U.S. patent application number 12/038389 was filed with the patent office on 2008-09-11 for automatic analyzer.
Invention is credited to Masashi Akutsu.
Application Number | 20080219887 12/038389 |
Document ID | / |
Family ID | 39415029 |
Filed Date | 2008-09-11 |
United States Patent
Application |
20080219887 |
Kind Code |
A1 |
Akutsu; Masashi |
September 11, 2008 |
AUTOMATIC ANALYZER
Abstract
An automatic analyzer is capable of performing analysis of a
precision control sample in response to an external factor to
alleviate the burden on the operator and surely performing
precision control at appropriate timing at which precision control
must be performed, thereby allowing automatic maintenance of the
measurement precision. Analysis of a precision control sample is
performed by creating an analysis request for the internally held
precision control sample and then transferring the precision
control sample in response to an external factor occurring, for
example, when a calibrator is inputted in the analyzer, the number
of remaining reagents under analysis satisfies a predetermined
condition (becomes zero or falls below a specified value), the date
changes, a specified time runs out, the operator is changed, the
number of analyzed samples exceeds a specified value, a specified
time period has elapsed, a new reagent is registered, a measurement
failure is detected, etc.
Inventors: |
Akutsu; Masashi;
(Hitachinaka, JP) |
Correspondence
Address: |
MATTINGLY, STANGER, MALUR & BRUNDIDGE, P.C.
1800 DIAGONAL ROAD, SUITE 370
ALEXANDRIA
VA
22314
US
|
Family ID: |
39415029 |
Appl. No.: |
12/038389 |
Filed: |
February 27, 2008 |
Current U.S.
Class: |
422/67 |
Current CPC
Class: |
G01N 2001/2893 20130101;
G01N 35/00623 20130101; Y10T 436/10 20150115; G01N 35/00712
20130101; G01N 35/00693 20130101 |
Class at
Publication: |
422/67 |
International
Class: |
G01N 35/10 20060101
G01N035/10 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 28, 2007 |
JP |
2007-048387 |
Claims
1. An automatic analyzer comprising: an analysis unit for analyzing
a sample; a rack transfer system for transferring a sample rack
arranging a sample vessel which holds a sample to the analysis
unit; a rack input slot for inputting a sample rack to the rack
transfer system; and a mechanism for internally holding a precision
control sample in the analyzer, the precision control sample being
provided in the sample rack; wherein the automatic analyzer
includes control means for creating, when a calibrator in the
analyzer, a predetermined measurement request according to a
requested item of the calibrator in relation to the precision
control sample and then transferring an internally held precision
control sample so as to be analyzed after the calibrator.
2. An automatic analyzer comprising: an analysis unit for analyzing
a sample; a rack transfer system for transferring a sample rack
arranging a sample vessel which holds a sample to the analysis
unit; a rack input slot for inputting a sample rack to the rack
transfer system; and a mechanism for internally holding a precision
control sample in the analyzer, the precision control sample being
provided in the sample rack; wherein a plurality of reagents
associated with the same item can be arranged and, when the reagent
currently being used has satisfied a first predetermined condition,
another waiting reagent can be automatically selected; and wherein
the automatic analyzer includes control means for creating a
measurement request for a precision control sample in relation to a
waiting reagent and then transferring an internally held precision
control sample so as to be analyzed, when the number of remaining
reagents currently being used has satisfied a second predetermined
condition.
3. An automatic analyzer comprising: an analysis unit for analyzing
a sample; a rack transfer system for transferring a sample rack
arranging a sample vessel which holds a sample to the analysis
unit; a rack input slot for inputting a sample rack to the rack
transfer system; and a mechanism for internally holding a precision
control sample in the analyzer, the precision control sample being
provided in the sample rack; wherein the automatic analyzer
includes control means for creating a predetermined measurement
request according to an internally held precision control sample
and then transferring the precision control sample so as to be
analyzed, when change of the date has been recognized.
4-24. (canceled)
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to an automatic analysis
system which performs qualitative and quantitative analyses of a
biological sample, such as blood, urine, etc. More particularly,
the present invention relates to an automatic analysis system which
is provided with a transfer system for transferring sample vessels
to analysis system.
[0003] 2. Description of the Related Art
[0004] There is a remarkable increase in the use of automatic
analyzers which automatically perform qualitative and quantitative
analyses of a biological sample, such as blood, urine, etc., mainly
in large hospitals and clinical inspection centers where it is
necessary to process biological samples of a number of patients in
a short time. Various types of automatic analyzers, i.e., large-,
medium-, and small-sized automatic analyzers are under development
in relation to the throughput. Particularly in the case of a
certain large-sized analyzer which performs analysis of a number of
samples, a sample vessel containing a biological sample is held in
a holder, called sample rack, and then transferred to a plurality
of analyzers through a transfer line (transfer system). When an
inspection engineer inputs the sample rack into a sample rack input
slot, the analyzer automatically performs processing up to output
of analysis results.
