WO2023007805A1 - Test method and test system - Google Patents

Test method and test system Download PDF

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Publication number
WO2023007805A1
WO2023007805A1 PCT/JP2022/009372 JP2022009372W WO2023007805A1 WO 2023007805 A1 WO2023007805 A1 WO 2023007805A1 JP 2022009372 W JP2022009372 W JP 2022009372W WO 2023007805 A1 WO2023007805 A1 WO 2023007805A1
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WO
WIPO (PCT)
Prior art keywords
sample
specimen
individual
pool
inspection
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Application number
PCT/JP2022/009372
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French (fr)
Japanese (ja)
Inventor
知幸 原田
有真 岡部
Original Assignee
株式会社島津製作所
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Priority to JP2023538240A priority Critical patent/JPWO2023007805A1/ja
Publication of WO2023007805A1 publication Critical patent/WO2023007805A1/en

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/6851—Quantitative amplification
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/686—Polymerase chain reaction [PCR]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the present invention relates to testing methods and testing systems, and more particularly to methods and systems for testing multiple specimens using specimen pool testing.
  • nucleic acid amplification methods such as polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR) using primers specific to the virus are used.
  • PCR polymerase chain reaction
  • RT-PCR reverse transcription PCR
  • Non-Patent Document 1 a sample pool inspection method (hereinafter sometimes simply referred to as “pool inspection method”) described in Non-Patent Document 1 and the like is known.
  • pooled specimens are prepared by mixing specimens (hereinafter sometimes referred to as "individual specimens") collected from multiple (generally 5 or less) subjects, and the pooled specimens is inspected using the inspection apparatus as described above. If the pooled specimen is determined to be negative, all of the individual specimens from which the pooled specimen is based are determined to be negative. On the other hand, if the pooled specimen is determined to be positive, the multiple individual specimens that are the source of the pooled specimen are tested individually, and the positive individual specimens among the multiple individual specimens are selected. Identify.
  • Such a pooled test method is effective in both improving the work efficiency of testing and reducing costs, especially in situations where there are relatively few positive specimens.
  • pooled test method Although it is possible to improve the efficiency of the test itself on the test equipment, it is not a general test for each individual sample, in which a pooled sample is prepared by dispensing and agitating multiple individual samples. additional pretreatment work is required. As the number of individual specimens to be tested increases, pretreatment operations for preparing pooled specimens become considerably more complicated. In addition, in order to improve the efficiency of the entire inspection work, it is necessary to perform this complicated pool specimen preparation work in parallel with the inspection work for the specimen. Furthermore, since pooled sample preparation work tends to increase the risk of worker infection, automation of testing, including pooled sample preparation work, is even more important in terms of both improving work efficiency and reducing risk.
  • a system that includes such a sample pretreatment device is useful for performing sample pool testing efficiently and at a low cost, but has the following problems.
  • the present invention was made to solve the above problems, and one of its purposes is to provide a person in charge of retesting an individual sample when the pooled sample is determined to be positive in the sample pool test method. It is an object of the present invention to provide an inspection method and an inspection system capable of reducing work load and preventing errors such as erroneous association between pooled samples and individual samples and mixing up of individual samples.
  • One aspect of the testing method according to the present invention includes a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample, a testing device that analyzes the pooled sample or the individual samples, An inspection method using a specimen pool inspection method using an inspection system comprising a management terminal capable of communicating with the pretreatment device and the inspection device, a database accessible from the management terminal, and a display unit. and A sample information input step of accepting input of sample information related to individual samples and pooled samples by a user's operation in the pretreatment device management software installed in the management terminal before pool sample preparation in the pretreatment device.
  • one aspect of the inspection system according to the present invention is an inspection system that performs an inspection by a sample pool inspection method, a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample; a testing device that analyzes pool samples or individual samples; a control device capable of communicating with the preprocessing device and the inspection device, respectively, including an input unit and a display unit, and independently controlling operations of the preprocessing device and the inspection device; a database accessible from the controller; a display unit; wherein the control device comprises A pretreatment device that receives input of specimen information regarding a plurality of individual specimens and pooled specimens through the input unit and stores the received specimen information in the database before pooled specimens are prepared by the pretreatment device.
  • the management department and display the results of analysis of one or more pooled samples by the testing device on the display unit, accept designation or selection of positive pooled samples through the input unit, and designate or select the pooled samples acquires sample information of a plurality of individual samples associated with the database from the database, and places the acquired sample information in a predetermined position of a sample information input screen for setting sample information of a sample to be inspected in the inspection device.
  • an inspection device management unit that is inserted and displayed on the display unit; Prepare.
  • the testing method and testing system when a pooled specimen is positive in testing by the specimen pooling testing method, it is not necessary to retest each of the plurality of individual specimens that are the sources of the pooled specimen.
  • the sample information of the individual sample to be retested is automatically set as the test target by a simple operation by the person in charge of testing.
  • FIG. 1 is an overall configuration diagram of an inspection system that is an embodiment of the present invention
  • FIG. Schematic diagram of the internal configuration of the pretreatment device.
  • FIG. 2 is a schematic top view of a work table on which various members are mounted in the pretreatment device;
  • FIG. 2 is a schematic top view of various members attached to the work table and the work table from which the members are removed;
  • FIG. 10 is a schematic top view for explaining how to mount an individual sample rack; Schematic diagram of the internal configuration of the inspection device.
  • FIG. 4 is a flowchart showing an example of an inspection procedure by a pool inspection method using the inspection system of the present embodiment
  • 4 is a flowchart showing an example of an inspection procedure by a pool inspection method using the inspection system of the present embodiment
  • the figure which shows an example of the specimen information setting screen for pretreatment The figure which shows an example of the inspection result display screen after an inspection.
  • FIG. 10 is a diagram showing two examples of test result display screens for explaining the work procedure when retesting an individual sample
  • FIG. 4 is a diagram showing the relationship between a sample map and a sample selection screen in the pretreatment device, for explaining the work procedure when retesting an individual sample;
  • FIG. 1 is an overall configuration diagram of an inspection system according to this embodiment.
  • This test system is a system that can test for the presence or absence of infection with the novel coronavirus (SARS-CoV-2), which is the cause of COVID-19, for example, using a sample pool test method.
  • SARS-CoV-2 novel coronavirus
  • this inspection system includes a pretreatment device 1, four inspection devices 2, a control/processing device 30, a database 31, an operation unit 32, a display unit 33, a barcode reader 4 and .
  • the control/processing device 30 includes a pretreatment device manager 300 , an inspection device manager 301 , and a database manager 302 .
  • the control/processing device 30, the database 31, the operation unit 32, and the display unit 33 are a general-purpose personal computer (PC) 3, and dedicated control/processing software is installed in the PC3.
  • the pretreatment device management unit 300 and the inspection device management unit 301 are functional blocks realized by operating predetermined software (application programs) installed in the PC 3 on the computer.
  • the database 31 may exist at a location remote from the PC 3 even if it is not built in the PC 3 as long as it is accessible from the PC 3 .
  • This testing system includes four testing devices 2, which in this example is the number of pooled specimens prepared within a predetermined time by pretreatment in the pretreatment device 1 and The number of inspection apparatuses 2 and pretreatment apparatuses 1 included in the inspection system is not limited to this example.
  • the control/processing device 30 is connected to the pretreatment device 1 and the four inspection devices 2 via communication lines 5, respectively.
  • This communication line 5 can conform to the general USB standard, for example.
  • the pretreatment device 1 is a pretreatment device for preparing a pooled specimen for examination by the pooled examination method, and is not used for examination of individual specimens collected from subjects.
  • the testing device 2 is a device capable of testing both individual samples and pooled samples. .shimadzu.co.jp/cl/products/autoamp/index.html>, etc.) can be used.
  • the methods of analysis and inspection in the inspection device 2 are not limited to those used in the above devices.
  • the pretreatment device 1 is a device that prepares one pool sample by collecting and mixing a plurality of individual samples.
  • each individual sample is a sample derived from a biological sample such as saliva, nasopharyngeal swab, blood, urine, etc. collected from a subject.
  • a biological sample such as saliva, nasopharyngeal swab, blood, urine, etc. collected from a subject.
  • the number of individual samples to be mixed is 5 or less in order to ensure the same level of test accuracy as in the individual test.
  • this pretreatment device 1 it is possible to prepare one pooled specimen from a maximum of five individual specimens, but generally one pooled specimen is prepared from four or less individual specimens. do.
  • pooled specimens may be prepared from six or more individual specimens.
  • the pooled samples prepared by the pretreatment device 1 are set in one of the testing devices 2 and subjected to testing. Further, when a certain pool sample is determined to be positive as a result of the inspection by the inspection device 2, a plurality of individual samples, which are the sources of the pool sample, are set in the inspection device 2 and inspected. In the example described below, it is assumed that the person in charge of inspection himself/herself transports the pool sample or individual sample from the pretreatment device 1 to the inspection device 2 by hand and sets it in the inspection device 2. It is of course possible to automate the setting work to the device using a robot or the like.
  • FIG. 2 is a schematic diagram of the internal configuration of the pretreatment device 1 as viewed from the side.
  • FIG. 3 is a schematic top view of a work table on which various members used for pretreatment are mounted in the pretreatment apparatus 1.
  • FIG. 4 is a schematic top view of various members attached to the work table and the work table with the members removed.
  • FIGS. 2 to 4 and FIG. 5, which will be described later, show three axes, the X-axis, the Y-axis, and the Z-axis, which are orthogonal to each other.
  • the installation surface of the preprocessing device 1 and the inspection device 2 is a plane parallel to the XY plane, and the Z-axis direction is the height (vertical) direction of the preprocessing device 1 and the inspection device 2 .
  • the pretreatment device 1 includes a dispensing unit 10, a first moving section 11, a work table 12, a second moving section 13, and a control section .
  • the first moving part 11 includes an actuator (not shown) that moves the dispensing unit 10 in the horizontal direction (X-axis-Y-axis direction).
  • the second moving part 13 includes an actuator (not shown) that moves the work table 12 in the horizontal direction (X-axis-Y-axis direction).
  • the actuators included in the first and second moving units 11 and 13 operate according to instructions from the control unit 14 that receives instructions from the control/processing device 30 .
  • One of the first and second moving parts 11 and 13 can be omitted.
  • the dispensing unit 10 includes a syringe 100 with a nozzle 101 extending in the Z-axis direction attached to its tip. Inside the nozzle 101, a plunger (not shown) is provided which is movable along the Z-axis direction.
  • the syringe 100 is configured to aspirate an amount of liquid corresponding to the stroke length of the plunger in the Z-axis direction and to discharge an amount of liquid corresponding to the stroke length of the plunger in the Z-axis direction.
  • the dispensing unit 10 includes an actuator (not shown) for moving the syringe 100 in the Z-axis direction and an actuator (not shown) for moving the plunger inside the nozzle 101 in the Z-axis direction. All of these actuators operate according to instructions from the control unit 14 .
  • the upper surface of the work table 12 extends generally parallel to the XY plane, and has a container storage section 120, a dispensing tip holding section 121, and a tip disposal section. A portion 122 and are provided.
  • a container 50 is detachably loaded in the container storage section 120 .
  • the container 50 has a substantially rectangular parallelepiped outer shape and includes a handle (not shown) that can be held by hanging.
  • the dispensing tip holder 121 is provided with a plurality (20 in this example) of circular holding holes when viewed from above. As shown in FIG. 2, each holding hole is configured to hold a dispensing tip 56, which is a long tip, in an upright state. This dispensing tip 56 is attached to the nozzle 101 of the syringe 100 and used.
  • the number of dispensing tips 56 that can be held in the dispensing tip holder 121 is the same as the maximum number of individual sample containers 54 that can be stored in the container 50 (20 in this example).
  • the tip disposal unit 122 is a detachable box with an open top in which used dispensing tips 56 are discarded.
  • the container 50 includes individual sample rack storage units 500 and 501 each capable of storing five individual sample racks 51 (51A to 51E), a pool sample rack storage unit 502 capable of storing one pool sample rack 52, Prepare.
  • the five individual sample racks 51 (51A to 51E) have substantially the same external shape of a substantially rectangular parallelepiped.
  • the individual sample rack storage units 500 that store the four individual sample racks 51A to 51D each extend in the Y-axis direction and are arranged side by side in the X-axis direction.
  • the individual sample rack storage section 501 in which the remaining individual sample rack 51E is stored extends in the X-axis direction and is arranged adjacent to the arrangement of the four individual sample racks 51A to 51D in the Y-axis direction. It is
  • the individual sample rack 51E is normally used when a pooled sample is to be prepared from 5 individual samples. That is, when preparing a pool sample from four individual samples, as described later, only the individual sample rack storage units 500 extending in the Y-axis direction and arranged in four rows in the X-axis direction have individual sample racks 51A- 51D is accommodated, and the individual sample rack 51E is unnecessary. In FIG. 2, the individual sample rack 51E is indicated by a dotted line to indicate the state in that case.
  • the pool sample rack storage section 502 extends in the X-axis direction, sandwiching the arrangement of the four individual sample racks 51A to 51D, and extending in the Y-axis direction. is placed on the opposite side of the
  • the colors assigned to the individual sample racks 51A to 51D (in this example, the container holding units are colored as described later). ) is provided) to which a label of the same color is attached.
  • Each of the individual sample racks 51A to 51D includes a container holding section 510 that can accommodate four individual sample containers 54 treated as one pool group for preparing one pool sample, lined up in a row with a predetermined interval. .
  • the container holders 510 are labeled with different colors for each of the individual sample racks 51A-51D. Specifically, in this example, from the left in FIG. 3, the individual sample rack 51A is labeled in red, the individual sample rack 51B in blue, the individual sample rack 51C in green, and the individual sample rack 51D in purple.
  • the color of this indicator corresponds to the color of the label of the color indicator section 503 on the container 50 described above. Of course, the color is just an example and is not limited to this.
  • the five container holding units 510 of the individual sample rack 51E that can be stored in the individual sample rack storage unit 501 are the same as the container holding units 510 in the individual sample racks 51A to 51D arranged in the Y-axis direction in the state shown in FIG. labeled in color. Therefore, in this example, the colors of the four container holders 510 in the individual sample rack 51E arranged as shown in FIG. 3 are red, blue, green, and purple in order from the left. That is, even when the individual sample rack 51E is used in addition to the individual sample racks 51A to 51D, the five container holding units 510 linearly aligned in the Y-axis direction have the same color and are aligned in the X-axis direction. The colors of the five rows of container holding portions 510 are different for each row.
  • One pool sample rack 52 can be stored in the pool sample rack storage unit 502 .
  • the pool sample rack 52 is provided with an inverted L-shaped handle 53 when viewed from the direction of measurement. By gripping the handle 53, the person in charge of testing can reliably grasp the pool sample rack 52 and take it in and out of the pool sample rack storage section 502 or carry it. Note that the handle 53 may be detachable from the pool sample rack 52 .
  • the pool sample rack 52 is also provided with four container holding units 520.
  • the four container holding units 520 are labeled in the same color as the container holding units 510 in the individual sample rack 51E. That is, in this example, the colors of the four container holders 520 in the pool sample rack 52 arranged as shown in FIG. 3 are red, blue, green, and purple in order from the left. Numbers P1, P2, P3, and P4 are written from the left on the upper surface of the handle 53 corresponding to the four container holding portions 520, and the display colors of the numbers are also given to the container holding portions 520. is the same as the original color.
  • the individual sample racks 51A to 51E basically have the same outer shape, and the individual sample rack storage units 500 and 501 also basically have the same shape.
  • the individual sample rack housing units 500 and 501 in which the individual sample racks 51A to 51E can be respectively housed are uniquely determined as follows, and their attachment orientations are also uniquely determined.
  • FIG. 5 is a schematic diagram for explaining the mounting method of the individual sample racks 51A-51E.
  • the leftmost individual sample rack storage section 500A is provided with a position regulating piece 500a protruding inward from its inner surface (a surface parallel to the YZ plane).
  • the individual sample rack 51A is formed with a notch 51a at a position corresponding to the position regulating piece 500a (see FIG. 5A).
  • the position regulating piece 500a fits exactly into the notch 51a, so the individual sample rack 51A can be stored up to the proper position (depth) (Fig. 5(B)).
  • depth Fig. 5(B)
  • the bottom of the individual sample rack 51A abuts against the position regulating piece 500a and is completely stored in the individual sample rack storage section 500A. not.
  • the person in charge of testing can easily recognize that the individual sample rack 51A has been stored in the wrong direction.
  • the individual sample rack storage section 500B located second from the left is also provided with a position regulating piece 500b protruding inward from its inner surface. is displaced in the Y-axis direction from the position regulating piece 500a.
  • a notch 51b is formed in the individual sample rack 51B at a position corresponding to the position regulating piece 500b (see FIG. 5(C)). Therefore, when the individual sample rack 51B is accommodated in the individual sample rack storage section 500B in an appropriate orientation, the position regulating piece 500b fits into the notch 51b, so that the individual sample rack 51B can be accommodated to the proper position (depth) ( See FIG. 5(D)).
  • the individual sample racks 51 and the individual sample rack storage units 500, 501 are physically (or structurally) in one-to-one correspondence, so that they cannot be attached to wrong positions. It is configured.
