being made available and/or by
different sensor apparatus 113 being provided. In particular, the
same main body 101 of the cartridge 100 may be used, and the
cartridges 100 may be designed for and/or specific to different
tests by using other reagents or methods for processing and/or
conveying the sample P, and/or in another manner.
[0307] One piece of control information 510 preferably corresponds
to each test. In order to carry out the different tests, different
pieces of control information 510 are therefore provided in order
to convey and/or treat the sample P in a different manner that is
specific to the test in question. As already explained above, the
pieces of control information 510 are designed in this case to
control actuators of the analysis device 200 such that the
actuators act on the cartridge 100 such that the analysis is
carried out, i.e., in particular that the sample P is conveyed
and/or treated, particularly preferably exclusively within the
cartridge 100.
[0308] The pieces of control information 510 are preferably
designed such that the actuators of the analysis device 200
transport the sample P in the cartridge 100 to the sensor apparatus
113, where the sample P is then analyzed by the sensor apparatus
113 and measurement results 713 corresponding to the sample P
and/or to properties of the sample P are produced or determined
using the sensor apparatus 113.
[0309] The pieces of control information 510 corresponding to the
different tests are preferably stored in the database 500 and/or
can be retrieved from the database 500. Alternatively, or
additionally, pieces of control information 510 corresponding to
different tests can also be stored in the operating instrument 400,
in particular stored temporarily in the memory 450.
[0310] Preferably, if required, the pieces of control information
510 that correspond to the cartridge 100 inserted into the analysis
device 200 and/or to the test to be carried out are transmitted to
the analysis device 200 by the operating instrument 400.
[0311] Preferably, the analysis device 200 only comprises pieces of
control information 510 for carrying out exactly one test at any
one time. Alternatively, or additionally, however, it is also
possible for the analysis device 200 to temporarily store and, in
particular depending on the inserted cartridge 100 and/or the
selected test, to select, preferably automatically, different
pieces of control information 510 corresponding to different tests,
and for the test to be carried out using this pieces of control
information 510.
[0312] In one aspect of the present invention, which can also be
implemented independently, one of a plurality of pieces of control
information 510 that correspond to different tests is selected for
carrying out the test using the cartridge 100, and/or a piece of
control information 510 of this type can be selected, particularly
preferably using the operating instrument 400.
[0313] Different pieces of control information 510 are preferably
different sets, units and/or sequences of instructions, data and/or
parameters that are each suitable for controlling a (complete) test
and/or that each correspond to a (complete) test.
[0314] Different pieces of control information 510 can preferably
be differentiated from one another. In particular, the different
pieces of control information 510 are each in the form of a file or
another data structure.
[0315] In one aspect of the present invention, which can also be
implemented independently, measurement results 713 are determined
by the sensor apparatus 113 of the cartridge 100 by means of the
test. Furthermore, at least two different pieces of evaluation
information 530 are preferably provided for carrying out different
evaluations of the measurement results 713. At least one piece of
the evaluation information 530 is selected and/or used for
evaluating the measurement results 713 determined by the test on
the sample P.
[0316] Using the different pieces of evaluation information 530,
the measurement results 713 that come from the same test can thus
be evaluated in different manners, meaning that different
evaluation results 740 are or can be generated.
[0317] The evaluation is preferably carried out by the operating
instrument 400. For this purpose, the operating instrument 400 can
receive the measurement results 713 from the analysis device 200
and can process said results using the pieces of evaluation
information 530, in order to generate, to output, to display and/or
to store the evaluation result(s) 740, in particular in the
database 500, in this case particularly preferably in the results
memory 550.
[0318] Particularly preferably, from the plurality of pieces of
evaluation information 530 that correspond to or are suitable for
different evaluations of the same measurement results 713, one
piece of the evaluation information 530 that corresponds to one of
the different evaluations of the measurement results 713 is
selected and/or is used to evaluate the measurement results
713.
[0319] In particular, the selected piece of evaluation information
530 is used by the operating instrument 400 to evaluate the
measurement results 713. For this purpose, the operating instrument
400 may comprise an evaluation module 440 which receives the
measurement results 713 as input values, processes the measurement
results 713 using the selected piece(s) of evaluation information
530, and generates the evaluation result 740 thereby.
[0320] Different pieces of evaluation information 530 are
preferably different sets, units and/or sequences of instructions,
data and/or parameters that are each suitable for carrying out an
evaluation and/or that each correspond to an evaluation. Different
pieces of evaluation information 530 can preferably be
differentiated from one another. In particular, the different
pieces of evaluation information 530 are each in the form of a file
or another data structure.
[0321] Selecting certain pieces of a plurality of different pieces
of control information 510 and/or evaluation information 530
provides the advantage of a particularly universally applicable
and/or configurable analysis system 1.
[0322] Preferably, different pieces of control information 510 are
stored, preferably in the database 500, for the same cartridge 100.
Here, preferably only certain pieces of control information 510 can
be and/or are retrieved or selected for retrieval and/or only
control using these certain pieces of control information 510 can
be and/or is retrieved or selected and/or evaluation using these
certain pieces of evaluation information 530 can be and/or is
retrieved or selected, preferably provided that the certain pieces
of control information 510 correspond to the cartridge 100 and/or
are compatible with the cartridge 100 and/or are enabled and/or
blocked for the cartridge 100.
[0323] Other pieces of control information 510 are preferably
prevented from being retrieved and/or the control using the other
pieces of control information 510 is preferably prevented, in
particular provided that the other pieces of control information
510 do not correspond to the cartridge 100 and/or are not
compatible with the cartridge 100 and/or are blocked and/or are not
enabled for the cartridge 100.