[0005] In this case, the transfer line having a form of a belt
conveyor transfers the sample rack inputted through the sample rack
input slot, a bar code reader provided in the middle of the
transfer line recognizes the rack type and sample, and then
analysis is performed. As such an automatic analysis system, a
system disclosed for example in JP-A-10-325839 is known.
SUMMARY OF THE INVENTION
[0006] With such a large-scale system, it is necessary to maintain
the measurement precision (quantitative characteristics) of the
system by placing a calibrator and a precision control sample
having known concentration, etc. and periodically performing
analysis. The calibrator and precision control sample are analyzed
according to the order in which they are inputted into the sample
rack input slot. Further, since not all items (TP, GOT, and other
analysis items) can be covered with a single calibrator and a
single precision control sample, measurement of a plurality of
calibrators and precision control samples is necessary.
[0007] With a medium- or small-sized automatic analyzer, a sample
vessel storing a sample under measurement is arranged on a
disk-shaped sample disk. Therefore, it is possible for the operator
of the analyzer to perform calibration and precision control simply
by inputting measurement commands in the analyzer.
[0008] However, with a large-sized automatic analyzer for
transferring racks by use of a transfer line, it is necessary for
the operator of the analyzer to install a sample rack mounting
sample vessels for storing a calibrator and a precision control
sample at the rack input unit of the analyzer.
[0009] Therefore, if the operator does not input a rack mounting a
calibrator and a precision control sample, calibration and
precision control cannot be performed.
[0010] In such a case, the operator needs to prepare a calibrator
and a precision control sample even during analysis of a general
sample. This may prevent analysis of general samples which is a
primary object of the analyzer.
[0011] An object of the present invention is to provide an
automatic analyzer that can accomplish precision control even if
the operator does not perform an operation of inputting a precision
control sample.
[0012] A configuration of the present invention for accomplishing
the above-mentioned object will be explained below.
[0013] An automatic analyzer comprising: an analysis unit for
analyzing a biological sample; a transferring mechanism for
transferring a sample rack to the analysis mechanism and a sample
rack (with sample dispensing completed) from the analysis
mechanism; a sample supply unit which supplies a sample to the
sample buffer; and a sample storage unit which stores a sample from
the sample buffer.
[0014] Although a typical transferring mechanism is structured such
that a space arranging racks moves by itself, such as a belt
conveyer, or a sample rack gripped by an arm or claw is slid on a
base without move of the base, any transferring mechanism is
possible as long as it is provided with a physically movable sample
rack.
[0015] There is provided a mechanism that can keep holding a
precision control sample inputted to the sample buffer.
[0016] There is provided a second sample provision unit that can
keep holding a precision control sample in each analysis unit.
[0017] When a precision control sample is kept internally holding,
the automatic analyzer according to the present invention is
capable of automatically performing analysis of a precision control
sample in response to an external factor, for example, when a
calibrator is inputted in the analyzer, the number of remaining
reagents satisfies a predetermined condition (becomes zero or falls
below a specified value), the number of analyzed samples exceeds a
specified value, a specified time period has elapsed, etc.
Accordingly, it is possible to easily accomplish precision control
at appropriate timing, thereby alleviating the burden on the
operator.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a diagram showing an embodiment of an automatic
analyzer according to the present invention.
[0019] FIG. 2 is a diagram showing an area which holds a precision
control sample of the automatic analyzer according to the present
invention.
[0020] FIG. 3 is a diagram showing a screen for registering various
setups for an internally held precision control sample in the
automatic analyzer according to the present invention.
[0021] FIG. 4 is a diagram showing a processing flow when a
precision control sample to be held internally in the automatic
analyzer according to the present invention.
[0022] FIG. 5 is a diagram showing a processing flow for performing
precision control by use of a precision control sample to be held
internally when a calibrator is inputted in the automatic analyzer
according to the present invention.
[0023] FIG. 6 is a diagram showing a processing flow for performing
precision control by use of a precision control sample to be held
internally when the number of remaining reagents satisfies a
predetermined condition when reagents are used in the automatic
analyzer according to the present invention.
[0024] FIG. 7 is a diagram showing a processing flow for performing
precision control by use of a precision control sample to be held
internally when each condition is satisfied in the automatic
analyzer according to the present invention.
[0025] FIG. 8 is a diagram showing a processing flow for performing
precision control by use of a precision control sample to be held
internally when measurement failure is detected in the automatic
analyzer according to the present invention.