  • the mounting direction of the individual sample rack 51 is also the same, and is configured to prevent mounting in the wrong direction.
  • the individual sample racks 51A to 51D are labeled with different colors, and the positions at which they are stored are also visually clearly indicated by the color indicator section 503. Accordingly, the person in charge of testing can refer to the color and store the individual sample racks 51A to 51D in appropriate positions.
  • this is a work error prevention measure that relies on the judgment of the person in charge of inspection, and mistakes may occur due to the lack of attention of the person in charge of inspection.
  • the positions and orientations of the individual sample racks 51A to 51E and the pool sample rack 52 are physically and uniquely determined by the position regulation structure as described above. For this reason, it is possible to reliably prevent sample mix-up due to incorrect mounting of the racks 51A to 51E and 52.
  • FIG. 6 is a schematic diagram of the internal configuration of the inspection device 2. As shown in FIG.
  • the inspection device 2 includes an inspection section 20, a holding section 23, a first moving section 21, a second moving section 22, and a control section 24.
  • the holding part 23 is configured to be able to hold a plurality of containers 25 and the like on its upper surface. and a temperature control holding unit 232 .
  • the first moving unit 21 includes an actuator (not shown) that moves the inspection unit 20 in the horizontal direction (X-axis-Y-axis direction).
  • the second moving part 22 includes an actuator (not shown) that moves the holding part 23 in the horizontal direction (X-axis-Y-axis direction).
  • the actuators included in the first and second moving parts 21 and 22 respectively operate according to instructions from the control part 24 that receives instructions from the control/processing device 30 .
  • One of the first and second moving parts 21 and 22 can be omitted.
  • the inspection section 20 includes an optical unit 201 , a dispensing unit 202 and an opening/closing unit 205 .
  • the dispensing unit 202 has the same configuration as the dispensing unit 10 of the pretreatment device 1, and includes a syringe 203 having a nozzle 204 extending in the Z-axis direction attached to its tip.
  • the syringe 203 is configured to suck in an amount of liquid corresponding to the stroke length in the Z-axis direction of a plunger provided inside the nozzle 204 and to discharge an amount of liquid corresponding to the stroke length.
  • the dispensing unit 202 includes an actuator (not shown) for moving the syringe 203 in the Z-axis direction and an actuator (not shown) for moving the plunger inside the nozzle 204 in the Z-axis direction. All of these actuators operate according to instructions from the control section 24 .
  • the opening/closing unit 205 includes an opening/closing mechanism having projections for automatically opening and closing the lid of the container 25 held by the holding portion 23 by coming into contact with the lid.
  • the opening/closing unit 205 operates according to instructions from the control section 24 .
  • the optical unit 201 irradiates the specimen in the container 25 with excitation light and detects the fluorescence emitted from the specimen, thereby analyzing infectious disease viruses or genes contained in the specimen. .
  • the optical unit 201 performs fluorescence detection corresponding to three wavelengths of red, green, and blue, respectively, and outputs the detection results to the control unit 24 .
  • the optical unit 201 includes a light source such as a light emitting diode (LED), an optical system that irradiates a sample with light emitted from the light source and collects fluorescence emitted from the sample, and a photo sensor that detects the fluorescence emitted from the sample and outputs it as digital data.
  • LED light emitting diode
  • PDs diodes
  • pool samples to be inspected are stored in pool sample containers 55 and set in the holding unit 23 while stored in the pool sample rack 52 described above.
  • the pool sample rack 52 is set so that four pool sample containers 55 are aligned in the X-axis direction. This also applies to individual specimens. In this testing apparatus 2, tests can be performed on four pool samples or individual samples in parallel.
  • FIG. 6 shows a state in which members necessary for testing one pool sample or individual sample are attached to the holding unit 23, and four PCR containers 25A constitute one set, and four reagent containers 25B are also included. is one set, and three dispensing tips 25C are one set.
  • Each of the four reagent containers contains a sample treatment liquid, a reaction liquid, a primer/probe liquid, and an enzyme liquid in advance. Usually, these are provided as a set of reagent kits in which reagents necessary for analysis of at least one sample are sealed in advance.
  • FIGS. 7 and 8 are flow charts showing the procedure of an inspection by the pool inspection method including sample pretreatment work in the pretreatment apparatus 1.
  • FIG. Here, the case of preparing one pool sample from four individual samples will be described as an example.
  • the person in charge of inspection confirms whether or not the following items necessary for inspection by the pool inspection method are available (step S1).
  • Individual specimen containers 54 (maximum 16) each containing an individual specimen (a specimen taken from a subject).
  • Empty pool specimen containers 55 (maximum of 4).
  • Dispensing tips 56 (up to 16). This number is the same as the number of individual sample containers 54 .
  • Pool sample rack 52 (1 piece).
  • Individual sample racks 51A-51D up to 4).
  • - Container 50 (1 piece).
  • the person in charge sets the dispensing tip 56 in the dispensing tip holder 121 of the pretreatment device 1 (step S2).
  • the person in charge sets an empty pool sample container 55 on the pool sample rack 52 (step S3).
  • step S4 the person in charge sets the individual sample containers 54 containing the individual samples in the individual sample racks 51A to 51D for the corresponding pool groups. Note that the order of steps S2 to S4 can be changed as appropriate.
  • the person in charge activates the pretreatment device management software in the control/processing device 30 .
  • the pretreatment device management unit 300 shown in FIG. 1 is activated.
  • the pretreatment device management unit 300 displays a sample information input screen 60 in a predetermined format on the display unit 33, an example of which is shown in FIG.
  • the person in charge enters sample information for all the individual samples set in step S4 on this sample information input screen 60 (step S5). This input may be manually input by the person in charge from the operation unit 32, or may be automatically input by reading the barcode attached to the individual sample container 54 with the barcode reader 4.
  • the specimen information input screen 60 displays a specimen map 61 on the left side and a management table 62 on the right side.
  • the sample map 61 is a schematic diagram corresponding to the top view of the container 50 as shown in FIG. 3, showing objects corresponding to five individual sample racks and one pool sample rack.
  • the management table 62 has four tabs corresponding to pool groups each including five individual samples arranged vertically in the sample map 61 .
  • Each tab of the management table 62 contains individual sample rack numbers P1 to P4 corresponding to the tab, and four (maximum five) individual sample container numbers set in the individual sample rack, for example, A1 to P4. A5 is shown.
  • each row in the management table 62 is provided with a check box indicating whether or not the test is performed, and input fields for sample information such as sample ID, sample name, subject name, sample collection date, and sample comment. there is This is an example of specimen information, and some may be omitted or other items may be added.
  • the pool A tab in the management table 62 is opened, and the positions of the pool specimens and individual specimens in the specimen map 61 are indicated accordingly.
  • the person in charge can easily visually grasp which position in the container 50 the pool group to be entered corresponds to the container in the individual sample rack.
  • the person in charge opens the tab where the sample information is to be entered, and clicks the check box for the row of the individual sample to be entered.
  • the pretreatment apparatus management unit 300 puts a check mark in the check box to enable input to the input column of that line.
  • the person in charge enters necessary information in each entry field.
  • the person in charge then enters specimen information for all individual specimens to be tested. At least the sample ID is input as the sample information for the pooled samples as well.
  • a check mark may be entered in the check box of that row.
  • the display mode of the container corresponding to that individual sample may be changed on the sample map 61 .
  • sample IDs should not be duplicated. Therefore, when a sample ID is input, the pretreatment apparatus management section 300 checks whether or not the sample ID is duplicated on the sample information input screen 60 . Also, the pretreatment device management unit 300 confirms the sample ID in the sample information already registered in the database 31 through the database management unit 302, and checks whether the input sample ID has already been used. As a result of such a check, if the sample ID is duplicated, a warning is issued and the input of another sample ID is prompted. This makes it possible to avoid duplicate use of the sample ID, which is the most important for managing individual samples and their test results.
  • the "Reinitialize" button 65 can be clicked. Upon receiving this operation, the pretreatment apparatus management section 300 clears all the information input to the management table 62 at that time.
  • the person in charge sets the pooled sample rack 52 and the four individual sample racks 51A to 51D at predetermined positions in the container 50 (step S6). ).
  • pool sample racks 52 can only be placed in container 50 in one orientation.
  • the positions of the individual sample rack storage section 500 in which the individual sample racks 51A to 51D are to be set are unique by matching the color assigned to the racks 51A to 51D with the color of the label of the color indicator section 503. to be determined.
  • the person in charge can associate the individual sample racks 51A to 51D with the individual sample rack storage unit 500 without hesitation.
  • the person in charge sets the container 50 in the container storage section 120 of the pretreatment device 1 (step S7).
  • the container housing portion 120 is provided with a position regulating piece 120a protruding inward from its inner surface.
  • the container 50 is formed with a notch 20a at a position corresponding to the position regulating piece 120a. Therefore, as with the individual sample rack 51, the reverse mounting of the container 50 is physically prevented. As a result, the person in charge can appropriately mount the container 50 on the container storage section 120 .
  • the pretreatment apparatus management section 300 stores the sample information entered in each tab of the sample information input screen 60 in the database 31 through the database management section 302 .
  • the sample information is information whose key is the sample ID, and information other than the sample ID is auxiliary information associated with the sample ID. Therefore, duplicate specimen IDs are not allowed, as described above. Further, the sample information of the pooled sample and the sample information of the plurality of individual samples that are the sources thereof are stored in association with each other.
  • the pretreatment device management unit 300 sends a pretreatment operation command based on the input sample information to the control unit 14 of the pretreatment device 1 . That is, the execution of preprocessing is instructed (step S8).
  • the control unit 14 that has received this command executes pool sample preparation processing by controlling the dispensing unit 10, moving units 11 and 13, and the like (step S9). Specifically, the pretreatment device 1 executes the following processes.
  • the control unit 14 attaches one dispensing tip 56 to the nozzle 101 of the syringe 100, and inserts it into the first individual sample container 54 (lowest in FIG. 3) held in the individual sample rack 51A.
  • the dispensing unit 10 and moving parts 11 and 13 are respectively controlled to aspirate a predetermined amount of the individual sample from the pool sample container 55 and dispense it into the pool sample container 55 located at the same position in the Y-axis direction.
  • the control section 14 controls the dispensing unit 10 and the moving sections 11 and 13 to discard the used dispensing tip 56 to the tip discarding section 122 .
  • control unit 14 attaches a new dispensing tip 56 to the nozzle 101 of the syringe 100, aspirates a predetermined amount of the individual sample from the second individual sample container 54 held in the individual sample rack 51A, and The dispensing unit 10 and the moving parts 11 and 13 are respectively controlled so as to dispense into the pool sample container 55 of .
  • the used dispensing tip 56 is disposed of in the tip disposal section 122 .
  • a similar operation is performed for the third and fourth individual sample containers 54 held in the individual sample rack 51A, thereby dispensing four individual samples into one pool sample container 55.
  • the control unit 14 reciprocates the syringe 100 up and down a predetermined number of times while the last used dispensing tip 56 is attached to the nozzle 101 so as to stir the dispensed sample. It controls the dispensing unit 10 and moving parts 11 and 13 . In this way, a pool sample is prepared by mixing the samples in the four individual sample containers 54 held in one individual sample rack 51A.
  • the pooled sample obtained by mixing the samples in the four individual sample containers 54 held in the individual sample rack 51B adjacent to the individual sample rack 51A is placed in the pooled sample rack 52 from the left. 1st pool sample container 55 is prepared. The same is true for the individual sample racks 51C and 51D. Since one dispensing tip 56 is used to aspirate one individual sample, all prepared dispensing tips 56 are used by preparing four pooled samples.
  • the preprocessing device management section 300 receiving the notification from the control section 14 displays on the display section 33 that the preprocessing has been completed. Moreover, the pretreatment device 1 can call the attention of the person in charge with a warning sound such as a buzzer. Upon receiving such notification, the person in charge takes out the container 50 from the pretreatment apparatus 1 (step S10).
  • the person in charge takes out the pool sample rack 52 from the taken out container 50 .
  • Pool sample containers 55 containing pool samples are held in the pool sample racks 52 that have been taken out.
  • the person in charge transports the pool sample rack 52 to the inspection device 2 and sets it in the holding section 23 of the inspection device 2 as it is (step S11).
  • the four pool sample containers 55 each containing a pool sample prepared in the pretreatment device 1 can be set in the testing device 2 without being removed from the pool sample rack 52 .
  • the person in charge temporarily stores the container 50 with the individual sample racks 51A to 51D in storage equipment such as a refrigerator.
  • the individual sample racks 51A to 51D are not taken out from the container 50 until the test results of the samples stored in the container 50 are obtained.
  • the person in charge activates predetermined inspection device management software in the control/processing device 30 (step S12).
  • the inspection apparatus management unit 301 shown in FIG. 1 is activated.
  • the inspection apparatus management unit 301 displays a PCR inspection screen 70 on the display unit 33, an example of which is shown in FIG.
  • On the right side of this PCR test screen 70 there is arranged a test result display area 71 in which four samples (pool samples in this example) can be selected by tab switching, and on the left side is a "specimen information input" button 74. are placed.
  • the person in charge inputs specimen information regarding the pooled specimen to be inspected as follows (step S13).
  • the person in charge clicks the "specimen information input” button 74 on the PCR test screen 70 .
  • the testing device management unit 301 displays a specimen information input screen 80 such as an example shown in FIG.
  • the apparatus selection screen is displayed prior to the sample information input screen 80. is displayed, and the person in charge selects only one device to be used for inspection from the combo box on the screen. After that, when the "next" button arranged on the device selection screen is clicked, the sample information input screen 80 is displayed.
  • This sample information input screen 80 is a screen for inputting information on a sample to be inspected in the inspection device 2 .
  • a test information input area 81 for inputting information about the test in general is arranged on the upper side
  • a sample information input area 81 for four samples to be tested is arranged on the lower side.
  • a sample information table 82 listing information is arranged.
  • the sample information input during preprocessing and stored in the database 31 can be used to simplify the work of inputting the sample information to be inspected in the inspection device 2 . That is, the person in charge moves the cursor to the sample ID column of the row (that is, the row corresponding to one of the samples 1 to 4) in which the sample information is to be input in the sample information table 82, and right-clicks with a mouse or the like. conduct.
  • the inspection apparatus management unit 301 displays the work menu as a dropdown menu. The person in charge selects and instructs the work item "select from specimen information registered with pretreatment apparatus management software" from the menu. Then, the testing apparatus management unit 301 displays a specimen selection screen 90 such as one example shown in FIG.
  • This sample selection screen 90 is a screen for selecting a sample to be inserted into a row specified on the sample information table 82 .
  • a managed sample list table 91 showing a list of samples stored in the database 31 is arranged on the lower side, and the managed sample list table 91 is displayed on the upper side.
  • a narrowing condition selection area 92 is arranged to indicate narrowing conditions for narrowing down the contents (specimen types).
  • each column of the management specimen list table 91 is blank to avoid complication of the drawing, but in reality, various information already registered in the database 31 is displayed in each column. be.
  • One row in the managed sample list table 91 corresponds to one sample (individual sample or pool sample).
  • one row in the sample information table 82 of the sample information input screen 80 is one pool sample. Select one row.
  • the inspection apparatus management unit 301 automatically inserts the sample information about the pool sample selected by receiving this operation into each column of the specified row of the sample information table 82 .
  • the person in charge performs a process of inserting the sample information of the corresponding pool sample into the row corresponding to each of the four samples in the sample information table 82 of the sample information input screen 80 . That is, by using the specimen information registered in the database 31 during the pretreatment by the pretreatment apparatus 1 as it is during the examination by the examination apparatus 2, it is possible to simplify the troublesome re-input work. .
  • the barcode can be used to simplify the troublesome re-input work. That is, with the sample information input screen 80 as shown in FIG. Select and instruct.
  • the person in charge uses the barcode reader 4 to read the barcode attached to the pool sample container 55 .
  • the person in charge manually inputs the numbers described in the bar code.
  • the inspection apparatus management unit 301 causes the database management unit 302 to search the database 31 for sample information corresponding to the sample ID indicated by the input barcode. When the corresponding sample ID is hit, the corresponding sample information is read out from the database 31 and inserted into each column of the sample information table 82 . As a result of the search, if the relevant specimen information does not exist in the database 31, it is assumed that the specimen is mixed up, that the specimen information is input incorrectly, or the like.
  • the inspection device management unit 301 sends an inspection operation command based on the set specimen information to the control unit 24 of the designated inspection device 2 . That is, the inspection device 2 is instructed to perform the inspection (step S14).
  • the control unit 24 controls the optical unit 201, the dispensing unit 202, the opening/closing unit 205, the moving units 21 and 22, the temperature control/holding unit 231, etc., thereby performing PCR tests on up to four pool samples.
  • step S15 the inspection device 2 performs the following processing. Prior to the inspection, the person in charge sets the PCR container 25A, the reagent container 25B, and the dispensing tip 25C at predetermined positions on the holding unit 23, respectively.
  • the controller 24 attaches one dispensing tip (long tip) 25C to the nozzle 204 of the syringe 203, aspirates a predetermined amount a of the pool specimen from the pool specimen container 55, and
  • the dispensing unit 202 and the moving parts 21 and 22 are respectively controlled so as to dispense to .