[0324] Preferably, different pieces of evaluation information 530
are stored, preferably in the database 500, for the same cartridge
100. Furthermore, preferably only certain pieces of evaluation
information 530 are enabled and/or unblocked for retrieval and/or
can be selected. The evaluation of the measurement results 713 from
the test, which test can be carried out using the cartridge 100, is
preferably only enabled, unblocked or possible using these certain
pieces of evaluation information 530. The certain pieces of
evaluation information 530 preferably correspond to the cartridge
100. Alternatively, or additionally, the certain pieces of
evaluation information 530 are suitable for evaluating measurement
results 713 that can be determined by the test using the cartridge
100. Alternatively, or additionally, the certain pieces of
evaluation information 530 are enabled and/or unblocked for the
cartridge 100. Alternatively, or additionally, other pieces of
evaluation information 530 are prevented or blocked from being
retrieved and/or the evaluation using the other pieces of
evaluation information 530 is prevented or blocked and/or other
pieces of evaluation information 530 are prevented or blocked from
being selected, the other pieces of evaluation information 530
preferably not corresponding to the cartridge 100 and/or not being
compatible with the cartridge 100 and/or being blocked and/or not
being enabled for the cartridge 100.
[0325] The pieces of control information 510 and/or evaluation
information 530 that correspond to, are supported by or compatible
with a specific cartridge 100 or a cartridge identifier 100C
corresponding thereto can preferably be selected or enabled for
selection. Tests or pieces of control information 510 corresponding
thereto that are not supported by a specific cartridge 100 are
blocked and/or prevented in this case on the basis of the cartridge
identifier 100C. The same applies to evaluations or pieces of
evaluation information 530 corresponding thereto in that they are
blocked and/or prevented if they are incompatible with the
cartridge 100 and/or cartridge identifier 100C.
[0326] In principle, pieces of control information 510 and/or
evaluation information 530 can alternatively or additionally be
blocked or enabled for reasons other than compatibility. In
particular, pieces of control information 510 and/or evaluation
information 530 corresponding to the cartridge 100 and/or cartridge
identifier 100C can also be blocked even if, in principle, a test
using the cartridge 100 corresponding to the cartridge identifier
100C is possible and/or an evaluation of measurement results 713
using said cartridge 100 is possible. In this case, pieces of
control information 510 and/or evaluation information 530 that are
generally blocked preferably are or can be enabled or unblocked on
the basis of the group affiliation of a user or operating
instrument 400 and/or as a result of obtaining permission.
[0327] In a particularly preferred embodiment, first pieces of the
different pieces of control information 510 correspond to a protein
assay and second pieces of the different pieces of control
information 510 correspond to a nucleic-acid assay, the analysis
device 200 preferably being controlled or controllable using the
pieces of control information 510 such that both the protein assay
and the nucleic-acid assay can be or are carried out by the same
cartridge 100 using the different pieces of control information
510.
[0328] In a particularly preferred embodiment, first pieces of the
different pieces of evaluation information 530 correspond to a
protein assay and second pieces of the different pieces of
evaluation information correspond to a nucleic-acid assay, the
measurement results 713 from the test preferably being evaluated
using the pieces of evaluation information 530 such that both the
protein assay and the nucleic-acid assay and/or the measurement
results 713 therefrom, which preferably have been obtained using
the same cartridge 100, can be analyzed using the different pieces
of evaluation information 530, in particular such that the presence
of certain amino-acid sequences, proteins and/or diseases is
determined and/or output.
[0329] FIG. 4 shows a schematic sequence using the proposed
analysis system 1. On the basis of the schematic sequence according
to FIG. 4, the proposed selection processes are explained in
greater detail in the following.
[0330] The pieces of control information 510 and the pieces of
evaluation information 530 can in principle be selected in the same
manner, in similar manners, separately, but also together.
Furthermore, the pieces of control information 510 may be or
comprise the pieces of calibration information 520. Owing to the
sequences preferably being substantially identical or similar, the
aspects of the invention relating thereto are explained together.
It is clear that said sequences can also be provided, implemented
and carried out separately, individually and independently from one
another.
[0331] The analysis system 1 in FIG. 4 comprises a plurality of
cartridges 100 for carrying out different tests or comprises one
cartridge 100 designed for carrying out different tests. The
analysis system 1 can therefore support different tests by
different cartridges 100 being used that each support one test,
with the tests being different from one another. Alternatively, or
additionally, the analysis system 1 comprises one or more
cartridges 100 that each support a plurality of tests. As
previously explained, the different tests may be protein assays,
nucleic-acid assays or the like.
[0332] The cartridges 100 preferably each comprise at least one
memory means 100D, in which a cartridge identifier 100C is stored.
For further details in this regard, reference is additionally made
to the explanations given in conjunction with FIG. 3.
[0333] In the example shown, the cartridge 100 or all the
cartridges 100 comprises/comprise two memory means 100D that are
independent from one another. One of the memory means 100D is in
the form of an electronically readable memory, flash memory or the
like as part of the sensor arrangement or sensor apparatus 113, or
is provided so as to be assigned to the sensor arrangement or
sensor apparatus 113. An additional memory means 100D is provided
in the form of the barcode 124 or another, wirelessly readable
memory means 100D.
[0334] The memory means 100D may preferably be read out using
different methods, and in the example shown they are read out
wirelessly/optically and in a wired manner/electronically. However,
in principle, other solutions are also possible here.
