JP3332167B2 - Microplate reader - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of clinical testing using biochemical, immunological, and bacteriological reagents, and is used to observe the reaction between a test substance and a reagent by light absorption, light scattering, and fluorescence. The present invention relates to an analyzer for performing luminescence, etc., and more particularly to a microplate reader using a microplate for measurement.

[0002]

2. Description of the Related Art In biochemical tests, immunological tests, and bacteriological tests, microplates are widely used as reaction cells and measurement cells, and many reaction reagents are prepared and light absorption,
Various items are measured by observation such as light scattering, fluorescence, and light emission. And general microplate reader is used for the observation of the reaction at these microplate, the test substance of recently computed sample measurements were negative /
Those having a function of performing positive determination and / or quantification are mainstream. Examples of the type of calculation in the apparatus include a cutoff value, a cutoff index value, a percent inhibition value, and the like for negative / positive determination, and a polynomial, Log-Logi for quantitative determination, for example.
There is a calibration curve calculation using t, 4-parameter Logic, a polygonal line, and the like. In addition, there are many test substances to be determined, such as HBs antigen / antibody, HCV antigen / antibody, HIV antigen / antibody, IgE, IgG, and IgA. For example, there are numerous immune complexes, anti-HBs antibodies, IgE, AFP, hemoglobin, anti-rubella virus antibodies and the like. The reagents used for each determination or quantification are supplied by many different reagent manufacturers, and the measurement conditions and the method for judging the validity of the measurement in each reagent are used. Is usually different for each reagent manufacturer (and sometimes for each reagent).

For example, a kit for HCV antibody of Company A comprises a reagent (for treating HCV antibody) and a comparative reagent (a reagent having a reference optical property when treated with a reagent, for example, a negative control). For the sake of explanation, the contents of the kit have been simplified in this specification:
A diluent or the like is also included as a reagent. ).

[0004] An operator prepares a test sample by treating a sample (blood, serum, urine, etc.) with a reagent according to a predetermined method. Then, the absorbance is measured using a known reader.

[0005] The measurement procedure will be described more specifically as follows. That is, first, the absorbance of a negative control (HCV antibody negative human serum) treated with three reagents is measured, and the average value C _AV (3) is obtained. Further, the average value C
_AV (3) in adding a predetermined constant K _1, obtaining the cut-off value (threshold value) C _TH.

Then, the absorbance C _{O of the} test sample is compared with the cutoff value C _TH . Here, when the absorbance C _O is smaller than the cut-off value C _TH , the serum (sample) to be tested is
Is determined to be negative.

Prior to or in parallel with such determination, the validity of the measurement is determined. In the kit of Company A, it is confirmed whether or not the absorbances of the negative control (comparative sample) treated with the three reagents are all within a predetermined range.

In the kit for HCV antibody of Company B, A
Negative control treated with 3 reagents as in the company
Average absorbance C '_AVFind (3). And the prescribed
Number K _TwoIs the average absorbance C ′_AVBy adding to (3)
Cut-off value C '_THAsk for.

In the kit of Company B, the validity of the measurement is determined.
Perform as follows. That is, each of the three negative controls
Check if the luminous intensity is within the first predetermined range.
Admit. At the same time, each absorbance is averaged C '_AV(3)
It is checked whether it is in the range of 0.5 to 1.5 times. 2
The absorbance of the negative control of the book is out of any range.
The measurement is invalid. One absorbance
If only one goes out of either range,
Average absorbance of two negative controls containing absorbance
Luminous intensity C '_AVCalculate (2). And this new average
Absorbance C '_AVCut-off value C 'based on (2)_THUpdate
I do. That is, the new cutoff value is C ' _TH= C '
_AV(2) + K_TwoBecomes

The method for determining the validity of the measurement at the time of HCV antibody measurement and the like will be described in more detail, for example, as follows.

