JP2007232510A - Sample analyzer and computer program - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a gene amplifying and analyzing system capable of recognizing that the measuring result of a sample is displayed on the basis of the measuring result of a precision control sample. <P>SOLUTION: The gene amplifying analyzing system 1 is equipped with a gene amplifying measuring instrument 101 capable of measuring a sample and the precision control sample, a control part 130 for judging whether the measuring result of the precision control sample is within a predetermined range and a display part 140 for controlling the display of the measuring result of the specimen sample measured by the gene amplifying measuring instrument 101. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a sample analyzer having a function of measuring a control sample and performing accuracy control, and a computer program for managing the measurement result, and more particularly, a sample used for a clinical test using a biological sample such as blood or urine. The present invention relates to an analyzer and a computer program.

  In clinical tests using a biological sample such as blood or urine as a specimen, it is widely performed to evaluate the quality state of the test apparatus and the test reagent and to perform a quality control test in order to increase the reliability of the test result. This is a test in which a control sample is measured in the same manner as a specimen and it is confirmed whether the measurement result is within the control range.

  An X-R control projection method is a quality control method that is often used. This is a method in which a control sample is measured twice a day and it is confirmed whether or not the average value X is within the control range.

  The frequency of the quality control test is variously set according to the inspection field, the type of the inspection device / reagent, and the like. The quality control test may be performed before or after the daily inspection, once a week, every predetermined time or every predetermined number of tests (measurements), and sometimes every measurement operation. . In addition, a quality control test is also performed when a test reagent is replaced in the middle of a test or when a specific adjustment is made to the test apparatus. For example, in the sample test automation system disclosed in Patent Document 1, a constant interval (for example, 20 racks containing general samples pass through a transport line) or a monitoring time ( For example, every 10 minutes after the rack containing the general sample is not supplied to the automatic analyzer, the rack containing the quality control sample is supplied to the automatic analyzer for analysis.

  In the inspection room, after confirming that the measurement result of the quality control test is within the control range, the inspection result is reported. If the measurement result of the quality control test is out of the control range, the condition of the test device or test reagent is not good, and maintenance of the test device or replacement of the test reagent is performed so that the measurement result of the quality control test is within the control range And so on.

  The operator of the laboratory performs the measurement result of the quality control test corresponding to the test result of the specimen. Various examinations are performed in the examination room, and the timing of the quality control test corresponding to the examination of the sample may be different. In biochemistry and immunological tests, many test items are tested with each test reagent. One control sample cannot cope with all measurement items, and a quality control test is often performed with a plurality of control samples. Therefore, in order to specify the quality control test corresponding to the sample test, attention must be paid to various points.

JP-A-8-220104

  However, Patent Document 1 does not describe outputting (displaying) the analysis result of the general sample based on the analysis result of the quality control sample of the automatic analyzer. Further, in the sample test automation system disclosed in Patent Document 1, since the general sample and the quality control sample are measured according to the predetermined parameters, the measurement result and accuracy of the general sample are not specified. It is considered that the measurement results of the management sample are stored in a storage device such as a memory in the order of measurement. Therefore, there is a problem that it becomes difficult to associate and manage the measurement result of the general sample and the measurement result of the quality control sample.

  The present invention has been made to solve the above-described problems, and one object of the present invention is to recognize that the measurement result of the specimen sample is displayed based on the measurement result of the control sample. A sample analyzer and a computer program that can be used. Another object of the present invention is to provide a sample analyzer and a computer program that can easily manage the measurement result of the specimen sample and the information related to the measurement result of the control sample.

Means for Solving the Problems and Effects of the Invention

  In order to achieve the above object, a sample analyzer according to a first aspect of the present invention includes a measurement unit capable of measuring a specimen sample and a control sample, and whether the measurement result of the control sample is within a predetermined range. A determination unit configured to determine whether or not, and a display unit configured to control display of the measurement result of the sample sample measured by the measurement unit based on the determination result of the determination unit.

  In the sample analyzer according to the first aspect, as described above, the determination unit that determines whether or not the measurement result of the control sample is within the predetermined range, and the measurement unit based on the determination result of the determination unit By providing the display unit that controls the display of the measurement result of the measured sample sample, the measurement result of the sample sample in consideration of the measurement result of the control sample can be displayed on the display unit. As a result, the user can recognize that the measurement result of the specimen sample displayed on the display unit is a result displayed based on the control sample.

  A sample analyzer according to a second aspect of the present invention stores a measurement unit capable of measuring a sample sample and a control sample, and a measurement result of the sample sample and a measurement result of the control sample measured by the measurement unit. A storage unit and an output unit that outputs the measurement result of the specimen sample and the measurement result of the control sample stored in the storage unit in association with each other under a preset condition.

  In the sample analyzer according to the second aspect, as described above, by providing a storage unit that stores the measurement result of the specimen sample measured by the measurement unit and the measurement result of the control sample, the measurement result and accuracy of the sample are provided. The measurement result of the control sample can be easily managed. In addition, by providing an output unit that outputs the measurement result of the sample sample stored in the storage unit and the measurement result of the control sample in association with each other under a preset condition, the measurement result of the sample sample stored in the storage unit is provided. And the measurement result of the control sample, the measurement result of the control sample and the measurement result of the specimen sample corresponding to the measurement result of the control sample can be easily output to the output unit.

  A sample analyzer according to a third aspect of the present invention includes a measurement unit capable of measuring a sample sample and a control sample, a display unit for displaying a measurement result of the sample sample measured by the measurement unit, and a control sample A determination unit that determines whether or not the measurement result is within a predetermined range, and the display unit does not display the measurement result of the specimen sample when there is no determination result by the determination unit.

  In the sample analyzer according to the third aspect, as described above, when the display unit does not display the measurement result of the specimen sample when there is no determination result by the determination unit, the measurement result of the control sample can be obtained. It is possible to prevent the measurement result of the specimen sample from being displayed in a state where it is not obtained. As a result, the user can recognize that the measurement result of the specimen sample displayed on the display unit is a result obtained after obtaining the measurement result of the control sample. For this reason, since the measurement result of the sample sample with low reliability is not displayed, it is possible to prevent the user from adopting the measurement result with low reliability for which the measurement result of the control sample is not obtained. Can do.

  A sample analyzer according to a fourth aspect of the present invention includes a measurement unit capable of measuring a specimen sample and a control sample, and a determination unit that determines whether or not the measurement result of the control sample is within a predetermined range. And a display unit for displaying the measurement result of the sample sample measured by the measurement unit and the determination result determined by the determination unit.

  In the sample analyzer according to the fourth aspect, as described above, the display unit displays the measurement result of the sample sample measured by the measurement unit and the determination result determined by the determination unit. The measurement result of the specimen sample and the determination result of the control sample can be displayed simultaneously. As a result, the user can recognize the measurement result of the sample sample corresponding to the measurement result of the control sample from the measurement result of the sample sample and the determination result of the control sample displayed on the display unit.

  A sample analyzer according to a fifth aspect of the present invention acquires a measurement unit capable of measuring a specimen sample and a control sample, and accuracy management information for managing measurement accuracy based on a measurement result of the control sample An accuracy management processing unit, a storage unit for storing the measurement result of the specimen sample measured by the measurement unit, the measurement result of the control sample, and the accuracy management information acquired by the accuracy management processing unit, and the measurement unit A display unit that displays a quality control information calling unit for calling quality control information together with the measurement result of the specimen sample, and an input unit that receives an input are provided. The display unit selects the quality control information calling unit. When input is accepted, quality control information is displayed.

  In the sample analyzer according to the fifth aspect, as described above, the measurement is performed by the accuracy management processing unit that acquires the accuracy management information for managing the measurement accuracy based on the measurement result of the control sample, and the measurement unit. By providing a display unit for displaying a quality control information calling unit for calling quality control information together with the measurement result of the sample sample, the user selects the quality control information calling unit displayed on the display unit, thereby allowing the sample After confirming the measurement result of the sample, the quality control information acquired based on the measurement result of the control sample can be confirmed. As a result, the user can recognize that the measurement result of the specimen sample displayed on the display unit is a result of managing the measurement accuracy.

  A sample analyzer according to a sixth aspect of the present invention stores a measurement unit capable of measuring a sample sample and a control sample, and a measurement result of the sample sample and a measurement result of the control sample measured by the measurement unit. A storage unit, and the storage unit stores the measurement result of the specimen sample and the measurement result of the control sample in association with each other under a preset condition.

  In the sample analyzer according to the sixth aspect, as described above, by providing a storage unit that stores the measurement result of the specimen sample and the measurement result of the control sample in association with each other in a preset condition, The measurement result of the specimen sample and the measurement result of the control sample can be stored in association with each other under a predetermined condition. As a result, the measurement result of the sample and the information related to the measurement result of the quality control sample can be easily managed.

  According to a seventh aspect of the present invention, there is provided a computer program comprising an acquisition means for acquiring measurement results of a specimen sample and a control sample, and determination means for determining whether or not the measurement result of the control sample is within a predetermined range. Then, based on the determination result of the determination means, it functions as a display means for controlling the display of the measurement result of the specimen sample acquired by the acquisition means.

  In the computer program according to the seventh aspect, as described above, the computer is acquired based on the determination means for determining whether the measurement result of the control sample is within a predetermined range and the determination result of the determination means. By functioning as a display means for controlling the display of the measurement result of the specimen sample acquired by the means, the measurement result of the specimen sample in consideration of the measurement result of the control sample can be displayed. As a result, the user can recognize that the measurement result of the displayed specimen sample is a result displayed based on the control sample.

  According to an eighth aspect of the present invention, a computer program stores an acquisition means for acquiring measurement results of a specimen sample and a control sample, and a measurement result of a specimen sample and a measurement result of a control sample acquired by the acquisition means. And a storage unit that functions as an output unit that outputs the measurement result of the specimen sample and the measurement result of the control sample stored in the storage unit in association with each other under a preset condition.

  In the computer program according to the eighth aspect, as described above, the computer is caused to function as a storage unit that stores the measurement result of the specimen sample acquired by the acquisition unit and the measurement result of the control sample, thereby measuring the sample. The result and the measurement result of the quality control sample can be easily managed. In addition, the sample stored in the storage unit is caused by causing the computer to function as an output unit that outputs the measurement result of the sample sample stored in the storage unit and the measurement result of the control sample in association with each other under a preset condition. By using the measurement result of the sample and the measurement result of the control sample, it is possible to easily output the measurement result of the control sample and the measurement result of the specimen sample corresponding to the measurement result of the control sample.

  According to a ninth aspect of the present invention, there is provided a computer program comprising: an acquisition means for acquiring measurement results of a specimen sample and a control sample; a display means for displaying the measurement result of the specimen sample acquired by the acquisition means; and a control sample The display means does not display the measurement result of the sample sample when there is no determination result by the determination means.

  In the computer program according to the ninth aspect, as described above, when there is no determination result by the determination means, the computer functions as a display means that does not display the measurement result of the specimen sample, thereby allowing the measurement result of the control sample to be displayed. It is possible to prevent the measurement result of the specimen sample from being displayed in a state where it is not obtained. As a result, the user can recognize that the measurement result of the displayed specimen sample is a result obtained after obtaining the measurement result of the control sample. For this reason, since the measurement result of the sample sample with low reliability is not displayed, it is possible to prevent the user from adopting the measurement result with low reliability for which the measurement result of the control sample is not obtained. Can do.

  A computer program according to a tenth aspect of the present invention includes a computer for obtaining means for obtaining measurement results of a specimen sample and a control sample, and determination means for determining whether or not the measurement result of the control sample is within a predetermined range. And the display unit that displays the measurement result of the specimen sample acquired by the acquisition unit and the determination result determined by the determination unit.

