U.S. patent application number 16/923167 was filed with the patent office on 2020-10-29 for method for controlling an analysis device and analysis system.
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 Bernhard Bender, Guenter Bruckmann, Armin Jahanpanah, Axel Niemeyer, Harald Pauls, Hannah Schmolke.
Application Number | 20200338563 16/923167 |
Document ID | / |
Family ID | 1000004957500 |
Filed Date | 2020-10-29 |
United States Patent
Application |
20200338563 |
Kind Code |
A1 |
Bruckmann; Guenter ; et
al. |
October 29, 2020 |
METHOD FOR CONTROLLING AN ANALYSIS DEVICE AND ANALYSIS SYSTEM
Abstract
An analysis system and a method for testing a biological sample
according to which, before the start of testing, the amount of
energy remaining in an energy storage of the analysis device is
compared with an energy requirement for the test, and the test is
only started if the amount of energy meets the energy requirement,
and/or a temperature-control apparatus designed for
temperature-controlling the cartridge is controlled depending on an
interior space temperature of the analysis device.
Inventors: |
Bruckmann; Guenter;
(Wuerselen, DE) ; Bender; Bernhard; (Herzogenrath,
DE) ; Jahanpanah; Armin; (Eschweiler, DE) ;
Niemeyer; Axel; (Bielefeld, DE) ; Pauls; Harald;
(Eschweiler, DE) ; Schmolke; Hannah; (Didderse,
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: |
1000004957500 |
Appl. No.: |
16/923167 |
Filed: |
July 8, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15725348 |
Oct 5, 2017 |
10710085 |
|
|
16923167 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 35/00584 20130101;
B01L 2200/027 20130101; B01L 2200/16 20130101; B01L 7/525 20130101;
B01L 2300/0681 20130101; B01L 3/502715 20130101; B01L 2300/0861
20130101; B01L 2200/04 20130101; B01L 2200/0684 20130101; B01L
2200/147 20130101; B01L 2300/0627 20130101; B01L 2400/0481
20130101; B01L 2300/0816 20130101; B01L 3/502738 20130101; B01L
2300/027 20130101; B01L 7/52 20130101; B01L 2200/143 20130101 |
International
Class: |
B01L 7/00 20060101
B01L007/00; B01L 3/00 20060101 B01L003/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 7, 2016 |
EP |
16 020 381.6 |
Claims
1. A method for controlling an analysis device for testing a
biological sample received in a cartridge, comprising: before
starting of testing, comparing an amount of energy remaining in an
energy storage means of the analysis device with an energy
requirement for said testing, and starting said testing only if the
comparison indicates that the energy storage means has a sufficient
amount of energy remaining to meet the energy requirement for
testing.
2. The method according to claim 1, wherein the energy requirement
is defined in accordance with a particular test or test procedure
to be carried out.
3. The method according to claim 1, wherein the energy requirement
is defined accordance with a particular cartridge to be used.
4. The method according to claim 3, wherein the energy requirement
is established, retrieved or determined using an identifier that
corresponds to the particular cartridge to be used.
5. The method according to claim 1, wherein the energy requirement
is established, retrieved or determined on the basis of the
particular test to be carried out.
6. The method according to claim 1, wherein control information for
carrying out the test comprises the energy requirement.
7. The method according to claim 6, wherein the control information
is retrieved or determined using an identifier that corresponds to
the particular cartridge to be used.
8. The method according to claim 1, wherein said energy requirement
is defined by selecting a specific test to be carried out of
multiple tests having different energy requirements.
9. The method according to claim 8, wherein said different energy
requirements correspond to different amounts of energy required for
at least one of heating the sample, cooling the sample, conveying
the sample, and electrochemically analyzing the sample.
10. An analysis system for testing a biological sample, comprising:
a cartridge for receiving a sample, and an analysis device for
receiving the cartridge and subsequently carrying out testing using
the received cartridge, wherein the analysis device has means for
comparing an amount of energy remaining in an energy storage of the
analysis device with an energy requirement for testing before the
start of the test, and means to enable starting of the test if the
amount of energy meets or exceeds the energy requirement and to
block starting of testing if the amount of energy is below said
energy requirement.
11. A computer readable storage media wherein the media contains
instructions for directing an analysis device to compare an amount
of energy remaining in an energy storage of the analysis device
with an energy requirement for testing a sample received in a
cartridge before starting of the test, and to start the test only
if the amount of energy meets or exceeds the energy requirement and
to block starting of testing if the amount of energy is below said
energy requirement.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 15/725,348 filed Oct. 5, 2017, which claims the benefit of
priority to European Patent Application No. 16 020 381.6 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 to an analysis
system for testing of a biological 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 of
or independently from 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] International Patent Application Publication No. WO
2013/134582 A1 and corresponding U.S. Pat. No. 9,632,053 B2
disclose an analyte sensing device and in particular relates to
devices for measuring pH, the potential of hydrogen, which is a
measure of the acidity or alkalinity of a solution. A firmware of
the system provides the function of a system check which verifies a
battery status or detects the charge level of a battery. However,
there is no hint how to improve the reliability of specific tests
regarding sufficient energy.
[0010] U.S. Patent Application Publication No. 2015/0260674 A1
relates to an electrochemical analysis and simulation device. The
device comprises an indicating unit coupled to a power supply unit
and configured to indicate an electric power status of the power
supply unit. However, there is no hint how to improve the
reliability of specific tests regarding sufficient energy.
[0011] U.S. Pat. No. 8,932,250 B2 discloses an insulin infusion
pump comprising a battery. A warning screen is displayed when the
battery in the infusion pump is very low and only has about another
hour of use. However, there is no hint how to improve the
reliability of specific tests regarding sufficient energy.
[0012] European Patent Application No. EP 1 980 851 A2 and
corresponding U.S. Pat. No. 8,315,808 B2 relate to a blood sugar
meter, wherein a notification is displayed when a battery of the
meter is to be replaced. However, there is no hint how to improve
the reliability of specific tests regarding sufficient energy.
[0013] U.S. Pat. No. 8,383,043 B2 discloses a portable sample
analyzer with a disposable fluidic cartridge. The temperature in or
around the sample analyzer may be periodically sensed and sent to a
remote site. However, there is no hint regarding improving
reliability and precision of a test in this regard.
[0014] U.S. Pat. No. 9,090,860 B2 relates to a system which
controls the temperature of biological samples on a support
structure. The temperature of the support structure, the samples,
and/or the complimentary probes may be increased or decreased. The
system is equipped with multiple temperature sensors which are used
to monitor the temperatures of the fluid introduced into, present
in, or exiting from the support structure. However, there is no
hint regarding improving reliability and precision of a test in
this regard.
SUMMARY OF THE INVENTION
[0015] When operated using an energy storage means, such as an
accumulator, the reliability of point-of-care systems depends on
sufficient energy reserves. Furthermore, the conclusiveness of a
test can depend on or be impaired by different ambient
temperatures.
[0016] The problem addressed by the present invention is to provide
a method, a computer program product and an analysis system for
more precisely and/or more reliably testing a sample.
[0017] The above problem is solved by a method and by an analysis
system as described herein.
[0018] The present invention relates in principle to the testing
of, in particular, a biological sample using an analysis system.
The analysis system preferably comprises a cartridge for receiving
the sample. The cartridge preferably comprises a fluid system
having a sensor portion through which fluid can flow. It is
preferable for the analysis system to comprise an analysis device
for receiving the cartridge and subsequently carrying out the test
using the received cartridge.
[0019] The present invention relates in particular to a method for
controlling the analysis device, in particular for preparing and/or
carrying out the test on a sample by means of the analysis device
acting on the cartridge.
[0020] In one aspect of the present invention, before the start of
the testing, the amount of energy remaining in an energy storage
means of the analysis device is compared with an energy requirement
for the testing, and the testing is only started if the amount of
energy meets the energy requirement.
[0021] The analysis device is preferably designed to be operated
autonomously and/or independently of the mains and/or is operated
autonomously or in a manner in which it is separated from mains
power networks. In particular, the analysis device obtains or is
designed to obtain power for the test from an energy storage means
of the analysis device. This makes it possible for the analysis
device to be used in a mobile manner and on site, without it being
necessary to ensure an external power supply for the test.