In the HCV antibody measurement reagent (Ortho Diagnostic Systems Co., Ltd.), the absorbance of each of the negative controls treated with the three measured reagents is -0.0.
005 and 0.150 or less, and if the absorbance of one of the three negative controls is out of the above range, the negative control is determined based on the absorbances of the remaining two negative controls. Calculate the average absorbance of. If the absorbance of two of the three negative controls is outside the above range, the test is invalid.
Furthermore, it was confirmed that the absorbance of each of the positive controls treated with the two reagents was 0.600 or more.
The average of the absorbance of the two positive controls was determined, and it was confirmed that the absorbance of the two positive controls was in the range of 0.5 to 1.5 times the average absorbance of the positive control. If it exceeds, invalidate the test.

In the HCV antibody measurement reagent (Eiken Chemical Co., Ltd.), the absorbance of each of the negative controls treated with the three measured reagents was -0.050 or more and 0.150 or less, and the average value was measured. It is confirmed that the absorbance is within the range of 0.5 to 1.5 times, and if the absorbance of one of the three negative controls is out of the above range, the absorbance of the two negative controls is determined based on the absorbance of the other two negative controls. Calculate the average absorbance of the negative control. If the absorbance of two of the three negative controls is outside the above range, the test is invalid. The absorbance of each of the positive controls treated with the three reagents was 0.600 or more and 1.999.
It is confirmed that the absorbance falls within the range of 0.5 to 1.5 times the average value. If the absorbance of one of the three positive controls falls outside the above range, the remaining two The average absorbance of the positive control is calculated based on the absorbance of the positive control. If the absorbance of two of the three positive controls is outside the above range, the test is invalid. Further, a difference between the average value of the positive control and the average value of the negative control obtained by the above means is determined, and when the difference is less than 0.500, the test is invalidated.

In the herpes simplex virus IgG type antibody measuring reagent (Denka Seiken Co., Ltd.), the absorbance difference of the corresponding control antigen well is subtracted from the absorbance of the herpes antigen well, and the absorbance difference is calculated. Take the average of Confirm that the absorbance difference of the negative control treated with the reagent is 0.1 or less and the absorbance difference of the positive control is 0.7 or more. If these conditions are not satisfied, the test is invalidated. In the case of a rubella IgM antibody measurement reagent (Asahi Medical Co., Ltd.), the absorbance of the corresponding control antigen well is subtracted from the absorbance of the rubella antigen well to obtain an absorbance difference, and a calibration curve is prepared using negative, weakly positive, and strongly positive controls. The correlation coefficient γ ^{2 of the} calibration curve is 0.95
It was confirmed that the calculated value obtained by substituting the absorbance difference of the reference control treated with the reagent into the calibration curve equation was within the display range indicated on the vial. If not, disable the test.

As described above, there are many different methods for judging the measurement conditions and the effectiveness of the measurement of various reagents for a microplate reader.

For example, in order to use the kit of Company A described above, a plate holding a test sample obtained by treating blood with a reagent and three negative controls, an apparatus for measuring the absorbance of both, and an arithmetic unit And a dedicated automatic judging device provided with a display (where the computing device is dedicated to make a negative / positive judgment by comparing the absorbance C _{O of the} test sample with the cutoff value C _TH ). performing an exclusive procedure for determining the effectiveness of the treatment procedure and the measurement. these procedures are stored in advance in the memory of the device. constant K ₁
Are also stored in the memory in advance. ), The automatic determination device cannot be used for the kit of the Company B. That is, as described above, the processing procedure until finally obtaining measurement data is significantly different between the kit of Company A and the kit of Company B, especially the processing procedure of judging the validity of the measurement. See examples of actual kits).

If the validity of the measurement is determined manually, in the above example, the determination of the negative / positive is performed in a similar processing procedure, that is, the cutoff value is calculated from the respective absorbances of the negative control. Since the processing procedure is to compare with the absorbance of the test sample, conventionally, when executing each kit, inputting unique parameters (K ₁ , K _2, etc.), etc.
Except for the validity check,
Automated devices are known.

[0017]

As described above, judging the validity of measurement requires examining a plurality of conditions per reagent kit in an actual test. If it increases, the number of conditions to consider becomes enormous. Therefore, skill is required to quickly and accurately perform the intended measurement using various kits.