  In the computer program according to the tenth aspect, as described above, the computer is caused to function as a display unit that displays the measurement result of the specimen sample acquired by the acquisition unit and the determination result determined by the determination unit. The measurement result of the specimen sample and the determination result of the control sample can be displayed at the same time. As a result, the user can recognize the measurement result of the sample sample corresponding to the measurement result of the control sample from the displayed measurement result of the sample sample and the determination result of the control sample.

  The computer program according to the eleventh aspect of the present invention manages the measurement accuracy based on the acquisition means for acquiring the measurement results of the specimen sample and the control sample and the measurement results of the control sample as described above. Quality control processing means for acquiring the quality control information, storage means for storing the measurement result of the specimen sample acquired by the acquisition means, the measurement result of the control sample, and the quality control information acquired by the quality control processing means, The display unit functions as a display unit for displaying the quality control information calling unit for calling up the quality control information together with the measurement result of the specimen sample acquired by the acquisition unit, and an input unit for receiving the input. When the input for selecting the information calling unit is received, the quality control information is displayed.

  In the computer program according to the eleventh aspect, as described above, the computer is acquired by the accuracy management processing means for acquiring the accuracy management information for managing the measurement accuracy based on the measurement result of the control sample, and the acquisition means. By selecting the displayed quality control information calling unit by causing the user to function as display means for displaying the quality control information calling unit for calling quality control information together with the measurement result of the sample sample, After confirming the measurement result, the quality control information acquired based on the measurement result of the control sample can be confirmed. As a result, the user can recognize that the measurement result of the displayed specimen sample is a result of managing the measurement accuracy.

  A computer program according to a twelfth aspect of the present invention stores an acquisition means for acquiring measurement results of a specimen sample and a control sample, a measurement result of the specimen sample measured by the acquisition means, and a measurement result of a control sample. The storage means stores the measurement result of the specimen sample and the measurement result of the control sample in association with each other under a preset condition.

  In the computer program according to the twelfth aspect of the present invention, as described above, the computer is caused to function as a storage unit that stores the measurement result of the specimen sample and the measurement result of the control sample in association with each other under a preset condition. Thus, the measurement result of the specimen sample and the measurement result of the control sample can be stored in association with each other under a predetermined condition. As a result, the measurement result of the sample and the information related to the measurement result of the quality control sample can be easily managed.

  DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments embodying the present invention will be described below with reference to the drawings.

(First embodiment)
FIG. 1 is a perspective view showing the overall configuration of a gene amplification analysis system according to a first embodiment of the present invention. 2 is a perspective view showing the overall configuration of the gene amplification measuring apparatus of the gene amplification analysis system shown in FIG. 1, and FIG. 3 is a schematic plan view of FIG. 4-9 is a figure for demonstrating the screen layout of the display part of a gene amplification measuring apparatus. The gene amplification analysis system 1 according to the first embodiment is a system that supports diagnosis of cancer metastasis in a resected tissue (lymph node) in cancer surgery. A target gene (mRNA) derived from cancer existing in the resected tissue is expressed by LAMP ( This is a system for determining the presence or absence of expression of a target gene by amplifying using a Loop-Mediated Isolation Amplification (Eiken Chemical) method and measuring white turbidity due to magnesium pyrophosphate generated by amplification by a turbidimetric method. Details of the LAMP method are disclosed in US Pat. No. 6,410,278.

  As shown in FIG. 1, the gene amplification analysis system 1 according to the first embodiment includes a gene amplification measurement apparatus 101 and a personal computer (PC) 102 connected to the gene amplification measurement apparatus 101 so as to perform wired or wireless communication. And is composed of.

  First, the details of the gene amplification measuring apparatus 101 will be described with reference to FIGS. As shown in FIGS. 2 and 3, the gene amplification measuring apparatus 101 includes a dispensing mechanism unit 10, a sample specimen setting unit 20, a chip setting unit 30, a chip discarding unit 40, and five reaction detection blocks 50a. And a transfer unit 60 for transferring the dispensing mechanism unit 10 in the X-axis direction and the Y-axis direction.

  As shown in FIGS. 2 and 3, the dispensing mechanism unit 10 has an arm unit 11 that is moved in the X-axis direction and the Y-axis direction (horizontal direction) by the transfer unit 60 and the arm unit 11, respectively. It includes two (two) syringe units 12 that can move independently in the Z-axis direction (vertical direction).

  As shown in FIG. 3, the sample specimen setting unit 20 includes, in order from the front of the apparatus, ten sample container setting holes 21a to 21j, one enzyme reagent container setting hole 21k, and one primer reagent container. A set hole 21l is provided. Further, the ten sample container setting holes 21a to 21j are provided so as to be arranged in 5 rows and 2 columns. The sample container setting holes 21c and 21d, the sample container setting holes 21e and 21f, the sample container setting holes 21g and 21h, and the sample container setting holes 21i and 21j are respectively sample sets in order from the back side of the apparatus. Position 1, sample set position 2, sample set position 3 and sample set position 4 are provided.

  In addition, the sample container set holes 21c, 21e, 21g and 21i on the left side of the front side contain a solubilized extract (sample sample) prepared by processing (homogenizing, filtering, etc.) a living tissue (lymph node) in advance. The sample container 22 is set, and the sample container 23 containing the diluted sample obtained by diluting the above-described sample sample 10 times is set in the sample container setting holes 21d, 21f, 21h and 21j on the right side of the front. ing. Specifically, the sample container 23 of the sample container setting hole 21d accommodates a diluted sample corresponding to the sample sample accommodated in the sample container 22 set in the sample container setting hole 21c. The sample container 23 in the sample container setting hole 21f accommodates a diluted sample corresponding to the sample sample accommodated in the sample container 22 set in the sample container setting hole 21e, and the sample container 23 in the sample container setting hole 21h. Contains a diluted sample corresponding to the sample sample accommodated in the sample container 22 set in the sample container set hole 21g, and set in the sample container set hole 21i in the sample container 23 of the sample container set hole 21j. A diluted sample corresponding to the sample sample stored in the sample container 22 is stored. That is, two samples (sample sample and diluted sample) are produced from one living tissue.

  In addition, a container 24 containing a positive control for confirming that the gene to be amplified is normally amplified is placed in the sample container setting hole 21a, and amplified in the sample container setting hole 21b. A container 25 containing a negative control for confirming that a gene that should not be amplified is not normally amplified is set.

  The enzyme reagent container set hole 21k and the primer reagent container set hole 21l are respectively an enzyme reagent container 26 containing a cytokeratin 19 (CK19) enzyme reagent and a primer reagent container containing a CK19 primer reagent. 27 is set.

  As shown in FIG. 3, two racks 32 each having a storage hole 32 a capable of storing 36 pipette tips 31 are detachably fitted in the chip set portion 30. The chip set unit 30 is provided with two removal buttons 33. By pushing the removal button 33, the rack 32 becomes removable.

  As shown in FIG. 3, the tip discarding unit 40 is provided with two tip discarding holes 40 a for discarding the used pipette tips 31. Further, a groove 40b having a width narrower than that of the chip disposal hole 40a is provided so as to be continuous with the chip disposal hole 40a.

  Each reaction detection block 50a of the reaction detection unit 50 includes a reaction unit 51, two turbidity detection units 52, and a lid closing mechanism unit 53 (see FIG. 3), as shown in FIGS. It is configured. As shown in FIG. 3, the reaction unit 51 provided in each reaction detection block 50a is provided with two detection cell setting holes 51a for setting the detection cells 54. Each reaction detection block 50a is arranged in the cell set position 1, the cell set position 2, the cell set position 3, the cell set position 4 and the cell set position 5 in order from the back side of the apparatus.

  Further, as shown in FIG. 3, the turbidity detection unit 52 includes an LED light source unit 52a composed of a blue LED having a wavelength of 465 nm attached to a substrate 55a disposed on one side of the reaction unit 51, and a reaction. And a photodiode light receiving portion 52b attached to the substrate 55b disposed on the other side surface of the portion 51. In each reaction detection block 50a, two sets of one set of turbidity detection units 52 each including one LED light source unit 52a and one photodiode light receiving unit 52b are arranged. Accordingly, the five reaction detection blocks 50a are provided with a turbidity detection unit 52 including a total of ten sets of LED light source units 52a and photodiode light receiving units 52b. The LED light source unit 52a and the photodiode light receiving unit 52b corresponding to the LED light source unit 52a irradiate light having a diameter of about 1 mm from the LED light source unit 52a to the lower part of the detection cell 54 so that the light can be received by the photodiode light receiving unit 52b. Has been placed. The presence or absence of the detection cell 54 is detected based on the intensity of light received by the photodiode light receiving unit 52b, and the turbidity of the liquid contained in the cell unit 54a of the detection cell 54 is displayed on the display unit of the personal computer 102 described later. 140 becomes possible to monitor. Specifically, when the detection cell 54 is set in the detection cell setting hole 51a, the detection cell 54 is disposed between the LED light source unit 52a and the photodiode light receiving unit 52b, so that the photodiode light receiving unit 52b receives light. The light to be weakened compared to the case where the detection cell 54 is not set. This makes it possible to detect that the detection cell 54 has been set.

  Further, the detection cell 54 has two cell portions 54a for accommodating a sample sample and a diluted sample, and two lid portions 54b for closing the two cell portions 54a.

  2 and 3, the transfer unit 60 includes a linear guide 61 and a ball screw 62 for transferring the dispensing mechanism unit 10 in the Y-axis direction, and a stepping motor 63 for driving the ball screw 62. And a linear motion guide 64 and a ball screw 65 for transferring the dispensing mechanism unit 10 in the X-axis direction, and a stepping motor 66 for driving the ball screw 65. In addition, the transfer to the X-axis direction and the Y-axis direction of the dispensing mechanism part 10 is performed by rotating the ball screws 62 and 65 by the stepping motors 63 and 66, respectively.

  As shown in FIG. 1, the personal computer 102 includes a keyboard 110 and a mouse 120 as input devices, a control unit 130 including a CPU 131 and a memory 132, and a display unit 140 including a monitor.

  Next, the details of the screen layout of the display unit 140 of the personal computer 102 will be described with reference to FIGS. 1 and 5 to 9. The display unit 140 (see FIG. 1) is a screen (data browser screen) that displays the measurement result of the sample sample measured by the gene amplification measuring apparatus 101, the sample of the sample sample and the quality control sample using the keyboard 110 and the mouse 120. It is provided to display a screen (workload list screen) for performing a measurement instruction such as ID registration and a screen (calibration curve display screen) for displaying a calibration curve.

  As shown in FIG. 5, the data browser screen includes a toolbar 111 on which buttons for executing various functions such as a help function are displayed, a sample information display unit 112 that displays various types of information on the sample specimen, and a sample information display unit. A measurement result display unit 113 showing the measurement result of the sample specimen displayed at 112 is displayed.

  The sample information display unit 112 includes a batch number display field 112a, a sample position display field 112b, a sample ID display field 112c, a comment display field 112d, a measurement date display field 112e, and a measurement time display field 112f. Is provided. In the batch number display column 112a, the number of batch processing is displayed. Note that the batch processing is processing for collectively processing a plurality of sample samples and diluted samples (in the first embodiment, a maximum of four sample samples and a maximum of four diluted samples). In the batch number display column 112a, a number (“2” in the screen) obtained by adding “1” to the number of times this batch processing has been performed after power-on is displayed. The sample position display field 112b displays the sample set position (“4” in the screen) where the sample specimen is set. In the sample ID display column 112c and the comment display column 112d, the sample ID (“Sample01” in the screen) and the sample sample (in the screen) input on the workload list screen (see FIG. 8) described later, respectively. A comment for the diluted sample is displayed (blank in the screen). The measurement date display field 112e and the measurement time display field 112f respectively include the date (“2004/08/09” on the screen) and the time (“09” on the screen) when the sample sample and the diluted sample are measured. : 37: 26 ") is displayed.