  • the control section 24 controls the dispensing unit 202 and the moving sections 21 and 22 so as to discard the used dispensing tip 25C to a tip discarding section (not shown).
  • the control unit 24 attaches one dispensing tip (short tip) 25C to the nozzle 204 of the syringe 203, aspirates a predetermined amount b ( ⁇ a) of the pool sample from the previous PCR container 25A, and The dispensing unit 202 and moving parts 21 and 22 are controlled to dispense into the PCR container 25A.
  • the control section 24 controls the dispensing unit 202 and the moving sections 21 and 22 respectively so as to discard the used dispensing tip 25C to the tip discarding section.
  • a predetermined amount b of the pool sample is collected using the short tip and transferred to another PCR container 25A.
  • the purpose of dispensing is to accurately dispense the predetermined amount b. Therefore, such procedures are not mandatory.
  • a process of adding a predetermined amount of the sample treatment liquid contained in the reagent container to the PCR container 25A in which the pool sample was collected is performed.
  • a process of heating and quenching the PCR container 25A to which the specimen treatment liquid has been added is performed.
  • the control unit 24 heats the PCR container 25A to maintain the sample temperature at 90° C. for 5 minutes, and then rapidly cools the PCR container 25A to reduce the sample temperature to 20° C. (normal temperature).
  • the temperature control part of the temperature control holding part 231 is controlled so as to return.
  • a process of sequentially adding predetermined amounts of the reaction solution, the primer/probe solution, and the reagent mixed solution to the PCR container 25A is performed.
  • control unit 24 performs a predetermined thermal cycle process on the PCR container 25A, and further controls the temperature control unit so that the amplification process for amplifying the gene is repeatedly performed. Every time one cycle of amplification processing is completed, the control unit 24 controls the optical unit 201 and the like so as to perform three-wavelength fluorescence detection while maintaining the liquid temperature in the PCR container 25A at 60°C.
  • the opening/closing unit 205 opens and closes the lid of the reagent container 25B and the like when collecting the reagent as described above.
  • the data obtained by the three-wavelength fluorescence detection performed in the process of repeating the amplification process is processed in the control unit 24.
  • the processing result is sent to the control/processing device 30 , and the inspection device management section 301 displays the inspection result on the screen of the display section 33 .
  • the test results are displayed as an amplification curve graph 72 and a Ct value table 73 in a test result display area 71 in a PCR test screen 70, as shown in FIG. 13(B).
  • the test result data is stored in a file specified as a file storage destination included in the test information input area 81 on the sample information input screen 80, and stored in the database 31 or another storage device in the control/processing device 30. Saved.
  • step S16 the doctor confirms the examination results on the screen of the display unit 33 as described above (step S16). Test results are obtained for each of the four pooled specimens. Then, if there is no pooled specimen that can be determined to be positive for virus infection (No in step S17), retesting of individual specimens is unnecessary, and the series of operations is terminated. On the other hand, if there is a pool sample that can be determined to be positive for virus infection, the process proceeds from step S17 to step S18.
  • the person in charge displays a positive specimen (in this example, specimen 1 ) and right-click within the area of the amplification curve graph 72 .
  • a result confirmation screen 71A as shown in FIG. 13B is displayed by designating an arbitrary data file to confirm the past test results, and the person in charge can check the amplification curve graph 72 in the screen 71A. Right click on it.
  • the inspection apparatus management unit 301 displays the work menu as a drop-down menu. Among them, the person in charge selects the work item of "Inspect individual samples contained in this pool sample". Note that this drop-down menu is displayed only for pooled assays.
  • the inspection apparatus management unit 301 displays a sample information input screen 80, an example of which is shown in FIG. 14, on the display unit 33.
  • the testing apparatus management unit 301 acquires sample information about a plurality of individual samples associated with the designated pool sample, that is, the individual samples from which the pool samples are prepared, from the database 31 through the database management unit 302. get. Then, the sample information is inserted into each column of the sample information table 82 .
  • the pool sample with number P1 is positive, four individual samples indicated by dotted lines in the sample map 61 superimposed on the sample information input screen 80 are is automatically inserted into each column of the sample information table 82. This simplifies the work of inputting specimen information of individual specimens to be retested. In addition, it is possible to avoid inputting incorrect sample information by the person in charge.
  • the sample map 61 shown in FIG. 14 may or may not be displayed in the sample information input screen 80 .
  • the person in charge After completing the sample information input work for the individual samples as described above, the person in charge removes the container 50 from the refrigerator, and removes the individual sample racks 51A to 51D associated with the positively determined pool samples from the container. Take out from 50.
  • the pool sample rack 52 the color of the container holding portion 520 of the pool sample container 55 in which the positive pool sample was stored is known. 51A-51D should be taken out. As a result, it is possible to reduce the mistake of the person in charge taking out the individual sample racks 51A to 51D corresponding to pooled samples whose test results are not positive.
  • the person in charge attaches a handle as an adapter to the individual sample rack 51 taken out of the container 50, grasps the handle, transports it to the inspection device 2, and sets it in the device 2 (step S20).
  • the individual sample rack 51 is set in the inspection apparatus 2
  • the four individual samples held in the individual sample rack 51 are inspected in the same manner as the inspection of the pooled samples and confirmation of the inspection results described in steps S13 to S16.
  • Each individual sample in the sample container 54 is tested (step S21). Then, the doctor confirms the test results for each individual sample (step S22). Thereby, it is possible to identify which individual specimens are positive.
  • the specific configurations of the pretreatment device 1 and the inspection device 2 described above are merely examples, and it goes without saying that the configurations of the respective devices 1 and 2 can be changed as appropriate.
  • the display mode including the layout and shape of each element on the screen for entering sample information or checking test results is merely an example, and it is natural that it can be changed as appropriate.
  • the procedure of operation on such a screen and the specific contents of operation are merely examples, and it is a matter of course that they can be changed as appropriate.
  • One aspect of the testing method according to the present invention includes a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample, a testing device that analyzes the pooled sample or the individual samples, and the pretreatment device. and a management terminal that can communicate with the testing device, a database that can be accessed from the management terminal, and a display unit.
  • an individual sample is a sample derived from a biological sample such as saliva, nasopharyngeal swab, blood, or urine collected from a subject.
  • the management terminal is a computer including a personal computer.
  • the software for managing the pretreatment device and the software for managing the inspection device are different application software (computer programs) pre-installed in the computer.
  • the database may be built into the management terminal or may be separate from the management terminal.
  • the database may be constructed in a storage device such as a hard disk drive or solid state drive built into the computer, or the database may be constructed in a storage device separate from the computer.
  • the user manages the pretreatment device on the management terminal before preparing the pooled sample with the pretreatment device.
  • the input sample information is saved in the database.
  • the pooled samples prepared by the pretreatment device are analyzed by the testing device, and the analysis results may indicate that the pooled samples are positive or negative.
  • the user specifies or selects the positive pooled specimen through the user interface on the testing device management software on the management terminal.
  • This designation or selection operation can be performed, for example, by a click operation using a pointing device.
  • the specimen information of the plurality of individual specimens associated with the pooled specimen is read from the database and displayed at a predetermined position on the specimen information input screen. It is inserted and displayed on the display.
  • the specimen information about a plurality of individual specimens that are the source of the pooled specimen can be obtained by the testing apparatus. is automatically set as sample information.
  • the specimen information of the individual specimens that are the source of positive pooled specimens is entered without error, it is possible to prevent errors such as errors in association between pooled specimens and individual specimens and mix-up of individual specimens. , can increase the reliability of the inspection.
  • the inspection device may be a PCR inspection device, and the result of analysis by the inspection device may be a PCR amplification curve.
  • PCR inspection can be performed efficiently and accurately.
  • the sample information of a plurality of individual samples to be inspected is set on the sample information input screen, and the user sets the corresponding individual samples in the inspection apparatus, When a predetermined button in the sample information input screen is clicked, the inspection apparatus starts analyzing the set individual samples.
  • the user can check the sample information automatically set on the sample information input screen and perform a very simple operation of clicking a button on the same screen. It is possible to instruct execution of retesting of individual specimens.
  • amplification curves are usually used to determine positive or negative.
  • positive pool specimens can be selected on the screen where the amplification curve is displayed, which eliminates unnecessary operations and is advantageous for improving work efficiency. is.
  • the sample information input screen into which the acquired sample information is inserted or together with the screen and container arrangement information corresponding to a working surface on which individual sample containers containing individual samples and pool sample containers containing prepared pool samples are set in the pretreatment device.
  • the user can confirm the position where the individual sample corresponding to the sample information inserted in the sample information input screen was placed by the container placement information. This makes it possible, for example, to check whether or not the inserted specimen information corresponds to the individual specimens used to prepare one pooled specimen. misunderstanding can be more reliably avoided.
  • one aspect of the inspection system is an inspection system that performs an inspection by a sample pool inspection method, a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample; a testing device that analyzes pool samples or individual samples; a control device capable of communicating with the preprocessing device and the inspection device, respectively, including an input unit and a display unit, and independently controlling operations of the preprocessing device and the inspection device; a database accessible from the controller; a display unit; wherein the control device comprises A pretreatment device that receives input of specimen information regarding a plurality of individual specimens and pooled specimens through the input unit and stores the received specimen information in the database before pooled specimens are prepared by the pretreatment device.
  • the management department and display the results of analysis of one or more pooled samples by the testing device on the display unit, accept designation or selection of positive pooled samples through the input unit, and designate or select the pooled samples acquires sample information of a plurality of individual samples associated with the database from the database, and places the acquired sample information in a predetermined position of a sample information input screen for setting sample information of a sample to be inspected in the inspection device.
  • an inspection device management unit that is inserted and displayed on the display unit; Prepare.
  • the inspection method described in paragraph 1 can be performed, and the specimen pool inspection can be performed efficiently while reducing the burden on the person in charge of inspection. can be done.
  • the inspection method described in paragraph 1 can be performed, and the specimen pool inspection can be performed efficiently while reducing the burden on the person in charge of inspection. can be done.
  • even if a positive test occurs in a pooled sample it is possible to accurately and quickly identify a positive individual sample, thereby increasing the reliability of the sample pool test.
  • Pretreatment apparatus 10 Dispensing unit 100... Syringe 101... Nozzle 11, 13... Moving part 12... Work table 120... Container storage part 120a... Position control piece 121... Dispensing tip holding part 122... Tip disposal part 14... Control part 2... Inspection device 20... Inspection part 201... Optical unit 202... Dispensing unit 203... Syringe 204... Nozzle 205... Opening/closing unit 21, 22... Moving part 23... Holding part 231... Temperature control holding part 232...
  • Non temperature control Holding unit 24 Control unit 25 Container 25A PCR container 25B Reagent container 25C Dispensing tip 30 Control/processing device 300 Pretreatment device management unit 301 Inspection device management unit 302 Database management unit 31 Database 32 Operation unit 33 Display unit 4 Barcode reader 5 Communication line 50 Containers 500, 500A to 500D, 501 Individual sample rack storage unit 502 Pool sample rack storage unit 503 Color indicator units 51, 51A to 51E Individual sample racks 510, 520 Container holding unit 52 Pool sample rack 53 Handle 54 Individual sample container 55 Pool sample container 56 Dispense tip 60 Sample information input screen 61 Sample map 62 Management table 63 "START" button 65... ⁇ Initialize'' button 70... PCR test screen 71... Test result display area 71A... Result confirmation screen 72...
  • Amplification curve graph 73 Ct value table 74... "Specimen information input” button 80... Specimen information input Screen 81... Examination information input area 82... Specimen information table 90... Specimen selection screen 91... Management specimen list table 92... Narrowing condition selection area

Abstract

One embodiment of a test method according to the present invention is carried out through specimen pooling using a test system equipped with a pre-treatment device for mixing a plurality of individual specimens to prepare a pooled specimen, a test device for analyzing the pooled specimen or an individual specimen, a management terminal capable of communicating with each of the pre-treatment device and the test device, a database that can be accessed from the management terminal, and a display unit, wherein: before preparation of the pooled specimen, software for pre-treatment device management that is installed in the management terminal has a step for receiving input of specimen information relating to the individual specimens and the pooled specimen through a user operation, a step for saving the received specimen information in the database, and a step for displaying the results of analysis of one or a plurality of pooled specimens on the display unit (S16); and when at least one pooled specimen is positive, the software for test device management that is installed in the management terminal has a specimen designation step (S18) for receiving designation or selection of a specific pooled specimen, and a specimen information input step (S19) for acquiring specimen information about the plurality of individual specimens associated with the designated or selected pooled specimen from the database, inserting the acquired specimen information at a prescribed position in a specimen information input screen image for setting the specimen information on a specimen to be tested, and displaying the specimen information on the display unit.

Description

検査方法及び検査システムInspection method and inspection system
　本発明は検査方法及び検査システムに関し、さらに詳しくは、検体プール検査法を使用して多数の検体を検査する方法及びシステムに関する。 The present invention relates to testing methods and testing systems, and more particularly to methods and systems for testing multiple specimens using specimen pool testing.
　新型コロナウイルス感染症（COVID-19）の拡大は世界的に深刻になっており、その拡大の抑止が喫緊の課題となっている。また、新型コロナウイルス感染症の拡大以前にも、重症急性呼吸器症候群（SARS）、中東呼吸器症候群（MERS）等、重篤な症状をもたらす様々なウイルス感染症がしばしば発生しており、新たなウイルス感染症に対する備えも重要な課題となっている。 The spread of the new coronavirus infection (COVID-19) is becoming more serious worldwide, and curbing its spread is an urgent issue. In addition, even before the spread of the new coronavirus infection, various viral infections that caused severe symptoms such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) frequently occurred. Preparedness against viral infections is also an important issue.
　こうしたウイルスを検出する装置として、そのウイルスに特異的なプライマーを使用したポリメラーゼ連鎖反応（Polymerase Chain Reaction：ＰＣＲ）又は逆転写ＰＣＲ（Reverse Transcription PCR：ＲＴ－ＰＣＲ）等の核酸増幅法を用い、目的とする遺伝子（ＤＮＡ）配列の有無の判定と定量とを行う装置が知られている。 As a device for detecting such viruses, nucleic acid amplification methods such as polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR) using primers specific to the virus are used. There is known an apparatus for determining the presence or absence of a gene (DNA) sequence and quantifying it.
　特にウイルス感染症の急速な拡大期においては、比較的小規模な医療機関や医療関係部署において、迅速で簡便に且つ低廉なコストで感染の有無の検査が行えることが望ましい。そうした検査方法の一つとして、非特許文献１等に記載の検体プール検査法（以下、単に「プール検査法」という場合がある）が知られている。 Especially during the period of rapid spread of viral infections, it is desirable to be able to test for the presence or absence of infection quickly, easily, and at low cost in relatively small medical institutions and medical departments. As one of such inspection methods, a sample pool inspection method (hereinafter sometimes simply referred to as “pool inspection method”) described in Non-Patent Document 1 and the like is known.
　プール検査法では、複数（一般には５人以下）の被検者からそれぞれ採取された検体（以下、これを「個別検体」という場合がある）を混合してプール検体を調製し、そのプール検体を上述したような検査装置を用いて検査する。そのプール検体が陰性であると判定された場合、そのプール検体の元である複数の個別検体は全て陰性であると判定される。一方、そのプール検体が陽性であると判定された場合には、そのプール検体の元である複数の個別検体について個々に検査を実施し、その複数の個別検体のうちの陽性である個別検体を特定する。こうしたプール検査法は、特に陽性を示す検体が比較的少ない状況下では、検査の作業効率の向上とコスト削減の両面において有効である。 In the pooled test method, pooled specimens are prepared by mixing specimens (hereinafter sometimes referred to as "individual specimens") collected from multiple (generally 5 or less) subjects, and the pooled specimens is inspected using the inspection apparatus as described above. If the pooled specimen is determined to be negative, all of the individual specimens from which the pooled specimen is based are determined to be negative. On the other hand, if the pooled specimen is determined to be positive, the multiple individual specimens that are the source of the pooled specimen are tested individually, and the positive individual specimens among the multiple individual specimens are selected. Identify. Such a pooled test method is effective in both improving the work efficiency of testing and reducing costs, especially in situations where there are relatively few positive specimens.
　プール検査法では、検査装置における検査自体の効率化を図ることは可能であるものの、複数の個別検体を分注し撹拌することでプール検体を調製するという、一般的な個別検体毎の検査にはない追加的な前処理作業が必要になる。検査すべき個別検体の数が増えるのに伴って、プール検体を調製するための前処理作業はかなり煩雑になる。また、検査作業全体を効率化するには、この煩雑なプール検体の調製作業を、検体に対する検査作業と並行して行えるようにする必要がある。さらに、プール検体の調製作業では作業者の感染リスクが高くなりがちであるから、作業の効率改善とリスク低減の両面から、プール検体の調製作業を含む検査の自動化が一層重要である。 In the pooled test method, although it is possible to improve the efficiency of the test itself on the test equipment, it is not a general test for each individual sample, in which a pooled sample is prepared by dispensing and agitating multiple individual samples. additional pretreatment work is required. As the number of individual specimens to be tested increases, pretreatment operations for preparing pooled specimens become considerably more complicated. In addition, in order to improve the efficiency of the entire inspection work, it is necessary to perform this complicated pool specimen preparation work in parallel with the inspection work for the specimen. Furthermore, since pooled sample preparation work tends to increase the risk of worker infection, automation of testing, including pooled sample preparation work, is even more important in terms of both improving work efficiency and reducing risk.