In addition, if a dedicated automatic measuring device is prepared for each reagent kit, there is a problem that the cost and the installation space are increased.

[0019]

SUMMARY OF THE INVENTION The present invention has been made to solve the above problems, and has a well for holding a test sample consisting of a sample containing a test substance which has been treated with a reagent, and a comparison device as required. Means for holding a microplate with sample wells, means for measuring the optical properties of the test and comparative samples, and the processing required to generate clinical data for the test substance based on the optical properties Input means for inputting a procedure, storage means for storing the input processing procedure, an arithmetic unit for forming data from the obtained optical characteristics according to the processing procedure, and means for outputting the data It is a microplate reader. In the above, the comparative sample refers to a comparative reagent treated with the reagent, an empty well, and the like. The means for holding the microplate may be known.

[0020]

According to the microplate reader having such a configuration, when different reagent kits are respectively applied to the same or different test substances, an input device is used to respond to each reagent kit. A processing procedure such as an arithmetic processing procedure and a processing procedure necessary for determining the validity of the measurement (validity determining processing procedure) is input and stored in the storage device. After the test sample to be measured and the comparative sample are set on the microplate, their optical characteristics are measured. The arithmetic unit reads out a processing procedure corresponding to the test sample from the storage device and executes the processing including determination of the validity of the measurement. As a result, clinical data such as negative / positive judgment and quantification of the test substance can be obtained.

In the above, the processing procedure, especially the program of the validity determination processing procedure, is enormous, so it is prepared by the manufacturer and stored in a general recording medium such as a floppy disk, and it is necessary to input it from the input device. It is desirable to input according to. If necessary, various parameters such as a measurement wavelength and a constant for determining a cutoff value may be input simultaneously with the processing procedure.

[0022]

Embodiments of the present invention will be described below. First Embodiment FIG. 1 shows a configuration of a microplate reader 1 of this embodiment. The microplate reader 1 includes a computer system 2, an absorbance measurement device 25, and a microplate 27. Each device is connected by a cable that can transmit data as needed.

The computer system 2 includes an arithmetic unit 3, memory groups 5 to 15, and input / output units 17 to 23.
Each device is connected via a bus and an interface.

The memory 5 stores programs necessary for operating the apparatus. Memory 7 stores the parameters K ₁ used therein processing procedures and necessary to use the A company reagent kit a determination object (or quantitative). The absorbance memory 13 stores the absorbance of the test sample and the comparative sample. The keyboard 17 is used to set conditions, enter file names,
It is used for inputting commands necessary for specifying the output format. The disk drive 19, the display 21, and the printer 23 are general-purpose ones.

The conventional dedicated machine of the company A kit has a computer system having such a configuration.

The computer system of the embodiment further comprises three different storage devices 9, 11 and 15. The memory 9 stores a processing procedure when a kit different from a kit manufactured by Company A (for example, a kit manufactured by Company B) is used. This processing procedure is set in the disk drive 19 (magnetic recording reading / writing device). Read from a floppy disk (not shown). Therefore, the disk drive 19 becomes an input device for a new processing procedure. Of course, this input device is not limited to this, and it goes without saying that it is appropriately selected according to the storage medium in which the processing procedure is stored. The parameter K ₂ required for executing a new processing procedure is also input from the disk drive 19 and stored in the input parameter memory 11. Memory 9
And 11 are random access memories in the illustrated example, but they may be PROMs (programmable read only memories). Further, the disk drive may be an external storage device, and the processing procedure may be transferred to an internal storage device (memory) as necessary. As described above, since the program of the processing procedure, especially the program of the validity judgment processing procedure, becomes enormous, it goes without saying that the memory 9 must have a capacity enough to store the enormous program. .

The process identification memory 15 stores information necessary for identifying the type of a sample to be inspected, such as the type of a kit, when inspecting different test samples.

FIG. 2 shows a schematic configuration of the microplate 27 and the absorbance measuring device 25.

The microplate 27 is formed of a transparent material and has a plurality of wells 29. This well 2
A test sample and a comparative sample are injected and held in 9. The microplate used for measuring luminescence or the like may be formed of a non-transparent material.