[0335] The cartridge identifier 100C corresponding to the cartridge
100 or cartridges 100 is preferably received by the operating
instrument 400. In particular, the operating instrument 400 can
scan the barcode 124 using the camera 421 for this purpose, in
particular using the data connection DVB, which represents optical
data transmission in this case. Alternatively, or additionally, the
analysis device 200 can read out the cartridge identifier 100C
electronically from the memory means 100D of the cartridge 100, in
particular via the data connection DVC as shown in FIG. 3, and can
transmit said identifier 100C to the operating instrument 400, in
particular via the data connection DVA. In principle, however, the
cartridge identifier 100C may also be determined or established in
another manner.
[0336] Preferably, the different pieces of control information 510
and/or evaluation information 530 that correspond to the cartridge
identifier 100C are identified by means of the cartridge identifier
100C. Thus, in particular, pieces of control information 510 and/or
evaluation information 530 of such type are identified that
correspond to a test supported by the cartridge 100 and/or to the
evaluation of measurement results 713 from a test of this type.
This is particularly preferably carried out by or in the operating
instrument 400 and/or by or in the database 500.
[0337] In the example shown, the operating instrument 400 transmits
the cartridge identifier 100C to the database 500. The database 500
preferably comprises an identification module 560, by means of
which pieces of control information 510 and/or evaluation
information 530 corresponding to the cartridge identifier 100C is
or can be identified. For this purpose, the database 500 may
comprise pieces of identification information 560A. The pieces of
identification information 560A preferably provide an allocation or
assignment of the cartridge identifier 100C to the pieces of
control information 510 and/or evaluation information 530
corresponding to the cartridge identifier 100C.
[0338] Preferably, pieces of control information 510 for the test
are enabled for or prevented from being retrieved and/or used
depending on the cartridge identifier 100C. Alternatively, or
additionally, pieces of evaluation information 530 for use in the
evaluation of measurement results 713 from the test are enabled for
or prevented from being retrieved or used.
[0339] Preferably, for this purpose, the analysis system 1, in
particular the database 500, is designed to block or disable
certain pieces of control information 510 and/or evaluation
information 530 and to enable or unblock other pieces of control
information 510 and/or evaluation information 530. In particular,
the identification module 560 is designed to identify and enable or
unblock pieces of control information 510 and/or evaluation
information 530 corresponding to the cartridge 100 or cartridge
identifier 100C in question by means of the pieces of
identification information 560A. Alternatively, or additionally,
the identification module 560 is designed to block or disable
pieces of control information 510 and/or evaluation information 530
that has not been enabled and/or does not correspond to the
cartridge 100 or cartridge identifier 100C. These functions may in
principle also be assumed or carried out by the operating
instrument 400.
[0340] Pieces of control information 510 and/or evaluation
information 530, preferably corresponding to the cartridge 100 or
cartridge identifier 100C, may be enabled or unblocked in
particular by a booking apparatus or a shop system (not shown).
[0341] Pieces of control information 510 and/or evaluation
information 530 that have been enabled or have not been blocked can
preferably be selected.
[0342] The database 500 may comprise an enabling module 563, which,
preferably controlled by the identification module 560, can enable
or unblock pieces of control information 510 and/or evaluation
information 530. The database may further comprise a blocking
module 564, which, preferably controlled by the identification
module 560, can disable or block pieces of control information 510
and/or evaluation information 530.
[0343] In order to select preferably enabled or unblocked pieces of
control information 510 and/or evaluation information 530, pieces
of control information 510 and/or evaluation information 530, which
are in particular enabled, or corresponding pieces of option
information 561 for identifying enabled pieces of control
information 510 and/or evaluation information 530 are preferably
transmitted to the operating instrument 400, as shown in FIG. 4 by
the arrow.
[0344] One piece of the control information 510 and/or one or more
pieces of the evaluation information 530 and/or one or more pieces
of the option information 561 can then be selected using the
operating instrument 400. In particular, graphical representations
of the pieces of control information 510 and/or evaluation
information 530 or the pieces of option information 561
corresponding thereto are displayed and can be selected, in
particular by means of the input apparatus 420, such as a touch
screen.
[0345] If the pieces of control information 510 and/or evaluation
information 530 have already been transmitted to the operating
instrument 400 and/or stored by the operating instrument 400, the
selected piece of control information 510 can subsequently be
transmitted to the analysis device 200.
[0346] Alternatively, pieces of selection information 562 are
transmitted from the operating instrument 400 to the database 500,
as indicated by the arrow in the example shown in FIG. 4. On the
basis of the pieces of selection information 562 that correspond to
the selection made by the operating instrument 400, the database
500 can determine selected pieces of control information 510 and/or
evaluation information 530 and transmit said pieces of information
to the operating instrument 400, as indicated by the arrow in FIG.
4. In this case too, the operating instrument 400 preferably
transmits the selected piece/pieces of control information 510 to
the analysis device 200.
[0347] The analysis device 200 preferably carries out the test on
the basis of the transmitted piece/pieces of control information
510.
[0348] The analysis device 200 is preferably controlled using the
selected piece(s) of control information 510, and therefore the
sample P is conveyed within the cartridge 100 in the manner that is
specific to the test corresponding to the selected piece(s) of
control information 510. Alternatively, or additionally, one or
more tests supported by the cartridge 100, in particular a
molecular assay and/or a protein assay, are controlled using the
selected pieces of control information 510. Here, the analysis
device 200 can be controlled using the different pieces of control
information 510 in order to carry out different tests on the sample
P, which can also be carried out separately.