　こうしたことを背景として、プール検査法を広く且つ簡便に、また安全に実施するために、プール検体の調製作業を効率的に且つ低感染リスクで行える検体前処理装置の開発が強く要望されている。 Against this background, there is a strong demand for the development of a sample pretreatment device that can efficiently prepare pooled samples with a low risk of infection in order to widely, simply, and safely implement the pooled test method. .
　こうした検体前処理装置を含めたシステムは、検体プール検査法を効率的に且つ低廉なコストで実施するのに有用であるものの次のような問題がある。 A system that includes such a sample pretreatment device is useful for performing sample pool testing efficiently and at a low cost, but has the following problems.
　プール検査法では、プール検体の元となった個別検体を全て冷蔵庫等に保管しておき、プール検体が陽性であった場合には、そのプール検体に対応する全ての個別検体を迅速に検査して陽性である個別検体を特定する必要がある。その個別検体の再検査の際に、検査担当者は、陽性であったプール検体に対応する個別検体を保管場所から取り出して検査装置まで搬送して該装置にセットするとともに、その複数の個別検体に関する検体情報を検査装置に入力する必要がある。このように、個別検体の再検査の際には検査担当者が行わなければならない作業が多く、担当者の作業負担が大きい。また、作業が煩雑であるために、本来検査対象とすべき個別検体とは異なる個別検体の検体情報を誤って入力してしまったり入力する検体情報自体を間違えたりするリスクも小さくない。 In the pooled test method, all individual samples from which the pooled sample is based are stored in a refrigerator, etc., and if the pooled sample is positive, all individual samples corresponding to the pooled sample are promptly tested. It is necessary to identify individual specimens that are positive for When retesting the individual specimens, the person in charge of testing retrieves the individual specimens corresponding to the positive pool specimens from the storage location, transports them to the testing apparatus, sets them in the testing apparatus, and sets the individual specimens It is necessary to enter the relevant sample information into the inspection device. In this way, when retesting an individual sample, there is a lot of work that the person in charge of the inspection must perform, and the work load on the person in charge is heavy. In addition, since the work is complicated, there is a considerable risk of erroneously inputting sample information of an individual sample that is different from the individual sample to be inspected, or of inputting the wrong sample information itself.
　本発明は上記課題を解決するためになされたものであり、その目的の一つは、検体プール検査法においてプール検体が陽性であると判定された場合において、個別検体を再検査する担当者の作業の負担を軽減するとともに、プール検体と個別検体との対応付けの誤りや個別検体の取違いなどのミスを防止することができる検査方法及び検査システムを提供することである。 The present invention was made to solve the above problems, and one of its purposes is to provide a person in charge of retesting an individual sample when the pooled sample is determined to be positive in the sample pool test method. It is an object of the present invention to provide an inspection method and an inspection system capable of reducing work load and preventing errors such as erroneous association between pooled samples and individual samples and mixing up of individual samples.
　上記課題を解決するためになされた本発明に係る検査方法の一態様は、複数の個別検体を混合してプール検体を調製する前処理装置と、プール検体又は個別検体を分析する検査装置と、前記前処理装置及び前記検査装置とそれぞれ通信可能である管理用端末と、前記管理用端末からアクセス可能であるデータベースと、表示部と、を備える検査システム、を用いた検体プール検査法による検査方法であって、
　前記前処理装置におけるプール検体の調製前に、前記管理用端末に搭載されている前処理装置管理用のソフトウェアにおいて、ユーザーの操作による個別検体及びプール検体に関する検体情報の入力を受け付ける検体情報入力工程と、
　前記検体情報入力工程で受け付けられた検体情報を前記データベースに保存する情報保存工程と、
　前記検査装置での一又は複数のプール検体に対する分析の結果を前記表示部に表示するプール検査結果表示工程と、
　前記プール検体の少なくとも一つが陽性であった場合に、前記管理用端末に搭載されている検査装置管理用のソフトウェアにおいて、特定のプール検体の指定又は選択を受け付ける検体指定工程と、
　前記検体指定工程で指定又は選択されたプール検体に関連付けられている複数の個別検体の検体情報を前記データベースから取得し、その取得した検体情報を、前記検査装置における検査対象の検体の検体情報を設定するための検体情報入力画面の所定位置に差し込んで前記表示部に表示する検体情報入力工程と、
　を有する。 One aspect of the testing method according to the present invention, which has been made to solve the above problems, includes a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample, a testing device that analyzes the pooled sample or the individual samples, An inspection method using a specimen pool inspection method using an inspection system comprising a management terminal capable of communicating with the pretreatment device and the inspection device, a database accessible from the management terminal, and a display unit. and
A sample information input step of accepting input of sample information related to individual samples and pooled samples by a user's operation in the pretreatment device management software installed in the management terminal before pool sample preparation in the pretreatment device. and,
an information storage step of storing the sample information received in the sample information input step in the database;
a pool test result display step of displaying the analysis results of one or more pool samples in the test device on the display unit;
a specimen designation step of accepting designation or selection of a specific pool specimen in software for testing device management installed in the management terminal when at least one of the pool specimens is positive;
acquiring sample information of a plurality of individual samples associated with the pool sample specified or selected in the sample specifying step from the database, and using the acquired sample information as the sample information of the sample to be inspected in the inspection apparatus; a sample information input step of inserting into a predetermined position of a sample information input screen for setting and displaying it on the display unit;
have
　また、上記課題を解決するためになされた本発明に係る検査システムの一態様は、検体プール検査法による検査を行う検査システムであって、
　複数の個別検体を混合してプール検体を調製する前処理装置と、
　プール検体又は個別検体を分析する検査装置と、
　前記前処理装置及び前記検査装置とそれぞれ通信可能であって、入力部及び表示部を含み、前記前処理装置及び前記検査装置における各々の動作を独立に制御する制御装置と、
　前記制御装置からアクセス可能であるデータベースと、
　表示部と、
を備え、前記制御装置は、
　前記前処理装置でのプール検体の調製前に、前記入力部を通した、複数の個別検体及びプール検体に関する検体情報の入力を受け付けるとともに、受け付けられた検体情報を前記データベースに保存する前処理装置管理部と、
　前記検査装置での一又は複数のプール検体に対する分析の結果を前記表示部に表示し、前記入力部を通した、陽性であったプール検体の指定又は選択を受け付け、指定又は選択されたプール検体に関連付けられている複数の個別検体の検体情報を前記データベースから取得して、取得した検体情報を、前記検査装置における検査対象の検体の検体情報を設定するための検体情報入力画面の所定位置に差し込んで前記表示部に表示する検査装置管理部と、
　を備える。 Further, one aspect of the inspection system according to the present invention, which has been made to solve the above problems, is an inspection system that performs an inspection by a sample pool inspection method,
a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample;
a testing device that analyzes pool samples or individual samples;
a control device capable of communicating with the preprocessing device and the inspection device, respectively, including an input unit and a display unit, and independently controlling operations of the preprocessing device and the inspection device;
a database accessible from the controller;
a display unit;
wherein the control device comprises
A pretreatment device that receives input of specimen information regarding a plurality of individual specimens and pooled specimens through the input unit and stores the received specimen information in the database before pooled specimens are prepared by the pretreatment device. management department and
display the results of analysis of one or more pooled samples by the testing device on the display unit, accept designation or selection of positive pooled samples through the input unit, and designate or select the pooled samples acquires sample information of a plurality of individual samples associated with the database from the database, and places the acquired sample information in a predetermined position of a sample information input screen for setting sample information of a sample to be inspected in the inspection device. an inspection device management unit that is inserted and displayed on the display unit;
Prepare.
　本発明の上記態様による検査方法及び検査システムによれば、検体プール検査法での検査において、プール検体が陽性であって、そのプール検体の元である複数の個別検体をそれぞれ再検査する必要がある場合に、検査担当者による簡単な操作によって、再検査すべき個別検体の検体情報が自動的に検査対象として設定される。 According to the testing method and testing system according to the above aspects of the present invention, when a pooled specimen is positive in testing by the specimen pooling testing method, it is not necessary to retest each of the plurality of individual specimens that are the sources of the pooled specimen. In some cases, the sample information of the individual sample to be retested is automatically set as the test target by a simple operation by the person in charge of testing.
　これにより、個別検体を再検査する際における、検体情報の入力作業に掛かる検査担当者の負担を軽減し、検査効率の改善を図ることができる。また、陽性であるプール検体の元である複数の個別検体の検体情報が間違い無く入力されるため、プール検体と個別検体との対応付けの誤りや個別検体の取違いなどのミスを防止することができ、検査の信頼性を高めることができる。 As a result, it is possible to reduce the burden on the person in charge of the specimen information input work when retesting an individual specimen, and improve the efficiency of the examination. In addition, since the specimen information of the multiple individual specimens that are the sources of the pooled specimens that are positive are entered without error, it is possible to prevent errors such as erroneous association between pooled specimens and individual specimens and mix-up of individual specimens. can improve the reliability of the inspection.
本発明の一実施形態である検査システムの全体構成図。1 is an overall configuration diagram of an inspection system that is an embodiment of the present invention; FIG. 前処理装置の内部構成の概略図。Schematic diagram of the internal configuration of the pretreatment device. 前処理装置において各種部材が装着された状態である作業テーブルの概略上面図。FIG. 2 is a schematic top view of a work table on which various members are mounted in the pretreatment device; 作業テーブルに装着される各種部材とこれを取り外した状態の作業テーブルの概略上面図。FIG. 2 is a schematic top view of various members attached to the work table and the work table from which the members are removed; 個別検体ラックの装着方法を説明するための概略上面図。FIG. 10 is a schematic top view for explaining how to mount an individual sample rack; 検査装置の内部構成の概略図。Schematic diagram of the internal configuration of the inspection device. 本実施形態の検査システムを用いたプール検査法による検査の手順の一例を示すフローチャート。4 is a flowchart showing an example of an inspection procedure by a pool inspection method using the inspection system of the present embodiment; 本実施形態の検査システムを用いたプール検査法による検査の手順の一例を示すフローチャート。4 is a flowchart showing an example of an inspection procedure by a pool inspection method using the inspection system of the present embodiment; 前処理用の検体情報設定画面の一例を示す図。The figure which shows an example of the specimen information setting screen for pretreatment. 検査後の検査結果表示画面の一例を示す図。The figure which shows an example of the inspection result display screen after an inspection. 検査用の検体情報設定画面の一例を示す図。The figure which shows an example of the specimen information setting screen for a test|inspection. 検査用の検体選択画面の一例を示す図。The figure which shows an example of the sample selection screen for a test|inspection. 個別検体を再検査する際の作業手順を説明するための検査結果表示画面の二つの例を示す図。FIG. 10 is a diagram showing two examples of test result display screens for explaining the work procedure when retesting an individual sample; 個別検体を再検査する際の作業手順を説明するための、前処理装置における検体マップと検体選択画面との関係を示す図。FIG. 4 is a diagram showing the relationship between a sample map and a sample selection screen in the pretreatment device, for explaining the work procedure when retesting an individual sample;
　以下、本発明に係る検査システムの一実施形態について、添付図面を参照して説明する。 An embodiment of an inspection system according to the present invention will be described below with reference to the accompanying drawings.
　　［検査システムの全体構成］
　図１は、本実施形態の検査システムの全体構成図である。この検査システムは、例えば、COVID-19の原因である新型コロナウイルス（SARS-CoV-2）の感染の有無を、検体プール検査法によって検査することが可能なシステムである。 [Overall configuration of inspection system]
FIG. 1 is an overall configuration diagram of an inspection system according to this embodiment. This test system is a system that can test for the presence or absence of infection with the novel coronavirus (SARS-CoV-2), which is the cause of COVID-19, for example, using a sample pool test method.
　図１に示すように、この検査システムは、前処理装置１と、４台の検査装置２と、制御・処理装置３０と、データベース３１と、操作部３２と、表示部３３と、バーコードリーダー４と、を含む。制御・処理装置３０は、前処理装置管理部３００、検査装置管理部３０１、及びデータベース管理部３０２、を含む。この例では、制御・処理装置３０、データベース３１、操作部３２、及び、表示部３３は、汎用的なパーソナルコンピューター（ＰＣ）３であり、該ＰＣ３に専用の制御・処理ソフトウェアがインストールされている。即ち、前処理装置管理部３００、検査装置管理部３０１はそれぞれ、ＰＣ３にインストールされている所定のソフトウェア（アプリケーションプログラム）をコンピューター上で動作させることで具現化される機能ブロックである。なお、データベース３１は、ＰＣ３からアクセス可能でありさえすれば、ＰＣ３に内蔵されていなくてもＰＣ３から離れた位置に存在していてもよい。 As shown in FIG. 1, this inspection system includes a pretreatment device 1, four inspection devices 2, a control/processing device 30, a database 31, an operation unit 32, a display unit 33, a barcode reader 4 and . The control/processing device 30 includes a pretreatment device manager 300 , an inspection device manager 301 , and a database manager 302 . In this example, the control/processing device 30, the database 31, the operation unit 32, and the display unit 33 are a general-purpose personal computer (PC) 3, and dedicated control/processing software is installed in the PC3. . That is, the pretreatment device management unit 300 and the inspection device management unit 301 are functional blocks realized by operating predetermined software (application programs) installed in the PC 3 on the computer. Note that the database 31 may exist at a location remote from the PC 3 even if it is not built in the PC 3 as long as it is accessible from the PC 3 .
　この検査システムは４台の検査装置２を含むが、これは、本例において、前処理装置１での前処理で所定時間内に調製されるプール検体の数と、検査装置２において同じ所定時間内に検査可能である検体の数とを凡そ合わせるためであり、検査システムに含まれる検査装置２及び前処理装置１の台数はこの例に限るものではない。 This testing system includes four testing devices 2, which in this example is the number of pooled specimens prepared within a predetermined time by pretreatment in the pretreatment device 1 and The number of inspection apparatuses 2 and pretreatment apparatuses 1 included in the inspection system is not limited to this example.
　制御・処理装置３０は、前処理装置１と４台の検査装置２とそれぞれ通信線５を介して接続されている。この通信線５は例えば、一般的なＵＳＢ規格に則ったものとすることができる。 The control/processing device 30 is connected to the pretreatment device 1 and the four inspection devices 2 via communication lines 5, respectively. This communication line 5 can conform to the general USB standard, for example.
　前処理装置１は、プール検査法による検査のためのプール検体を調製するための前処理装置であり、被検者から採取された個別検体に対する検査の際には使用されない。一方、検査装置２は、個別検体とプール検体の両方の検査が可能な装置であり、例えば、本出願人が市販している「AutoAmpTM　遺伝子解析装置」（インターネット＜URL: https://www.shimadzu.co.jp/cl/products/autoamp/index.html＞など参照） のような既存の装置を用いることができる。但し、検査装置２における分析や検査の手法は上記の装置で用いられているものに限らない。 The pretreatment device 1 is a pretreatment device for preparing a pooled specimen for examination by the pooled examination method, and is not used for examination of individual specimens collected from subjects. On the other hand, the testing device 2 is a device capable of testing both individual samples and pooled samples. .shimadzu.co.jp/cl/products/autoamp/index.html>, etc.) can be used. However, the methods of analysis and inspection in the inspection device 2 are not limited to those used in the above devices.
　図１の上側に示すように、前処理装置１は、複数の個別検体を分取し混合することで一つのプール検体を調製する装置である。本例では、個別検体はそれぞれ、被検者から採取された唾液、鼻咽腔拭い液、血液、尿などの生体試料由来の検体である。現在の知見によれば、プール検査法の場合、個別検査と同程度の検査精度を確保するには、混合される個別検体の数は５以下が望ましいとされている。この前処理装置１では、最大５個の個別検体から１個のプール検体を調製することが可能であるが、一般的には、４個又はそれ以下の個別検体から１個のプール検体を調製する。但し、これらは単に一例であり、適宜に変更が可能であって、例えば６以上の個別検体からプール検体の調製を行うようにしてもよい。 As shown on the upper side of FIG. 1, the pretreatment device 1 is a device that prepares one pool sample by collecting and mixing a plurality of individual samples. In this example, each individual sample is a sample derived from a biological sample such as saliva, nasopharyngeal swab, blood, urine, etc. collected from a subject. According to current knowledge, in the case of the pooled test method, it is desirable that the number of individual samples to be mixed is 5 or less in order to ensure the same level of test accuracy as in the individual test. With this pretreatment device 1, it is possible to prepare one pooled specimen from a maximum of five individual specimens, but generally one pooled specimen is prepared from four or less individual specimens. do. However, these are merely examples, and can be modified as appropriate. For example, pooled specimens may be prepared from six or more individual specimens.