[0022] It is also preferable for the analysis device and/or the
cartridge and/or different cartridges to support different tests
and/or tests having different energy requirements. In this case, it
is preferable to define the energy requirement according to the
test to be carried out and/or the cartridge to be used. In other
words, the energy requirement is defined and/or is or can be
specified depending on the test to be carried out. This makes it
possible to ensure, individually and according to the test to be
carried out, that said test can be carried out completely using the
amount of energy remaining in the energy storage means. At the same
time, this prevents a test having a lower energy requirement from
also being blocked if the remaining amount of energy only fails to
meet the higher energy requirement of another test.
[0023] In particular, a test in the form of a nucleic-acid assay
and a test in the form of a protein assay can be carried out using
the analysis device, which tests can be differentiated by the
analysis device in terms of the energy requirement. These tests are
examples of different tests that the analysis system, in particular
the analysis device, can support using the same or different
cartridges. In general, the energy consumption is significantly
greater in the nucleic-acid assay than in the protein assay due to
the PCR to be carried out in the former case. It is therefore
possible to carry out a protein assay using a remaining amount of
energy in the energy storage means of the analysis device, whereas
a nucleic-acid assay could not be completely carried out.
Accordingly, in such a case, it can be provided that the protein
assay can be permitted, but not the nucleic-acid assay.
[0024] Preferably, the energy requirement is established, retrieved
or determined using a cartridge identifier that corresponds to the
cartridge. Preferably, the energy requirement is established,
retrieved or determined on the basis of the test to be carried out.
In this case, the test to be carried out is particularly preferably
determined or established using the cartridge identifier that
corresponds to the cartridge, and the energy requirement for this
test is compared with the remaining amount of energy.
[0025] Control information is preferably provided for carrying out
the test. Using the control information, the analysis device can
control procedures/processes on or using the cartridge in order to
carry out the test. In particular, the control information
specifies a sequence in which actuators that act on the cartridge
in order to carry out the test are actuated. It is preferable for
the control information to comprise the energy requirement or for
the energy requirement to be determined using the control
information. In this way, the energy requirement for the specific
test to which the control information corresponds can be
determined, and the start of the test can be enabled and/or blocked
by means of comparison with the remaining amount of energy.
[0026] The control information and/or the energy requirement is/are
preferably identified, determined and/or retrieved using the
identifier that corresponds to the cartridge. This makes it
possible to always determine the energy requirement individually
for the upcoming test, and to then prevent and/or block the start
of the test only if the amount of energy does not meet this energy
requirement.
[0027] Another aspect of the present invention, which can also be
implemented independently, relates to the analysis system for
carrying out the proposed method.
[0028] The analysis system is preferably designed for testing the
in particular biological sample, the analysis system comprising a
cartridge for receiving the sample, and the analysis system
comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received
cartridge.
[0029] The analysis device, preferably together with a control
apparatus, is designed to compare the amount of energy remaining in
an energy storage means of the analysis device with an energy
requirement for the test before the start of the test, and to block
a start of the test if the amount of energy is below the energy
requirement. Alternatively, or additionally, the analysis device is
designed to allow or enable the start of the test if the amount of
energy meets the energy requirement.
[0030] In particular, the analysis device comprises an energy
management module for determining the amount of energy remaining in
the energy storage means. Moreover, the control apparatus is
designed for carrying out the test, in particular for controlling
actuators for acting on the cartridge.
[0031] The energy management module can be configured to determine,
in particular to measure, preferably continuously, the amount of
energy, and to transmit this to the control apparatus.
[0032] The control apparatus can then compare the amount of energy
with the energy requirement, and render the start of the test
dependent on the result of the comparison. It is in particular
provided in this case for the control apparatus to first determine
and/or retrieve the energy requirement for an upcoming test and/or
a specific cartridge, in order to be able to carry out the
comparison for the individual cartridge and/or test.
[0033] Particularly preferably, the energy requirement or control
information comprising the energy requirement or control
information designed for determining or establishing, in particular
calculating, the energy requirement, is stored in a database and
can be identified, retrieved and/or transmitted to the analysis
device on the basis of the cartridge identifier that corresponds to
the cartridge, preferably such that the control apparatus can carry
out the comparison and can allow or block the start of the test
according to the result of the comparison.
[0034] In addition to a sufficient amount of energy, it has been
found that taking account of the device temperature is an essential
criterion for a reliable test.
[0035] Another aspect of the present invention, which can also be
implemented independently, relates to a method for controlling the
analysis device, in which a temperature-control apparatus designed
for (directly) temperature-controlling the cartridge and/or the
sample in the cartridge is controlled depending on an interior
space temperature of the analysis device.
[0036] In view of the fact that the analysis device can be used in
a mobile manner, very different temperatures are possible for the
surroundings, and thus also the interior space of the analysis
device, at the time at which the test is intended to be carried
out. In particular, temperatures below normal or standard room
temperatures of for example 20.degree. C. are possible. In this
regard, in order to carry out the test in a reliable and/or
reproducible manner, it is advantageous to be able to influence the
interior space temperature of the analysis device, in particular to
be able to heat up the interior space of the analysis device. This
can take place without the cartridge, without the cartridge or
sample being inserted into analysis device, and/or before the
testing starts.
[0037] Climate control of the interior space of the analysis device
is in principle possible using heating elements or the like known
in the art. In the present invention, using the temperature-control
apparatus makes it possible, in contrast, to avoid the need for
additional apparatus for climate control of the interior space of
the analysis device, as a result of which the analysis device can
be produced more simply and more cost-effectively. The analysis
device thus preferably comprises a temperature-control apparatus
for temperature-controlling the cartridge, for example in order to
carry out a PCR on the sample in the cartridge. This
temperature-control apparatus is used according to the present
invention for temperature-controlling, in particular heating up,
the interior space.
[0038] Preferably, for this purpose, the interior space temperature
is measured using a temperature sensor that is not directly in
contact with the temperature-control apparatus and/or the
cartridge. In particular, said temperature sensor is arranged not
to get into or is not used in direct thermal contact with the
cartridge and/or is not in contact with said cartridge while/when
measuring the interior space temperature.
[0039] In order to temperature-control the cartridge and/or the
sample, the temperature of the side of the temperature-control
apparatus facing the cartridge is usually measured, and the
temperature is feedback controlled on this basis. This does not
allow any direct control or feedback control of the interior space
temperature. In contrast, in the operating mode according to the
present invention, a temperature sensor that is independent of the
temperature-control apparatus, from the cartridge and/or from the
sample is preferably used for feedback controlling and/or for
providing an actual value for feedback controlling the
temperature-control apparatus.
[0040] The interior space temperature is preferably changed, in
particular increased, using the temperature-control apparatus
before the testing is started, before the cartridge is or can be
inserted into the analysis device and/or before the sample is
conveyed.
[0041] By means of the present aspect, the sample temperature
preferably is not changed or influenced directly. The sample can be
stored in a receiving cavity of the cartridge while the method is
being carried out, which cavity cannot be temperature-controlled
directly by the temperature-control apparatus. In this way, the
interior space temperature can be controlled or feedback controlled
using the temperature-control apparatus, preferably without the
temperature-control apparatus directly changing the temperature of
the sample. It is, however, not impossible for the temperature of
the sample to be indirectly influenced by changing the interior
space temperature, e.g., the air temperature within the analysis
device.
[0042] In other words, a basic concept of this aspect is that the
interior space of the analysis device is preferably heated to a
specified or specifiable value, value range or the like using the
waste heat from the temperature-control apparatus. As a result,
space and costs are saved compared with alternative solutions
having separate apparatus for climate control.
[0043] In this aspect, it is not necessary that the cartridge is
inserted in the analysis device. Rather, the analysis device
preferably is brought to a desired work temperature/interior space
temperature before the cartridge is inserted or insertable.
Alternatively, or additionally, the interior space temperature can
be controlled when the cartridge has already been inserted. In
particular, the analysis device can be pre-heated before insertion
of the cartridge and afterwards the cartridge is inserted or
insertable into the analysis device. Then, the cartridge might warm
up due to the interior space temperature then being the temperature
of the ambient of the inserted cartridge.
[0044] The temperature sensor measuring the interior space
temperature preferably is not in direct contact with cartridge
and/or with a receptacle for the cartridge of the analysis device
and/or with the temperature-control apparatus.
[0045] The ambient space temperature preferably is measured remote
from the cartridge and/or a receptacle for the cartridge of the
analysis device and/or the temperature-control apparatus.
[0046] A temperature threshold value is preferably provided for the
test. If the interior space temperature is or goes below this
temperature threshold value, the temperature-control apparatus is
operated such that the temperature-control apparatus heats the
interior space of the analysis device until the interior space
temperature reaches or exceeds the temperature threshold value.