  Further, the measurement result display unit 113 includes a graph 113a showing the relationship between the turbidity of the sample sample specified from the batch number display column 112a and the sample position display column 112b and time (min), and an amplification rise time. A display column 113b, a density measurement value display column 113c, and a determination result display column 113d are provided. Note that the measurement results (graph, amplification rise time, concentration measurement value, and determination result) for the diluted sample are set so that a user other than the administrator cannot see. As a result, it is possible to prevent the user from mistaking the measurement result for the diluted sample as the measurement result for the sample sample.

  In the amplification rise time display column 113b, a time corresponding to 0.1 of the turbidity which is the vertical axis of the graph 113a (“10.4” in the screen) is displayed.

In the concentration measurement value display column 113c, the concentration of the sample sample calculated from the rise time (= 10.4) (min) displayed in the amplification rise time display column 113b (in the screen, “4.0E + 02”). ) (Copies / μl) is displayed. Specifically, the concentration is calculated from the amplification rise time (= 10.4) based on a calibration curve (see FIG. 9) that is a linear function of the amplification rise time and concentration prepared by a calibrator measured in advance. Is done. In addition, since the detection limit of the concentration of the gene amplification measuring apparatus 101 of the first embodiment is 2.5 × 10 ² (copies / μl), a concentration of less than 2.5 × 10 ² (copies / μl) is “< 2.5E + 02 "is displayed.

  In addition, the determination result display column 113d displays whether or not the target gene (mRNA) is expressed in the sample sample based on the measurement result (concentration) of the sample sample and the measurement result (concentration) of the diluted sample (positive “( +) ", Negative" (-) ").

Here, in the first embodiment, the measurement of the quality control sample (positive control, negative control) is performed following the measurement of the sample sample in the same batch process as the measurement of the sample sample. In the above-described amplification rise time display column 113b, concentration measurement value display column 113c, and determination result display column 113d, the measurement result of the sample sample is displayed based on the measurement result of the quality control sample (positive control, negative control). Yes. Specifically, the concentration of the positive control at the measurement elapsed time of 9.0 min to 13.0 min is outside the range of 5.0 × 10 ² (copies / μl) to 5.0 × 10 ⁴ (copies / μl). In the case where the concentration at the measurement elapsed time of 16.0 min of the negative control is outside the range of 0 to 2.5 × 10 ² (copies / μl), the amplification rise time display column 113b, concentration measurement value display A flag “*” indicating abnormality information is displayed along with each measurement result in the column 113c and the determination result display column 113d. Further, when a flag “*” indicating abnormality information is displayed, an error button 113e is displayed below the determination result display field 113d of the measurement result display unit 113.

  The amplification rise time display column 113b, the concentration measurement value display column 113c, and the determination result display column 113d are not displayed until the measurement of the quality control sample during the batch processing is completed. This prevents the user from adopting the measurement result with low reliability without displaying the measurement result of the sample sample with low reliability because the measurement result of the quality control sample has not been obtained. It becomes possible. Further, when the measurement result of the quality control sample is out of the predetermined range, the flag “*” indicating the abnormality information and the error button 113e may be displayed and the measurement result of the sample sample may not be displayed.

  In the first embodiment, as shown in FIGS. 6 and 7, the error display screen 150 is displayed by clicking the error button 113 e using the mouse 120 of the personal computer 102. On this error display screen 150, an error list display unit 151 for displaying the contents of various error information, an action display unit 152 for displaying details of error information of the error list display unit 151 and a coping method, A button 153 for closing the error display screen 150 is provided.

As shown in FIG. 6, the error list display unit 151 has a positive control concentration in the range of 5.0 × 10 ² (copies / μl) to 5.0 × 10 ⁴ (copies / μl) as described above. If it is outside, or if the concentration of the negative control is outside the range of 0 to 2.5 × 10 ² (copies / μl), “accuracy control error” is displayed. In addition, as shown in FIG. 7, when no positive control or negative control is measured, “no control measurement” is displayed. Further, as shown in FIGS. 6 and 7, the action display unit 152 selects the error information (accuracy control error, no control measurement) displayed on the error list display unit 151, thereby displaying the selected error information. Details and corrective actions are displayed.

  As shown in FIG. 8, the workload list screen includes a toolbar 121 on which buttons for executing various functions such as a print function are displayed, an order input unit 122 for inputting a measurement order (measurement instruction), and a measurement order. An order list display section 123, a batch number display section 124, a group selection section 125, cell set position display sections 126a to 126e, a sample set position display section 127, and a measurement start button 128. It is displayed.

  In addition, the order input unit 122 inputs measurement orders for the sample setting positions 1 to 4 and the quality control samples (positive control and negative control) set in the sample container setting holes 21a and 21b (see FIG. 3). It is provided for inputting measurement orders. The order input unit 122 is provided with a sample ID input field 122a, a comment input field 122b, and a confirmation button 122c. Specifically, sample IDs are input to the sample ID input field 122a using the keyboard 110 for the sample specimens at the sample setting positions 1 to 4 and the quality control specimens of the sample container setting holes 21a and 21b. As the sample ID, in addition to the ID corresponding to the sample sample, an ID corresponding to a negative control or a positive control is input. For example, “Sample01 to Sample04” is used as the sample ID. For example, “QC [CK19-PC]” is used as the sample ID of the positive control. As the sample ID of the negative control, for example, “QC [CK19-NC]” is used. Further, when there is a comment about a sample sample or a quality control sample (positive control, negative control), it is possible to input a comment in the comment input field 122b of the order input unit 122. When the confirmation button 122 c is clicked with the mouse 120, the input sample ID and comment are reflected in the order list display unit 123.

  The batch number display field 124 displays the number of batch processing as in the batch number display field 112a of the sample information display unit 112 on the data browser screen (see FIGS. 5 to 7). In the group selection field 125, a group is selected from the pull-down menu 125a. Examples of this group include a group for measuring a sample specimen and a group for measuring a calibrator for obtaining a calibration curve. In 1st Embodiment, the example at the time of selecting the group (Sample) which measures a sample sample is shown. By selecting this group (Sample), the order list display unit 123 displays “◯” at the corresponding position of CK19.

  The cell set position display units 126a to 126e are provided for displaying the set state of the detection cells 54 of the reaction detection blocks 50a of the reaction detection unit 50. As a set state of the detection cell 54, when there is a plan to use and the detection cell 54 is set in the detection cell set hole 51a, as shown in FIG. “G” (displayed in green) is displayed in 126b. If the detection cell 54 is not set in the detection cell set hole 51a even though it is scheduled to be used, “NG” (displayed in red) at a predetermined position of the cell set position display portions 126a to 126e. Is displayed. If it is not necessary to set the detection cell 54 in the detection cell set hole 51a because there is no plan to use it, predetermined positions of the cell set position display parts 126a to 126e (in FIG. 8, the cell set position display part 126c). To 126e), a symbol (displayed in gray) indicating the reaction unit 51 in a state where it is not necessary to set the detection cell 54 is displayed.

  The sample set position display unit 127 includes a sample container 22 for storing the sample sample of the sample sample setting unit 20 of the gene amplification measuring apparatus 101, a sample container 23 for storing the diluted sample, a container 24 for storing the positive control, and negative. It is provided for displaying the set state of the container 25 in which the control is accommodated, the enzyme reagent container 26 and the primer reagent container 27. The sample set position display unit 127 includes sample container display units 127a to 127j corresponding to the ten sample container set holes 21a to 21j, an enzyme reagent container display unit 127k corresponding to the enzyme reagent container set hole 21k, and a primer reagent. And a primer reagent container display portion 127 l corresponding to the container setting hole 21 l. Then, the alphabet (“PC” in the screen) corresponding to the sample ID (QC [CK19-PC]) displayed on the order list display unit 123 is displayed on the sample container display unit 127a. In addition, an alphabet (“NC” in the screen) corresponding to the sample ID (QC [CK19-NC]) displayed on the order list display unit 123 is displayed on the sample container display unit 127b.

  In addition, alphabets corresponding to the sample IDs displayed on the order list display unit 123 (“S” meaning “sample” in the screen) are displayed on the sample container display units 127c, 127e, 127g, and 127i. The In the sample container display portions 127d, 127f, 127h, and 127j, alphabets (“D” meaning dilution on the screen) indicating the diluted sample are displayed. An alphabet (“E” in the screen) indicating that the enzyme reagent container 26 is set is displayed on the enzyme reagent container display part 127k, and the primer reagent container 27 is displayed on the primer reagent container display part 127l. The alphabet ("P" in the screen) indicating that is placed is displayed. In the first embodiment, a screen in a state where the input of the measurement order for the sample set position 1 is completed is shown.

As shown in FIG. 9, the calibration curve display screen has three types of known concentrations (2.5 × 10 ³ (copies / μl), 2.5 × 10 ⁵ (copies / μl), 2.5 × 10 ⁷ ( copy / μl)) is a screen displaying a calibration curve produced by measuring the calibrator, and a straight line approximating the three points plotting the concentration against the rise time of the calibrator by a linear expression is displayed.

  Next, as shown in FIG. 1, the control unit 130 has a function of controlling a gene amplification measuring apparatus 101 that measures a sample sample, a diluted sample, and a quality control sample (positive control, negative control). The CPU 131 and the memory 132 are included.

In the first embodiment, the CPU 131 has a function of analyzing the measurement result (concentration) of the quality control sample measured by the gene amplification measuring apparatus 101, and the measurement result (concentration) of the acquired quality control sample. Is determined to be within a predetermined range. Specifically, the CPU 131 has a positive control measurement result (concentration) at a measurement elapsed time of 9.0 min to 13.0 min of 5.0 × 10 ² (copies / μl) or more and 5.0 × 10 ⁴ (copies / μl) It is determined whether it is within the following range. Further, the CPU 131 determines whether or not the measurement result (concentration) of the negative control at the measurement elapsed time of 16.0 min is in the range of 0 to 2.5 × 10 ² (copies / μl).

  Here, in the first embodiment, the CPU 131 has a function of controlling the display unit 140 to display the measurement results of the sample sample and the diluted sample based on the determination result of the quality control sample. Specifically, when the measurement result (concentration) of the quality control sample (positive control, negative control) is outside the above-mentioned predetermined range, the CPU 131 displays the data in the batch on the data browser screen (see FIG. 6). A flag “*” indicating that “accuracy control abnormality” was found in the measurement result of the sample sample is displayed on the display unit 140. At this time, the CPU 131 has a function of displaying an error button 113e below the determination result display column 113d of the display unit 140.

  In the first embodiment, the CPU 131 also has a function of determining whether or not a quality control sample (positive control, negative control) set in the sample sample setting unit 20 of the gene amplification measuring apparatus 101 has been measured. Yes. Even when the quality control sample is not measured, the CPU 131 displays a flag “indicating that there is no control measurement” in the measurement result of the sample sample in the batch on the data browser screen (see FIG. 7). “*” Is added and displayed on the display unit 140. At this time, the CPU 131 has a function of displaying an error button 113e below the determination result display column 113d of the display unit 140.

  In the first embodiment, the CPU 131 associates the measurement results (concentrations) of the sample sample and the diluted sample with information (accuracy control abnormality, no control measurement) related to the analysis results of the positive control and the negative control. It has a function of controlling the memory 132 so as to store it.

  Next, the operation of the gene amplification analysis system 1 according to the first embodiment will be described with reference to FIGS. In the gene amplification analysis system 1 according to the first embodiment, as described above, a target gene (mRNA) derived from cancer present in a resected tissue in cancer surgery is amplified using the LAMP method, and pyrroline generated along with the amplification The presence or absence of target gene expression is determined by measuring white turbidity due to magnesium acid.