　プール検査法では、前処理装置１で調製されたプール検体がいずれかの検査装置２にセットされ検査に供される。また、検査装置２による検査の結果、或るプール検体が陽性であると判定されると、そのプール検体の元である複数の個別検体が検査装置２にセットされて検査される。なお、以下に述べる例では、検査担当者自身が前処理装置１から検査装置２までプール検体や個別検体を手持ちで搬送し検査装置２にセットすることを想定しているが、この搬送作業や装置へのセット作業などを、ロボット等を用いて自動化することが可能であることは当然である。 In the pooled test method, the pooled samples prepared by the pretreatment device 1 are set in one of the testing devices 2 and subjected to testing. Further, when a certain pool sample is determined to be positive as a result of the inspection by the inspection device 2, a plurality of individual samples, which are the sources of the pool sample, are set in the inspection device 2 and inspected. In the example described below, it is assumed that the person in charge of inspection himself/herself transports the pool sample or individual sample from the pretreatment device 1 to the inspection device 2 by hand and sets it in the inspection device 2. It is of course possible to automate the setting work to the device using a robot or the like.
　　［前処理装置の構成］
　前処理装置１の詳細な構成について述べる。図２は、前処理装置１の内部構成を側面から見た状態の概略図である。図３は、前処理装置１において前処理に使用される各種部材が装着された状態である作業テーブルの概略上面図である。図４は、作業テーブルに装着される各種部材とこれを取り外した状態の作業テーブルの概略上面図である。 [Configuration of pretreatment device]
A detailed configuration of the pretreatment device 1 will be described. FIG. 2 is a schematic diagram of the internal configuration of the pretreatment device 1 as viewed from the side. FIG. 3 is a schematic top view of a work table on which various members used for pretreatment are mounted in the pretreatment apparatus 1. FIG. FIG. 4 is a schematic top view of various members attached to the work table and the work table with the members removed.
　図２～図４及び後述する図５には、説明の便宜上、互いに直交するＸ軸、Ｙ軸、Ｚ軸の３軸を示している。前処理装置１及び検査装置２の設置面はＸ－Ｙ平面に平行な面であり、Ｚ軸方向は前処理装置１及び検査装置２の高さ（上下）方向である。 For convenience of explanation, FIGS. 2 to 4 and FIG. 5, which will be described later, show three axes, the X-axis, the Y-axis, and the Z-axis, which are orthogonal to each other. The installation surface of the preprocessing device 1 and the inspection device 2 is a plane parallel to the XY plane, and the Z-axis direction is the height (vertical) direction of the preprocessing device 1 and the inspection device 2 .
　図２に示すように、前処理装置１は、分注ユニット１０と、第１移動部１１と、作業テーブル１２と、第２移動部１３と、制御部１４と、を含む。第１移動部１１は、分注ユニット１０を水平方向（Ｘ軸－Ｙ軸方向）に移動させるアクチュエーター（図示せず）を含む。第２移動部１３は、作業テーブル１２を水平方向（Ｘ軸－Ｙ軸方向）に移動させるアクチュエーター（図示せず）を含む。第１、第２移動部１１、１３にそれぞれ含まれるアクチュエーターは、制御・処理装置３０から指令を受けた制御部１４による指示により動作する。なお、第１、第２移動部１１、１３の一方は省略することができる。 As shown in FIG. 2, the pretreatment device 1 includes a dispensing unit 10, a first moving section 11, a work table 12, a second moving section 13, and a control section . The first moving part 11 includes an actuator (not shown) that moves the dispensing unit 10 in the horizontal direction (X-axis-Y-axis direction). The second moving part 13 includes an actuator (not shown) that moves the work table 12 in the horizontal direction (X-axis-Y-axis direction). The actuators included in the first and second moving units 11 and 13 operate according to instructions from the control unit 14 that receives instructions from the control/processing device 30 . One of the first and second moving parts 11 and 13 can be omitted.
　分注ユニット１０は、Ｚ軸方向に延伸するノズル１０１が先端に取り付けられたシリンジ１００を含む。ノズル１０１の内部には、Ｚ軸方向に沿って移動自在であるプランジャー（図示せず）が備えられている。シリンジ１００は、プランジャーのＺ軸方向のストローク長に応じた量の液体を吸引し、プランジャーのＺ軸方向のストローク長に応じた量の液体を吐出するように構成される。分注ユニット１０は、シリンジ１００をＺ軸方向に移動させるためのアクチュエーター（図示せず）と、ノズル１０１内のプランジャーをＺ軸方向に移動させるためのアクチュエーター（図示せず）とを含む。これらアクチュエーターはいずれも、制御部１４による指示により動作する。 The dispensing unit 10 includes a syringe 100 with a nozzle 101 extending in the Z-axis direction attached to its tip. Inside the nozzle 101, a plunger (not shown) is provided which is movable along the Z-axis direction. The syringe 100 is configured to aspirate an amount of liquid corresponding to the stroke length of the plunger in the Z-axis direction and to discharge an amount of liquid corresponding to the stroke length of the plunger in the Z-axis direction. The dispensing unit 10 includes an actuator (not shown) for moving the syringe 100 in the Z-axis direction and an actuator (not shown) for moving the plunger inside the nozzle 101 in the Z-axis direction. All of these actuators operate according to instructions from the control unit 14 .
　図３及び図４に示すように、作業テーブル１２の上面は概ねＸ－Ｙ平面に平行に延展しており、その上面には、コンテナ収納部１２０と、分注チップ保持部１２１と、チップ廃棄部１２２と、が設けられている。 As shown in FIGS. 3 and 4, the upper surface of the work table 12 extends generally parallel to the XY plane, and has a container storage section 120, a dispensing tip holding section 121, and a tip disposal section. A portion 122 and are provided.
　コンテナ収納部１２０には、コンテナ５０が着脱自在に装填される。コンテナ５０は外形が略直方体形状であって、吊り下げ持ち可能な把手（図示せず）を備える。分注チップ保持部１２１には、上面視で円形状である保持穴が複数（この例では２０個）設けられている。その保持穴にはそれぞれ、図２に示すように、ロングチップである分注チップ５６が起立した状態で保持されるように構成されている。この分注チップ５６は、シリンジ１００のノズル１０１に取り付けて使用される。 A container 50 is detachably loaded in the container storage section 120 . The container 50 has a substantially rectangular parallelepiped outer shape and includes a handle (not shown) that can be held by hanging. The dispensing tip holder 121 is provided with a plurality (20 in this example) of circular holding holes when viewed from above. As shown in FIG. 2, each holding hole is configured to hold a dispensing tip 56, which is a long tip, in an upright state. This dispensing tip 56 is attached to the nozzle 101 of the syringe 100 and used.
　分注チップ保持部１２１に保持可能である分注チップ５６の数は、コンテナ５０に収納可能である個別検体容器５４の最大数（この例では２０）と同数である。チップ廃棄部１２２は、使用済みの分注チップ５６が廃棄される、上面が開口した取り外し可能な箱である。 The number of dispensing tips 56 that can be held in the dispensing tip holder 121 is the same as the maximum number of individual sample containers 54 that can be stored in the container 50 (20 in this example). The tip disposal unit 122 is a detachable box with an open top in which used dispensing tips 56 are discarded.
　コンテナ５０は、５個の個別検体ラック５１（５１Ａ－５１Ｅ）がそれぞれ収納され得る個別検体ラック収納部５００、５０１と、１個のプール検体ラック５２が収納され得るプール検体ラック収納部５０２と、を備える。５個の個別検体ラック５１（５１Ａ－５１Ｅ）は、外形が略直方体形状でほぼ同じである。このうち、４個の個別検体ラック５１Ａ－５１Ｄが収納される個別検体ラック収納部５００は、それぞれＹ軸方向に延伸し、Ｘ軸方向に並んで配列されている。残りの１個の個別検体ラック５１Ｅが収納される個別検体ラック収納部５０１は、Ｘ軸方向に延伸し、上記４個の個別検体ラック５１Ａ－５１Ｄの配列に対しＹ軸方向に隣接して配置されている。 The container 50 includes individual sample rack storage units 500 and 501 each capable of storing five individual sample racks 51 (51A to 51E), a pool sample rack storage unit 502 capable of storing one pool sample rack 52, Prepare. The five individual sample racks 51 (51A to 51E) have substantially the same external shape of a substantially rectangular parallelepiped. Of these, the individual sample rack storage units 500 that store the four individual sample racks 51A to 51D each extend in the Y-axis direction and are arranged side by side in the X-axis direction. The individual sample rack storage section 501 in which the remaining individual sample rack 51E is stored extends in the X-axis direction and is arranged adjacent to the arrangement of the four individual sample racks 51A to 51D in the Y-axis direction. It is
　個別検体ラック５１Ｅは、通常、５個の個別検体からプール検体を調製したい場合に使用される。即ち、後述するように４個の個別検体からプール検体を調製する場合には、Ｙ軸方向に延伸しＸ軸方向に４列に並ぶ個別検体ラック収納部５００にのみ、それぞれ個別検体ラック５１Ａ－５１Ｄが収納され、個別検体ラック５１Ｅは不要である。図２では、その場合の状態を示すために、個別検体ラック５１Ｅを点線で示している。 The individual sample rack 51E is normally used when a pooled sample is to be prepared from 5 individual samples. That is, when preparing a pool sample from four individual samples, as described later, only the individual sample rack storage units 500 extending in the Y-axis direction and arranged in four rows in the X-axis direction have individual sample racks 51A- 51D is accommodated, and the individual sample rack 51E is unnecessary. In FIG. 2, the individual sample rack 51E is indicated by a dotted line to indicate the state in that case.
　プール検体ラック収納部５０２は個別検体ラック収納部５０１と同様に、Ｘ軸方向に延伸し、上記４個の個別検体ラック５１Ａ－５１Ｄの配列を挟んで、Ｙ軸方向に個別検体ラック収納部５０１と反対側に配置されている。 Like the individual sample rack storage section 501, the pool sample rack storage section 502 extends in the X-axis direction, sandwiching the arrangement of the four individual sample racks 51A to 51D, and extending in the Y-axis direction. is placed on the opposite side of the
　４列の個別検体ラック収納部５００とプール検体ラック収納部５０２との間には、その個別検体ラック５１Ａ－５１Ｄにそれぞれ付与されている色（この例では、後述するように容器保持部が彩色されている）と同色のラベルが貼付された色標識部５０３が設けられている。 Between the four rows of individual sample rack storage units 500 and the pool sample rack storage unit 502, the colors assigned to the individual sample racks 51A to 51D (in this example, the container holding units are colored as described later). ) is provided) to which a label of the same color is attached.
　個別検体ラック５１Ａ－５１Ｄは、一つのプール検体を調製するために一つのプールグループとして扱われる４個の個別検体容器５４を、一列に所定間隔離して並べて収容可能である容器保持部５１０を備える。４個の個別検体ラック５１Ａ－５１Ｄにおいて、容器保持部５１０はその個別検体ラック５１Ａ－５１Ｄ毎に異なる色で標識されている。本例では具体的には、図３において左から順に、個別検体ラック５１Ａは赤、個別検体ラック５１Ｂは青、個別検体ラック５１Ｃは緑、個別検体ラック５１Ｄは紫で標識されている。この標識の色は、上述したコンテナ５０上の色標識部５０３のラベルの色と対応している。もちろん、色は一例であってこれに限らない。 Each of the individual sample racks 51A to 51D includes a container holding section 510 that can accommodate four individual sample containers 54 treated as one pool group for preparing one pool sample, lined up in a row with a predetermined interval. . In the four individual sample racks 51A-51D, the container holders 510 are labeled with different colors for each of the individual sample racks 51A-51D. Specifically, in this example, from the left in FIG. 3, the individual sample rack 51A is labeled in red, the individual sample rack 51B in blue, the individual sample rack 51C in green, and the individual sample rack 51D in purple. The color of this indicator corresponds to the color of the label of the color indicator section 503 on the container 50 described above. Of course, the color is just an example and is not limited to this.
　個別検体ラック収納部５０１に収納され得る個別検体ラック５１Ｅの５個の容器保持部５１０はそれぞれ、図３に示した状態においてＹ軸方向に並ぶ個別検体ラック５１Ａ－５１Ｄにおける容器保持部５１０と同じ色に標識されている。従って、この例では、図３に示すように配置された個別検体ラック５１Ｅにおける４個の容器保持部５１０の色は、左から順に、赤、青、緑、及び紫である。即ち、個別検体ラック５１Ａ－５１Ｄに加えて個別検体ラック５１Ｅが使用される場合でも、Ｙ軸方向に直線的に並ぶ５個の容器保持部５１０の色は同じであり、且つＸ軸方向に並ぶ５列の容器保持部５１０の色は列毎に互いに異なる。 The five container holding units 510 of the individual sample rack 51E that can be stored in the individual sample rack storage unit 501 are the same as the container holding units 510 in the individual sample racks 51A to 51D arranged in the Y-axis direction in the state shown in FIG. labeled in color. Therefore, in this example, the colors of the four container holders 510 in the individual sample rack 51E arranged as shown in FIG. 3 are red, blue, green, and purple in order from the left. That is, even when the individual sample rack 51E is used in addition to the individual sample racks 51A to 51D, the five container holding units 510 linearly aligned in the Y-axis direction have the same color and are aligned in the X-axis direction. The colors of the five rows of container holding portions 510 are different for each row.
　プール検体ラック収納部５０２には１個のプール検体ラック５２が収納され得る。プール検体ラック５２には、図２に示すように測方から見た状態で逆Ｌ字形状のハンドル５３が設けられている。検査担当者はこのハンドル５３を把持することでプール検体ラック５２を確実に掴んで、プール検体ラック収納部５０２に出し入れしたり持ち運んだりすることができる。なお、ハンドル５３はプール検体ラック５２に着脱自在であってもよい。 One pool sample rack 52 can be stored in the pool sample rack storage unit 502 . As shown in FIG. 2, the pool sample rack 52 is provided with an inverted L-shaped handle 53 when viewed from the direction of measurement. By gripping the handle 53, the person in charge of testing can reliably grasp the pool sample rack 52 and take it in and out of the pool sample rack storage section 502 or carry it. Note that the handle 53 may be detachable from the pool sample rack 52 .
　個別検体ラック５１と同様に、プール検体ラック５２にも、４個の容器保持部５２０が設けられる。その４個の容器保持部５２０は、それぞれ、個別検体ラック５１Ｅにおける容器保持部５１０と同じ色に標識されている。即ち、この例では、図３に示すように配置されたプール検体ラック５２における４個の容器保持部５２０の色は、左から順に、赤、青、緑、及び紫である。また、ハンドル５３の上面には、４個の容器保持部５２０に対応して左からＰ１、Ｐ２、Ｐ３、Ｐ４と番号が記載されており、その番号の表示色も容器保持部５２０に付された色と同じである。 Similarly to the individual sample rack 51, the pool sample rack 52 is also provided with four container holding units 520. The four container holding units 520 are labeled in the same color as the container holding units 510 in the individual sample rack 51E. That is, in this example, the colors of the four container holders 520 in the pool sample rack 52 arranged as shown in FIG. 3 are red, blue, green, and purple in order from the left. Numbers P1, P2, P3, and P4 are written from the left on the upper surface of the handle 53 corresponding to the four container holding portions 520, and the display colors of the numbers are also given to the container holding portions 520. is the same as the original color.
　上述したように、個別検体ラック５１Ａ－５１Ｅは基本的に外形形状が同一であり、個別検体ラック収納部５００、５０１の形状も基本的には同じである。しかしながら、個別検体ラック５１Ａ－５１Ｅがそれぞれ収納され得る個別検体ラック収納部５００、５０１は、次のようにして一意に決められており、且つその取り付けの向きも一意に決められている。 As described above, the individual sample racks 51A to 51E basically have the same outer shape, and the individual sample rack storage units 500 and 501 also basically have the same shape. However, the individual sample rack housing units 500 and 501 in which the individual sample racks 51A to 51E can be respectively housed are uniquely determined as follows, and their attachment orientations are also uniquely determined.
　図５は、個別検体ラック５１Ａ－５１Ｅの装着方法を説明するための概略図である。図３及び図４において、最も左側に位置する個別検体ラック収納部５００Ａには、その内側面（Ｙ－Ｚ面に平行な面））から内方に突出する位置規制片５００ａが設けられている。一方、個別検体ラック５１Ａには、上記位置規制片５００ａに対応する位置に切欠き５１ａが形成されている（図５（Ａ）参照）。 FIG. 5 is a schematic diagram for explaining the mounting method of the individual sample racks 51A-51E. In FIGS. 3 and 4, the leftmost individual sample rack storage section 500A is provided with a position regulating piece 500a protruding inward from its inner surface (a surface parallel to the YZ plane). . On the other hand, the individual sample rack 51A is formed with a notch 51a at a position corresponding to the position regulating piece 500a (see FIG. 5A).
　個別検体ラック５１Ａを適切な向きで個別検体ラック収納部５００Ａに収納すると、位置規制片５００ａがちょうど切欠き５１ａに嵌るため、個別検体ラック５１Ａは正規の位置（深さ）まで収納され得る（図５（Ｂ）参照）。例えば、個別検体ラック５１Ａの向きを逆にして個別検体ラック収納部５００Ａに収納しようとすると、個別検体ラック５１Ａの底部は位置規制片５００ａに当接し、個別検体ラック収納部５００Ａに完全には収納されない。これにより、検査担当者は、向きを間違えて個別検体ラック５１Ａを収納しようとしたことを容易に認識することができる。 When the individual sample rack 51A is stored in the individual sample rack storage section 500A in an appropriate orientation, the position regulating piece 500a fits exactly into the notch 51a, so the individual sample rack 51A can be stored up to the proper position (depth) (Fig. 5(B)). For example, if the direction of the individual sample rack 51A is reversed and stored in the individual sample rack storage section 500A, the bottom of the individual sample rack 51A abuts against the position regulating piece 500a and is completely stored in the individual sample rack storage section 500A. not. As a result, the person in charge of testing can easily recognize that the individual sample rack 51A has been stored in the wrong direction.