The absorbance measuring device 25 comprises a light emitting section 31 and a light receiving section 37. The light emitting unit 31 includes a light source (which may be a halogen lamp or the like) 33 and an optical fiber 35. The optical fibers 35 face the wells 29, respectively, and irradiate light from the light source 33 to the wells 29. The light receiving section 37 is a light receiving element 3
9, an amplifier 41 and an A / D converter 43. The light receiving element 39 is arranged to face each well 29, receives light passing through the well 29, and converts the light into an electric signal. This signal is amplified by the amplifier 41, converted into a digital signal by the A / D converter 43, and sent to the arithmetic unit 3 of the computer system 2. The arithmetic unit 3 calculates the signal, that is, the optical characteristic, and writes the absorbance of each well into the memory 13 together with the address. When the absorbance is used as the optical characteristic, the ratio of the amount of transmitted light between the reference well and the target well is usually calculated, but the absorbance is obtained from the temporal change of the amount of transmitted light in the target well without using the reference well. You can also. Thus, the absorbances of the test sample and the comparative sample in the well are measured.

After preparing the test sample, the operator sets it on the microplate together with the comparative sample.
When the measurement may be performed using eight or twelve strip well microplates, a plurality of areas are designated in one microplate, and each area is treated with a different type of reagent kit. The test sample obtained by this may be set. If the optical characteristics of the comparative sample are separately measured and the results are stored in the memory 13 or are stored in the memory 11 as calculation parameters, the comparative sample can be renewed for each test sample. There is no need to set it on the plate. It is preferable to attach a first identifier indicating which reagent kit was used for each microplate or strip-well type microplate and a second identifier identifying each sample (blood, serum, urine, etc.). A well-known identifier such as a barcode is used as the identifier.

The used reagent kit and sample can be manually specified without using an identifier. In addition, the order of the reagent kits used is determined according to the microplate, or in the case of a strip well type microplate, the order of the reagent kits used is determined according to the address of the microplate, and the order is determined accordingly. If the processing procedure can be read out sequentially, the identifier of the microplate becomes unnecessary. The order of inspection is specified by the operator using the keyboard 17,
It is stored in the process specific memory 15.

In the above, the dedicated processing procedure and the parameter memory 7 can be omitted. However, in that case,
The information stored in the memory 7 must be written to the memories 9 and 11.

Next, the operation of the apparatus according to the embodiment will be described with reference to the flowchart of FIG. It is assumed that the memory 7 stores processing procedures and parameters corresponding to the reagent kit manufactured by Company A.

In steps 1 and 2, the operator sets a floppy disk in which the processing procedure and parameters corresponding to the reagent kit manufactured by Company B to be used for the inspection are stored in the disk drive 19. And step 3
, The correspondence between the identifier of the microplate and the type of the reagent kit is specified from the keyboard, and the processing specifying memory 15
To save. In Step 4, the identifier is recognized, and the test sample , more specifically, the reagent kit used for adjusting the test sample is specified with reference to the contents of the memory 15. still,
When the identifier is not used, the used reagent kit is specified according to the contents of the memory 15.

In step 6, a measurement parameter such as a measurement wavelength corresponding to the reagent kit is specified from the contents of the memory 15, and then the absorbance of each well of the prepared microplate into which the test sample and the comparative sample are injected is determined. The measurement is performed by a known method (measurement procedure) corresponding to the specified reagent kit using the measurement device 25, and is stored in the memory 13 (step 7).

In step 9, the processing procedure and parameters corresponding to the test sample specified in step 4 are read from the floppy disk and stored in the memories 9 and 11, respectively. When the test sample is prepared using a kit manufactured by Company A, this step is omitted.