[0047] It is preferable for the test to only be (enabled to be
automatically) started and/or for the sample to only be conveyed
once the interior space temperature reaches or exceeds the
temperature threshold value in this manner Thus, before the test
has begun, the temperature-control apparatus is operated only in
order to temperature-control, in particular heat up, the interior
space of the analysis device. Subsequently, i.e., during the test,
the temperature-control apparatus can be used for
temperature-controlling the sample.
[0048] On the side remote from the cartridge, the
temperature-control apparatus preferably comprises a heat sink that
is arranged in the interior space of the analysis device and is or
can be heated in order to temperature-control the interior space.
The use of the heat sink allows effective and efficient
temperature-control of the interior space on account of the low
thermal contact resistance between the temperature-control
apparatus and the interior space, which is typically achieved in a
heat sink by material with good thermal conductivity and structures
having a large surface area. The heat sink is preferably heated for
temperature-controlling the interior space of the analysis
device.
[0049] The temperature-control apparatus preferably comprises a
Peltier element, by means of which heat and/or waste heat is or can
be generated and/or the interior space temperature of the analysis
device is or can be controlled.
[0050] In this case, it is preferable for the Peltier element to be
operated cyclically, i.e., having a voltage and/or current profile
that comprises a change of sign, such that the side of the Peltier
element facing the interior space and/or facing away from the
cartridge is alternately cooled and heated. As a result, on account
of the efficiency of the Peltier element, more heat is produced
than cold, and therefore the interior space of the analysis device
can be heated up. The cyclical operation of the Peltier element
furthermore means that the cartridge is not adversely affected
either by being heated too much or by being cooled too much.
[0051] It is alternatively also possible, however, for the Peltier
element to be operated continuously such that it cools on the side
facing the cartridge and heats on the side facing away from the
cartridge. In this case, the interior space is preferably likewise
heated by the waste heat and/or dissipated power of the Peltier
element. It is preferable for the side of the temperature-control
apparatus facing the cartridge not to fall below a specific minimum
temperature, in particular the dew point of the atmosphere in the
interior space of the analysis device, preferably by taking account
of the temperature on the cold side and/or on the side facing the
cartridge when controlling the Peltier element. This prevents the
formation of condensation.
[0052] Alternatively, or additionally, the Peltier element is
operated such that none of the sides falls below 0.degree. C., in
order to prevent icing. The temperature-control apparatus is
preferably controlled or feedback controlled such that the
temperature does not fall below the minimum temperature, in
particular the dew point. This control and/or feedback control can
be implemented, provided or carried out in addition to the control
and/or feedback control of the interior space temperature, in
particular as a secondary condition.
[0053] The test is preferably started only if the interior space
temperature has reached a desired value and/or the temperature
threshold value. It is also preferable for the cartridge to be
returned, using the temperature-control apparatus and before the
start of the test, to a temperature or a temperature range that
allows or does not endanger the test, in particular at least
substantially to the interior space temperature.
[0054] Another aspect of the present invention, which can also be
implemented independently, relates to the analysis system
comprising the analysis device, which is designed to carry out the
method. In particular, the analysis device comprises the
temperature-control apparatus that is designed for
temperature-controlling the cartridge, the analysis device being
designed to control the temperature-control apparatus according to
the interior space temperature of the analysis device, particularly
preferably in the manner explained above.
[0055] 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
method to be implemented. In particular, the computer program
product is designed to control actuators of the analysis system
and/or analysis device in the manner described, a control apparatus
of the analysis device being able to control and/or feedback
control the operation of the temperature-control apparatus using
the program code means, preferably depending on a sensor value from
the temperature sensor for determining the interior space
temperature.
[0056] Moreover, the control apparatus can compare the amount of
energy remaining in the energy storage means with an energy
requirement and enable or block the start of a test depending on
the result using the program code means. The computer program
product preferably is a non-transitory computer-readable media.
[0057] The term "analysis device" is preferably understood to mean
an instrument which is in particular mobile and/or can be used on
site, and/or which 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.
[0058] 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.
[0059] 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.
[0060] The term "test", also called and optionally replaceable with
"testing", as used herein preferably means a test procedure, test
sequence, 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.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] The "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 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 "control information", thus, preferably has
instructions being configured for controlling the assay, test or
test procedure. In particular, the 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.
[0067] 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.
[0068] The above-mentioned aspects and features of the present
invention and aspects and features of the present invention that
will become apparent from the following description can in
principle be implemented independently from one another, but also
in any combination or order.
[0069] 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
[0070] FIG. 1 is a schematic view of a proposed analysis system
and/or analysis device comprising a proposed cartridge received
therein;
[0071] FIG. 2 is a schematic view of the cartridge;
[0072] FIG. 3 is a schematic view of the proposed analysis
system;
[0073] FIG. 4 is another schematic view of the proposed analysis
system; and
[0074] FIG. 5 is a highly schematic detail of the analysis
device.
DETAILED DESCRIPTION OF THE INVENTION
[0075] 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.
[0076] 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.
[0077] 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.
[0078] 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.
[0079] 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.
[0080] The analysis system 1 preferably comprises one or more
cartridges 100 for receiving the sample P. 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.
[0081] By means of the proposed analysis system 1, analysis device
200 and/or the 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.
[0082] 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.
[0083] 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.
[0084] 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.
[0085] 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 or analytes A are thus
produced.
[0086] 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.
[0087] The cartridge 100 is preferably at least substantially
planar, flat, plate-shaped and/or card-shaped.
[0088] 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.
[0089] 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.
[0090] 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.
[0091] 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.
[0092] 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 109, at
least one intermediate temperature-control cavity 110 and/or at
least one collection cavity 111, as shown in FIG. 1 and FIG. 2.
[0093] 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.
[0094] 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.
[0095] 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 109, 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.
[0096] 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.
[0097] 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.
[0098] 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.
[0099] 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.
[0100] The sensor apparatus 113 is used in particular for
detecting, particularly preferably qualitatively and/or
quantitatively determining, the analyte 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.
[0101] 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.
[0102] 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.
[0103] 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.
[0104] 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.
[0105] 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.
[0106] 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.
[0107] 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.
[0108] 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.
[0109] 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.
[0110] 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.
[0111] 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.
[0112] 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 there-through 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.
[0113] 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.
[0114] 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
[0115] 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.
[0116] 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 on the inlet 104B, then
preferably only the valve 115A either at the outlet 104C or at the
intermediate connection 104D is opened.
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] The analysis system 1 or the cartridge 100 preferably
contains all the reagents and liquids required for pretreating 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.
[0124] 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.
[0125] 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.
[0126] 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.
[0127] 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.
[0128] 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.
[0129] 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.
[0130] 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, and/or in the operating position. In this state, the
cartridge 100 is therefore linked to, received by and/or inserted
into the analysis device 200.
[0131] 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.
[0132] The analysis system 1 or analysis device 200 preferably
comprises a mount or receptacle 201 for mounting and/or receiving
the cartridge 100.
[0133] 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.
[0134] It is however provided that the analysis device 200 can be
connected or coupled mechanically, electrically, thermally and/or
pneumatically to the cartridge 100.
[0135] 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.
[0136] 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.
[0137] 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.
[0138] 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.
[0139] Particularly preferably, the pump is constructed as
described in German Patent No. DE 10 2011 015 184 B4 and
corresponding U.S. Pat. No. 8,950,424. However, other structural
solutions are also possible.
[0140] 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.
[0141] 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.
[0142] 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.
[0143] The analysis system 1 or analysis device 200 preferably
comprises one or more temperature-control apparatus 204 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 204 (each) preferably
comprising or being formed by a heating resistor or a Peltier
element.
[0144] 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.
[0145] Preferably, the temperature-control apparatus 204A, 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.
[0146] 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.
[0147] 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.
[0148] Alternatively, each reaction cavity 109A-C can be
temperature-controlled independently and/or individually.
[0149] The temperature-control apparatus 204B, 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.
[0150] 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.
[0151] 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.
[0152] Preferably, the analysis system 1, analysis device 200
and/or the cartridge 100 and/or one or each temperature-control
apparatus 204 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 the temperature.
[0153] 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.
[0154] 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.
[0155] 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.
[0156] The analysis system 1 or analysis device 200 preferably
comprises a control apparatus 207 for controlling the
sequence/procedure of a test or assay and/or for collecting,
evaluating and/or outputting or providing measured values in
particular from the sensor apparatus 113, and/or test results
and/or other data or values.
[0157] The control apparatus 207 preferably comprises an internal
clock or time base by means of which the sequence/procedure of the
test is or can be controlled and/or by means of which test steps
that temporally follow one another or that extend over time are
controlled or can be controlled by the control apparatus 207.