　一方、図３及び図４において、左から二番目に位置する個別検体ラック収納部５００Ｂにも、その内側面から内方に突出する位置規制片５００ｂが設けられているが、その位置規制片５００ｂの位置は上記の位置規制片５００ａとはＹ軸方向にずれている。個別検体ラック５１Ｂには、位置規制片５００ｂに対応する位置に切欠き５１ｂが形成されている（図５（Ｃ）参照）。そのため、個別検体ラック５１Ｂを適切な向きで個別検体ラック収納部５００Ｂに収納すると、位置規制片５００ｂが切欠き５１ｂに嵌るため、個別検体ラック５１Ｂは正規の位置（深さ）まで収納され得る（図５（Ｄ）参照）。 On the other hand, in FIGS. 3 and 4, the individual sample rack storage section 500B located second from the left is also provided with a position regulating piece 500b protruding inward from its inner surface. is displaced in the Y-axis direction from the position regulating piece 500a. A notch 51b is formed in the individual sample rack 51B at a position corresponding to the position regulating piece 500b (see FIG. 5(C)). Therefore, when the individual sample rack 51B is accommodated in the individual sample rack storage section 500B in an appropriate orientation, the position regulating piece 500b fits into the notch 51b, so that the individual sample rack 51B can be accommodated to the proper position (depth) ( See FIG. 5(D)).
　例えば、誤って個別検体ラック５１Ａを個別検体ラック収納部５００Ｂに収納しようとすると、位置規制片５００ｂと切欠き５１ａの位置が合わないため、個別検体ラック５１Ａの底部は位置規制片５００ｂに当接する。その結果、個別検体ラック５１Ａは個別検体ラック収納部５００Ｂに完全には収納されない。これにより、検査担当者は、個別検体ラック収納部５００Ｂに対応しない個別検体ラック５１Ａを収納しようとしたことを容易に認識することができる。これは、全ての個別検体ラック５１Ａ－５１Ｅ及び個別検体ラック収納部５００、５０１において同様である。 For example, if the individual sample rack 51A is accidentally stored in the individual sample rack storage section 500B, the positions of the position regulating piece 500b and the notch 51a do not match, so the bottom of the individual sample rack 51A contacts the position regulating piece 500b. . As a result, the individual sample rack 51A is not completely accommodated in the individual sample rack storage section 500B. As a result, the person in charge of testing can easily recognize that the individual sample rack 51A that does not correspond to the individual sample rack storage section 500B has been attempted to be stored. This is the same for all individual sample racks 51A to 51E and individual sample rack storage units 500 and 501. FIG.
　即ち、この前処理装置１では、個別検体ラック５１と個別検体ラック収納部５００、５０１とが物理的（又は構造的）に一対一に対応しており、誤った位置への装着ができないように構成されている。また、個別検体ラック５１の取付けの向きについても同様であり、誤った向きでの装着ができないように構成されている。また、プール検体ラック５２についても同様であり、プール検体ラック５２もプール検体ラック収納部５０２のみに、且つ決まった向きでのみ装着可能となっている。 That is, in the pretreatment apparatus 1, the individual sample racks 51 and the individual sample rack storage units 500, 501 are physically (or structurally) in one-to-one correspondence, so that they cannot be attached to wrong positions. It is configured. The mounting direction of the individual sample rack 51 is also the same, and is configured to prevent mounting in the wrong direction. The same applies to the pool sample rack 52, and the pool sample rack 52 can be attached only to the pool sample rack storage section 502 and only in a predetermined orientation.
　上述したように、個別検体ラック５１Ａ－５１Ｄはそれぞれ異なる色で標識されており、それらをそれぞれ収納する位置も色標識部５０３で視覚的に明確に示されている。それにより、検査担当者は、その色を参照して、個別検体ラック５１Ａ－５１Ｄをそれぞれ適切な位置に収納することができる。但し、これは検査担当者の判断に頼る作業ミス防止策であり、検査担当者の注意不足等によるミスは起こり得る。それに対し、この前処理装置１では、上述したような位置規制構造によって、個別検体ラック５１Ａ－５１Ｅ及びプール検体ラック５２をそれぞれ装着すべき位置及びその向きが物理的に一意に決められている。このため、ラック５１Ａ－５１Ｅ、５２の装着ミスに起因する検体の取違いを確実に防止することができる。 As described above, the individual sample racks 51A to 51D are labeled with different colors, and the positions at which they are stored are also visually clearly indicated by the color indicator section 503. Accordingly, the person in charge of testing can refer to the color and store the individual sample racks 51A to 51D in appropriate positions. However, this is a work error prevention measure that relies on the judgment of the person in charge of inspection, and mistakes may occur due to the lack of attention of the person in charge of inspection. On the other hand, in the pretreatment apparatus 1, the positions and orientations of the individual sample racks 51A to 51E and the pool sample rack 52 are physically and uniquely determined by the position regulation structure as described above. For this reason, it is possible to reliably prevent sample mix-up due to incorrect mounting of the racks 51A to 51E and 52. FIG.
　　［検査装置の構成］
　上述したように検査装置２としては、既存の遺伝子解析装置を利用することができる。その構成と動作を概略的に説明する。図６は、検査装置２の内部構成の概略図である。 [Configuration of inspection device]
As described above, an existing gene analysis device can be used as the testing device 2 . The configuration and operation thereof will be briefly described. FIG. 6 is a schematic diagram of the internal configuration of the inspection device 2. As shown in FIG.
　図６に示すように、検査装置２は、検査部２０と、保持部２３と、第１移動部２１と、第２移動部２２と、制御部２４と、を含む。保持部２３は、その上面に複数の容器２５等を保持可能に構成され、ペルチエ素子などによる温調機能（加熱及び冷却機能）を有する温調保持部２３１と、温調機能を有さない非温調保持部２３２と、を含む。 As shown in FIG. 6, the inspection device 2 includes an inspection section 20, a holding section 23, a first moving section 21, a second moving section 22, and a control section 24. The holding part 23 is configured to be able to hold a plurality of containers 25 and the like on its upper surface. and a temperature control holding unit 232 .
　第１移動部２１は、検査部２０を水平方向（Ｘ軸－Ｙ軸方向）に移動させるアクチュエーター（図示せず）を含む。第２移動部２２は、保持部２３を水平方向（Ｘ軸－Ｙ軸方向）に移動させるアクチュエーター（図示せず）を含む。第１、第２移動部２１、２２にそれぞれ含まれるアクチュエーターは、制御・処理装置３０から指令を受けた制御部２４による指示により動作する。なお、第１、第２移動部２１、２２の一方は省略することができる。 The first moving unit 21 includes an actuator (not shown) that moves the inspection unit 20 in the horizontal direction (X-axis-Y-axis direction). The second moving part 22 includes an actuator (not shown) that moves the holding part 23 in the horizontal direction (X-axis-Y-axis direction). The actuators included in the first and second moving parts 21 and 22 respectively operate according to instructions from the control part 24 that receives instructions from the control/processing device 30 . One of the first and second moving parts 21 and 22 can be omitted.
　検査部２０は、光学ユニット２０１と、分注ユニット２０２と、開閉ユニット２０５と、を含む。分注ユニット２０２は、前処理装置１の分注ユニット１０と同様の構成を有し、Ｚ軸方向に延伸するノズル２０４が先端に取り付けられたシリンジ２０３を含む。シリンジ２０３は、ノズル２０４の内部に設けられたプランジャーのＺ軸方向のストローク長に応じた量の液体を吸引し、又そのストローク長に応じた量の液体を吐出するように構成される。分注ユニット２０２は、シリンジ２０３をＺ軸方向に移動させるためのアクチュエーター（図示せず）と、ノズル２０４内のプランジャーをＺ軸方向に移動させるためのアクチュエーター（図示せず）とを含む。これらアクチュエーターはいずれも、制御部２４による指示に従って動作する。 The inspection section 20 includes an optical unit 201 , a dispensing unit 202 and an opening/closing unit 205 . The dispensing unit 202 has the same configuration as the dispensing unit 10 of the pretreatment device 1, and includes a syringe 203 having a nozzle 204 extending in the Z-axis direction attached to its tip. The syringe 203 is configured to suck in an amount of liquid corresponding to the stroke length in the Z-axis direction of a plunger provided inside the nozzle 204 and to discharge an amount of liquid corresponding to the stroke length. The dispensing unit 202 includes an actuator (not shown) for moving the syringe 203 in the Z-axis direction and an actuator (not shown) for moving the plunger inside the nozzle 204 in the Z-axis direction. All of these actuators operate according to instructions from the control section 24 .
　開閉ユニット２０５は、保持部２３に保持されている容器２５の蓋に接触して該蓋を自動的に開閉するための突起部を備える開閉機構を含む。開閉ユニット２０５は、制御部２４による指示に従って動作する。 The opening/closing unit 205 includes an opening/closing mechanism having projections for automatically opening and closing the lid of the container 25 held by the holding portion 23 by coming into contact with the lid. The opening/closing unit 205 operates according to instructions from the control section 24 .
　光学ユニット２０１は、励起用の光を容器２５中の検体に照射し、それに対して検体から放出される蛍光を検出することによって、該検体に含まれる感染症ウイルス又は遺伝子を解析するものである。光学ユニット２０１は、赤、緑、青の三つの波長に対応する蛍光検出をそれぞれ実施し、その検出結果を制御部２４に出力する。光学ユニット２０１は、発光ダイオード（ＬＥＤ）などの光源、光源から出射した光を検体に照射するとともに検体から発した蛍光を集める光学系、検体から放出される蛍光を検出しデジタルデータとして出力するフォトダイオード（ＰＤ）を含む検出器、などを含む周知の構成を用いることができる。 The optical unit 201 irradiates the specimen in the container 25 with excitation light and detects the fluorescence emitted from the specimen, thereby analyzing infectious disease viruses or genes contained in the specimen. . The optical unit 201 performs fluorescence detection corresponding to three wavelengths of red, green, and blue, respectively, and outputs the detection results to the control unit 24 . The optical unit 201 includes a light source such as a light emitting diode (LED), an optical system that irradiates a sample with light emitted from the light source and collects fluorescence emitted from the sample, and a photo sensor that detects the fluorescence emitted from the sample and outputs it as digital data. Known configurations can be used, including detectors including diodes (PDs), and the like.
　この検査装置２では、例えば検査対象のプール検体は各々プール検体容器５５に収容され、上述したプール検体ラック５２に収納された状態で保持部２３にセットされる。プール検体ラック５２は、４本のプール検体容器５５がＸ軸方向に並ぶようにセットされる。これは個別検体でも同様である。この検査装置２では、４個のプール検体又は個別検体に対して並行して検査が実施され得る。 In this inspection apparatus 2, for example, pool samples to be inspected are stored in pool sample containers 55 and set in the holding unit 23 while stored in the pool sample rack 52 described above. The pool sample rack 52 is set so that four pool sample containers 55 are aligned in the X-axis direction. This also applies to individual specimens. In this testing apparatus 2, tests can be performed on four pool samples or individual samples in parallel.
　図６は、保持部２３に、一つのプール検体又は個別検体を検査するのに必要な部材が装着された状態を示しており、ＰＣＲ容器２５Ａは四つで１セット、試薬容器２５Ｂも四つで１セット、分注チップ２５Ｃは三つで１セットである。四つの試薬容器にはそれぞれ、検体処理液、反応液、プライマー／プローブ液、酵素液が予め収容されている。通常、これらは少なくとも一つの検体の分析に必要な量の試薬が予め封入された状態で１セットで試薬キットとして提供されるものである。 FIG. 6 shows a state in which members necessary for testing one pool sample or individual sample are attached to the holding unit 23, and four PCR containers 25A constitute one set, and four reagent containers 25B are also included. is one set, and three dispensing tips 25C are one set. Each of the four reagent containers contains a sample treatment liquid, a reaction liquid, a primer/probe liquid, and an enzyme liquid in advance. Usually, these are provided as a set of reagent kits in which reagents necessary for analysis of at least one sample are sealed in advance.
　　［プール検査法を実施する際の作業手順］
　本検査システムにおけるプール検査の手順を説明する。図７及び図８は、前処理装置１における検体前処理作業を含むプール検査法による検査の手順を示すフローチャートである。なお、ここでは、四つの個別検体から一つのプール検体を調製する場合を例に挙げて説明する。 [Work procedure when performing the pool inspection method]
A pool inspection procedure in this inspection system will be described. FIGS. 7 and 8 are flow charts showing the procedure of an inspection by the pool inspection method including sample pretreatment work in the pretreatment apparatus 1. FIG. Here, the case of preparing one pool sample from four individual samples will be described as an example.
　まず、検査担当者（以下、「担当者」という）は、プール検査法での検査に必要な以下のものが揃っているか否かを確認する（ステップＳ１）。
　・それぞれ個別検体（被検者から採取された検体）が収容されている個別検体容器５４（最大１６個）。
　・空のプール検体容器５５（最大で４個）。
　・分注チップ５６（最大１６個）。これは個別検体容器５４の数と同数。
　・プール検体ラック５２（１個）。
　・個別検体ラック５１Ａ－５１Ｄ（最大４個）。
　・コンテナ５０（１個）。 First, the person in charge of inspection (hereinafter referred to as "person in charge") confirms whether or not the following items necessary for inspection by the pool inspection method are available (step S1).
• Individual specimen containers 54 (maximum 16) each containing an individual specimen (a specimen taken from a subject).
• Empty pool specimen containers 55 (maximum of 4).
• Dispensing tips 56 (up to 16). This number is the same as the number of individual sample containers 54 .
• Pool sample rack 52 (1 piece).
• Individual sample racks 51A-51D (up to 4).
- Container 50 (1 piece).
　担当者は、前処理装置１の分注チップ保持部１２１に分注チップ５６をセットする（ステップＳ２）。 The person in charge sets the dispensing tip 56 in the dispensing tip holder 121 of the pretreatment device 1 (step S2).
　また、担当者は、空のプール検体容器５５をプール検体ラック５２にセットする（ステップＳ３）。 Also, the person in charge sets an empty pool sample container 55 on the pool sample rack 52 (step S3).
　また、担当者は、個別検体が収容された個別検体容器５４を、それぞれ対応するプールグループ用の個別検体ラック５１Ａ－５１Ｄにセットする（ステップＳ４）。なお、ステップＳ２～Ｓ４の順序は適宜入れ替え可能である。 Also, the person in charge sets the individual sample containers 54 containing the individual samples in the individual sample racks 51A to 51D for the corresponding pool groups (step S4). Note that the order of steps S2 to S4 can be changed as appropriate.
　担当者は、制御・処理装置３０において前処理装置管理ソフトウェアを起動させる。これにより、図１に示した前処理装置管理部３００が能動化される。担当者が操作部３２で所定の操作を行うと、前処理装置管理部３００は、図９に一例を示すような、所定形式の検体情報入力画面６０を表示部３３に表示する。担当者は、この検体情報入力画面６０上で、ステップＳ４においてセットした全ての個別検体についての検体情報を入力する（ステップＳ５）。この入力は担当者が操作部３２からｗ手入力してもよいし、個別検体容器５４に貼付されているバーコードをバーコードリーダー４で読み取ることによって自動的に入力することもできる。 The person in charge activates the pretreatment device management software in the control/processing device 30 . As a result, the pretreatment device management unit 300 shown in FIG. 1 is activated. When the person in charge performs a predetermined operation on the operation unit 32, the pretreatment device management unit 300 displays a sample information input screen 60 in a predetermined format on the display unit 33, an example of which is shown in FIG. The person in charge enters sample information for all the individual samples set in step S4 on this sample information input screen 60 (step S5). This input may be manually input by the person in charge from the operation unit 32, or may be automatically input by reading the barcode attached to the individual sample container 54 with the barcode reader 4. FIG.
　図９に示す例では、検体情報入力画面６０には、左側に検体マップ６１、右側に管理テーブル６２が表示される。
　検体マップ６１は、図３に示したようなコンテナ５０の上面図に対応する模式的な図であり、５個の個別検体ラックと１個のプール検体ラックに対応するオブジェクトが示される。 In the example shown in FIG. 9, the specimen information input screen 60 displays a specimen map 61 on the left side and a management table 62 on the right side.
The sample map 61 is a schematic diagram corresponding to the top view of the container 50 as shown in FIG. 3, showing objects corresponding to five individual sample racks and one pool sample rack.