  First, as shown in FIG. 2 and FIG. 3, a sample container 22 containing a solubilized extract (sample specimen) prepared by processing (homogenizing, filtering, etc.) the excised tissue in advance is placed in a sample container setting hole 21c, Set to 21e, 21g and 21i. And in 1st Embodiment, the sample container 23 which accommodated the diluted sample which diluted the sample sample accommodated in the sample container 22 10 times is set to the sample container setting holes 21d, 21f, 21h, and 21j. Further, the container 24 containing the positive control and the container 25 containing the negative control are set in the sample container setting holes 21a and 21b (see FIG. 3), respectively. The enzyme reagent container set hole 21k (see FIG. 3) and the primer reagent container set hole 21l respectively contain an enzyme reagent container 26 containing the CK19 enzyme reagent and a primer reagent container 27 containing the CK19 primer reagent. And set. In addition, two racks 32 each storing 36 disposable pipette tips 31 are installed in the chip set unit 30.

  Before starting the measurement, the sample ID is displayed on the screen (workload list screen (see FIG. 8)) of the display unit 140 of the personal computer 102 using the keyboard 110 and the mouse 120 of the personal computer 102 shown in FIG. Instruct measurement such as registration.

  Then, the user clicks the measurement start button 128 on the workload list screen shown in FIG. 8 using the mouse 120 (see FIG. 1). Thereby, the measurement operation in the gene amplification measuring apparatus 101 is started.

  When the operation of the gene amplification measuring apparatus 101 starts, first, the arm unit 11 of the dispensing mechanism unit 10 is moved from the initial position to the chip set unit 30 by the transfer unit 60 shown in FIG. The two syringe parts 12 of the dispensing mechanism part 10 are moved downward. As a result, the tips of the nozzle portions of the two syringe portions 12 are press-fitted into the upper openings of the two pipette tips 31, so that the pipette tips 31 are automatically attached to the tips of the nozzle portions of the two syringe portions 12. . After the two syringe parts 12 are moved upward, the arm part 11 of the dispensing mechanism part 10 is moved in the X-axis direction toward the upper side of the primer reagent container 27 containing the CK19 primer reagent. . Then, after one syringe part 12 positioned above the primer reagent container 27 is moved downward and the primer reagent is sucked, the one syringe part 12 is moved upward. Thereafter, the arm part 11 of the dispensing mechanism part 10 is moved in the Y-axis direction by the transfer part 60 so that the other syringe part 12 is positioned above the same primer reagent container 27. Then, after the other syringe part 12 is moved downward and the primer reagent is aspirated from the same primer reagent container 27, the other syringe part 12 is moved upward. In this manner, the primer reagent of CK19 in the primer reagent container 27 is aspirated by the two pipette tips 31 attached to the syringe unit 12.

  After aspirating the primer reagent, after the two syringe parts 12 are moved upward, the arm part 11 of the dispensing mechanism part 10 is moved to the cell set position 1 which is the farthest side (the back side of the apparatus front side) by the transfer part 60. It is moved above the reaction detection block 50a. Then, in the innermost reaction detection block 50a, the two syringe parts 12 are moved downward, so that the two pipette tips 31 attached to the two syringe parts 12 are respectively 2 of the detection cells 54. It is inserted into one cell part 54a. And using the syringe part 12, the primer reagent of CK19 is discharged to the two cell parts 54a, respectively.

  After the primer reagent is discharged, the two syringe parts 12 are moved upward, and then the arm part 11 of the dispensing mechanism part 10 is moved in the X-axis direction by the transfer part 60 toward the upper part of the tip discarding part 40. . In the tip discarding unit 40, the pipette tip 31 is discarded. Specifically, the pipette tip 31 is inserted into the two tip disposal holes 40a (see FIG. 3) of the tip disposal portion 40 by moving the two syringe portions 12 downward. In this state, when the arm part 11 of the dispensing mechanism part 10 is moved in the Y-axis direction by the transfer part 60, the pipette tip 31 is moved below the groove part 40b. When the two syringe parts 12 are moved upward, the collar part on the upper surface of the pipette tip 31 abuts on the lower surface on both sides of the groove part 40b and receives downward force from the lower surface. 31 is automatically detached from the nozzle portions of the two syringe portions 12. As a result, the pipette tip 31 is discarded in the tip discarding unit 40.

  Next, the arm part 11 of the dispensing mechanism part 10 is moved again to the chip set part 30 by the transfer part 60. Thereafter, two new pipette tips 31 are automatically attached to the tips of the nozzle portions of the two syringe portions 12 in the tip set portion 30 by the same operation as described above. And the arm part 11 of the dispensing mechanism part 10 is moved to the X-axis direction toward the upper direction of the enzyme reagent container 26 in which the enzyme reagent of CK19 was accommodated. And after one syringe part 12 located above the enzyme reagent container 26 is moved downward and the enzyme reagent is sucked, the one syringe part 12 is moved upward. Thereafter, the arm part 11 of the dispensing mechanism part 10 is moved in the Y-axis direction by the transfer part 60 so that the other syringe part 12 is positioned above the same enzyme reagent container 26. Then, after the other syringe part 12 is moved downward and the enzyme reagent is sucked from the same enzyme reagent container 26, the other syringe part 12 is moved upward. In this manner, the enzyme reagent in the enzyme reagent container 26 is aspirated by the two pipette tips 31 attached to the syringe unit 12.

  The arm 11 of the dispensing mechanism 10 is moved above the innermost reaction detection block 50 a by the transfer unit 60, and then the enzyme reagent of CK19 is discharged to the two cell parts 54 a of the detection cell 54. Is done. After the enzyme reagent is discharged, the arm portion 11 of the dispensing mechanism unit 10 is moved above the tip discarding unit 40 by the transfer unit 60, and then the pipette tip 31 is discarded.

  Next, after the arm portion 11 of the dispensing mechanism portion 10 is moved again to the tip setting portion 30 by the transfer portion 60, two new pipette tips 31 are automatically attached to the tips of the nozzle portions of the two syringe portions 12. It is attached to. And the arm part 11 of the dispensing mechanism part 10 was moved to the X-axis direction toward the upper part of the sample container 22 and the sample container 23 in which the sample specimen set in the sample specimen setting part 20 and the diluted specimen were accommodated. Thereafter, the sample sample and the diluted sample in the sample containers 22 and 23 are simultaneously sucked by the same operation as the primer reagent and enzyme reagent suction operations. After that, the arm part 11 of the dispensing mechanism part 10 is moved above the innermost reaction detection block 50a by the transfer part 60, and then the two syringe parts 12 are moved downward to detect the detection cell 54. A sample sample and a diluted sample are discharged to the two cell portions 54a, respectively. Note that the liquid temperature in the detection cell 54 is maintained at about 20 ° C. during dispensing of the primer reagent, enzyme reagent, and sample sample (diluted sample). Thereafter, the pipette tip 31 is discarded after the arm portion 11 of the dispensing mechanism portion 10 is moved above the tip discarding portion 40 by the transfer portion 60.

  Then, after the primer reagent, enzyme reagent, sample sample, and diluted sample are discharged into the cell portion 54a, the lid closing operation of the lid portion 54b of the detection cell 54 is performed. After the lid closing operation is completed, the target gene (mRNA) is amplified by a LAMP (gene amplification) reaction by heating the liquid temperature in the detection cell 54 from about 20 ° C. to about 65 ° C. And the white turbidity by the magnesium pyrophosphate produced | generated with amplification is detected by a turbidimetric method. Specifically, turbidity is detected by detecting (monitoring) the turbidity in the detection cell 54 during the amplification reaction using the LED light source unit 52a and the photodiode light receiving unit 52b shown in FIG. .

  At this time, the CPU 131 of the personal computer 102 displays a graph 113a showing the relationship between the reaction time (min) and the turbidity on the data browser screen of the display unit 140, as shown in FIG. Then, the CPU 131 displays the time corresponding to 0.1 of the turbidity that is the vertical axis of the graph 113a in the amplification rise time display column 113b. Then, the CPU 131 displays the concentration of the sample sample calculated from the rise time and the calibration curve (see FIG. 9) in the concentration measurement value display column 113c.

  As described above, the target gene (mRNA) is detected in the reaction detection block 50a located on the innermost side, and the measurement result is displayed on the display unit 140. In addition, the second to fourth reaction detection blocks 50a from the back are sequentially operated in the same manner as the target gene detection operation in the reaction detection block 50a at the cell set position 1. Then, in the reaction detection block 50a located at the fifth position from the back (located at the cell set position 5), similarly to the above-described target gene detection operation in the reaction detection block 50a at the cell set position 1, the sample specimen setting unit The positive control in the container 24 set in the 20 sample container setting holes 21a and the negative control in the container 25 set in the sample container setting holes 21b are measured, and the reaction detection blocks at the cell setting positions 1 to 4 are measured. It is determined whether or not the measurement result at 50a is normal. In other words, in the first embodiment, after batch processing for measuring up to four sample samples at a time is performed, the quality control samples (positive control and negative control) are measured, whereby the sample samples in the batch processing are measured. It is determined whether the measurement result is normal.

  At this time, when the quality control sample is not measured, as shown in FIG. 7, the CPU 131 displays a flag “*” indicating “no control measurement” together with each measurement result. At this time, the CPU 131 stores information on the analysis result of the quality control sample (without control measurement) and the measurement result of the sample sample and the diluted sample in the memory 132 in association with each other.

And when the concentration at the measurement elapsed time of 9.0 min to 13.0 min of the measured positive control is outside the range of 5.0 × 10 ² (copies / μl) or more and 5.0 × 10 ⁴ (copies / μl) or less. Alternatively, if the concentration at the measurement elapsed time of 16.0 min of the negative control is outside the range of 0 to 2.5 × 10 ² (copies / μl), the CPU 131 determines each measurement as shown in FIG. A flag “*” indicating “accuracy control error” is displayed together with the result. At this time, the CPU 131 stores information on the analysis result of the quality control sample (accuracy control abnormality) and the measurement result of the sample sample and the diluted sample in the memory 132 in association with each other. Therefore, the measurement results of up to four sample samples measured before measuring the quality control sample are stored in the memory 132 in association with the measurement result information of the quality control sample by the CPU 131.

  When the flag “*” is added to the amplification rise time display column 113b, the concentration measurement value display column 113c, and the determination result display column 113d of the display unit 140, the CPU 131 displays the determination result display column 113d below. An error button 113e is displayed. Then, when the user clicks the error button 113e using the mouse 120, as shown in FIGS. 6 and 7, an error list display unit 151 that displays “accuracy control error” or “no control measurement”, An error display screen 150 having an action display unit 152 describing details of error information of the error list display unit 151 and a coping method is displayed.

  Then, when the user confirms “accuracy control error” in the error list display section 151 on the error display screen 150, according to the coping method displayed on the action display section 152, has the expiration date of the quality control sample passed? Confirm that the quality control sample has been stored correctly. Further, when the user confirms “no control measurement” in the error list display section 151 of the error display screen 150, according to the coping method displayed on the action display section 152, the sample specimen and the diluted specimen, the quality control specimen, Perform re-measurement. In the first embodiment, since the quality control sample is measured for each batch process, if an abnormality occurs in the quality control sample (abnormality control accuracy, no control measurement), all (up to 4) in the batch process. It is necessary to re-measure the sample sample and the diluted sample. Note that only the quality control reagent may be re-measured before the transition to the next batch process.

  Thus, the operation of the gene amplification analysis system 1 is completed by executing the batch processing a predetermined number of times.