In steps 11 to 19, the specified test
The processing procedure corresponding to the fee is read from the memory 7 or 9
Is executed. This is performed by the arithmetic unit 3. First,
In step 11, the validity of the measurement is determined according to the validity determination procedure.
Is determined. For example, a kit manufactured by Company A has three reagents
The absorbance of the negative control treated with
It is compared whether it is within the range. All absorbances are within the range
If so, it is determined to be valid, and the process proceeds to step 13. Stay
In step 13, the three negative controllers are operated in accordance with the arithmetic processing procedure.
Average value C of absorbance of roll_AV(3) and given parameters
K₁And the cutoff value C_THIs calculated, and the
Absorbance C_OAnd C_THCompare. C_O<C _THWhen is shade
Gender, C_O≧ C_THIs positive, the result is
Output to the display 21 and the printer 23
You.

If the validity is denied in step 11, the fact is displayed on the display 21 in step 17. When the operator instructs re-examination, the process returns to step 4 (step 19).

In the above, when it is determined in step 4 that the test sample has been prepared using the kit manufactured by Company B, the processing procedure is read from the memory 9 in step 9 and
In step 11, an average value C ' _AV (3) of the absorbances of the three negative controls is calculated, and the absorbance of each negative control is compared with the average value. At the same time, it is determined whether the absorbance of each of the negative controls is within a predetermined range. In step 13, as described above, the cutoff value _{C'TH is set} as _C'TH = _C'AV (3) +
K ₂ or C ′ _TH = C ′ _AV (2) + K ₂ is used.

In this way, all prepared microplates are automatically inspected.

Second Embodiment Next, a second embodiment of the present invention will be described with reference to FIGS. In each drawing, the same members or the same steps as those in FIGS. 1 and 3 are denoted by the same reference numerals, and description thereof will be omitted.

In this embodiment, the processing procedure and parameters corresponding to the kits manufactured by the company A and the kits manufactured by the company B are stored in the memory 7. Then, the arithmetic unit reads out the processing procedure corresponding to the test sample specified in step 4 from the memory 7 and executes the negative / positive judgment according to the readout.

Third Embodiment Next, a third embodiment of the present invention will be described with reference to FIGS. In each drawing, the same members or the same steps as those in FIGS. 1 and 3 are denoted by the same reference numerals, and description thereof will be omitted.

In FIG. 6, the memory 67 has a measurement calculation processing procedure (a combination of the measurement procedure and the calculation processing procedure).
Has been saved. This measurement calculation processing procedure is a procedure in which the validity determination processing procedure is omitted from the processing procedures described in the previous embodiment, that is, in the example of the kits of Company A and Company B, it is a procedure for making a negative / positive determination. . This procedure compares the cutoff values C _TH and C ′ _TH with the measured value _CO, and the calculation of the cutoff value is similar. Therefore, in this embodiment, the measurement calculation processing procedure is shared. The parameter _{K 1} and _{K 2} should be specified.

When the measurement targets are the same or the same type, the measurement calculation processing procedure can often be shared even if the reagent kits are different. This embodiment focuses on this point. Therefore, the memory 67 can store a plurality of measurement calculation processing procedures that can be shared. The measurement calculation processing procedure can be transferred from an external storage device such as a magnetic disk or a magnetic tape to a memory as needed.

In the memory 69, the validity determination processing procedure is written later through the input device in the same manner as in the previous embodiment. As long as the measurement calculation processing procedure already stored in the memory 67 can be used, the validity determination processing procedure corresponding to various reagent kits (even if it is completely new) is written in the memory 69, The measurement using the reagent can be automated.

In this embodiment, the validity determination procedure is stored as magnetic data on a floppy disk . Simultaneously with this procedure, parameters necessary for executing the measurement calculation processing procedure may be stored in a floppy disk , and the parameter may be input simultaneously with the input of the procedure from the disk drive 19.
Furthermore, when a plurality of types of measurement calculation processing procedures are stored in the memory 67, the specification of which measurement calculation processing procedure, validity determination processing procedure, and which parameter to select for which reagent kit is specified. Information is input to the memory 15.