[0349] The analysis device 200 then returns to the operating
instrument 400 measurement results 713 that have been generated by
means of the test. For this purpose, the measurement results 713
can be transmitted to the operating instrument 400 and/or can be
retrieved by the operating instrument 400.
[0350] The measurement results 713 are preferably received by the
operating instrument 400 and are evaluated by means of the
preferably selected piece/pieces of evaluation information 530. The
evaluation is preferably carried out by or in the operating
instrument 400, but can in principle also be carried out at another
point. Particularly preferably, the evaluation is carried out so as
to generate evaluation results 740 and/or is carried out outside
the analysis device 200.
[0351] Particularly preferably, measurement results 713 from the
same test on the sample P carried out using the cartridge 100 are
evaluated using different pieces of evaluation information 530 or
the analysis system 1 is designed for this purpose. Alternatively,
or additionally, measurement results 713 from different tests on
the sample P carried out using the same cartridge 100 are evaluated
using the different pieces of evaluation information 530 or the
analysis system 1 is designed for this purpose.
[0352] Optionally, the evaluation results 740 can be stored in the
database 500, in particular can be saved in the results memory 550.
For this purpose, as indicated by an arrow in the example shown, it
is in particular provided that the evaluation results 740 are sent
to the database 500 by the operating instrument 400. However, other
solutions are also conceivable here.
[0353] Another aspect of the present invention, which can also be
implemented independently, relates to a computer program product
comprising program code means which, when executed, cause the steps
of the method to be carried out. The computer program product may
comprise components which are and/or can be executed on the
operating instrument 400 and/or the database 500, in particular in
order to facilitate or implement the selection process according to
the proposed method. The computer program product can be stored in
the memory 450 of the operating instrument 400 in full or in part.
The computer program product preferably is a non-transitory
computer-readable media.
[0354] Another aspect of the present invention, which can also be
implemented independently, relates to the analysis system 1 for
testing an in particular biological sample P, which is preferably
designed to carry out the method.
[0355] Here, it is provided in one aspect that the analysis device
200 and/or the cartridge 100 support different tests on the sample
P, which can also be carried out separately, and for which the
sample P is conveyed and/or treated within the cartridge 100 in
different manners specific to the respective tests. Furthermore, at
least two pieces of control information 510 are provided that
correspond to the different tests, it being possible to select at
least one piece or certain pieces of the control information 510
for carrying out the test using the cartridge 100, and it being
possible to control the analysis device 200 using the selected
piece(s) of control information 510 such that the sample P is
conveyed and/or treated within the cartridge 100 in the manner
specific to the test corresponding to the selected piece(s) of
control information 510.
[0356] Alternatively, or additionally, it is provided that
measurement results 713 can be determined by the test by means of
the sensor apparatus 113 of the cartridge 100. Furthermore, at
least two different pieces of evaluation information 530 are
provided for carrying out different evaluations of the measurement
results 713, and at least one piece or certain pieces of the
evaluation information 530 can be selected for the evaluation of
the measurement results 713 determined by the test on the sample
P.
[0357] Furthermore, it is preferable for the different pieces of
control information 510 to be designed to control different tests
on the sample P, which can preferably also be carried out
separately, using the same cartridge 100, it preferably being
possible to control the analysis device 200 using the different
pieces of control information 510 in order to carry out the
different tests on the sample P.
[0358] Alternatively, or additionally, one or more of the different
pieces of control information 510 can be selected, it preferably
being possible to carry out one or more tests supported by the
cartridge 100, in particular a nucleic-acid assay and/or a protein
assay, using the selected piece or pieces of control information
510.
[0359] The different pieces of evaluation information 530 may be
designed for differently evaluating measurement results 713 from
the test, the different pieces of evaluation information 530
preferably being designed for differently evaluating measurement
results 713 determined in the same test and/or for evaluating
different tests on the sample P, which can preferably also be
carried out separately, using the same cartridge 100.
[0360] In the following, a particular example is described of a
preferred work flow. Although the preferred work flow, of course,
is particularly advantageous, different aspects of the following
example can be realized independently and form distinct inventive
concepts and can be combined in different configurations leading
two further advantages.
[0361] In this example, the operating instrument 400 is realized as
a mobile device like a smartphone or tablet. The operating
instrument 400 has an input apparatus 420 in form of a touch
sensitive display. The operating instrument 400 is separated from
and remote of the analysis device 200 and from the cartridge 100
and the database 500.
[0362] A specific cartridge 100 is provided and at least one and
preferably multiple pieces of control information 510 stored in
said database 500 corresponding to said specific cartridge 100.
[0363] First, said specific cartridge 100 is identified by means of
said operating instrument 400. This particularly preferably is
conducted by input or reading a cartridge identifier 100C with the
operating instrument 400, the cartridge identifier 100C identifying
unambiguously the cartridge or a charge or batch of cartridges said
specific cartridge 100 belongs to. The cartridge identifier 100C
can be or comprise a piece of code like a sequence of numbers, bits
or the like.
[0364] Preferably, the cartridge identifier 100C is scanned, in
particular with the camera 421 of the input apparatus 420. However,
the cartridge identifier 100C can alternatively or additionally be
input via the input apparatus 420, in particular via touchpad
422.
[0365] Optionally, the operating instrument 400 identifies the
analysis device 200 to be used for the test and/or which has a data
connection with said operating instrument 400.