  In the first embodiment, as described above, the measurement result of the sample sample measured by the gene amplification measurement apparatus 101 is stored in the memory 132. The control unit 130 can display a list of the measurement results stored in the memory 132 in this way on the display unit 140 (sample explorer screen (see FIG. 4)). As shown in FIG. 4, the sample explorer screen is a screen in a table format provided with fields of measurement date, measurement time, sample ID, measurement status, batch number, sample position, error, unoutput, and logon name, The measurement result of the sample sample and the measurement result of the quality control sample are displayed in a list format arranged in order of measurement time. In this screen, the measurement result of the sample sample and the measurement result of the quality control sample related to the measurement result of the sample sample are displayed in association with each other. More specifically, the same batch number is given to the measurement result of the sample specimen and the measurement result of the quality control specimen corresponding to the measurement result of the sample specimen. Therefore, it is possible to easily specify the measurement result of the quality control sample corresponding to the measurement result of the sample sample only by confirming the batch number. In this way, the measurement result of the sample specimen and the measurement result of the quality control specimen corresponding thereto are displayed in association with each other, so that the user can correspond to the measurement result of the sample specimen in the screen and the corresponding measurement result. The measurement result of the quality control sample can be easily confirmed.

  Moreover, in 1st Embodiment, based on the measurement part of the display part 140 which displays the measurement result of the sample sample measured by the gene amplification measuring apparatus 101, and a quality control sample (positive control, negative control), a sample sample is shown. By providing the control unit 130 for controlling the display unit 140 so as to display the measurement result, the measurement result of the sample sample in consideration of the measurement result of the quality control sample is displayed on the display unit 140 (data browser screen (FIGS. 5 to 7). See)). As a result, the user can recognize that the measurement result of the sample sample displayed on the display unit 140 is a result displayed based on the quality control sample.

Moreover, in 1st Embodiment, the control part 130 is 5.0 * 10 < ² > (copies / microliter) or more in the density | concentration in measurement elapsed time 9.0min-13.0min of the positive control analyzed by CPU131 5.0. When out of the range of 10 ⁴ (copies / μl) or less, or when the concentration at the measurement elapsed time of 16.0 min of the negative control is outside the range of 0 to 2.5 × 10 ² (copies / μl) or less Controls the display unit 140 so as to display only the measurement result of the sample sample. If the analysis result of the quality control sample is out of the above range, the measurement result of the sample sample is added to the measurement result of the sample sample. By controlling the display unit 140 so as to display the flag “*” indicating that there is a possibility of abnormality and the error button 113e, the analysis result of the quality control sample is improved. If outside the range, abnormality information indicating that in addition to the measurement results of the sample specimen measurement of sample specimen results in the possibility of the abnormality (the flag "*") can be displayed on the display unit 140. As a result, when the user confirms the measurement result of the sample sample, it can be easily confirmed whether the measurement result of the sample sample is abnormal or normal.

  In the first embodiment, in the data browser screen (see FIGS. 5 to 7), when there is an abnormality in the measurement result of the quality control sample, a flag “*” attached to the measurement result of the sample sample and an error By displaying the button 113e and the error display screen 150 displaying the details of the abnormality information on the display unit 140, the user can easily check the sample by checking the flag attached to the measurement result of the sample sample. It can be recognized that the measurement result of the sample may be abnormal. Then, the user can easily confirm the details of the abnormality information by confirming the action display unit 152 on the error display screen 150.

  In the first embodiment, the control unit 130 controls the display unit 140 to display a flag “*” indicating whether or not the quality control sample is determined as determined by the CPU 131, thereby “accuracy control abnormality”. Not only in the case of, but also when there is no measurement result of the quality control sample corresponding to the measurement result of the sample sample (in the case of “no control measurement”), the sample sample is taken into consideration that the quality control sample is not measured These measurement results can be displayed on the display unit 140. As a result, the user can recognize that the measurement result of the sample sample displayed on the display unit 140 is a result of displaying the quality control sample without measuring.

  In the first embodiment, the memory 132 stores information related to the measurement result of the sample sample and the measurement result of the quality control sample measured by the gene amplification measuring apparatus 101, and the measurement result of the sample sample and the quality control sample. By providing the control unit 130 that controls the storage unit so as to store the information related to the measurement result in association with each other, the measurement result of the sample sample and the measurement result of the quality control sample are stored in the memory 132 in association with each other. be able to. As a result, it is possible to easily manage the measurement result of the sample specimen and the information related to the measurement result of the quality control specimen.

(Second Embodiment)
FIG. 10 is a perspective view showing the entire configuration of the immune agglutination measurement apparatus according to the second embodiment of the present invention, and FIG. 11 is a front view of the immune agglutination measurement apparatus shown in FIG. 12-20 is a figure for demonstrating the detail of the immune-aggregation measuring apparatus shown in FIG. The immune agglutination measurement apparatus 200 according to the second embodiment is an apparatus for measuring a trace amount of protein (antigen) in blood by PCIA (Particle counting immunoassay). In addition, it is possible to select whole blood or serum as a sample sample of the immunoagglutination measuring apparatus 200 of the second embodiment. In addition, in the immunoagglutination measurement apparatus 200 according to the second embodiment, the measurement result of the sample sample (whole blood or serum) is reported by measuring the quality control sample as in the gene amplification analysis system 100 of the first embodiment. (Measurement result of specimen sample is confirmed).

  As shown in FIGS. 10 to 12, the immune agglutination measurement apparatus 200 according to the second embodiment includes a dispensing unit 210, a reagent installing unit 220, a sample holder unit 230, a reaction unit 240, and a measurement dilution dispensing unit. 250, a sample receiving unit 260, an optical detection unit 270, a reaction plate tray 280 that stores unused reaction plates 201, a reaction plate waste box 290 that stores used reaction plates 201, a cleaning unit 300a, 300b and the control part 310 are included. As shown in FIGS. 10 and 11, a power switch 320 for starting the apparatus and a display unit 330 including a touch panel are provided on the front surface of the immune agglutination measurement apparatus 200.

  The dispensing unit 210 is configured to move between a rack 231 and a reaction unit 240 of sample holders 230a to 230e described later. As shown in FIG. 12, the dispensing unit 210 has a horizontal movement mechanism unit (not shown) movable in the X2 axis direction and the Y2 axis direction orthogonal to the horizontal direction, and a horizontal movement mechanism unit. A specimen / latex pipette unit 211 that can move in the vertical direction (Z2 axis direction) and a plate catcher unit 212 are included. The specimen / latex pipette unit 211 also dispenses and discharges a sample specimen (whole blood or serum) in a sample cup 202 (see FIG. 13) placed on a rack 231 of specimen holders 230a to 230e described later. have. The sample / latex pipette unit 211 also has a function of dispensing and discharging a latex reagent, a buffer solution, and a sample diluent in a reagent bottle 203 set in a reagent installing unit 220 described later. The plate catcher unit 212 is provided for transporting the unused reaction plate 201 from the reaction plate tray 280 to the reaction unit 240 and transporting the used reaction plate 201 to the reaction plate waste box 290. The reaction plate 201 is provided with 25 cuvettes 201a that can accommodate sample samples and various reagents.

  The reagent installing unit 220 is provided to place a reagent bottle 203 containing a buffer solution, a latex reagent, and a sample diluent. At this time, the reagents (buffer solution, latex reagent, sample dilution solution) in the reagent bottle 203 are kept at a predetermined temperature (15 ° C. or lower). The reagent installing unit 220 is provided with a buffer solution container setting unit 221, a latex reagent container setting unit 222, and a sample diluent container setting unit 223 in order from the back side of the apparatus.

  The specimen holder unit 230 is provided to process all the sample specimens registered in order in a predetermined order. As shown in FIG. 13, the specimen holder unit 230 places five specimen holders 230a to 230e for setting a rack 231 on which 10 sample cups 202 can be placed, and one sample cup 202. One emergency specimen holder 230f for setting a possible rack 231 is provided. Ten sample cups 202 can be placed on the rack 231 of the specimen holders 230a to 230e, and a total of 50 sample cups 202 can be set to the five specimen holders 230a to 230e. The racks 231 of the specimen holders 230a to 230e are arranged at the rack set position 1, the rack set position 2, the rack set position 3, the rack set position 4 and the rack set position 5 in order from the left side when viewed from the front of the apparatus. . The sample cups 202 placed on the racks 231 of the five specimen holders 230a to 230e are respectively arranged at the cup set position 1 to the cup set position 10 in order from the back side of the apparatus.

  In addition, one sample cup 202 containing a quality control sample is placed at a predetermined position of the rack 231 of the sample holders 230a to 230e of the sample holder unit 230. Sample LEDs 231a to 231e (see FIGS. 11 and 13) are provided on the front surfaces of the five sample holders 230a to 230e of the sample holder unit 230, respectively. An emergency sample LED 231f (see FIG. 11) is also provided on the front surface of the emergency sample holder 230f. The sample LEDs 231a to 231e and the emergency sample LED 231f are configured to illuminate in green when the sample holders 230a to 230e and the emergency sample holder 230f can be pulled out, and to light in red when they cannot be pulled out. Yes. Then, the user can add the sample cup 202 to the rack 231 of the sample holders 230a to 230e and the emergency sample holder 230f when the sample LEDs 231a to 231e and the emergency sample LED 231f are lit in green.

  Further, the emergency specimen sample in the sample cup 202 held in the rack 231 set in the emergency specimen holder 230f interrupts the sample specimen in the sample cup 202 held in the rack 231 set in the specimen holders 230a to 230e. Measured with priority.

  In addition, the reaction unit 240 is provided for reacting the sample sample and the emergency sample sample accommodated in the cuvette 201a of the two reaction plates 201 with various reagents (buffer solution, latex reagent, sample dilution solution). ing. Specifically, the sample sample and emergency sample sample dispensed by the dispensing unit 210 described above and various reagents (buffer solution, latex reagent, sample dilution solution) are agitated and mixed, and the agitation and mixing are performed. By maintaining the prepared sample sample, the emergency specimen sample, and various reagents at a predetermined temperature, a prepared sample is prepared to promote the agglutination reaction of the latex reagent. That is, in the reaction unit 240, as shown in FIG. 14, an agglutination reaction is performed in which latex particles in the latex reagent to which the antibody is bound aggregate with the antigen in the sample sample as a medium.

  In addition, as shown in FIG. 12, the measurement dilution dispensing unit 250 is disposed behind the dispensing unit 210 and has a function of sucking and discharging the prepared sample in the cuvette 201a of the reaction plate 201 of the reaction unit 240. Have. The measurement dilution dispensing unit 250 includes a horizontal movement mechanism unit (not shown) that is movable in the X2 axis direction and the Y2 axis direction orthogonal to the horizontal direction, and a vertical direction (Z2 axis) with respect to the horizontal movement mechanism unit. And a measurement dilution pipette unit 251 movable in the direction). Then, the measurement dilution dispensing unit 250 samples the prepared sample in the cuvette 201a of the aspirated reaction plate 201 together with the measurement diluent stored in a tank (not shown) installed in the lower part of the immune agglutination measurement apparatus 200. It discharges to the receiving part 260.

  The sample receiving section 260 is provided for receiving the prepared sample and the measurement diluent in the cuvette 201a of the reaction plate 201 of the reaction section 240 described above. Then, the particle suspension (prepared sample and measurement diluent) received in the sample receiver 260 is guided to a sheath flow cell 274 (see FIG. 15) of the optical detector 270 described later.

  As shown in FIG. 15, the optical detection unit 270 includes a laser diode 271 as a light source, a condenser lens 272 and a collector lens 273, a sheath flow cell 274, and a photodiode 275 as a light receiving element. . The sheath flow cell 274 has a function of converting the flow of the particle suspension (prepared sample and measurement dilution liquid) into a flat flow by sandwiching the flow of the particle suspension with the flow of the sheath liquid flowing on both sides of the particle suspension. . The light applied to the particle suspension flowing through the sheath flow cell 274 from the laser diode 271 is scattered by an aggregate of latex particles in the particle suspension (see FIG. 14) and received by the photodiode 275. It is configured as follows.

  Moreover, the reaction plate tray 280 can accommodate a maximum of four unused reaction plates 201 (see FIG. 12), as shown in FIGS. And the reaction plate 201 accommodated in the reaction plate tray 280 is conveyed to the reaction part 240 by the plate catcher part 212 (refer FIG. 12) of the dispensing part 210. FIG. Further, the reaction plate disposal box 290 can store the used reaction plate 201 and is transported from the reaction unit 240 by the plate catcher of the dispensing unit 210.