[0026] FIG. 9 is a diagram showing a processing flow when an
expiration date of an internally held precision control sample has
expired in the automatic analyzer according to the present
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] A configuration and operations of an automatic analysis
system according to an embodiment of the present invention will be
explained below with reference to FIGS. 1 to 9.
[0028] FIG. 1 is a diagram showing a general configuration of an
automatic analyzer according to an embodiment of the present
invention.
[0029] The automatic analysis system according to the present
embodiment comprises: a sample rack input part 10; a sample rack
storage part 11; an ID reader 12; a transfer line 13, a sample rack
buffer unit 21; analysis modules 31 and 32; and management
computers 1 and 2.
[0030] The sample rack input part 10 is used to input sample racks
which holds samples. The analysis modules 31 and 32 are arranged
along the transfer line 13 and removably connected to the transfer
line 13. There may be any number of analysis modules. The present
embodiment includes two analysis modules.
[0031] The transfer line 13 transfers a sample rack from the sample
rack input part 10 to the analysis modules 31 and 32 according to
an analysis request, transfers a sample rack holding a sample that
has been analyzed by the analysis modules 31 and 32 to the sample
rack buffer unit 21, or transfers a sample rack not requested for
analysis to the sample rack storage part 11.
[0032] The sample rack buffer unit 21 provided in the transfer line
13, with which a rack storing a calibrator, a precision control
sample, and a general sample are transferred, is a line mechanism
that is capable of holding one or more sample racks. The sample
rack buffer unit 21 makes it possible to hold a rack holding any
sample transferred from the transfer line 13 for a desired time
period and then resupply the sample rack to the analysis modules or
the sample rack storage part 11 at desired timing.
[0033] The sample rack input part 10 includes the management
computers which perform necessary control of the sample rack input
part 10, the sample rack storage part 11, the ID reader 12, the
transfer line 13, and the sample rack buffer unit 21. Further, a
memory unit of the management computer 1 for storing input/output
information and a display unit 2 for inputting information and
displaying analysis results are connected to the management
computers 1 and 2.
[0034] A sample held by the sample rack has a sample ID which
indicates sample-related attribute information (receipt number,
patient name, request analysis item, etc.) and further the sample
rack has a rack ID which indicates rack identification information,
such as the rack number. The sample rack placed in the sample rack
input part 10 is transferred by the transfer line 13. When the
sample rack is moved on the transfer line 13, the sample ID and the
sample rack ID are read by the ID reader 12 and then transferred to
the total management computers 1 and 2. The total management
computers 1 and 2 determine an analysis module that will analyze a
requested analysis item based on the attribute information.
[0035] Although a sample mentioned here is typically serum which is
liquid under inspection, it is also possible to perform analysis
with whole blood or diluted liquid sample. Further, a sample rack
means a rack in which one or more sample vessels for storing
samples can be arranged. A sample vessel can be a test tube, a
blood collecting vessel, or any other vessels that can store a
sample.
[0036] The following explains processing for internally holding a
precision control sample in the automatic analysis system according
to the present embodiment, with reference to FIGS. 2, 3, and 4.
[0037] When a rack from the sample rack input part 10, the sample
type is determined from the sample ID and the sample rack ID read
by the ID reader 12.
[0038] In this case, if a recognized sample rack arranges a
precision control sample, if holding is set with setup of holding
of precision control samples 111a, if number of internally held
precision control samples 112a is 1 or above, and if a precision
control sample hold area 21a is empty, the sample is held in the
analyzer for each rack.
[0039] If the sample is not a precision control sample or if the
setup is disabled, the sample is subjected to normal analysis and
then collected in the sample rack storage part 11 as usual.
[0040] The following explains analysis of an internally held
precision control sample with input of a calibrator in the
automatic analysis system according to the present embodiment, with
reference to FIG. 5.
[0041] As mentioned above, when the sample type is determined by
the sample ID and the sample rack ID read by the ID reader 12, if
the sample type is recognized as a calibrator and if an effective
precision control sample is held in the analyzer, an analysis
request for a predetermined item (for example, the same item) is
created for an item to be analyzed with a calibrator in relation to
the precision control sample.
[0042] After a calibrator is transferred, internally held precision
control samples are transferred in succession and then
measured.
[0043] If the sample is not a calibrator or if no effective
precision control sample is held, only the calibrator is subjected
to normal measurement processing.
[0044] The above-mentioned analysis makes it possible to perform
measurement of a precision control sample based on a calibrator.
Therefore, it becomes possible for the operator to omit the
creation of an analysis request for a precision control sample and
the preparation of a sample.
[0045] The following explains analysis of an internally held
precision control sample in relation to a waiting reagent in the
automatic analysis system according to the present embodiment, with
reference to FIG. 6. With the present embodiment, assuming an
automatic analyzer in which a waiting reagent is automatically
selected when the number of remaining reagents currently being used
becomes zero, the following explains a case where measurement of a
precision control sample is automatically performed when the number
of remaining reagents falls below a threshold value.