[0158] 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.
[0159] The analysis system 1 or analysis device 200 preferably
comprises one or more sensors 206A-H.
[0160] In particular, one or more fluid sensors 206A are designed
or provided to detect liquid fronts and/or flows of fluid in the
fluid system 103.
[0161] 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.
[0162] The fluid sensor or sensors 206A preferably measure a fluid
or a liquid 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.
[0163] 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.
[0164] 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 control 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
[0165] 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.
[0166] Alternatively, or additionally, the analysis device 200
preferably comprises one or more (different, other and/or further)
sensors 206B-206H which preferably generate or are designed to
generate measurement results 706A-H.
[0167] The further sensor 206B can be a pressure sensor for
determining the (relative) air pressure.
[0168] 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.
[0169] Alternatively, or additionally, one or more temperature
sensors 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-control apparatus 204.
[0170] 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.
[0171] 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.
[0172] 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.
[0173] 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.
[0174] 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.
[0175] The control apparatus 207 controls or is designed to control
the test and/or the actuators, preferably using or taking into
account one or more of the measurement results 706A-706H from the
sensors 206A-206H. In this case, the control apparatus 207
preferably controls or feedback controls the actuators of the
analysis device 200 in such a way that said actuators act on the
cartridge 100 in order for the test to be carried out. In
particular, the control apparatus 207 controls the pump drive 202,
the temperature-control apparatus 204 and/or the valve actuators
205, in particular taking into account or depending on one or more
of the measurement results 706A-706H from the sensors
206A-206H.
[0176] The flows of fluid are controlled in particular by
accordingly activating the pump or pump apparatus 112 and actuating
the valves 115A, 115B. 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.
[0177] 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.
[0178] 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.
[0179] 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/measurement
results 713 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.
[0180] 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. Preferably, an integrated accumulator is
provided as a power supply 211 and can be (re)charged by an
external and/or internal charging device (not shown) via a
connection 211A and/or is interchangeable.
[0181] 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.
[0182] 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.
[0183] 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.
[0184] 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.
[0185] 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.
[0186] Preferably, the working medium can be compressed and/or
pressurized in the analysis device 200 or by means of the analysis
device 200.
[0187] 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.
[0188] 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.
[0189] 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.
[0190] 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.
[0191] 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.
[0192] 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.
[0193] 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.
[0194] 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.
[0195] 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.
[0196] 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.
[0197] The operating instrument 400 is preferably designed to
control the analysis device 200. Alternatively, or additionally,
the operating instrument 400 can receive or retrieve 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.
[0198] The term "operating instrument" is preferably understood to
mean an apparatus by means of which the analysis device 200 can be
controlled, control information 510 can be transmitted to the
analysis device 200, and/or measurement results 713 can be received
from the analysis device 200 and/or measurement results 713 can be
evaluated. Preferably, the operating instrument 400 is or forms a
user interface for controlling the test and/or the evaluation or
outputting of measurement results 713.
[0199] The operating instrument 400 can alternatively be called
operator control instrument. The operating instrument 400
preferably is configured to be operated by an operator (user) for
controlling, in particular of the analysis device 200, the test
and/or the evaluation. Thus, the operating instrument 400 is or
comprises a user interface for input of commands and transfer of
pieces of control information 510 to the analysis device 200.
[0200] The operating instrument 400 preferably comprises an input
apparatus 420 for controlling the analysis device 200, for
controlling data transmission and/or for controlling the evaluation
of measurement results 713. Alternatively, or additionally, the
operating instrument 400 comprises an output apparatus 410 for
outputting, in particular displaying, information, in particular
status information, operating elements and/or results. The
operating instrument 400 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.
[0201] Particularly preferably, the operating instrument 400 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 400 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 200. The
operating instrument 400 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.
[0202] 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. 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.
[0203] 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.
[0204] Particularly preferably, the operating instrument 400
comprises an interface 430 for establishing data connections DVA,
DVD.
[0205] 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.
[0206] 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.
[0207] 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.
[0208] 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 control information 510 to be
received and/or accepted or to be acceptable and/or receivable
and/or for measurement results 713, in particular measurement
results 713 from the sensor apparatus 113, 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.
[0209] The analysis device 200 preferably comprises a receiver 210A
for, preferably wirelessly, receiving the control information 510
from the operating instrument 400. Preferably, the interface 210
comprises the receiver 210A, via which signals, in particular
control information 510, are or can be received from the operating
instrument 400.
[0210] 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.
[0211] 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.
[0212] 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.
[0213] 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.
[0214] The analysis system 1, in particular the database 500,
preferably comprises control information 510 by means of which the
analysis device 200 can be controlled in order to carry out a
testing (test procedure/assay).
[0215] The control information 510 preferably defines 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 the control information 510 such that said
actuators act on the cartridge 100 and/or the sample P, in
particular in a manner dependent on the specific cartridge 100, on
a cartridge batch of the specific cartridge 100 and/or on the
specific test.
[0216] Preferably, the analysis system 1 comprises calibration
information 520 that can be stored in the database 500 and/or can
be retrieved from the database 500. The calibration information 520
is 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.
[0217] The calibration information 520 is 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.
[0218] Calibration information 520 can be used in addition to
control information 510 for carrying out the test, the calibration
information 520 preferably influencing or specifying the control
information 510. The calibration information 520 can be or can form
the control information 510 or a part of the control information
510, even if this is not explicitly mentioned in the following.
[0219] The analysis device 200 can be calibrated and/or configured
by calibration information 520 that can form part of the control
information 510 or can be provided separately. For this purpose,
the calibration information 520 can be determined, retrieved and/or
transmitted to the analysis device 200 by means of the operating
instrument 400.
[0220] In one example, fluid sensor calibration information 521 is
provided which influences setting and/or evaluation of the fluid
sensor 206A. The fluid sensor calibration information 521 is
preferably dependent on the test to be carried out, the phase of
the test and/or effects on the fluid sensor 206A of a content
change in a sensor portion 116 that are to be expected in the test
sequence, and/or contains different specifications which are
dependent thereon.
[0221] Alternatively, or additionally, 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.
[0222] Alternatively, or additionally, 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 sensor
arrangement calibration information 528 is 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 sensor arrangement calibration
information 528.
[0223] The proposed analysis system 1 preferably comprises
evaluation information 530 which is in particular stored in the
database 500 and/or is retrievable or can be retrieved from the
database 500. The evaluation information 530 is preferably designed
to be able to interpret measurement results 713 that originate from
the cartridge 100, in particular from the sensor apparatus 113. For
this purpose, measurement results 713 originating from the sensor
apparatus 113 can be transmitted via a data connection DVC to the
analysis device 200, which preferably transmits the measurement
results 713 to the operating instrument 400 for evaluation.
[0224] The control information 510 and/or the evaluation
information 530 particularly preferably comprises 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.
[0225] 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
an (in particular exchangeable) module of the operating instrument
400 and/or of the analysis device 200. 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. For this purpose, the control
information 510 and/or the evaluation information 530 can comprise
a (software) interface for coupling or implementation by the
control apparatus 207 and/or an evaluation module 440, in
particular of the operating instrument 400.
[0226] 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 calibration
information 520. Alternatively, the control information 510 and/or
evaluation information 530 can however also merely comprise
parameters and/or other information for the control and/or
evaluation.
[0227] The 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 originating from the sensor apparatus 113
are evaluated using the evaluation information 530 and/or the
evaluation module 440 is designed for this purpose.
[0228] Evaluation results 740 can preferably be generated by
evaluating the measurement results 713, in particular by means of
evaluation using the evaluation information 530.
[0229] The database 500 preferably comprises a results memory 550
in which results, in particular the measurement results 713 and/or
evaluation results 740, can be stored and/or saved.
[0230] 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 subdatabases.
[0231] In order to control the test and/or the analysis device 200,
the operating instrument 400 can retrieve control information 510
from the database 500 and transmit said information to the analysis
device 200 in unaltered or altered form.
[0232] The operating instrument 400 is preferably designed to
evaluate the measurement results 713 by means of the evaluation
module 740 or in another manner, which measurement results 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 result 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 evaluation information 530 from the database 500 and,
using this evaluation information 530, evaluate the measurement
results 713, in particular in the evaluation module 440 of the
operating instrument 400.
[0233] The operating instrument 400 preferably comprises a memory
450. The memory 450 can be used to store, at least temporarily,
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, the measurement results 713 and/or the 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.
[0234] 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.