  The cleaning unit 300 a is provided for cleaning the specimen / latex pipette unit 211 of the dispensing unit 210. The cleaning unit 300b is provided to clean the measurement dilution pipette unit 251 of the measurement dilution dispensing unit 250.

  Next, details of the screen layout of the display unit 330 will be described with reference to FIGS. 10, 11, and 13 to 19. The display unit 330 (see FIG. 10) displays a screen (progress status screen) that displays measurement results (concentration, flag, etc.) calculated from the intensity of scattered light received by the optical detection unit 270 (see FIG. 15) (FIG. 10). 17 and FIG. 18), and a screen (measurement registration screen) (see FIG. 16) for performing measurement instructions (order registration) such as registration of sample IDs of sample samples and quality control samples is provided.

  On the measurement registration screen, as shown in FIG. 16, five rack designation buttons 311a to 311e for designating the rack 231 of the specimen holders 230a to 230e, a specimen number input button 312 used for registering the specimen number, and a cursor Cursor movement button 313 used when moving 350, dilution factor input button 314 used when registering the dilution factor, clear key 315 for erasing the input specimen number and dilution factor, and the type of sample specimen ( Whole blood / serum input button 316 for designating a whole blood or serum), a registration button 317 for confirming an order-registered sample sample as an object of measurement (dispensing), and an order list for displaying the contents of the order registration A display unit 318 and a measurement start button 319 are displayed.

  The five rack designation buttons 311a to 311e are provided for designating the racks 231 of the predetermined sample holders 230a to 230e of the sample holder unit 230. For example, when the user touches a rack designation button 311a (“Rack 1” in the screen), the rack 231 (see FIG. 13) to be placed on the specimen holder 230a of the specimen holder unit 230 is designated, and the specimen is designated. Order registration of the rack 231 placed on the holder 230a is possible. The sample number input button 312 is used when inputting the sample ID of the sample sample at the cup set positions 1 to 10 and the quality control sample selected by the cursor 350 moved by touching the cursor movement button 313. As the sample ID, an ID corresponding to the quality control sample is input in addition to the ID corresponding to the sample sample. For example, “121 or 222” is used as the sample ID. For example, “QC01” is used as the sample ID of the quality control sample. For example, when a quality control sample is stored in the sample cup 202 corresponding to the cup set position 3 of the rack set position 1, the user touches the rack designation button 311a to display the rack set on the order list display unit 318. After displaying the contents of the order registration at position 1, the cursor 350 is moved to the cup setting position 3 using the cursor movement button 313, and “QC01” is registered using the sample number input button 312.

  The dilution factor input button 314 is used when inputting the dilution factor of the sample specimen at the cup set positions 1 to 10 selected by the cursor 350. A whole blood / serum input button 316 is provided to select the type of sample specimen at the cup set positions 1 to 10 selected by the cursor 350. For example, “WB” is displayed when the sample is whole blood, and “S” is displayed when the sample is serum. The contents registered with the various buttons described above are reflected in the order list display unit 318.

  As shown in FIGS. 17 and 18, the progress status screen includes a main menu section 321 in which buttons for displaying a measurement registration screen (see FIG. 16) and the like are arranged, and a sample progress status confirmation screen shown in FIG. A sample progress status display button 322 to be displayed, an all rack usage status display button 323 for displaying the rack usage status confirmation screen shown in FIG. 18, and a measurement start button 324 are displayed.

  Then, when the user touches the specimen progress display button 322 shown in FIGS. 17 and 18, a specimen progress confirmation screen is displayed as shown in FIG. On the sample progress confirmation screen, five rack designation buttons 325a to 325e, one emergency sample rack designation button 325f, and a measurement result display unit 326 for displaying measurement results of the sample sample and the quality control sample are displayed.

  The five rack designation buttons 325a to 325e have the same function as the rack designation buttons 311a to 311e on the measurement registration screen (see FIG. 16), and are used to designate a predetermined rack 231 of the sample holder unit 230. Is provided. For example, when the user touches the rack designation button 325a (“Rack 1 is being measured” on the screen), the rack 231 placed on the sample holder 230a (see FIG. 13) of the sample holder unit 230 is designated, The measurement result display unit 326 displays the measurement results of the sample samples and the quality control samples in the ten sample cups 202 placed on the rack 231 of the sample holder 230a. The emergency sample rack designation button 325f designates the emergency sample holder 230f of the sample holder section 230. When the user touches the emergency sample rack designation button 325f, the emergency sample holder 230f (see FIG. 11 and FIG. 13) is designated, and the measurement result display unit 326 displays the measurement result of the emergency sample.

  The measurement result display section 326 includes a sample position display field 326a, a sample ID display field 326b, a whole blood / serum display field 326c, and a result display field 326d that displays measurement results (concentrations, flags, etc.) for each measurement item. And are provided. In the measurement result display unit 326, the sample ID and the measurement result for the rack 231 designated by touching the rack designation buttons 325a to 325e and the emergency sample rack designation button 325f described above are displayed. The second embodiment shows a screen when the rack designation button 325a for designating the rack 231 of the sample holder 230a is touched.

  In the sample ID display field 326b, sample IDs corresponding to the cup set positions 1 to 10 displayed in the sample position display field 326a are displayed. This sample ID is input in advance on the measurement registration screen (see FIG. 16). In the whole blood / serum display field 326c, the type of the sample sample registered using the whole blood / serum input button 316 on the measurement registration screen (for example, whole blood: “WB”, serum: “S”) is displayed. It is displayed. In the result display column 326d, the concentration of the sample sample calculated from the intensity of the scattered light detected by the optical detection unit 270 (in the screen, “> 56.00” or “1.30 / +”). Etc.) (ng / ml) is displayed. The concentration of the sample specimen is determined by a calibrator created by a calibrator that measures the aggregation degree of latex particles (see FIG. 14) calculated from the intensity of scattered light acquired by the optical detection unit 270 (see FIG. 15) in advance. This is calculated by substituting into a calibration curve (see FIG. 19) that is a function of the concentration of γ and the degree of aggregation of the calibrator.

  In addition, when the user touches the all-rack usage status display button 323 shown in FIG. 17, the sample progress status confirmation screen is switched to a rack usage status confirmation screen in which the usage status of the rack 231 can be confirmed. On the rack usage status confirmation screen, as shown in FIG. 18, rack display units 327a to 327e for displaying the state of the sample cup 202 placed on each rack 231 of the sample holders 230a to 230e, and the emergency sample holder An emergency sample rack display section 327f for displaying the state of the sample cup 202 placed on the 230f rack 231 is provided. Each of the rack display units 327a to 327e includes ten sample cup display units 328. The sample cup display unit 328 is in a state of order registration of the sample sample and the quality control sample in the sample cup 202. It has a function to display. As the measurement state of the sample sample and the quality control sample, when the order is not registered, the sample cup display unit 328 is displayed in white. When the order is registered, the sample cup display unit 328 is displayed in green. When the sample sample and the quality control sample are being measured, the sample cup display unit 328 is displayed in red. FIG. 18 shows a case where the sample sample at the cup set position 10 at the rack set position 1 is being measured and the sample cup display section 328 at the cup set position 10 at the rack set position 1 is displayed in red. ing. In FIG. 18, the sample cup display portion 328 other than the cup set position 10 in the rack set position 1 is displayed in green when the order of the sample sample other than the cup set position 10 in the rack set position 1 is already registered. Shows the case.

  Next, details of the control unit 310 will be described with reference to FIGS. 15, 16, and 20. As shown in FIG. 20, the control unit 310 includes a ROM 310a, a CPU 310b, a RAM 310c, an input / output interface 310d, and an image output interface 310e, which are connected so as to be able to perform data communication via a bus 310f. Has been.

  In the second embodiment, the ROM 310a has a sample cup 202 that contains sample specimens placed on the racks 231 of the five specimen holders 230a to 230e of the specimen holder section 230, and a sample cup 202 that contains quality control specimens. Is stored. Specifically, the user uses the sample number input button 312 displayed on the display unit 330 (touch panel) on the measurement registration screen (see FIG. 16), the sample ID of the sample sample, and the sample ID of the quality control sample. , The position of the sample specimen and the quality control specimen is stored in the ROM 310a.

  The CPU 310b has a function of calculating the concentration of the antigen in the sample sample from the intensity of the scattered light detected by the optical detection unit 270 (see FIG. 15). The CPU 310b has a function of analyzing the measurement result (concentration) of the measured quality control sample, and determines whether or not the acquired measurement result (concentration) of the quality control sample is within a normal range. ing. This normal range is preset and stored in the ROM 310a. The normal range is set by manual setting manually set by the user or automatic setting automatically set by the CPU 310b. Then, the CPU 310b reports the measurement result of the sample sample (determines the measurement result of the sample sample) based on the determination result of the quality control sample.

  The RAM 310c is used as a work area for the CPU 310b. Specifically, the RAM 310c is used as a work area when the CPU 310b calculates the degree of aggregation and concentration from the intensity of scattered light detected by the optical detection unit 270.

  The input / output interface 310d is, for example, a serial interface such as USB, IEEE 1394, or RS-232C, a parallel interface such as SCSI, IDE, or IEEE 1284, and an analog including a D / A converter, an A / D converter, or the like. It consists of an interface. The input / output interface 310d is connected to a display unit 330 including a touch panel, and is configured to output input data provided when the user touches the display unit 330 including a touch panel to the CPU 310b. The image output interface 310e is connected to the display unit 330, and is configured to output a video signal corresponding to the image data given from the CPU 310b to the display unit 330.

  Next, the operation of the immune agglutination measurement apparatus 200 according to the second embodiment will be described with reference to FIGS. In the immune agglutination measurement apparatus 200 according to the second embodiment, as described above, latex particles holding an antibody that binds to an antigen in blood (sample sample) are aggregated, and light is applied to the aggregates of the aggregated latex particles. Thus, the degree of aggregation is calculated, and the concentration of the antigen in the blood (sample sample) is measured from the degree of aggregation.

  First, as shown in FIG. 13, the sample cup 202 containing the whole blood or serum (sample sample) is set in the rack 231 of the specimen holders 230a to 230e. In addition, one sample cup 202 in which the quality control sample is accommodated is set at a predetermined position of the rack 231 of the specimen holders 230a to 230e.

  Further, before starting the measurement, the sample of the sample sample and the quality control sample are displayed on the measurement registration screen (see FIG. 16) using various buttons displayed on the display unit 330 (touch panel) shown in FIGS. Register the order such as ID and dilution factor. Thereby, in 2nd Embodiment, the position of a sample sample and a quality control sample is memorize | stored in ROM310a of the control part 310. FIG. At this time, by using “QC” as the sample ID of the quality control sample, the position of the quality control sample is stored in the ROM 310a so as to be distinguished from other sample samples.

  Then, when the user touches the measurement start button 319 (see FIG. 16) or 324 (see FIGS. 17 and 18), the measurement operation of the immune agglutination measurement apparatus 200 is started.

  When the operation of the immunoagglutination measurement apparatus 200 starts, first, an unused reaction plate 201 is conveyed from the reaction plate tray 280 to the reaction unit 240 by the plate catcher unit 212 of the dispensing unit 210 shown in FIG.

  Then, the CPU 310b of the control unit 310 of the immune agglutination measurement apparatus 200 determines whether there is an order registration of the sample specimen. When the CPU 310b determines that there is a sample sample order registration, the CPU 310b controls the dispensing unit 210 to dispense the sample sample in the sample cup 202. Then, the concentration of this sample is measured by a measurement process according to the flowchart shown in FIG.