In the operation of the measuring apparatus of this embodiment, as shown in FIG. 7, the validity determination procedure corresponding to the test sample specified in step 4 is read out in step 79. It should be noted that this validity determination processing procedure has been written in the memory 69 in step 71, or
At 9 the data is transferred from the external storage device to the memory 69. In step 11, the validity of the measurement is determined according to the read validity determination processing procedure. When it is determined to be “valid”, the measurement calculation processing procedure is executed at step 82 in the memory 67.
, And a negative / positive judgment and display are made in step 13. As described above, since the program of the validity determination processing procedure is enormous, it goes without saying that the memory 69 must have a capacity enough to store the enormous program.

In this embodiment, the target calculation data is formed by combining the measurement calculation processing procedure and the validity judgment processing procedure. The validity determination processing procedure may be combined as a subprogram included in the measurement calculation processing procedure program, or may be an independent program completely different from the measurement calculation processing procedure program.

In the latter case, the procedure for determining the validity may be, for example, a resident type program, or a separate program in a multitasking, pseudo multitasking or single task environment. Therefore, since the validity judgment processing procedure can be developed and defined completely independently of the subprograms included in the measurement calculation processing procedure, a new validity judgment processing procedure is required when the apparatus is adapted to a new reagent kit. The procedure is provided as an execution file, and a new validity determination procedure name is simply given as a parameter to the measurement computation procedure, and the measurement computation procedure does not need to be changed at all.

Some of the validity determination processing procedures use the result of the measurement calculation processing procedure or data obtained during the execution of the procedure, or the reverse. In these cases, the common memory 16 is used to transfer the data between the validity determination procedure and the measurement calculation procedure.
Note that an external storage device or a buffer may be used instead of the common memory 16.

In the above description, only two types of reagent kits are used, but it is clear that the present invention can be applied to three or more types. In addition, the target of the test is not limited to only the negative / positive determination, and quantitative and other determinations can be made. Also, instead of absorbance, such inspection can be performed by measuring light scattering, fluorescence, luminescence, and other optical properties.

The description of the claims is not limited to the above embodiment.

[0055]

As described above, there has been no microplate reader that covers a large number of test reagents and automates from the measurement of a test sample to the determination of the validity of the measurement and the output of the result. According to the present invention, from the measurement of a test sample to the determination of the validity of the measurement and the output of the result for a large number of measurement items, the present invention is completely automated, and one measurement is possible even with various test reagents of different manufacturers. It becomes possible to provide a microplate reader that can be handled by one device. Thus measurer, without human mistakes complicated procedure for validity determination of measurement, and the measurement items and reagents manufacturing industries
The present invention is a great invention that contributes to the industry, since the measurement of a test sample can be performed using a single microplate reader without discrimination between persons .

In addition to the above description, the following is further disclosed. (1) means for holding a microplate provided with a well for holding a test sample composed of a sample containing a test substance treated with a reagent and a well for a comparison sample, if necessary, Means for measuring an optical property; input means for inputting a processing procedure necessary for forming clinical data of the test substance based on the optical property; and storage means for storing the input processing procedure A microplate reader comprising: an arithmetic unit that forms the data from the obtained optical characteristics in accordance with the processing procedure; and a unit that outputs the data.

(2) There is further provided a means for setting the measurement order for two or more kinds of test samples, wherein the storage means can store two or more kinds of processing procedures, and the arithmetic unit sets the measurement order. The microplate reader according to (1), wherein the processing procedure corresponding to the test sample is sequentially read from the storage unit based on the measurement order of the test sample set by the unit to form the data.

(3) There is further provided a means for specifying the type of the test sample, wherein the storage means can store two or more kinds of processing procedures, and the arithmetic unit is a test sample specified by the specifying means. The microplate reader according to the above (1), wherein a processing procedure corresponding to (1) is read from the storage means and the data is formed.

(4) The above-mentioned (1) further comprising a second input means for inputting parameters necessary for executing the processing procedure, and a second storage means for storing the input parameters. The microplate reader according to any one of (1) to (3).

(5) The microplate reader according to any of the above (1) to (4), further comprising a third storage means for storing a predetermined processing procedure for a predetermined test sample in advance.