　管理テーブル６２は、検体マップ６１において縦方向に並ぶ５個の個別検体を含むプールグループにそれぞれ対応する四つのタブを有する。管理テーブル６２の各タブには、そのタブに対応する個別検体ラックの番号Ｐ１～Ｐ４と、その個別検体ラックにセットされる４個（最大で５個）の個別検体容器の番号、例えばＡ１～Ａ５が示されている。また、管理テーブル６２中の各行にはそれぞれ、実施の有無を示すチェックボックスのほか、検体ＩＤ、検体名、被検者名、検体採取日、サンプルコメントなどの検体情報の入力欄が設けられている。これは検体情報の一例であり、一部を省いたり別の項目を追加したりしてもよい。 The management table 62 has four tabs corresponding to pool groups each including five individual samples arranged vertically in the sample map 61 . Each tab of the management table 62 contains individual sample rack numbers P1 to P4 corresponding to the tab, and four (maximum five) individual sample container numbers set in the individual sample rack, for example, A1 to P4. A5 is shown. In addition, each row in the management table 62 is provided with a check box indicating whether or not the test is performed, and input fields for sample information such as sample ID, sample name, subject name, sample collection date, and sample comment. there is This is an example of specimen information, and some may be omitted or other items may be added.
　図９では、管理テーブル６２中のプールＡのタブが開かれており、それに対応して検体マップ６１中のプール検体及び個別検体の位置が明示されている。これにより、担当者は、自分が入力しようとしているプールグループがコンテナ５０内のどの位置にある個別検体ラック内の容器に対応するものであるのかを、視覚的に容易に把握することができる。担当者は、検体情報を入力したいタブを開き、入力したい個別検体の行の実施チェックボックスをクリック操作する。この操作に応じて、前処理装置管理部３００は、そのチェックボックスにチェックマークを入れ、その行の入力欄への入力を可能とする。その状態で、担当者は各入力欄に必要な情報を入力する。そうして担当者は、検査対象である全ての個別検体についての検体情報を入力する。また、プール検体についても、少なくとも検体ＩＤを検体情報として入力する。 In FIG. 9, the pool A tab in the management table 62 is opened, and the positions of the pool specimens and individual specimens in the specimen map 61 are indicated accordingly. As a result, the person in charge can easily visually grasp which position in the container 50 the pool group to be entered corresponds to the container in the individual sample rack. The person in charge opens the tab where the sample information is to be entered, and clicks the check box for the row of the individual sample to be entered. In response to this operation, the pretreatment apparatus management unit 300 puts a check mark in the check box to enable input to the input column of that line. In that state, the person in charge enters necessary information in each entry field. The person in charge then enters specimen information for all individual specimens to be tested. At least the sample ID is input as the sample information for the pooled samples as well.
　上記の入力操作の際には、担当者が、検体マップ６１上で検体情報を入力したい個別検体の位置をクリック操作すると、管理テーブル６２において、その個別検体に対応するチェックボックスにチェックマークが入力されるようにしてもよい。 In the above input operation, when the person in charge clicks the position of the individual sample for which the sample information is to be input on the sample map 61, a check mark is entered in the check box corresponding to the individual sample in the management table 62. may be made.
　また、管理テーブル６２において適宜の行の任意の欄をクリック操作することによって、その行のチェックボックスにチェックマークが入力されるようにしてもよい。 Also, by clicking an arbitrary column in an appropriate row in the management table 62, a check mark may be entered in the check box of that row.
　また、或る一つの個別検体についての検体情報の入力が終了すると、検体マップ６１上でその個別検体に対応する容器の表示の態様が変化するようにしてもよい。 Also, when the sample information input for a certain individual sample is completed, the display mode of the container corresponding to that individual sample may be changed on the sample map 61 .
　また、例えば実施チェックボックスにチェックマークが入っているにも拘わらず検体ＩＤが入力されていない場合、或いは逆に、検体ＩＤが入力されているのに実施チェックボックスにチェックマークが入っていない場合には、担当者の入力誤りの可能性があるので、次の工程に進めない（具体的には、「開始」ボタン６３の操作が受け付けられない）ようにしてもよい。
　このような様々な入力の制約等によって、ユーザーによる入力ミスや作業ミスの発生を回避することができる。 Also, for example, when the sample ID is not entered even though the implementation check box is checked, or conversely, when the sample ID is entered but the implementation check box is not checked. , there is a possibility that the person in charge made an input error, so it is possible to prevent the process from proceeding to the next step (specifically, the operation of the "start" button 63 is not accepted).
Due to such various input restrictions and the like, it is possible to avoid the occurrence of input errors and operation errors by the user.
　また、検体の取違いを防止するために、検体ＩＤは重複することがないように規定されている。そこで、前処理装置管理部３００は、検体ＩＤが入力されたとき、検体情報入力画面６０上で検体ＩＤの重複がないか否かをチェックする。また、前処理装置管理部３００は、データベース管理部３０２を通してデータベース３１に既に登録されている検体情報における検体ＩＤを確認し、入力された検体ＩＤがすでに使用されていていないかどうかをチェックする。そうしたチェックの結果、検体ＩＤが重複していた場合には警告報知を行い、別の検体ＩＤの入力を促す。これにより、個々の検体やその検査結果を管理するために最も重要である検体ＩＤが重複して使用されることを回避することができる。 Also, in order to prevent sample mix-ups, it is stipulated that sample IDs should not be duplicated. Therefore, when a sample ID is input, the pretreatment apparatus management section 300 checks whether or not the sample ID is duplicated on the sample information input screen 60 . Also, the pretreatment device management unit 300 confirms the sample ID in the sample information already registered in the database 31 through the database management unit 302, and checks whether the input sample ID has already been used. As a result of such a check, if the sample ID is duplicated, a warning is issued and the input of another sample ID is prompted. This makes it possible to avoid duplicate use of the sample ID, which is the most important for managing individual samples and their test results.
　なお、担当者が全ての入力操作をやり直したい場合には、「再初期化」ボタン６５をクリック操作すればよい。この操作を受けて前処理装置管理部３００は、その時点で管理テーブル６２に入力されていた情報を全てクリアする。 If the person in charge wants to redo all the input operations, the "Reinitialize" button 65 can be clicked. Upon receiving this operation, the pretreatment apparatus management section 300 clears all the information input to the management table 62 at that time.
　個別検体及びプール検体についての検体情報の入力が全て終了したならば、担当者は、プール検体ラック５２及び４個の個別検体ラック５１Ａ－５１Ｄをそれぞれをコンテナ５０の所定位置にセットする（ステップＳ６）。上述したように、プール検体ラック５２は決まった向きでのみコンテナ５０にセット可能である。また、個別検体ラック５１Ａ－５１Ｄをそれぞれセットすべき個別検体ラック収納部５００の位置は、該ラック５１Ａ－５１Ｄにそれぞれ付与されている色と色標識部５０３のラベルの色とを合わせることで一意に決まる。それにより、担当者は判断に迷うことなく、個別検体ラック５１Ａ－５１Ｄと個別検体ラック収納部５００とを対応付けることができる。 When the input of sample information for all individual samples and pooled samples is completed, the person in charge sets the pooled sample rack 52 and the four individual sample racks 51A to 51D at predetermined positions in the container 50 (step S6). ). As mentioned above, pool sample racks 52 can only be placed in container 50 in one orientation. In addition, the positions of the individual sample rack storage section 500 in which the individual sample racks 51A to 51D are to be set are unique by matching the color assigned to the racks 51A to 51D with the color of the label of the color indicator section 503. to be determined. As a result, the person in charge can associate the individual sample racks 51A to 51D with the individual sample rack storage unit 500 without hesitation.
　また、仮に、担当者が個別検体ラック５１Ａ－５１Ｄを対応しない個別検体ラック収納部５００に装着しようとした場合であっても、上述した位置規制構造のために装着することができない。装着しようとしている個別検体ラック５１Ａ－５１Ｄの向きが逆である場合も同様に、位置規制構造のために装着することができない。結果的に、個別検体ラック５１Ａ－５１Ｄはそれぞれ対応する個別検体ラック収納部５００にしか装着され得ず、その対応は一意に決まる。そのため、ステップＳ５において担当者が入力した検体情報と、実際にコンテナ５０に収納されている個別検体との食い違いが生じることを防止することができる。 Also, even if the person in charge tries to attach the individual sample racks 51A to 51D to the individual sample rack storage unit 500 that does not correspond to them, they cannot be attached due to the position regulation structure described above. Similarly, when the individual sample racks 51A to 51D to be mounted are oriented in the opposite direction, they cannot be mounted due to the position regulating structure. As a result, the individual sample racks 51A to 51D can only be attached to the corresponding individual sample rack storage units 500, and the correspondence is uniquely determined. Therefore, it is possible to prevent discrepancies between the specimen information input by the person in charge in step S5 and the individual specimens actually stored in the container 50 .
　続いて、担当者はコンテナ５０を前処理装置１のコンテナ収納部１２０にセットする（ステップＳ７）。図４に示すように、コンテナ収納部１２０にはその内側面から内方に突出する位置規制片１２０ａが設けられている。一方、コンテナ５０には、位置規制片１２０ａに対応する位置に切欠き２０ａが形成されている。そのため、コンテナ５０についても個別検体ラック５１と同様に、逆向きの装着が物理的に阻止される。これにより、担当者は、コンテナ５０をコンテナ収納部１２０に適切に装着することができる。 Subsequently, the person in charge sets the container 50 in the container storage section 120 of the pretreatment device 1 (step S7). As shown in FIG. 4, the container housing portion 120 is provided with a position regulating piece 120a protruding inward from its inner surface. On the other hand, the container 50 is formed with a notch 20a at a position corresponding to the position regulating piece 120a. Therefore, as with the individual sample rack 51, the reverse mounting of the container 50 is physically prevented. As a result, the person in charge can appropriately mount the container 50 on the container storage section 120 .
　そのあと、担当者は、表示部３３に表示されている検体情報入力画面６０上の「開始」ボタンをクリック操作する。この指示を受けて前処理装置管理部３００は、検体情報入力画面６０の各タブにそれぞれ入力されている検体情報を、データベース管理部３０２を通してデータベース３１に格納する。検体情報は検体ＩＤをキーとする情報であり、検体ＩＤ以外の情報は検体ＩＤに対し関連付けられる補助的な情報である。それ故に、上述したように、検体ＩＤの重複は許容されない。また、プール検体の検体情報とその元である複数の個別検体の検体情報は互いに関連付けて保存される。 After that, the person in charge clicks the "start" button on the sample information input screen 60 displayed on the display unit 33. Upon receiving this instruction, the pretreatment apparatus management section 300 stores the sample information entered in each tab of the sample information input screen 60 in the database 31 through the database management section 302 . The sample information is information whose key is the sample ID, and information other than the sample ID is auxiliary information associated with the sample ID. Therefore, duplicate specimen IDs are not allowed, as described above. Further, the sample information of the pooled sample and the sample information of the plurality of individual samples that are the sources thereof are stored in association with each other.
　併せて、前処理装置管理部３００は、入力された検体情報に基く前処理動作の指令を、前処理装置１の制御部１４に送る。即ち、前処理の実行を指示する（ステップＳ８）。この指令を受けた制御部１４は、分注ユニット１０、移動部１１、１３等をそれぞれ制御することで、プール検体の調製処理を実行する（ステップＳ９）。具体的に、前処理装置１では、次のような処理を実行する。 At the same time, the pretreatment device management unit 300 sends a pretreatment operation command based on the input sample information to the control unit 14 of the pretreatment device 1 . That is, the execution of preprocessing is instructed (step S8). The control unit 14 that has received this command executes pool sample preparation processing by controlling the dispensing unit 10, moving units 11 and 13, and the like (step S9). Specifically, the pretreatment device 1 executes the following processes.
　制御部１４は、まず、シリンジ１００のノズル１０１に１個の分注チップ５６を装着し、個別検体ラック５１Ａに保持されている一番目（図３中では最も下側）の個別検体容器５４中から所定量の個別検体を吸引してＹ軸方向に同じ位置にあるプール検体容器５５へ分注するように、分注ユニット１０、移動部１１、１３をそれぞれ制御する。そのあと、制御部１４は、使用済みの分注チップ５６をチップ廃棄部１２２に廃棄するように、分注ユニット１０、移動部１１、１３をそれぞれ制御する。 First, the control unit 14 attaches one dispensing tip 56 to the nozzle 101 of the syringe 100, and inserts it into the first individual sample container 54 (lowest in FIG. 3) held in the individual sample rack 51A. The dispensing unit 10 and moving parts 11 and 13 are respectively controlled to aspirate a predetermined amount of the individual sample from the pool sample container 55 and dispense it into the pool sample container 55 located at the same position in the Y-axis direction. After that, the control section 14 controls the dispensing unit 10 and the moving sections 11 and 13 to discard the used dispensing tip 56 to the tip discarding section 122 .
　次いで、制御部１４は、シリンジ１００のノズル１０１に新しい分注チップ５６を装着し、個別検体ラック５１Ａに保持されている二番目の個別検体容器５４中から所定量の個別検体を吸引して先のプール検体容器５５へ分注するように、分注ユニット１０、移動部１１、１３をそれぞれ制御する。そのあと、使用済みの分注チップ５６をチップ廃棄部１２２に廃棄する。 Next, the control unit 14 attaches a new dispensing tip 56 to the nozzle 101 of the syringe 100, aspirates a predetermined amount of the individual sample from the second individual sample container 54 held in the individual sample rack 51A, and The dispensing unit 10 and the moving parts 11 and 13 are respectively controlled so as to dispense into the pool sample container 55 of . After that, the used dispensing tip 56 is disposed of in the tip disposal section 122 .
　同様の動作を、個別検体ラック５１Ａに保持されている三番目、四番目の個別検体容器５４についても実施することで、４個の個別検体を１個のプール検体容器５５に分注する。そのあと、制御部１４は、最後に使用した分注チップ５６がノズル１０１に装着されている状態で、シリンジ１００を上下に所定回数往復動させることによって分注された検体を撹拌するように、分注ユニット１０及び移動部１１、１３を制御する。
　こうして、１個の個別検体ラック５１Ａに保持されている４個の個別検体容器５４中の検体を混合したプール検体が調製される。 A similar operation is performed for the third and fourth individual sample containers 54 held in the individual sample rack 51A, thereby dispensing four individual samples into one pool sample container 55. FIG. Thereafter, the control unit 14 reciprocates the syringe 100 up and down a predetermined number of times while the last used dispensing tip 56 is attached to the nozzle 101 so as to stir the dispensed sample. It controls the dispensing unit 10 and moving parts 11 and 13 .
In this way, a pool sample is prepared by mixing the samples in the four individual sample containers 54 held in one individual sample rack 51A.
　次に、同様にして、個別検体ラック５１Ａの隣にある個別検体ラック５１Ｂに保持されている４個の個別検体容器５４中の検体を混合したプール検体が、プール検体ラック５２中の左から二番目のプール検体容器５５に調製される。個別検体ラック５１Ｃ、５１Ｄについても全く同様である。一個の個別検体の吸引には一個の分注チップ５６が使用されるため、４個のプール検体の調製がなされることで、用意された全ての分注チップ５６が使用される。 Next, in the same way, the pooled sample obtained by mixing the samples in the four individual sample containers 54 held in the individual sample rack 51B adjacent to the individual sample rack 51A is placed in the pooled sample rack 52 from the left. 1st pool sample container 55 is prepared. The same is true for the individual sample racks 51C and 51D. Since one dispensing tip 56 is used to aspirate one individual sample, all prepared dispensing tips 56 are used by preparing four pooled samples.
　前処理装置１において全ての処理が終了すると、制御部１４からの通知を受けた前処理装置管理部３００は、前処理が終了した旨を表示部３３に表示する。また、前処理装置１では、ブザーなどの警告音によって担当者の注意を喚起し得る。こうした報知を受けて担当者は、コンテナ５０を前処理装置１から取り出す（ステップＳ１０）。 When all the processes in the preprocessing device 1 are completed, the preprocessing device management section 300 receiving the notification from the control section 14 displays on the display section 33 that the preprocessing has been completed. Moreover, the pretreatment device 1 can call the attention of the person in charge with a warning sound such as a buzzer. Upon receiving such notification, the person in charge takes out the container 50 from the pretreatment apparatus 1 (step S10).
　担当者は、取り出したコンテナ５０からプール検体ラック５２を取り出す。取り出されたプール検体ラック５２には、それぞれプール検体が収容されたプール検体容器５５が保持されている。担当者は、プール検体ラック５２を検査装置２まで搬送し、検査装置２の保持部２３にそのままセットする（ステップＳ１１）。このようにして、前処理装置１において調製されたプール検体がそれぞれ収容されている４個のプール検体容器５５を、プール検体ラック５２から出すことなく検査装置２にセットすることができる。これにより、複数のプール検体を検査装置２にセットする過程でのプール検体の取り違いも回避することができる。 The person in charge takes out the pool sample rack 52 from the taken out container 50 . Pool sample containers 55 containing pool samples are held in the pool sample racks 52 that have been taken out. The person in charge transports the pool sample rack 52 to the inspection device 2 and sets it in the holding section 23 of the inspection device 2 as it is (step S11). In this way, the four pool sample containers 55 each containing a pool sample prepared in the pretreatment device 1 can be set in the testing device 2 without being removed from the pool sample rack 52 . As a result, it is possible to avoid mixing up pooled samples in the process of setting a plurality of pooled samples in the testing device 2 .