  Further, the CPU 310b determines whether there is an order registration of the quality control sample. When the CPU 310b determines that there is an order registration of the quality control sample, the CPU 310b controls the dispensing unit 210 (see FIG. 12) to dispense the quality control sample in the sample cup 202. For example, when the order of the quality control sample is registered at the cup set position 3 at the rack set position 1, the dispensing unit 210 dispenses the quality control sample at the cup set position 3 at the rack set position 1. Is done. And also about a quality control sample, a density | concentration is measured by the measurement process along the flowchart shown in FIG. 21 mentioned later.

  Next, the details of the measurement process of the sample specimen and the quality control specimen will be described with reference to FIG. FIG. 21 is a flowchart showing a measurement process of the immune agglutination measurement apparatus shown in FIG. First, as shown in FIG. 21, when diluting the sample specimen in the sample cup 202 in step S21 (when the dilution factor registered on the measurement registration screen is larger than 1), the specimen diluent is aspirated. Then, the sample / latex pipette unit 211 of the dispensing unit 210 is moved to the sample diluent container setting unit 223 of the reagent installing unit 220. The specimen / latex pipette unit 211 sucks the sample specimen from the sample cup 202 after sucking the specimen diluent. Thereafter, the specimen / latex pipette unit 211 discharges the specimen diluted solution and the sample specimen sucked into the cuvette 201a of the reaction plate 201 set in the reaction unit 240. Thereby, a diluted sample is prepared in the cuvette 201a of the reaction plate 201. Note that this step is omitted when the sample is not diluted (when the dilution factor registered on the measurement registration screen is 1) and when the sample is a quality control sample.

  In step S22, the sample / latex pipette unit 211 of the dispensing unit 210 is moved to the buffer container setting unit 221 of the reagent installing unit 220 after discharging the diluted sample (sample diluted solution and sample sample). Then, the sample / latex pipette unit 211 sucks the buffer solution, and then moves to the cuvette 201a in which the diluted sample is accommodated to suck the diluted sample in the cuvette 201a. Dispense buffer and diluted specimen. In the case of an undiluted sample in which a diluted sample is not prepared (when the dilution factor registered on the measurement registration screen is 1), the sample / latex pipette unit 211 moves to the sample cup 202 after aspirating the buffer solution. Then, the sample sample (quality control sample) in the sample cup 202 is sucked, and the buffer solution and the sample sample (quality control sample) are discharged to the cuvette 201a of the reaction plate 201.

  In step S23, the sample / latex pipette unit 211 of the dispensing unit 210 is replaced with the latex reagent container setting unit of the reagent installing unit 220 after about 80 seconds have passed since the diluted sample or the undiluted sample and the buffer solution were dispensed. To 222. The sample / latex pipette unit 211 sucks the latex reagent, and then moves to the cuvette 201a in which the diluted sample or the undiluted sample and the buffer solution are stored, and discharges the latex reagent into the cuvette 201a. As a result, as shown in FIG. 14, the antigen in the sample sample (quality control sample) and the antibody bound to the latex particle in the latex reagent bind to each other, and the agglutination reaction of the latex particle is started.

  Next, in step S24, about 20 seconds and about 15 minutes after the latex reagent is dispensed, the measurement dilution pipette unit 251 of the measurement dilution dispensing unit 250 is moved to the cuvette 201a from which the latex reagent has been discharged. The The measurement dilution pipette unit 251 sucks the prepared sample (sample sample (quality control sample), buffer solution and latex reagent) in the cuvette 201a, and is then moved to the sample receiving unit 260 (see FIG. 12). The prepared sample is discharged to the sample receiver 260. At this time, the measurement dilution dispensing unit 250 discharges the measurement diluent contained in a tank (not shown) installed in the lower part of the immunoagglutination measurement apparatus 200 together with the prepared sample to the sample receiving unit 260. Then, the aggregation degree (T1) of the prepared sample after about 20 seconds is obtained by performing Steps S25 to S28 described later on the prepared sample after about 20 seconds and about 15 minutes after the latex reagent is dispensed. Measurement result) and the degree of aggregation (T2 measurement result) of the prepared sample after about 15 minutes.

  FIG. 22 is a graph showing the relationship between the aggregation degree and the concentration of the T1 measurement result and the T2 measurement result. When the concentration of the antigen of the sample sample is high, as shown in the graph of the T2 measurement result in FIG. 22, the aggregation of latex particles may be weak, and an appropriate concentration may not be calculated from the degree of aggregation. Therefore, in the second embodiment, T2 measurement is performed so that an inappropriate concentration is not acquired due to weak aggregation of latex particles by acquiring the above-described T1 measurement result and T2 measurement result. When the result (aggregation degree) is E, the determination is made based on the T1 measurement result (aggregation degree). Specifically, when the T2 measurement result (aggregation degree) is E and the T1 measurement result (aggregation degree) is D, the concentration A corresponding to the T1 measurement result is within the measurement range. The concentration is calculated from (aggregation degree). On the other hand, when the T2 measurement result (aggregation degree) is E and the T1 measurement result (aggregation degree) is C, the concentration B corresponding to the T1 measurement result is outside the measurement range (overrange region). Therefore, if the concentration is calculated from the T2 measurement result (aggregation degree) as it is, an appropriate concentration may not be calculated. Therefore, when the concentration B corresponding to the T1 measurement result is out of the measurement range (overrange region), the dilution rate of the sample specimen is changed and remeasured.

  Thereafter, in step S25, the particle suspension (prepared sample and measurement diluent) discharged to the sample receiver 260 (see FIG. 12) is guided to the sheath flow cell 274 (see FIG. 15) of the optical detection unit 270. The sheath flow cell 274 converts the flow into a flat flow. In this state, the laser light having a wavelength of about 780 nm is irradiated from the laser diode 271 (see FIG. 15) to the aggregate of latex particles flowing through the sheath flow cell 274, and the intensity corresponding to the size of the aggregate of the latex particles. A plurality of scattered light having a light beam is received by a photodiode 275 (see FIG. 15). At this time, the CPU 310b (see FIG. 20) of the control unit 310 counts each scattered light received by the photodiode 275 as a pulse signal.

In step S26, the CPU 310b (see FIG. 20) calculates the degree of aggregation by discriminating into unaggregated latex particles and aggregated latex particles based on the intensity of scattered light received as a pulse signal. Specifically, when the intensity of the scattered light received by the CPU 310b is equal to or greater than a predetermined magnitude, the aggregate of latex particles that caused the scattered light is polymer (P) (aggregated latex particles). When the intensity of the received scattered light is less than a predetermined magnitude, the aggregate of latex particles that caused the scattered light is monomer (M) (unaggregated latex particles). judge. Then, the CPU 310b uses the count number P of scattered light having a predetermined size or more and the count number M of scattered light having a size less than a predetermined size, from the following equation (1), the degree of latex particle aggregation P / T is calculated.
P / T = P / (P + M) (1)

  In step S27, the CPU 310b converts the degree of aggregation P / T into a concentration from the calculated degree of aggregation P / T and a calibration curve prepared in advance (see FIG. 19).

  In step S28, as shown in FIG. 17, the CPU 310b displays the obtained concentration on the display unit 330, and causes the ROM 310a to display the sample cup 202 of the sample holder unit 230 (cup set position 1 of the rack set position 1). Are stored in correspondence with each other. In this way, the measurement process of the sample specimen at the cup set position 1 at the rack set position 1 is completed.

  The measurement result of the sample specimen and the measurement result of the quality control specimen thus measured are stored in the ROM 310a or the RAM 310c. The immune agglutination measurement apparatus 200 can display a list of the measurement results stored in this way on the display unit 330. As shown in FIG. 23, the measurement result list display screen includes a measurement date, a measurement time, a sample number, a measurement item (AFP, CEA, FRN, HBsAg, HBsAb, etc.), a measurement result, and a QC correspondence number. It is a screen in a table format provided with fields, and is displayed in a list format in which measurement results of sample samples and measurement results of quality control samples are arranged. In this screen, the measurement result of the sample sample and the measurement result of the quality control sample related to the measurement result of the sample sample are displayed in association with each other. This screen display will be described in more detail below. In the immune agglutination measurement apparatus 200, it is possible to register in advance a rule for associating the measurement result of the sample specimen with the measurement result of the accuracy control. The following rules are an example. Immediately after starting the apparatus, the quality control sample is measured. If the measurement result is normal, one or a plurality of sample samples are measured, and then the quality control sample is measured. If the number of measurements is large, then, for example, the quality control sample is measured every predetermined time. Here, the measurement result of the sample sample corresponds to the measurement result of the quality control sample performed immediately thereafter. As another example, the rule of associating the measurement result of the sample sample using the reagent of the same lot number with the measurement result of the quality control sample, the measurement result of the sample sample, and the measurement result of the quality control sample immediately before A rule of associating, a rule of associating a measurement result of a sample sample having the same measurement date with a measurement result of a quality control sample, and the like. In the immunoagglutination measurement, there are a plurality of measurement items, and quality control measurement is performed for each measurement item. Therefore, even if the sample samples are the same, the measurement results of the corresponding quality control samples are different between the measurement results of different measurement items. In accordance with the rules set as described above, the CPU 310b of the immune agglutination measurement apparatus 200 adds the measurement result of each sample sample and the measurement result of the quality control sample to the measurement result of the sample sample and the measurement result of the quality control sample. A QC correspondence number indicating the correspondence is assigned. The QC correspondence numbers are the same for the measurement results of the sample samples corresponding to each other and the measurement results of the quality control sample, and are different numbers between the measurement results that do not correspond. For example, as shown in FIG. 23, the measurement results of the sample sample with the specimen number “001” and the specimen number “005” being “AFP” and the accuracy management with the measurement item having the specimen number “QC001” being “AFP” A QC correspondence number “A001” is assigned to the measurement result of the sample. In addition, the measurement result of the sample sample whose specimen number “001” and “005” is “CEA” and the measurement result of the quality control specimen whose specimen item “QC001” is “CEA” are compatible with QC. The number “C001” is assigned. In addition, the measurement result of the sample sample with the measurement item “HBsAg” of the specimen numbers “002” to “004” and the measurement result of the quality control sample with the measurement item of the specimen number “QC001” “HBsAg” Corresponding number “G002” is assigned. The measurement result of the sample number “101” for the sample number “HBsAg” and the measurement result of the quality control sample “HBsAg” for the sample number “QC001” measured thereafter are measured in the afternoon. Is assigned a QC correspondence number “G003”. In this way, the measurement result of the sample specimen and the measurement result of the quality control specimen corresponding thereto are displayed in association with each other, so that the user can correspond to the measurement result of the sample specimen in the screen and the corresponding measurement result. The measurement result of the quality control sample can be easily confirmed. This QC correspondence number is not only automatically input according to a preset rule, but also configured so that the operator can check, correct and input the measurement status of the sample specimen and the quality control specimen.

  Note that the measurement result of the sample specimen and its QC correspondence number, and the measurement result of the quality control specimen and its QC correspondence number as described above are stored in the ROM 310a or the RAM 310c. That is, the measurement result of the sample specimen and the measurement result of the quality control specimen are associated with each other and stored in the ROM 310a or the RAM 310c.

  Further, the immunoagglutination measuring apparatus 200 can display detailed information (detailed information screen) of the measurement result of the sample specimen. When the CPU 310b receives selection of a measurement result of a desired measurement item from the user on the measurement result list display screen, the CPU 310b displays a detailed information screen of the measurement result of the measurement item on the display unit 330. FIG. 24 is a diagram illustrating an example of a detailed information screen. As shown in FIG. 24, on the detailed information screen 400, information such as the sample number 401, the measurement result 402, the measurement date 403, the measurement item 404, and numerical information 405 indicating the measurement result in detail are displayed. The measurement result is displayed as a graph 406. The detailed information screen 400 displays a quality control result button 407 for displaying the measurement result of the corresponding quality control sample.