(6) A microplate reader for inspecting a plurality of types of test samples, comprising: means for holding the test samples and, if necessary, a comparative sample; Means for measuring a property, input means for inputting a processing procedure necessary for forming clinical data of the test substance based on the optical property, and storage means for storing the input processing procedure (this The storage means can store a plurality of processing procedures according to the test sample);
Means for specifying the type of the test sample held by the holding means, and a processing procedure corresponding to the test sample specified by the specifying means is read from the storage means, and the optical characteristic obtained according to the processing procedure A microplate reader further comprising: means for forming the clinical data; and means for outputting the data.

(7) A microplate reader for inspecting a plurality of types of test samples, comprising: means for holding the test samples and, if necessary, a comparative sample; Means for measuring characteristics; and means for storing a processing procedure necessary for forming clinical data of the test substance based on the optical characteristics (the storage means includes a storage section for each type of the test sample, (A processing procedure is stored), means for specifying the type of the test sample held by the holding means, and a processing procedure corresponding to the test sample specified by the specifying means is read out from the storage means. A microplate reader comprising: means for forming the clinical data from the optical characteristics obtained according to a processing procedure; and means for outputting the data.

(8) Means for holding a microplate having a well for holding a test sample composed of a sample containing a test substance treated with a reagent and, if necessary, a well for a comparative sample; Means for measuring the optical properties of the comparative sample, storage means for storing a measurement calculation processing procedure necessary to form clinical data of the test substance based on the optical properties, and manual inputting a validity determination procedure for determining the validity of the measurement
Steps, storage means for storing the input validity determination processing procedure, according to the measurement calculation processing procedure, means for forming the data from the obtained optical characteristics, according to the validity determination processing procedure, A microplate reader comprising: means for judging the validity of the measurement from the obtained optical characteristics; and means for outputting the data.

[Brief description of the drawings]

FIG. 1 is a configuration diagram of a microplate reader according to a first embodiment of the present invention.

FIG. 2 is a configuration explanatory view of a microplate and an absorbance measuring device.

FIG. 3 is a flowchart illustrating the operation of the microplate reader according to the first embodiment.

FIG. 4 is a configuration diagram of a microplate reader according to a second embodiment of the present invention.

FIG. 5 is a flowchart illustrating the operation of the second embodiment.

FIG. 6 is a configuration diagram of a microplate reader according to a third embodiment of the present invention.

FIG. 7 is a flowchart illustrating the operation of the third embodiment.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 Microplate reader 3 Arithmetic unit 5, 7, 9, 11, 13, 15, 16, 67, 69 Memory 17, 19 Input means 21, 23 Output means 25 Optical characteristic measuring device 27 Microplate

Continuation of the front page (56) References JP-A-3-75562 (JP, A) JP-A-63-8537 (JP, A) JP-A-4-118558 (JP, A) JP-A-5-240869 (JP) JP-A-2-67962 (JP, A) JP-A-60-40955 (JP, A) JP-A-3-75563 (JP, A) JP-A-3-23868 (JP, B2) JP-B 1-445581 (JP, B2) JP 2-16875 (JP, B2) (58) Field surveyed (Int. Cl. ⁷ , DB name) G01N 35/00-35/10 G01N 33/48-33 / 98 JICST File (JOIS)

Claims (1)

(57) [Claims] Claims: 1. A plurality of identical or different samples in a test sample
Different reagent kits for each test substance
For holding a test sample and, if necessary, a comparative sample
, Means for measuring the optical characteristics of the test sample and the comparative sample
And a measurement processing procedure for performing the measurement of the optical characteristic, and the measurement
Performs calculations based on the measurement results obtained in the processing procedure.
Calculation procedure and the execution of the calculation procedure.
Clinical judgment based on the results
A series of processes consisting of judgment procedures for obtaining data
An input means for inputting each of a plurality of reagent kits, and a record for storing those processes input from the input means.
Storage means and, when inspecting the test sample held by the holding means,
Means for specifying the type of reagent kit to be used for the test, and the means corresponding to the reagent kit specified by the specifying means
Reading one of the processes from the storage means;
To perform optical processes to measure optical properties and
Means for forming the clinical data based on biological characteristics
And a means for outputting the data .