[0235] 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
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.
[0236] Preferably, the transmission of commands and/or information
to the analysis device 200 is triggered via the input apparatus 420
or can be triggered by the input apparatus 420. In particular,
transmission of the 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, preferably
by means of a command received via the input apparatus 420, in
order to start the test.
[0237] The operating instrument 400 is preferably designed to
transmit, to the analysis device 200, control information 510 for
receiving or ejecting the cartridge 100. In this case, a cartridge
100 can in particular be accordingly controlled 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 optionally eject said cartridge or block a test if an
error, such as incompatibility, is detected.
[0238] Alternatively, or additionally, the operating instrument 400
is designed to transmit a command for starting the test to the
analysis device 200. The test is preferably started only by the
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.
[0239] 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.
[0240] 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.
[0241] 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 identical 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.
[0242] 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.
[0243] 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.
[0244] The analysis system 1 can comprise one or a plurality of
cartridges 100 which each can preferably be distinguished from one
another by means of at least one cartridge identifier 100C and/or
which are assigned to a batch.
[0245] Alternatively, or additionally, 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.
[0246] 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.
[0247] The cartridge identifier 100C is preferably used for
determining, identifying and/or retrieving the control information
510, calibration information 520 and/or evaluation information 530.
For this purpose, the cartridge identifier 100C can be transmitted
to the database 500, whereupon the database 500 identifies and/or
sends back the control information 510, calibration information 520
and/or evaluation information 530. In principle, however, other
mechanisms are also possible, by means of which the control
information 510, calibration information 520 and/or evaluation
information 530 is identified, determined and/or retrieved on the
basis of the cartridge identifier 100C.
[0248] Preferably, the cartridge identifier 100C is determined
and/or read out by the operating instrument 400. Furthermore, the
control information 510, the calibration information 520 and/or the
evaluation information 530 is preferably retrieved using or by the
operating instrument 400. The operating instrument 400 can
preferably subsequently transmit the control information 510 for
carrying out the test to the analysis device 200 and/or can
evaluate the measurement results 713 on the basis of the evaluation
information 530.
[0249] The operating instrument 400 can read out the cartridge
identifier 100C from the memory means 100D directly, preferably
wirelessly, in particular optically. Alternatively or additionally,
the cartridge identifier 100C can be transmitted to the operating
instrument 400 by the analysis device 200 that has previously
received the cartridge identifier 100C from the cartridge 100,
preferably in a wired manner, in particular read out said
identifier, in particular via a wired data connection DVC.
[0250] FIG. 4 is another schematic view of the proposed analysis
system 1 for testing the in particular biological sample P.
[0251] The analysis system 1 comprises the cartridge 100 for
receiving the sample P. Furthermore, the analysis system 1
comprises the analysis device 200 for receiving the cartridge 100
and subsequently carrying out the test using the received cartridge
100.
[0252] As shown schematically in FIG. 4, in one aspect, which can
also be implemented independently, the analysis device 200
preferably comprises the energy storage means 211B. The energy
storage means 211B is preferably designed to store and output
electrical energy. Said storage means 211B is in particular an
accumulator, a battery, a capacitor or the like.
[0253] An energy management module 211C is preferably associated
with the energy storage means 211B. The energy storage means 211B
is in particular connected to the energy management module
211C.
[0254] The energy management module 211C is designed to determine,
to calculate, to estimate and/or to measure the amount of energy
711C contained in the energy storage means 211B. In particular, the
energy management module 211C is designed to measure an electrical
voltage that is present at the energy storage means 211B and/or
electrical currents flowing into or out of the energy storage means
211B. The energy management module 211C can then determine the
charge state and/or the amount of energy 711C contained in the
energy storage means 211B from the measured values or in another
manner
[0255] FIG. 4 also schematically shows the control apparatus 207 of
the analysis device 200. The control apparatus 207 is preferably
designed to control and/or to feedback control and/or to supply
electricity to actuators of the analysis device 200, in particular
the temperature-control apparatus 204, which is shown merely as an
example in FIG. 4.
[0256] Particularly preferably, the control apparatus 207 is
designed to enable and/or to cause the test to be started and/or
the actuators for testing the sample P to be controlled only
provided that the amount of energy 711C remaining in the energy
storage means 211B meets or exceeds an energy requirement 510D for
the test.
[0257] Alternatively, or additionally, the control apparatus 207 is
designed to stop, to block and/or to omit the start of the test
and/or the control of actuators for carrying out the test if the
amount of energy 711C remaining in the energy storage means 211B is
below the energy requirement 510D.
[0258] The charge state of the energy storage means 211B and the
amount of energy 711C contained in the energy storage means 211B
preferably correspond to one another, it also being possible for
the amount of energy 711C to be understood as or replaced by the
charge state. Within the meaning of the present invention, the term
"amount of energy 711C" should therefore preferably be understood
in a broad sense and includes the charge state or a value
corresponding thereto that can optionally be expressed in
ampere-hours (when the voltage is specified) or watt-hours or a
percentage with respect to the capacity of the energy storage means
211B, or the like.
[0259] The energy requirement 510D preferably corresponds to a
desired charge state and/or desired value or minimum value for the
charge state, or can be understood as such or replaced thereby, in
particular in order for it to be possible to carry out the or a
specific test. Within the meaning of the present invention, the
term " energy requirement 510D" should therefore preferably be
understood in a broad sense and includes a requirement for
electrical energy or a desired charge state corresponding thereto
or a value corresponding thereto that can optionally be expressed
in ampere-hours (when the voltage is specified) or watt-hours or a
percentage with respect to the capacity of the energy storage means
211B, or the like.
[0260] In other words, the test is therefore preferably enabled or
triggered only if the charge state reaches or exceeds the desired
charge state and/or the desired value or minimum value for the
charge state, and/or the test is blocked if the charge state is
below the desired charge state and/or the desired value or minimum
value for the charge state.
[0261] For the sake of clarity, in the following the invention will
always be described on the basis of the amount of energy 711C and
the energy requirement 510D.
[0262] The amount of energy 711C is preferably determined by the
energy management module 211C and/or provided as a value or
electrically. Alternatively or additionally, the control apparatus
207 can determine or retrieve the amount of energy 711C, preferably
using or from the energy management module 211C.
[0263] The analysis device 200, preferably the control apparatus
207, is preferably designed to receive or retrieve the energy
requirement 510D as part of or separately from the control
information 510. The energy requirement 510D is particularly
preferably retrieved from the database 500 and/or by the operating
instrument 400 and/or via the operating instrument 400 and/or can
be transmitted to the analysis device 200 and/or the control
apparatus 207.
[0264] For details regarding retrieving and/or receiving the
control information 510, reference is made to the preceding
explanations, the aspects explained for the control information 510
also being correspondingly applicable or transferrable to the
energy requirement 510D, regardless of whether the energy
requirement 510D is provided separately or as part of the control
information 510.
[0265] Particularly preferably, the operating instrument 400
retrieves the energy requirement 510D from the database 500 and
transmits the energy requirement 510D to the analysis device 200,
in particular the control apparatus 207, in order to make possible
the comparison with the remaining amount of energy 711C.
Alternatively, or additionally, the amount to energy 711C can be
provided to the operating instrument 400 which determines, e.g., by
comparison with the energy requirement 510D, whether the remaining
amount of energy 711C exceeds the energy requirement 510D. Then,
the operating instrument sends only under the condition that the
remaining amount of energy 711C exceeds the energy requirement the
start command and/or control information 510 to the analysis device
200 or starts the testing by this or a different measure.
[0266] For this purpose, the operating instrument 400 can determine
or receive the cartridge identifier 100C of the cartridge 100 and
can retrieve the energy requirement 510D corresponding to the
cartridge 100 or to the test supported by the cartridge 100 from
the database 500 using the cartridge identifier 100C. This energy
requirement 510D that corresponds to the cartridge 100 and/or test
is then used by the analysis device 200 in the manner described in
order to start the test and/or to block or enable the start of the
test.
[0267] The analysis device 200, in particular the control apparatus
207, can furthermore render the start of the test dependent on a
measurement result from one or more of the sensors 206A-H that
is/are preferably designed to detect environmental and/or boundary
conditions that relate to the analysis device 200. These include in
particular temperature and/or inclination and/or acceleration
and/or atmospheric humidity and/or position and/or the (correct)
alignment of the cartridge 100 in the analysis device 200.