[0366] Using the cartridge identifier 100C and, optionally, an
identifier identifying the analysis device 200, a particular piece
of control information 410 is received or retrieved from the
database 500. However, receiving or retrieving said piece of
control information 510 can also be realized without
identifiers.
[0367] Preferably, different pieces of control information 510
corresponding to different tests (test sequences) are stored in the
data base 500 and can be received or retrieved from the data base
500 by the operating instrument 400. For receiving or retrieving
one of said pieces of control information 510, a data connection
DVD is provided or established between the operating instrument 400
and the data base 500 which transmits the one of said pieces of
control information 510 which is configured for controlling the
test or test sequence of the sample P within said specific
cartridge 100 using the analysis device 200 to the operating
instrument 400.
[0368] If the data base 500 stores multiple pieces of control
information 510 which are each configured to controlling the test
or test sequence with the specific cartridge 100, the analysis
system 1 preferably is configured to enable or enables selection of
a particular one of the said pieces of control information 510 such
that merely the test or the test sequence defined by the selected
one of the pieces of control information 510 is used to carry out
the test or test sequence. In the present example, the operating
instrument 400 supports selecting a particular one of said pieces
of control information 510 using the touchpad 422, for example by
clicking, dragging and/or dropping an icon representing said
particular piece of control information 510.
[0369] For this purpose, the data base 500 can send the piece of
option information 561 identifying different pieces of control
information 510 being compatible with a particular cartridge 100 to
the operating instrument 400. The operating instrument 400 then
displays those pieces of option information 561, and enables
selection. Alternatively, the data base 500 can forward the
different pieces of control information 510 and the operating
instrument 400 displays information like icons representing those
different pieces of control information 510.
[0370] Anyway, one particular piece of control information 510
and/or test or a test sequence defined by said piece of control
information 510 is selected by means of the operating instrument
400. This selected piece of control information 510 is retrieved
from the data base 500 and/or selected within the operating
instrument 400 to be forwarded or provided to the analysis device
200.
[0371] The piece of control information 510 which the operating
instrument 400 received or selected is forwarded or provided to the
analysis device 200. The analysis device 200 is programmed by the
piece of control information 510 to carry out a specific test or
test sequence using the specific cartridge 100.
[0372] Preferably an additional start command input into the
operating instrument 400 and transmitted to the analysis device 200
starts the test or test sequence. This start, of course, is under
the precondition that the specific cartridge 100 is input into the
analysis device 200 and, preferably, the analysis device 200 and/or
the operations instrument has verified that the piece of control
information 510 is compatible with the cartridge 100 to carry out
the test or test sequence.
[0373] The analysis device 200 then preferably full automatically
acts on the cartridge 100 such that the test or test sequence, in
particular assay, is carried out as defined by the selected piece
of control information 520.
[0374] Afterwards, the analysis device 200 transmits a measurement
result 713 measured by the test or test sequence to the operating
instrument 400.
[0375] A specific piece of evaluation information 530 can be
received or retrieved from the same or a different data base 500 as
previously described in connection with the piece of control
information 510. This can take place together with selection,
receiving and/or retrieval of said piece of control information 510
or separately, in particular afterwards.
[0376] Further, there might be multiple pieces of evaluation
information 530 which can be selected as described in connection
with selection of the piece of control information 510, but
preferably is not transmitted to the analysis device 200. Instead,
the selected piece of evaluation information 530 is directly used
by the operating instrument 400. Here, a processor of the operating
instrument 400 is used to calculate the outcome from the received
measurement result 713 using the piece of evaluation information
530 which can be or comprise instructions and/or an algorism for
calculating the outcome from the measurement result 713.
[0377] The operating instrument 400 computes, using the specific
piece of evaluation information 530, an outcome based on said
measurement result 713. Afterwards, an outcome of this evaluation
is output by the operating instrument 400, in particular displayed,
and/or transmitted to the data base 500 or to a different
receiver.
[0378] In general, the analysis device 200, the cartridge 100 or in
particular the sensor apparatus 113 may measure, detect or identify
the one or more analytes A by means of specific bonding, in
particular by means of capture molecules and/or of means of
electrochemical detection such as redox cycling, or the like,
preferably performed on the cartridge 100 and/or in the sensor
apparatus 113. Preferably, the capture molecules are arranged or
immobilized on a sensor array or on sensor fields or electrodes of
the sensor apparatus 113. In particular, an immuno-assay or a
protein assay for detecting or identifying a protein and/or a
nucleic-assay for detecting or identifying a nucleic-acid sequence
can be or is realized.
[0379] Alternatively, or additionally, measurements without
specific bonding and/or without electrochemical detection can be
used or performed, preferably in or by the analysis device 200
and/or cartridge 100. Such measurements can include an optical
measurement, impedance measurement, capacitance measurement,
spectrometric measurement, mass spectrometric measurement, or the
like. For this purpose, the analysis device 200 or cartridge 100
may comprise an optical spectrometer and/or allow optical
measurements of the treated or untreated sample P. Thus, it is
possible to measure, detect or identify other or further analytes
A, compounds, material characteristics, or the like of the sample
P, e.g., within the cartridge 100 or any other sample carrier.
These alternative or additional measurements can be used or
processed and/or evaluated in a similar manner as described or
differently.