[0046] With a rack holding a sample, which is assigned an analysis
item and transferred to the analysis modules 31 and 32, the sample
will be dispensed in order to analyze the item.
[0047] At this timing, analysis of the item is started and, when
reagents from the analysis modules 31 and 32 have been consumed,
the update of the number of remaining analyzable reagents is
reported and then the total management computers 1 and 2 update the
number of analyzable reagents.
[0048] In this case, if it is determined that the updated number of
remaining analyzable reagents falls below the number of remaining
analyzable reagents designated in Waiting reagent analysis
condition 112c at this time, if a reagent that can be replaced in
relation to the inspection item is waiting, and if there is an
internally held precision control sample, a predetermined analysis
request is created in relation to an internally held precision
control sample, the internally held precision control sample is
transferred, and analysis is performed.
[0049] If the updated number of remaining analyzable reagents does
not fall below the number of remaining analyzable reagents
designated in Waiting reagent analysis condition 112c, if no
reagent that can be replaced in relation to the inspection item is
waiting, or if there is no internally held precision control
sample, analysis of the precision control sample is not
performed.
[0050] This makes it possible to perform measurement of the
precision control sample immediately before the waiting reagent is
selected, thereby making it easier to maintain the measurement
precision of the inspection item.
[0051] The following explains analysis on each condition with an
internally held precision control sample in the automatic analysis
system according to the present embodiment, with reference to FIG.
7.
[0052] If the date changes when setup of measurement at change of
date hid is enabled, if specified time 112e1 or 112e2 runs out when
setup of measurement at specified time 111e1 or 111e2 is enabled,
if the operator is changed when setup of measurement at change of
operator 111f is enabled, if time interval 112g has elapsed since
the last measurement time when setup of measurement at time
intervals 111g is enabled, if the number of patient samples that
has been measured since the last measurement of precision control
exceeds number of samples 112h when setup of measurement by the
number of samples 111h is enabled, if a new reagent is registered
when setup of measurement at registration of new reagent 111k is
enabled, or if an analytical curve is manually changed when setup
of measurement at manual change of analytical curve 111l is
enabled, a predetermined analysis request is created, an internally
held precision control sample is transferred, and analysis is
performed.
[0053] This makes it possible to perform measurement of a precision
control sample under each condition. Therefore, it becomes possible
for the operator to perform measurement of a precision control
sample at appropriate timing without creating a request for a
precision control sample and preparing a sample.
[0054] The following explains analysis with different internally
held precision control samples based on failure detection at the
time of precision control measurement in the automatic analysis
system according to the present embodiment, with reference to FIG.
8.
[0055] If the precision control sample itself is deteriorated at
the time of measurement of a precision control sample, the
concentration may have changed and accordingly measurement results
may indicate an abnormal value. In this case, if another precision
control sample is held in the analyzer, which allows analysis of a
requested item with which an abnormal value is detected with the
precision control sample, when setup of measurement with different
sample at failure detection 111j is enabled, the requested item is
created for another internally held precision control sample, the
precision control sample is transferred, and analysis is
performed.
[0056] This makes it possible to determine whether the measurement
item with abnormal value detection is really abnormal or the
precision control sample itself with abnormal value detection is
deteriorated.
[0057] The following explains expiration date control of an
internally held precision control sample in the automatic analysis
system according to the present embodiment, with reference to FIG.
9.
[0058] Generally, a precision control sample is provided with an
expiration date. When the expiration date has expired, some
components of the sample may vary making it impossible to acquire
an expected concentration value. This is why it is necessary to
provide and control an expiration date for the sample. The
expiration date depends on components, i.e., samples.
[0059] Further, since some samples are subjected to a few component
variations, it is also assumed that a sample may have been consumed
before component variation occurs while it is internally held.
Therefore, it is also possible to make setting so as not to perform
expiration date control.
[0060] The time when a precision control sample is stored in the
management computers 1 and 2, and when the present time exceeds
Precision control sample expiration date 112i, the precision
control sample is disabled so as to be unusable. Subsequently, it
becomes possible to inhibit analysis with a deteriorated precision
control sample by making the precision control sample unusable.
[0061] Although the above has explained a case of an automatic
analyzer in which a precision control sample is internally held by
arranging it in a rack, similar control applies also to a case
where a precision control sample is provided in the second sample
provision unit of each analysis unit.
[0062] If the operator prepares a precision control sample in
advance, it becomes possible to perform analysis of the precision
control sample in response to an external factor, thereby
alleviating the burden on the operator. Further, it becomes
possible to surely perform precision control at appropriate timing
at which precision control must be performed, thereby allowing
automatic maintenance of the measurement precision.
* * * * *