[0268] The energy requirement 510D can correspond to one or more
specific tests, to a group of tests or to one or more, preferably
different, cartridges 100 or tests using one or more cartridges
100. The energy requirement 510D is preferably specified or defined
for the test that is to be carried out and/or for the cartridge 100
that is to be used, or is specified or defined depending on the
test to be carried out and/or the cartridge 100 or batch used, for
example as a value, indicator or the like.
[0269] The energy requirement 510D can be received, determined or
calculated by the analysis device 200. The energy requirement 510D
can be stored or, in particular as described above, received in a
memory 207A of the analysis device 200.
[0270] In a preferred variant, the control apparatus 207 or the
operating instrument 400 can determine or estimate the energy
requirement 510D from the control information 510.
[0271] The energy requirement 510D is preferably compared with the
amount of energy 711C, in particular by the analysis device 200,
the control apparatus 207 and/or the operating instrument 400. For
this purpose, it is possible for the energy requirement 510D and/or
the amount of energy 711C to be transmitted to the operating
instrument 400 and compared thereby with the amount of energy 711C.
In principle, however, the comparison can also be carried out in
another manner
[0272] The test can be enabled or blocked using the result of the
comparison of the energy requirement 510D with the amount of energy
711C. Alternatively or additionally, it is possible for the result
to be output. In this case, the result can be output, in particular
displayed, in particular by means of the operating instrument 400
or another user interface, as a value, symbol, graphic and/or as a
recommendation for action or a user guidance instruction, animation
or the like. In particular, the need to establish a connection to
the energy network, the need to charge the energy storage means
211B and/or the need to exchange the energy storage means 211B is
output or signaled.
[0273] Even when the analysis device 200 is connected to the mains
power supply network, the test is preferably still only started or
enabled if the test could also be carried out solely using the
amount of energy 711C remaining in the energy storage means 211B.
Following connection to the energy supply network, the test is
therefore nonetheless enabled or started (in particular
automatically) only if or as soon as the amount of energy 711C
meets the energy requirement 510D. This ensures that the test can
be completed even if there is an interruption in the external power
supply.
[0274] Another aspect of the present invention, which can also be
implemented independently, relates to the climate control of the
analysis device 200. On account of its, in particular biological,
nature, the test in particular requires boundary conditions such as
temperature to be adhered to. In this case, the analysis system 1
is preferably designed to carry out the test at a temperature of
the cartridge 100 and/or the analysis device 200 that is above
(normal) room temperature of for example 20.degree. C.
[0275] FIG. 5 is a highly schematic detail of the analysis device
200, in which the cartridge 100, the control apparatus 207 and at
least one temperature-control apparatus 204 are arranged.
[0276] The temperature-control apparatus 204 is arranged inside the
analysis device 200, i.e., is located in an interior space 212A of
the analysis device 200, which space 212A is preferably delimited
by the housing 212 of the analysis device 200.
[0277] The temperature-control apparatus 204 or a plurality of
temperature control apparatus 204 is/are, as already explained in
particular in conjunction with FIG. 1, designed for
temperature-controlling the cartridge 100 and/or the sample P.
[0278] The temperature-control apparatus 204 is in particular
designed or used to temperature-control a sample P located in the
cartridge 100 and/or a fluid or other parts of the fluid system 103
of the cartridge 100 by being in direct contact with the cartridge
100.
[0279] In order to temperature-control the cartridge 100, a part of
the temperature-control apparatus 204 that is in contact with or
positioned against the cartridge 100 can be brought, in particular
feedback controlled, to a specifiable temperature, in particular by
means of the control apparatus 207. The temperature is transmitted
to the cartridge 100 via the thermal coupling and can thus
temperature-control the sample P, another fluid or other contents
of the cartridge 100. For this purpose, the temperature-control
apparatus 204 is spring-loaded or can be brought into direct
contact with or positioned against the cartridge 100 in another
manner during or following loading or insertion of the cartridge
100 into the analysis device 200.
[0280] The temperature-control apparatus 204 preferably comprises a
temperature sensor 204F which, in the example shown, is provided on
the side of the temperature-control apparatus 204 facing the
cartridge 100, in particular is thermally connected to a Peltier
element 204E or to another heating and/or cooling apparatus of the
temperature-control apparatus 204, and/or is produced using
thin-film technology.
[0281] Measured values from this temperature sensor 204F of the
temperature-control apparatus 204 can be used to feedback control,
in a control-loop system, the temperature at which the
temperature-control apparatus 204 acts on the cartridge 100. For
this purpose, the control apparatus 207 and/or the analysis device
200 may comprise a feedback-control apparatus 204G that determines
the temperature of the temperature-control apparatus 204 using the
temperature sensor 204F and feedback controls the Peltier element
204E or the other heating and/or cooling apparatus to a desired
value. This can be achieved by the temperature measured by the
temperature sensor 204F being compared, as an actual value, with
the desired value for the temperature of the cartridge 100 and/or
of the sample P, and the current and/or the voltage at the Peltier
element 204E, or the power supply of the other heating and/or
cooling apparatus, being feedback controlled as the manipulated
variable. However, in principle, other solutions are also possible
here. The temperature feedback control using the temperature sensor
204F of the temperature-control apparatus 204 is optional in the
present aspect.
[0282] In the example shown, the temperature-control apparatus 204
comprises a thermal coupling element 204H that facilitates direct
thermal connection of the temperature-control apparatus 204 to the
cartridge 100. This may be a thermally conductive pad or the like.
The temperature sensor 204F can be formed below, on and/or in the
thermal coupling element 204H.
[0283] In the example shown, the temperature-control apparatus 204
comprises a heat sink 204D on the side facing away from the
cartridge 100 in order to be able to conduct away or remove waste
heat from the temperature-control apparatus 204. For this purpose,
the heat sink 204D preferably comprises rib-like and/or bar-like
structures for increasing the effective surface area for emitting
heat W.
[0284] The control apparatus 207 is preferably designed to control
and/or to feedback control the temperature-control apparatus
204.
[0285] In one aspect of the present invention, which can also be
implemented independently, one or more temperature-control
apparatus 204 designed for temperature-controlling the cartridge
100 is or are controlled depending on an interior space temperature
of the analysis device 200, and/or the analysis device 200 is
designed for this purpose.
[0286] In the example shown in FIG. 5, the analysis device 200
comprises a temperature sensor 206C that measures or can measure a
temperature of the interior space 212A of the analysis device 200
as the interior space temperature. The interior space temperature
is in particular an average and/or air temperature of the interior
space 212A.
[0287] The temperature sensor 204F of the temperature-control
apparatus 204 is preferably implemented or provided so as to be
separated and/or thermally decoupled from a temperature sensor 206C
for determining the interior space temperature.
[0288] The temperature sensor 206C for determining the interior
space temperature is preferably thermally decoupled from both the
temperature-control apparatus 204 and the cartridge 100 and/or
preferably measures the air temperature and/or interior space
temperature of the analysis device 200 or is designed, set up
and/or arranged for this purpose. In other words, the temperature
sensor 206C for determining the interior space temperature of the
analysis device 200 is not in direct contact, in particular
mechanically and/or thermally, with the temperature-control
apparatus 204 and/or the cartridge 100.
[0289] Preferably, the temperature sensor 206C is separated from,
spaced apart from, thermally decoupled from, and/or not in direct
contact, in particular mechanically and/or thermally, with the
temperature-control apparatus 204 and/or the cartridge 100, in
particular during or at least during the determination or
measurement of the interior space temperature.
[0290] The temperature sensor 206C is preferably designed and/or
set up to generate, in particular to measure, the actual value of a
feedback control for a temperature of the interior space 212A of
the analysis device 200. For this purpose, the temperature sensor
206C is preferably in principle spaced apart from and/or thermally
decoupled from heat sources of the analysis device 200.
[0291] In the example shown, the temperature sensor 206C is spaced
apart from the temperature-control apparatus 204, including the
heat sink 204D, and from the cartridge 100, so that heat W or cold
generated by the temperature-control apparatus 204 only indirectly
reaches or can reach the interior space 212A via air and/or the
temperature sensor 206C via thermal radiation.
[0292] A plurality of temperature sensors 206C and/or a plurality
of temperature-control apparatus 204 may also be provided, which
are each thermally decoupled from one another. In this case, an
average temperature can be formed as or can function as the actual
value.