[0380] Preferably, the analysis system 1 or parts thereof control
the testing of the sample (P) and/or is/are used to evaluate the
testing. Particularly preferably, the analysis system 1 or the
analysis device 200 carries out or controls the testing
automatically, in particular based on or as defined by a/the piece
of control information 510. Alternatively, or additionally, the
analysis system 1 or the operating instrument 400 carries out or
controls the evaluation automatically, preferably based on or as
defined by a/the piece of evaluation information 530.
[0381] In particular, the present invention relates also to any one
of the following aspects which can be realized independently or in
any combination, also in combination with any aspects described
above or in the claims.
1. Method for testing, in particular, a biological sample P by
means of an analysis system 1, the analysis system 1 comprising a
cartridge 100 for receiving the sample P, the cartridge 100
comprising, for a test supported by the cartridge 100, a sensor
apparatus 113 and a fluid system 103 for conveying the sample P to
the sensor apparatus 113, the analysis system 1 comprising an
analysis device 200 for receiving the cartridge (100) and
subsequently carrying out the test using the received cartridge
100, characterized [0382] in that the cartridge 100 supports
different tests on the sample P, which can also be carried out
separately, and for which the sample P is conveyed and/or treated
in different manners specific to the respective tests, in that at
least two different pieces of control information 510 are provided
that correspond to the different tests, and in that at least one
piece or certain pieces of the control information 510 is/are
selected for carrying out the test using the cartridge 100, and/or
[0383] in that measurement results 713 are determined by the sensor
apparatus 113 of the cartridge 100 by means of the test, in that at
least two different pieces of evaluation information 530 are
provided for carrying out different evaluations of the measurement
results 713, and in that at least one piece or certain pieces of
the evaluation information 530 is/are selected and/or used for
evaluating the measurement results 713 determined by the test on
the sample P. 2. Method according to aspect 1, characterized in
that the analysis device 200 is controlled using the selected piece
of control information 510, such that the sample P is conveyed
and/or treated within the cartridge 100 in the manner that is
specific to the test corresponding to the selected piece of control
information 510, and/or in that one or more tests supported by the
cartridge 100, in particular a nucleic-acid assay and/or a protein
assay, are controlled using the selected piece of control
information 510, and/or in that the analysis device 200 is
controlled using the different pieces of control information 510 in
order to carry out different tests on the sample P, which can also
be carried out separately. 3. Method according to aspect 1 or 2,
characterized in that measurement results 713 from the same test on
the sample P carried out using the cartridge 100 are evaluated
using the different pieces of evaluation information 530, and/or in
that measurement results 713 from different tests on the sample P
carried out using the same cartridge 100 are evaluated using the
different pieces of evaluation information 530. 4. Method according
to any one of the preceding aspects, characterized in that the
different pieces of control information 510 are stored, preferably
in a database 400, for the same cartridge 100, only certain pieces
of control information 510 being enabled for retrieval and/or the
control using only the certain pieces of control information 510
being enabled, preferably provided that the certain pieces of
control information 510 correspond to the cartridge 100 and/or are
compatible with the cartridge 100 and/or are enabled for the
cartridge 100, and/or other pieces of control information 510 being
prevented from being retrieved and/or the control using the other
pieces of control information 510 being prevented, preferably
provided that the other pieces of control information 510 do not
correspond to the cartridge 100 and/or are not compatible with the
cartridge 100 and/or are not enabled for the cartridge 100. 5.
Method according to any one of the preceding aspects, characterized
in that different pieces of evaluation information 530 are stored,
preferably in a database 400, for the same cartridge 100, only
certain pieces of evaluation information 530 being enabled for
retrieval and/or the evaluation of the measurement results 713,
from the test that can be carried out using the cartridge 100,
using only the certain pieces of evaluation information 530 being
enabled, the certain pieces of evaluation information 530
preferably corresponding to the cartridge 100 and/or being suitable
for evaluating measurement results 713 that can be determined by
the test using the cartridge 100 and/or being enabled for the
cartridge 100, and/or other pieces of evaluation information 530
being prevented from being retrieved or the evaluation using the
other pieces of evaluation information 530 being prevented, the
other pieces of evaluation information 530 preferably not
corresponding to the cartridge 100 and/or not being compatible with
the cartridge 100 and/or not being enabled for the cartridge 100.
6. Method according to any one of the preceding aspects,
characterized in that a cartridge identifier 100C of the cartridge
100 is determined and, depending on the cartridge identifier 100C,
pieces of control information 510 for the test are enabled for or
blocked from being retrieved or used, and/or pieces of evaluation
information 530 for use in the evaluation of measurement results
713 from the test are enabled for or blocked from being retrieved
or used. 7. Method according to any one of the preceding aspects,
characterized in that the analysis system 1 comprises an operating
instrument 400 which can preferably be separated from the analysis
device 200 in with respect to a data connection and/or which can
preferably be wirelessly connected to the analysis device 200, the
pieces of control information 510 being retrieved using the
operating instrument 400 and/or being transmitted to the analysis
device (200) by the operating instrument 400 in order to control
the test, and/or the pieces of evaluation information 530 being
retrieved using the operating instrument 400, and/or measurement
results 713 determined during the test being transmitted to the
operating instrument 400 and/or being analyzed by the operating
instrument 400, in particular in different manners and/or in order
to determine different characteristic values or to detect diseases.