  When the display unit 330 displays the detailed information screen 400 described above, when the user touches an area where the quality control result button 407 (see FIG. 24) of the display unit 330 formed of a touch panel is displayed, The CPU 310b detects this, and displays the measurement result of the quality control sample corresponding to the measurement result of the sample sample on the display unit 330. FIG. 25 is a diagram showing a detailed information screen when the measurement result of the quality control sample is displayed. As shown in FIG. 25, when the detailed information screen 400 of the measurement item AFP is displayed, the measurement result display area 410 of the quality control sample of the measurement item AFP is superimposed on the detailed information screen 400. The measurement result display area 410 of the quality control sample is displayed in an area other than the area where at least the specimen number 401 and the measurement result 402 are displayed in the detailed information screen 400. FIG. 25 shows a case where the measurement result display area 410 of the quality control sample is displayed so as to overlap the numerical information 405 and the graph 406. As a result, the sample number 401 and the measurement result 402 are not hidden in the measurement result area 410 of the quality control sample. Therefore, the user confirms the sample number 401, the measurement result 402, and the measurement result of the quality control sample on the same screen. be able to.

  In the measurement result display area 410 of the quality control sample, the measurement result of the quality control sample regarding the measurement item is displayed in a graph in time series, and corresponds to the measurement result of the sample sample displayed on the detailed information screen 400. A cursor (vertical line) 411 indicating when the measurement result of the quality control sample is the one of the measurement results displayed in time series is displayed superimposed on the time series graph. Thereby, the user can easily confirm the measurement result of the corresponding quality control sample. In the measurement result display area 410 of the quality control sample, cursor data 412 including the measurement date and time of the measurement result specified by the cursor 411 and numerical data of the measurement result is displayed. A plurality of horizontal lines indicating the median value 413, the first upper limit value 414, the second upper limit value 415, the first lower limit value 416, and the second lower limit value 417 of the quality control measurement result are also displayed in the measurement result display area of the quality control sample. 410 is displayed. As a result, the user can set the median value 413, the first upper limit value 414, the second upper limit value 415, the first lower limit value 416, and the second lower limit value 417 to indicate whether the measurement result of the quality control sample is normal or abnormal. Can be used for confirmation.

  In the second embodiment, the sample specimen and the quality control sample can be placed on the same specimen holder section 230 by providing the specimen holder section 230 on which the sample specimen and the quality control specimen can be placed. As a result, it is necessary to separately provide a specimen holder part (sample placing part) capable of placing a sample specimen and a specimen holder part (sample placing part) capable of placing a quality control sample. Therefore, the increase in size of the device can be suppressed.

  The embodiment disclosed this time should be considered as illustrative in all points and not restrictive. The scope of the present invention is shown not by the above description of the embodiment but by the scope of claims for patent, and all modifications within the meaning and scope equivalent to the scope of claims for patent are included.

  For example, in the first embodiment, the example in which the present invention is applied to a gene amplification analysis system constructed by a gene amplification measurement apparatus and a personal computer has been shown. However, the present invention is not limited to this, and only the gene amplification measurement apparatus. Alternatively, the gene amplification measurement apparatus may have a personal computer function.

Moreover, in the said 1st Embodiment, the density | concentration in measurement elapsed time 9.0min-13.0min of positive control is 5.0 * 10 < ² > (copies / microliter) or more and 5.0 * 10 < ⁴ > (copies / microliter) or less. When the concentration at the measurement elapsed time of 16.0 min of the negative control is out of the range of 0 to 2.5 × 10 ² (copies / μl) or less, the flag “*” indicating a quality control abnormality ”Is displayed on the display unit. However, the present invention is not limited to this, and the display unit displays not only a flag indicating a quality control abnormality but also a flag indicating normality when the measurement result of the quality control sample is normal. May be displayed.

  In the first embodiment, the example in which the flag “*” indicating the abnormality information is displayed together with the measurement result on the data browser screen has been described. However, the present invention is not limited thereto, and the measurement result is not displayed. Only the flag may be displayed.

1 is a perspective view showing an overall configuration of a gene amplification analysis system according to a first embodiment of the present invention. It is the perspective view which showed the whole structure of the gene amplification measuring apparatus of the gene amplification analysis system by 1st Embodiment shown in FIG. FIG. 3 is a schematic plan view of FIG. 2. It is the figure which showed the sample explorer screen displayed on the display part of the personal computer which constructs | assembles the gene amplification analysis system by 1st Embodiment shown in FIG. It is the figure which showed the data browser screen displayed on the display part of the personal computer which constructs | assembles the gene amplification analysis system by 1st Embodiment shown in FIG. It is the figure which showed the data browser screen displayed on the display part of the personal computer which constructs | assembles the gene amplification analysis system by 1st Embodiment shown in FIG. It is the figure which showed the data browser screen displayed on the display part of the personal computer which constructs | assembles the gene amplification analysis system by 1st Embodiment shown in FIG. It is the figure which showed the workload list screen displayed on the display part of the personal computer which builds the gene amplification analysis system by 1st Embodiment shown in FIG. It is the figure which showed the calibration curve display screen displayed on the display part of the personal computer which constructs | assembles the gene amplification analysis system by 1st Embodiment shown in FIG. It is the perspective view which showed the whole structure of the immunoagglutination measuring apparatus by 2nd Embodiment of this invention. It is a front view of the immunoagglutination measuring apparatus by 2nd Embodiment shown in FIG. It is the top view which showed the internal structure of the immunoagglutination measuring apparatus by 2nd Embodiment shown in FIG. It is an expansion perspective view of the sample holder part of the immune agglutination measuring apparatus by 2nd Embodiment shown in FIG. It is the figure which showed the aggregation reaction of the antibody couple | bonded with an antigen and latex particle | grains. It is a schematic diagram of the optical detection part of the immunoagglutination measuring apparatus by 2nd Embodiment shown in FIG. It is the figure which showed the measurement registration screen displayed on the display part of the immune aggregation measuring apparatus by 2nd Embodiment shown in FIG. It is the figure which showed the progress condition screen (sample progress confirmation screen) displayed on the display part of the immune agglutination measuring apparatus by 2nd Embodiment shown in FIG. It is the figure which showed the progress condition screen (rack usage condition confirmation screen) displayed on the display part of the immune aggregation measuring apparatus by 2nd Embodiment shown in FIG. 11 is a graph on which a calibration curve showing the relationship between the concentration of a calibrator and the degree of aggregation used in the immune agglutination measurement apparatus according to the second embodiment shown in FIG. 10 is drawn. It is a block diagram of the control part of the immune agglutination measuring apparatus by 2nd Embodiment shown in FIG. It is the flowchart which showed the measurement process of the immune aggregation measuring apparatus by 2nd Embodiment shown in FIG. It is the graph which showed the relationship between the aggregation degree of a T1 measurement result and a T2 measurement result, and a density | concentration. It is the figure which showed the measurement result list display screen displayed on the display part of the immune aggregation measuring apparatus by 2nd Embodiment shown in FIG. It is the figure which showed the detailed information screen displayed on the display part of the immune aggregation measuring apparatus by 2nd Embodiment shown in FIG. It is the figure which showed the detailed information screen when the measurement result of the quality control sample displayed on the display part of the immune aggregation measuring apparatus by 2nd Embodiment shown in FIG. 10 is displayed.

Explanation of symbols

1 Gene amplification analysis system (sample analyzer)
101 Gene amplification measuring device (measurement unit)
110 Keyboard (input unit)
120 mouse (input unit)
130 Control unit (determination unit, quality control processing unit)
132 Memory (storage unit)
140 Display unit (output unit)
200 Immunoagglutination measuring device (sample analyzer)
240 reaction part (measurement part)
330 Display unit (input unit, output unit)
310 Control unit (determination unit, quality control processing unit)
310a ROM (storage unit)
310c RAM (storage unit)

Claims (12)

A measurement unit capable of measuring a specimen sample and a control sample;
A determination unit for determining whether the measurement result of the control sample is within a predetermined range; and
A sample analyzer comprising: a display unit that controls display of a measurement result of the sample sample measured by the measurement unit based on a determination result of the determination unit. A measurement unit capable of measuring a specimen sample and a control sample;
A storage unit for storing the measurement result of the specimen sample and the measurement result of the control sample measured by the measurement unit;
A sample analyzer comprising: an output unit that outputs the measurement result of the specimen sample stored in the storage unit and the measurement result of the control sample in association with each other under a preset condition. A measurement unit capable of measuring a specimen sample and a control sample;
A display unit for displaying a measurement result of the sample sample measured by the measurement unit;
A determination unit that determines whether the measurement result of the control sample is within a predetermined range;
The sample analysis apparatus, wherein the display unit does not display the measurement result of the specimen sample when there is no determination result by the determination unit. A measurement unit capable of measuring a specimen sample and a control sample;
A determination unit for determining whether the measurement result of the control sample is within a predetermined range; and
A sample analyzer comprising: a display unit that displays a measurement result of the sample sample measured by the measurement unit and a determination result determined by the determination unit. A measurement unit capable of measuring a specimen sample and a control sample;
Based on the measurement result of the control sample, an accuracy management processing unit that acquires accuracy management information for managing measurement accuracy;
A storage unit for storing the measurement result of the sample sample measured by the measurement unit, the measurement result of the control sample, and the quality control information acquired by the quality control processing unit;
A display unit for displaying a quality control information calling unit for calling the quality control information together with a measurement result of the sample sample measured by the measurement unit;
An input unit for receiving input,
The display unit displays the quality control information when the input unit receives an input for selecting the quality control information calling unit. A measurement unit capable of measuring a specimen sample and a control sample;
A storage unit for storing the measurement result of the specimen sample measured by the measurement unit and the measurement result of the control sample;
The storage unit stores a sample sample measurement result and a control sample measurement result in association with each other under a preset condition. Computer
An acquisition means for acquiring the measurement results of the specimen sample and the control sample;
Determination means for determining whether the measurement result of the control sample is within a predetermined range;
A computer program for functioning as a display unit for controlling display of a measurement result of a specimen sample acquired by the acquisition unit based on a determination result of the determination unit. Computer
An acquisition means for acquiring the measurement results of the specimen sample and the control sample;
Storage means for storing the measurement result of the specimen sample and the measurement result of the control sample acquired by the acquisition means;
A computer program for functioning as output means for outputting the measurement result of the specimen sample and the measurement result of the control sample stored in the storage means in association with each other under a preset condition. Computer
An acquisition means for acquiring the measurement results of the specimen sample and the control sample;
Display means for displaying the measurement result of the specimen sample acquired by the acquisition means;
Function as a determination means for determining whether the measurement result of the control sample is within a predetermined range;
The computer program in which the display means does not display the measurement result of the specimen sample when there is no determination result by the determination means. Computer
An acquisition means for acquiring the measurement results of the specimen sample and the control sample;
Determination means for determining whether the measurement result of the control sample is within a predetermined range;
A computer program for functioning as display means for displaying a measurement result of a specimen sample acquired by the acquisition means and a determination result determined by the determination means. Computer
An acquisition means for acquiring the measurement results of the specimen sample and the control sample;
Accuracy management processing means for acquiring accuracy management information for managing measurement accuracy based on the measurement result of the control sample;
Storage means for storing the measurement result of the specimen sample acquired by the acquisition means, the measurement result of the control sample, and the quality control information acquired by the quality control processing means;
Display means for displaying a quality control information calling unit for calling the quality control information together with the measurement result of the specimen sample acquired by the acquisition means;
Function as an input means to accept input,
The display unit displays the quality control information when the input unit receives an input for selecting the quality control information calling unit. Computer
An acquisition means for acquiring the measurement results of the specimen sample and the control sample;
Function as storage means for storing the measurement result of the specimen sample and the measurement result of the control sample measured by the acquisition means;
The storage means stores a sample sample measurement result and a control sample measurement result in association with each other under a preset condition.

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