[0293] The temperature-control apparatus 204 that is designed for
temperature-controlling the cartridge 100 is preferably controlled,
in particular feedback controlled, depending on the interior space
temperature of the analysis device 200. In other words, the
temperature-control apparatus 204 is used other than intended and,
instead of being used for temperature-controlling the cartridge
100, the sample P and/or the fluid system 103, the
temperature-control apparatus 204 is or the or all the
temperature-control apparatus 204 are used for
temperature-controlling the interior space 212A, by the interior
space temperature being used for the control and/or feedback
control. In this case, waste heat is preferably generated by the
temperature-control apparatus 204, by means of which the interior
space 212A of the analysis device 200 is heated in order to achieve
a desired interior space temperature for carrying out the test.
[0294] The analysis system 1 is preferably designed such that the
test is or can be carried out at temperatures above (normal) room
temperature, in particular at over 20.degree. C., preferably over
25.degree. C. or 30.degree. C., in particular over 35.degree. C.,
and/or below 60.degree. C., preferably below 55.degree. C. or
50.degree. C. A particularly preferred temperature range for the
interior space temperature is between 25.degree. C. and 35.degree.
C. This design makes it possible for the analysis system 1 to be
used in a highly universal manner, since cooling of the interior
space 212A is generally not required, and the interior space 212A
can be heated in a simple, cost-effective and resource-saving
manner using the proposed method.
[0295] Since the temperature-control apparatus 204 required and/or
already provided for temperature-controlling the cartridge 100
is/are used for temperature-controlling the interior space 212A,
additional climate-control apparatus are not required. This is
particularly advantageously the case in combination with the
analysis system 1 designed or set up for carrying out the test at
the interior space temperatures described.
[0296] In the example shown, the interior space temperature of the
analysis device 200 is controlled, preferably feedback controlled,
by the control apparatus 207. In this case, the control apparatus
207 receives the interior space temperature and/or a corresponding
measurement result 706C from the temperature sensor 206C, compares
said temperature/result with a desired value, i.e., a specified or
specifiable interior space temperature, particularly preferably in
the form of a temperature threshold value 529, referred to in the
following as a temperature threshold value 529. The feedback
control can also be implemented in another manner, however.
[0297] The interior space temperature is preferably changed, in
particular increased, to the temperature threshold value 529. This
can be achieved in the described manner by heating the interior
space 212A using waste heat from the temperature-control apparatus
204. In principle, however, another climate-control and/or heating
element, in particular a resistive heater, a refrigerating machine
or the like, can be provided alternatively or in addition.
[0298] The interior space temperature is changed, in particular
increased, preferably using the temperature-control apparatus 204,
before the test is started and/or before the sample P is conveyed
on the cartridge 100. This makes it possible for the test to always
be carried out under suitable climatic conditions, which is
conducive to the reliability of the test.
[0299] The control apparatus 207 can feedback control the interior
space temperature by means of a desired value/actual value
comparison. In this case, upon identification of an interior space
temperature that is below the temperature threshold value 529, the
temperature-control apparatus 204 can be operated such that the
temperature-control apparatus 204 heats the interior space 212A of
the analysis device 200 until the interior space temperature
reaches or exceeds the temperature threshold value 529.
[0300] The test is preferably only started and/or the sample P is
preferably only conveyed and/or treated on the cartridge 100 if the
interior space temperature of the interior space 212A has reached
or exceeded the temperature threshold value 529, and/or the
analysis device 200 is designed for this purpose. In other words,
the test or the start of the test is preferably prevented and/or
blocked until the temperature threshold value 529 has been reached
or exceeded.
[0301] Particularly preferably, the temperature threshold value 529
is or can be defined and/or stored according to or individually for
a specific test and/or cartridge 100, or the analysis system 1 is
designed for this purpose. There can therefore be different
temperature threshold values 529 for different cartridges 100
and/or tests, the values 529 being determined, retrieved and/or
used depending on or according to the test to be carried out and/or
the cartridge 100 to be used.
[0302] The temperature threshold value 529 can be part of the
control information 510 or calibration information 520. The
temperature threshold value 529 can be stored, determined,
retrieved and transmitted, etc., as part of the control information
510 or calibration information 520, in particular as described
above, or can be provided separately from the control information
510 and/or calibration information 530. The explanations in this
regard therefore apply accordingly to the temperature threshold
value 529 per se and as part of the calibration information 520 or
the control information 510.
[0303] In particular, the temperature threshold value 529 can be
stored in the database 500 and/or can be retrieved from the
database 500. The method and the apparatus preferably used therefor
are preferably the same as those for retrieving and/or receiving
the control information 510 and/or the energy requirement 510D, as
described in conjunction with FIGS. 3 and 4.
[0304] With respect to the temperature threshold value 529, it is
therefore also preferable for the operating instrument 400 to
identify said value using the cartridge identifier 100C and/or to
retrieve said value from the database 500, and to transmit said
value to the analysis device 200, in particular the control device
207 and/or via the interface 210. Alternatively, the operating
instrument can receive the interior space temperature and compares
it with the temperature threshold value 529. Only if this
temperature threshold value 529 exceeded by the interior space
temperature, a start command is or can be transmitted from the
operating instrument 400 to the analysis device 200 for starting
the test.
[0305] Alternatively, or additionally, temperature threshold values
529 could, however, also be stored in advance for different
cartridges 100 and/or analysis devices 200, in particular saved in
the memory 207A of the analysis device 200. Said threshold values
529 can be identified while or by means of loading the cartridge
100 and can be used for controlling, feedback controlling and/or
setting the interior space temperature.
[0306] In principle, the temperature-control of the interior space
212A can also be carried out, deviating from the
temperature-control apparatus 204, using another climate-control
apparatus by means of the desired value/actual value comparison
and/or by means of the control apparatus 207 on the basis of the
temperature threshold value 529.
[0307] The aspect whereby the temperature of the interior space
212A is feedback controlled to the temperature threshold value 529
or controlled using the temperature threshold value 529 that is
stored in the database 500, retrieved by the operating instrument
400, determined by the cartridge identifier 100C and/or transmitted
to the analysis device 200 and preferably used for feedback
controlling a temperature of the analysis device 200 is therefore
also achievable and advantageous independently of the
temperature-control of the interior space 212A, using one or more
of the temperature-control apparatus 204.
[0308] For the sake of simplicity, however, in the following the
method for temperature-controlling the interior space 212A is
described merely in conjunction with the temperature-control
apparatus 204 that is preferably used for temperature-controlling,
in particular heating, the interior space 212A.
[0309] The temperature threshold value 529 can also be/comprise a
desired temperature value and/or a desired temperature range. The
interior space temperature can be feedback controlled, in
particular by feedback controlling an addition of heat inside the
analysis device 200 depending on the interior space temperature
and/or the measured value 706C from the temperature sensor
206C.
[0310] In one aspect, the temperature-control apparatus 204, the
Peltier element 204E of the temperature-control apparatus 204,
and/or the interior space temperature is/are controlled, in
particular feedback controlled, by operating the Peltier element
204E cyclically. This is preferably intended to mean that an
alternating current, i.e., a current having a change of sign, is
applied to the Peltier element 204E, and/or the Peltier element
204E is operated with alternating polarities such that the same
side of the Peltier element 204E is alternately heated and cooled.
In this case, overall, on account of the finite efficiency which,
in Peltier elements 204E, is usually approximately 50%, waste heat
is generated that causes the interior space 212A to be heated.
[0311] The cyclical operation of the Peltier element 204E means
that the Peltier element 204E, which is preferably already in
contact with the cartridge 100 and/or thermally coupled to the
cartridge 100, and/or the temperature-control apparatus 204 does
not overheat and/or excessively cool the cartridge 100.
[0312] It is possible, in principle, for Peltier elements 204E to
be able to generate temperatures or temperature differences of over
40.degree. C. for example. It is therefore conceivable for the
cartridge 100 to fall below the dew point or freezing point, to
become brittle and/or to be overheated, to melt or to be damaged in
another manner or, in any case, to be adversely affected, when the
temperature-control apparatus 204 is being used for
temperature-controlling the interior space 212A. The cyclical
actuation of the Peltier element 204E makes it possible for the
temperatures of the cartridge 100 to remain in an acceptable
range.
[0313] At the same time, however, the temperature-control apparatus
204 is also supplied with as much energy as possible in order to
maximize the waste heat. As an alternative or in addition to the
cyclical operating mode, it is also preferable here to cool the
cartridge 100 relative to the interior space temperature, in
particular substantially constantly and/or to a constant
temperature, using the temperature-control apparatus 204. In this
case, heat is returned to the cartridge 100 via the interior space
212A, which results in the cooled side of the temperature-control
apparatus 204 facing the cartridge 100 to be heated, which leads to
an increased generation of heat and/or a stronger heating of the
side of the temperature-control apparatus 204 remote from the
cartridge 100, and thus supports or facilitates the generated
amount of heat W and thus rapid heating of the interior space
212A.