8. Method according to any one of the preceding aspects,
characterized in that first pieces of the different pieces of
control information 510 correspond to a protein assay and second
pieces of the different pieces of control information 510
correspond to a nucleic-acid assay, the analysis device 200
preferably being controlled using the pieces of control information
510 such that both the protein assay and the molecular assay can be
or are carried out by means of the different pieces of control
information 510 using the same analysis device 200 and/or the same
cartridge 100. 9. Method according to any one of the preceding
aspects, characterized in that first pieces of the different pieces
of evaluation information 530 correspond to a protein assay and
second pieces of the different pieces of evaluation information 530
correspond to a nucleic-acid assay, the measurement results 713
from the test preferably being evaluated using the pieces of
evaluation information 530 such that measurement results 713 from
both the protein assay and the nucleic-acid assay can be analyzed
by the different pieces of evaluation information 530, in
particular such that the presence of certain amino-acid sequences,
proteins and/or diseases is/are determined and/or output. 10.
Computer program product comprising program code means which, when
executed, cause the steps of the method according to any one of the
preceding claims to be carried out. 11. Analysis system 1 for
testing, in particular, a biological sample P, the analysis system
1 preferably being designed to carry out the steps of the method
according to any one of aspects 1 to 10, the analysis system 1
comprising a cartridge 100 for receiving the sample P, the
cartridge 100) comprising, for a test supported by the cartridge
100, a sensor apparatus 113 and a fluid system comprising channels
for conveying the sample P to the sensor apparatus 113, and the
analysis system 1 comprising an analysis device 200 for receiving
the cartridge 100 and subsequently carrying out the test using the
received cartridge 100, characterized [0384] in that the cartridge
100 supports different tests on the sample P, which can also be
carried out separately, and for which the sample P is conveyed
and/or treated within the cartridge 100 in different manners
specific to the respective tests, in that at least two pieces of
control information 510 are provided that correspond to the
different tests, in that at least one piece or certain pieces of
the control information 510 can be selected for carrying out the
test using the cartridge 100, and in that the analysis device 200
can be controlled using the selected piece of control information
510 such that the sample P is conveyed and/or treated within the
cartridge 100 in the manner specific to the test corresponding to
the selected piece of control information 510, and/or [0385] in
that measurement results 713 can be determined using the sensor
apparatus 113 of the cartridge 100 by means of the test, in that at
least two different pieces of evaluation information 530 are
provided for carrying out different evaluations of the measurement
results 713, and in that at least one piece or certain pieces of
the evaluation information 530 can be selected for evaluating the
measurement results 713 determined by the test on the sample P, and
in that the measurement results 713 can be evaluated in different
manners, in the manners specified by the pieces of evaluation
information 530. 12. Analysis system according to aspect 11,
characterized in that the different pieces of control information
510 are designed to control different tests on the sample P, which
can preferably also be carried out separately, using the same
cartridge 100, it preferably being possible to control the analysis
device 200 using the different pieces of control information 510 in
order to carry out the different tests on the sample P, and/or in
that one or more of the different pieces of control information 510
can be selected, it preferably being possible to carry out one or
more tests supported by the cartridge 100, in particular a
nucleic-acid assay and/or a protein assay, using the selected piece
or pieces of control information 510. 13. Analysis system according
to aspect 11 or 12, characterized in that the different pieces of
evaluation information 530 are designed for differently evaluating
measurement results 713 from the test, the different pieces of
evaluation information 530 preferably being designed for
differently evaluating measurement results 713 determined in the
same test and/or for evaluating different tests on the sample P,
which can preferably also be carried out separately, using the same
cartridge 100. 14. Analysis system according to any one of aspects
11 to 13, characterized in that different pieces of control
information 510 and/or evaluation information 530 are stored for
the same cartridge 100, the analysis system 200 being designed a)
to only enable certain pieces of control information 510 and/or
certain pieces of evaluation information 530 for retrieval and/or
to enable the control using said certain pieces of control
information 510 and/or to enable the evaluation using said certain
pieces of evaluation information 530, preferably provided that the
certain pieces of control information 510 and/or evaluation
information 530 correspond to the cartridge 100 and/or are
compatible with the cartridge 100 and/or are enabled for the
cartridge 100, and/or b) to prevent other pieces of control
information 510 and/or other pieces of evaluation information 530
from being retrieved, or to prevent the control using the other
pieces of control information 510 and/or to prevent the evaluation
using the other pieces of evaluation information 530, the other
pieces of control information 510 and/or evaluation information 530
preferably not corresponding to the cartridge 100 and/or not being
compatible with the cartridge 100 and/or not being enabled for the
cartridge 100. 15. Analysis system according to any one of aspects
11 to 14, characterized in that the analysis system 1 comprises an
operating instrument 400 which can preferably be separated from the
analysis device 200 with respect to a data connection and/or which
can preferably be wirelessly connected to the analysis device 200
and which is designed to retrieve pieces of control information 510
and to transmit said pieces of information to the analysis device
200 in order to control the test and/or to evaluate the measurement
results 713 determined by the test in different manners using the
different pieces of evaluation information 530, in particular in
order to detect different characteristic values or diseases, it
preferably being possible to determine a cartridge identifier 100C
of the cartridge 100 using the operating instrument 400 and,
depending on the cartridge identifier 100C, it being possible for
pieces of control information 510 for the test and/or pieces of
evaluation information 530 for use in the evaluation of measurement
results 713 from the test to be enabled for or blocked from being
retrieved and/or used. Individual aspects and features of the
present invention and individual method steps and/or method
variants may be implemented independently from one another, but
also in any desired combination and/or order. 16. Analysis system
for testing, in particular, a biological sample, the analysis
system comprising a cartridge for receiving the sample, the
analysis system comprising an analysis device for receiving the