[0314] Alternatively, or additionally, the temperature-control
apparatus 204 is feedback controlled or controlled such that the
side of the temperature-control apparatus 204 facing the cartridge
does not leave a specific temperature range. In particular, a
minimum temperature and/or maximum temperature can be specified or
provided.
[0315] The temperature-control apparatus 204 can be feedback
controlled such that in particular the side facing the cartridge
100 does not fall below the minimum temperature. The minimum
temperature may correspond to the dew point of the atmosphere in
the interior space 212A of the analysis device 200 or may take
account of this dew point. The dew point can be determined using
the temperature sensor 206C and/or the (atmospheric) humidity
sensor 206F, in particular by means of the analysis device 200.
This prevents the formation of condensation. Alternatively, or
additionally, the Peltier element 204E is operated such that none
of the sides falls below 0.degree. C., in order to prevent
icing.
[0316] Alternatively, or additionally, the temperature-control
apparatus 204 can be feedback controlled such that in particular
the side facing the cartridge 100 does not exceed the maximum
temperature. The maximum temperature may take account of the
structure of and/or the materials used in the cartridge 100. The
maximum temperature is preferably selected such that the cartridge
100 is not damaged.
[0317] The minimum temperature and/or maximum temperature can be
part or form part of the control information 510 and/or calibration
information 520, or can be processed in a corresponding manner
and/or can have corresponding properties, as described above.
[0318] This control and/or feedback control can be carried out by
the temperature-control apparatus 204 in addition to the control
and/or feedback control of the interior space temperature, in
particular as a boundary condition or boundary conditions for
feedback controlling the interior space temperature.
[0319] For temperature-controlling the sample P, the
temperature-control apparatus 204 is preferably operated such that
the side of the temperature-control apparatus 204 coupled to the
cartridge 100 heats the cartridge 100 and cools the heat sink 204D,
whereas, in order to temperature-control, in particular heat, the
interior space 212A, the temperature-control apparatus 204 is
preferably operated such that the cartridge 100 is cooled and the
heat sink 204D is heated, particularly preferably on average or
with a mean value during varied operation and/or during varied
control of the temperature-control apparatus 204. The cartridge 100
is therefore preferably cooled to below the interior space
temperature in order to temperature-control the interior space
212A.
[0320] Alternatively, or additionally, it is in principle also
possible for the temperature-control apparatus 204 to be controlled
such that the cartridge 100 is heated and, consequently, the heat
sink 204D is cooled. In this case too, overall, on account of the
dissipated power of the Peltier element 204E, more heat is
generated than cold, as a result of which the interior space
temperature can be increased overall. On account of the minimal
coupling of the region of the cartridge 100 temperature-controlled
by the temperature-control apparatus 204 to the surroundings, i.e.,
the interior space 212A, although this variant is possible, it is
less preferred for temperature-controlling the interior space
212A.
[0321] It is further preferable for the test to be started
automatically if the interior space temperature reaches or exceeds
the temperature threshold value 529. It is therefore possible for a
test to start automatically, in a temperature-dependent manner From
another perspective, the temperature-control of the interior space
212A can also precede the test or can form part of the test,
preferably the start of the test.
[0322] The temperature-control of the interior space 212A using the
temperature-control apparatus 204 is preferably carried out
exclusively before the start of the test on the sample P, in
particular before the sample P is conveyed, treated and/or prepared
inside the cartridge 100 and/or fed to a sensor apparatus 113 of
the cartridge 100. During execution of the test on the sample P,
during which the sample P is conveyed, the temperature-control
apparatus 204, in contrast, is preferably used for
temperature-controlling the sample P, the temperature of the sample
P and/or the cartridge 100 or the fluid system 103 being specified
and/or feedback controlled by the temperature-control apparatus
204, in particular as already explained above.
[0323] 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.
[0324] 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.
[0325] Individual aspects and features of the present invention and
individual method steps and/or variants of the method may be
implemented independently from one another, but also in any desired
combination and/or order.
[0326] 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. [0327] 1. Method for controlling an analysis device 200, the
analysis device 200 being designed for testing an in particular
biological sample P, the sample P preferably being able to be
received in a cartridge 100 and the analysis device 200 being
designed for receiving the cartridge 100 and subsequently carrying
out the test using the received cartridge 100, characterized [0328]
in that, before the start of the test, the amount of energy 711C
remaining in an energy storage means 211B of the analysis device
200 is compared with an energy requirement 510D for the test, and
the test is only started if the amount of energy 711C meets the
energy requirement 510D, and/or [0329] in that a
temperature-control apparatus 204 designed for
temperature-controlling the cartridge 100 is controlled depending
on an interior space temperature of the analysis device 200. [0330]
2. Method according to aspect 1, characterized in that the energy
requirement 510D is defined depending on the test to be carried out
and/or the cartridge 100 to be used. [0331] 3. Method according to
either aspect 1 or 2, characterized in that the energy requirement
711C is established, retrieved or determined using an identifier
100C that corresponds to the cartridge 100 and/or on the basis of
the test to be carried out. [0332] 4. Method according to any one
of the preceding aspects, characterized in that control information
510 for carrying out the test comprises the energy requirement 510D
or the energy requirement 510D is determined using the control
information 510. [0333] 5. Method according to any one of the
preceding aspects, characterized in that the control information
510 and/or the energy requirement 510D is retrieved or determined
using an identifier 100C that corresponds to the cartridge 100.
[0334] 6. Method according to any one of the preceding aspects,
characterized in that the interior space temperature is measured
using a temperature sensor 206C that is not directly in contact
with the temperature-control apparatus 204 and/or the cartridge
100. [0335] 7. Method according to any one of the preceding
aspects, characterized in that the interior space temperature is
changed using the temperature-control apparatus 204 before the test
is started and/or the sample P is conveyed. [0336] 8. Method
according to any one of the preceding aspects, characterized in
that the interior space temperature is controlled or feedback
controlled using the temperature-control apparatus 204, the
interior space 212A of the analysis device 200 preferably being
heated using waste heat from the temperature control apparatus 204,
and/or the feedback control using the temperature threshold value
as the desired value, the interior space temperature as the actual
value and the temperature-control apparatus 204 as the control
element, and/or a minimum temperature and/or maximum temperature of
the temperature-control apparatus 204 being taken into account.
[0337] 9. Method according to any one of the preceding aspects,
characterized in that, upon identification of an interior space
temperature that is below a temperature threshold value 529, the
temperature-control apparatus 204 is operated such that the
temperature-control apparatus 204 heats the interior space 212A of
the analysis device 200 until the interior space temperature
reaches or exceeds the temperature threshold value 529, the test
preferably only being started and/or the sample P only being
conveyed once the temperature threshold value 529 has been reached
or exceeded. [0338] 10. Method according to any one of the
preceding aspects, characterized in that the temperature-control
apparatus 204 for temperature-controlling the cartridge 100 can be
or is positioned directly against the cartridge 100. [0339] 11.
Method according to any one of the preceding aspects, characterized
in that, on the side facing away from the cartridge 100, the
temperature-control apparatus 204 comprises a heat sink 204D that
is arranged in the interior space 212A of the analysis device 200
and that is heated in order to temperature-control the interior
space 212A of the analysis device 200. [0340] 12. Method according
to any one of the preceding aspects, characterized in that the
temperature-control apparatus 204 comprises a Peltier element 204E
by means of which the waste heat is generated and/or the interior
space temperature is controlled or feedback controlled, the Peltier
element 204E preferably being operated cyclically. [0341] 13.
Method according to any one of the preceding aspects, characterized
in that the test is started when the temperature threshold value
529 is reached. [0342] 14. Computer program product comprising
program code means which, when executed, cause the steps of the
method of any one of the preceding aspects to be implemented.
[0343] 15. Analysis system 1 for testing an in particular
biological sample P, [0344] the analysis system 1 comprising a
cartridge 100 for receiving the sample P, and [0345] 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 [0346] in that the analysis
device 200 is designed to compare the amount of energy 711C
remaining in an energy storage means 211B of the analysis device
200 with an energy requirement 510D for the test before the start
of the test, and to enable or to block a start of the test if the
amount of energy 711C is below the energy requirement 510D; and/or
[0347] in that the analysis device 200 comprises a
temperature-control apparatus 204 designed for
temperature-controlling the cartridge 100 and is designed to
control this temperature-control apparatus 204 depending on an
interior space temperature of the analysis device 200.
* * * * *