cartridge and subsequently carrying out the test using the received
cartridge, the cartridge supporting different tests on the sample,
which can also be carried out separately, and for which the sample
is conveyed and/or treated within the cartridge in different
manners specific to the respective tests, wherein at least two
pieces of control information are provided that correspond to said
different tests, wherein at least one piece or certain pieces of
said control information is/are selectable for carrying out the
test, and in that the analysis device is configured to be
controlled using the selected piece of control information,
preferably such that the sample is conveyed and/or treated within
the cartridge in the manner specific to the test corresponding to
the selected piece of control information, and in that said
different pieces of control information are stored in a database,
wherein only certain of said pieces of control information are
unblocked for the cartridge, the analysis system being configured
to only enable unblocked pieces of control information for
selection, for retrieval and/or to enable the control using said
certain pieces of control information; and/or wherein, in
particular other, one or ones of said pieces of control information
are blocked for the cartridge, the analysis system being configured
to prevent blocked pieces of control information for one or more
of: to be selected, to be retrieved, and to enable the control
using said blocked pieces of control information. 17. Analysis
system according to aspect 16, wherein the different pieces of
control information are configured to control different tests on
the sample using the same cartridge. 18. Analysis system according
to aspect 16, wherein the analysis device is configured for control
using the different pieces of control information in order to carry
out the different tests on the sample. 19. Analysis system
according to aspect 18, wherein the analysis device or analysis
system is configured to carry out one or more tests supported by
the cartridge using the selected piece or pieces of control
information. 20. Analysis system according to aspect 19, wherein
the analysis system or the analysis device is configured to carry
out a nucleic-acid assay and/or a protein assay using the selected
piece or pieces of control information. 21. Analysis system
according to aspect 16, wherein the certain or unblocked pieces of
control information correspond to the cartridge and/or are
compatible with the cartridge. 22. Analysis system according to
aspect 16, wherein the analysis system is configured to prevent
other or blocked pieces of control information from being selected,
being retrieved, or to prevent the control using the other or
blocked pieces of control information. 23. Analysis system
according to aspect 22, wherein the other pieces of control
information are blocked that do not correspond to the cartridge
and/or are not compatible with the cartridge and/or are disabled
for the cartridge. 24. Analysis system according to aspect 16,
wherein the analysis system comprises an operating instrument which
is configured to retrieve said selected pieces of control
information and to transmit said selected pieces of control
information to the analysis device in order to control the test.
25. Analysis system according to aspect 24, wherein the operating
instrument is configured to retrieve pieces of control information
and to transmit said pieces of control information to the analysis
device and/or in order to detect different characteristic values or
diseases. 26. Analysis system according to aspect 24, wherein the
operating instrument is configured to determine a cartridge
identifier of the cartridge and, depending on the cartridge
identifier, pieces of control information for the test can be
unblocked for or blocked from being selected, retrieved and/or
used. 27. Analysis system according to aspect 24, wherein the
operating instrument can be separated from the analysis device
physically and/or with respect to a data connection and/or can be
wirelessly connected to the analysis device. 28. Analysis
system for testing, in particular, a biological sample, the
analysis system comprising a cartridge for receiving the sample,
the analysis system comprising an analysis device for receiving the
cartridge and subsequently carrying out the test using the received
cartridge, the analysis device being configured to determine
measurement results by means of the test, wherein at least two
different pieces of evaluation information are provided for
carrying out different evaluations of the measurement results, and
at least one piece or certain pieces of said evaluation information
is/are selectable for evaluating the measurement results, and/or
the measurement results are evaluable specified by the selected
piece or pieces of evaluation information. 29. Analysis system
according to aspect 28, wherein said different pieces of evaluation
information are stored in a database, wherein only certain of said
different pieces of control information are unblocked for the
cartridge, thus being enabled for selection, being enabled for
retrieval and/or the evaluation using only the certain of said
pieces of evaluation information being enabled; and/or wherein, in
particular other, are or ones of said different pieces of control
information are blocked for the cartridge, thus being prevented
from being selected, being prevented from being retrieved and/or
the evaluation using said, in particular other, pieces of
evaluation information being prevented. 30. Analysis system
according to aspect 28, wherein said different pieces of evaluation
information are configured for differently evaluating measurement
results from the same test or for evaluating different tests on the
sample obtainable using the same cartridge. 31. Analysis system
according to aspect 28, wherein the different pieces of evaluation
information are configured for evaluating measurement results of
different tests on the sample which can also be carried out
separately. 32. Analysis system according to aspect 28, wherein the
certain or unblocked pieces of evaluation information correspond to
the cartridge and/or are compatible with the cartridge, wherein the
analysis system is configured to prevent other or blocked pieces of
evaluation information from being selected and/or retrieved, and/or
to prevent the evaluation using the other pieces of evaluation
information, wherein the other or blocked pieces of evaluation
information do not correspond to the cartridge and/or are not
compatible with the cartridge and/or are disabled for the
cartridge. 33. Analysis system according to aspect 28, wherein the
analysis system comprises an operating instrument which is
configured to evaluate the measurement results determined by the
test in different manners using the different pieces of evaluation
information. 34. Analysis system according to aspect 33, wherein
the operating instrument is designed to evaluate the measurement
results in order to detect different analytes characteristic values
or diseases. 35. Analysis system according to aspect 34, wherein
the operating instrument is configured to determine a cartridge
identifier of the cartridge and, depending on the cartridge
identifier, pieces of evaluation information for use in the
evaluation of measurement results from the test are unblockable or
blockable from being selected, retrieved and/or used.
* * * * *