　上記ステップＳ１１においてコンテナ５０からプール検体ラック５２が取り出されたあと、担当者は、個別検体ラック５１Ａ－５１Ｄが収納されたままのコンテナ５０を冷蔵庫等の保管設備に一時保管する。原則として、そのコンテナ５０に収容された検体の検査結果が出るまでは、コンテナ５０からの個別検体ラック５１Ａ－５１Ｄの取り出しは行わないものとする。 After the pool sample rack 52 is removed from the container 50 in step S11, the person in charge temporarily stores the container 50 with the individual sample racks 51A to 51D in storage equipment such as a refrigerator. In principle, the individual sample racks 51A to 51D are not taken out from the container 50 until the test results of the samples stored in the container 50 are obtained.
　そのあと、担当者は、制御・処理装置３０において所定の検査装置管理ソフトウェアを起動させる（ステップＳ１２）。これにより、図１に示した検査装置管理部３０１が能動化される。担当者が操作部３２で所定の操作を行うと、検査装置管理部３０１は、図１０に一例を示すような、ＰＣＲ検査画面７０を表示部３３に表示する。このＰＣＲ検査画面７０の右側には、４個の検体（今の例ではプール検体）をタブ切替えによって選択可能な検査結果表示領域７１が配置されており、左側には「検体情報入力」ボタン７４が配置されている。 After that, the person in charge activates predetermined inspection device management software in the control/processing device 30 (step S12). As a result, the inspection apparatus management unit 301 shown in FIG. 1 is activated. When the person in charge performs a predetermined operation on the operation unit 32, the inspection apparatus management unit 301 displays a PCR inspection screen 70 on the display unit 33, an example of which is shown in FIG. On the right side of this PCR test screen 70, there is arranged a test result display area 71 in which four samples (pool samples in this example) can be selected by tab switching, and on the left side is a "specimen information input" button 74. are placed.
　続いて、次のようにして担当者は、検査対象であるプール検体に関する検体情報を入力する（ステップＳ１３）。
　プール検査を行う場合、担当者はＰＣＲ検査画面７０上の「検体情報入力」ボタン７４をクリック操作する。検査装置管理部３０１はこの操作を受けて、図１１に一例を示すような検体情報入力画面８０を、ＰＣＲ検査画面７０の上に重ねて又は並べて表示する。 Subsequently, the person in charge inputs specimen information regarding the pooled specimen to be inspected as follows (step S13).
When the pool test is to be performed, the person in charge clicks the "specimen information input" button 74 on the PCR test screen 70 . In response to this operation, the testing device management unit 301 displays a specimen information input screen 80 such as an example shown in FIG.
　なお、図１に示した例のように、制御・処理装置３０に稼働可能である状態の複数の検査装置２が接続されている場合には、検体情報入力画面８０に先立って装置の選択画面が表示され、担当者はその画面上でコンボボックスから、検査に使用する装置を一つだけ選択する。そのあと、その装置選択画面上に配置されている「次へ」ボタンをクリック操作すると、検体情報入力画面８０へと移行する。  Note that, as in the example shown in FIG. 1, when a plurality of inspection apparatuses 2 in an operable state are connected to the control/processing apparatus 30, the apparatus selection screen is displayed prior to the sample information input screen 80. is displayed, and the person in charge selects only one device to be used for inspection from the combo box on the screen. After that, when the "next" button arranged on the device selection screen is clicked, the sample information input screen 80 is displayed. 
　この検体情報入力画面８０は、検査装置２における検査対象の検体の情報を入力するための画面である。図１１に示すように、検体情報入力画面８０には、上側に、検査全般に関する情報を入力するための検査情報入力領域８１が配置され、下側に検査対象である４個の検体についての検体情報が一覧となっている検体情報テーブル８２が配置されている。前処理装置１を使用せずに（つまりはプール検査法ではない個別検査で）個別検体を検査する際には、この検体情報テーブル８２に各検体についての検体情報を一つ一つ入力する必要がある。 This sample information input screen 80 is a screen for inputting information on a sample to be inspected in the inspection device 2 . As shown in FIG. 11, on the sample information input screen 80, a test information input area 81 for inputting information about the test in general is arranged on the upper side, and a sample information input area 81 for four samples to be tested is arranged on the lower side. A sample information table 82 listing information is arranged. When inspecting individual samples without using the pretreatment device 1 (that is, in an individual test that is not a pool test method), it is necessary to input the sample information for each sample into the sample information table 82 one by one. There is
　これに対し、プール検査法では、前処理の際に入力しデータベース３１に保存されている検体情報を利用して、検査装置２における検査対象の検体情報の入力作業を簡略化することができる。即ち、担当者は、検体情報テーブル８２において検体情報を入力したい行（つまりは検体１～検体４のいずれかに対応する行）の検体ＩＤ欄にカーソルを移動し、マウス等による右クリック操作を行う。この操作に応じて検査装置管理部３０１は、作業メニューをドロップダウンメニューとして表示する。担当者はそのメニューの中で「前処理装置管理ソフトウェアで登録した検体情報から選択する」の作業項目を選択して指示する。すると、検査装置管理部３０１は、図１２に一例を示すような検体選択画面９０を、検体情報入力画面８０の上に重ねて又は横に並べて表示する。 On the other hand, in the pool test method, the sample information input during preprocessing and stored in the database 31 can be used to simplify the work of inputting the sample information to be inspected in the inspection device 2 . That is, the person in charge moves the cursor to the sample ID column of the row (that is, the row corresponding to one of the samples 1 to 4) in which the sample information is to be input in the sample information table 82, and right-clicks with a mouse or the like. conduct. In response to this operation, the inspection apparatus management unit 301 displays the work menu as a dropdown menu. The person in charge selects and instructs the work item "select from specimen information registered with pretreatment apparatus management software" from the menu. Then, the testing apparatus management unit 301 displays a specimen selection screen 90 such as one example shown in FIG.
　この検体選択画面９０は、検体情報テーブル８２上で指定された行に差し込むべき検体を選択するための画面である。図１２に示すように、検体選択画面９０には、下側に、データベース３１に格納されている検体の一覧を示す管理検体一覧テーブル９１が配置され、上側に、管理検体一覧テーブル９１に表示する内容（検体の種類）を絞るための絞り込み条件を示す絞り込み条件選択領域９２が配置されている。 This sample selection screen 90 is a screen for selecting a sample to be inserted into a row specified on the sample information table 82 . As shown in FIG. 12, on the sample selection screen 90, a managed sample list table 91 showing a list of samples stored in the database 31 is arranged on the lower side, and the managed sample list table 91 is displayed on the upper side. A narrowing condition selection area 92 is arranged to indicate narrowing conditions for narrowing down the contents (specimen types).
　図示した例では条件による絞り込みはなされていないが、絞り込み条件選択領域９２に示されている絞り込み条件の一つにチェックマークが付されると、検査装置管理部３０１は、データベース管理部３０２を通してデータベース３１から取得した検体情報を、その条件に応じて絞り込んで管理検体一覧テーブル９１に掲載する。これにより、例えばプール検体のみの検体情報や未検査である検体の検体情報のみを確認することができる。なお、図１２では、図が煩雑になるのを避けるため管理検体一覧テーブル９１の各欄が空欄であるが、実際には、すでにデータベース３１に登録されている様々な情報が各欄に表示される。 In the illustrated example, narrowing down by conditions is not performed. The sample information acquired from 31 is narrowed down according to the conditions and listed in the managed sample list table 91 . As a result, for example, it is possible to confirm only the sample information of pooled samples or only the sample information of untested samples. In FIG. 12, each column of the management specimen list table 91 is blank to avoid complication of the drawing, but in reality, various information already registered in the database 31 is displayed in each column. be.
　管理検体一覧テーブル９１における１行は一つの検体（個別検体又はプール検体）に対応する。この場合、検体情報入力画面８０の検体情報テーブル８２における一つの行は一つのプール検体であるから、担当者は、管理検体一覧テーブル９１に表示されている検体情報を参照してプール検体である一つの行を選択する。検査装置管理部３０１は、この操作を受けて選択されたプール検体についての検体情報を、検体情報テーブル８２の指定された行の各欄に自動的に差し込む処理を行う。担当者は、検体情報入力画面８０の検体情報テーブル８２における四つの検体にそれぞれ対応する行に、それぞれ該当するプール検体の検体情報を差し込む処理を行う。即ち、前処理装置１での前処理の際にデータベース３１に登録した検体情報を、そのまま検査装置２における検査の際にも利用することで、再度の面倒な入力作業を簡略化することができる。 　One row in the managed sample list table 91 corresponds to one sample (individual sample or pool sample). In this case, one row in the sample information table 82 of the sample information input screen 80 is one pool sample. Select one row. The inspection apparatus management unit 301 automatically inserts the sample information about the pool sample selected by receiving this operation into each column of the specified row of the sample information table 82 . The person in charge performs a process of inserting the sample information of the corresponding pool sample into the row corresponding to each of the four samples in the sample information table 82 of the sample information input screen 80 . That is, by using the specimen information registered in the database 31 during the pretreatment by the pretreatment apparatus 1 as it is during the examination by the examination apparatus 2, it is possible to simplify the troublesome re-input work. .
　また、前処理装置１において調製したプール検体をバーコードで管理する場合には、バーコードを利用して再度の面倒な入力作業を簡略化することができる。即ち、図１１に示すような検体情報入力画面８０が表示された状態で、担当者は、検体情報テーブル８２において検体情報を入力したい行の検体ＩＤ欄にカーソルを移動し、その検体ＩＤ欄を選択指示する。その状態で、担当者は、バーコードリーダー４を用い、プール検体容器５５に貼付されているバーコードを読み取らせる。或いは、担当者が、バーコードに記載されている数字を手入力する。この入力操作を受けて検査装置管理部３０１は、データベース管理部３０２により、入力されたバーコードで示される検体ＩＤに対応する検体情報をデータベース３１において検索する。そして、該当する検体ＩＤがヒットすると、それに対応する検体情報をデータベース３１から読み出し、検体情報テーブル８２の各欄に差し込む。なお、検索の結果、該当する検体情報がデータベース３１に存在しなければ、検体の取違い、検体情報の入力ミス等が想定されるため、警告を報知して担当者の注意を喚起する。 In addition, when managing the pool samples prepared in the pretreatment device 1 with barcodes, the barcode can be used to simplify the troublesome re-input work. That is, with the sample information input screen 80 as shown in FIG. Select and instruct. In this state, the person in charge uses the barcode reader 4 to read the barcode attached to the pool sample container 55 . Alternatively, the person in charge manually inputs the numbers described in the bar code. In response to this input operation, the inspection apparatus management unit 301 causes the database management unit 302 to search the database 31 for sample information corresponding to the sample ID indicated by the input barcode. When the corresponding sample ID is hit, the corresponding sample information is read out from the database 31 and inserted into each column of the sample information table 82 . As a result of the search, if the relevant specimen information does not exist in the database 31, it is assumed that the specimen is mixed up, that the specimen information is input incorrectly, or the like.
　上述したいずれかの方法によって、担当者による面倒な入力作業を簡略化しながら、検査装置２での検査対象であるプール検体についての検体情報を確実に且つ間違いなく入力することができる。入力が終了したならば、担当者は、検体情報入力画面８０上の「検査開始」ボタン８３をクリック操作することで検査開始を指示する。検査装置管理部３０１は、設定された検体情報に基く検査動作の指令を、指定された検査装置２の制御部２４に送る。即ち、検査装置２に対し検査の実行を指示する（ステップＳ１４）。 By any of the above-described methods, it is possible to input the sample information of the pool sample to be inspected by the inspection device 2 reliably and without error while simplifying the troublesome input work by the person in charge. After completing the input, the person in charge clicks the “start inspection” button 83 on the sample information input screen 80 to instruct the start of inspection. The inspection device management unit 301 sends an inspection operation command based on the set specimen information to the control unit 24 of the designated inspection device 2 . That is, the inspection device 2 is instructed to perform the inspection (step S14).
　指令を受けた制御部２４は、光学ユニット２０１、分注ユニット２０２、開閉ユニット２０５、移動部２１、２２、温調保持部２３１等をそれぞれ制御することで、最大４個のプール検体に対するＰＣＲ検査を実行する（ステップＳ１５）。具体的に、検査装置２では、次のような処理を実行する。なお、検査に先立って、担当者は、ＰＣＲ容器２５Ａ、試薬容器２５Ｂ、分注チップ２５Ｃをそれぞれ保持部２３の所定位置にセットしておく。 Upon receipt of the command, the control unit 24 controls the optical unit 201, the dispensing unit 202, the opening/closing unit 205, the moving units 21 and 22, the temperature control/holding unit 231, etc., thereby performing PCR tests on up to four pool samples. is executed (step S15). Specifically, the inspection device 2 performs the following processing. Prior to the inspection, the person in charge sets the PCR container 25A, the reagent container 25B, and the dispensing tip 25C at predetermined positions on the holding unit 23, respectively.
　制御部２４は、まず、シリンジ２０３のノズル２０４に１個の分注チップ（ロングチップ）２５Ｃを装着し、プール検体容器５５中から所定量ａのプール検体を吸引してＰＣＲ容器２５Ａの一つへ分注するように、分注ユニット２０２、移動部２１、２２をそれぞれ制御する。そのあと、制御部２４は、使用済みの分注チップ２５Ｃをチップ廃棄部（図示せず）に廃棄するように、分注ユニット２０２、移動部２１、２２をそれぞれ制御する。 First, the controller 24 attaches one dispensing tip (long tip) 25C to the nozzle 204 of the syringe 203, aspirates a predetermined amount a of the pool specimen from the pool specimen container 55, and The dispensing unit 202 and the moving parts 21 and 22 are respectively controlled so as to dispense to . After that, the control section 24 controls the dispensing unit 202 and the moving sections 21 and 22 so as to discard the used dispensing tip 25C to a tip discarding section (not shown).
　次いで、制御部２４は、シリンジ２０３のノズル２０４に１個の分注チップ（ショートチップ）２５Ｃを装着し、先のＰＣＲ容器２５Ａから所定量ｂ（＜ａ）のプール検体を吸引して別のＰＣＲ容器２５Ａへ分注するように、分注ユニット２０２、移動部２１、２２をそれぞれ制御する。そのあと、制御部２４は、使用済みの分注チップ２５Ｃをチップ廃棄部に廃棄するように、分注ユニット２０２、移動部２１、２２をそれぞれ制御する。なお、ロングチップを用いてプール検体を所定量ａ採取して一つのＰＣＲ容器２５Ａに一時的に分注したあと、ショートチップを用いてプール検体を所定量ｂ採取して別のＰＣＲ容器２５Ａに分注するのは、所定量ｂを正確に分注するためである。従って、こうした手順は必須ではない。 Next, the control unit 24 attaches one dispensing tip (short tip) 25C to the nozzle 204 of the syringe 203, aspirates a predetermined amount b (<a) of the pool sample from the previous PCR container 25A, and The dispensing unit 202 and moving parts 21 and 22 are controlled to dispense into the PCR container 25A. After that, the control section 24 controls the dispensing unit 202 and the moving sections 21 and 22 respectively so as to discard the used dispensing tip 25C to the tip discarding section. After a predetermined amount a of the pool sample is collected using the long tip and temporarily dispensed into one PCR container 25A, a predetermined amount b of the pool sample is collected using the short tip and transferred to another PCR container 25A. The purpose of dispensing is to accurately dispense the predetermined amount b. Therefore, such procedures are not mandatory.
　次に、プール検体を採取したＰＣＲ容器２５Ａに、試薬容器に収容されている検体処理液を所定量添加する処理を行う。引き続いて、検体処理液が添加されたＰＣＲ容器２５Ａを加熱及び急冷する処理を実施する。具体的には、例えば、制御部２４はそのＰＣＲ容器２５Ａを加熱して検体温度を９０℃に５分間維持し、そのあと、そのＰＣＲ容器２５Ａを急冷して検体温度を２０℃（常温）に戻すように温調保持部２３１の温調部を制御する。続いて、そのＰＣＲ容器２５Ａに反応液、プライマー／プローブ液、試薬混合液を順にそれぞれ所定量添加する処理を行う。 Next, a process of adding a predetermined amount of the sample treatment liquid contained in the reagent container to the PCR container 25A in which the pool sample was collected is performed. Subsequently, a process of heating and quenching the PCR container 25A to which the specimen treatment liquid has been added is performed. Specifically, for example, the control unit 24 heats the PCR container 25A to maintain the sample temperature at 90° C. for 5 minutes, and then rapidly cools the PCR container 25A to reduce the sample temperature to 20° C. (normal temperature). The temperature control part of the temperature control holding part 231 is controlled so as to return. Subsequently, a process of sequentially adding predetermined amounts of the reaction solution, the primer/probe solution, and the reagent mixed solution to the PCR container 25A is performed.
　次に、制御部２４は、ＰＣＲ容器２５Ａに対し所定のサーマルサイクル処理を行い、さらに遺伝子を増幅させる増幅処理を繰り返し行うように、温調部を制御する。１サイクルの増幅処理が終了する度に、制御部２４は、ＰＣＲ容器２５Ａ内の液温度を６０℃に維持した状態で、３波長蛍光検出を実行するように、光学ユニット２０１等を制御する。なお、開閉ユニット２０５は、上記のような試薬を採取する際に、試薬容器２５Ｂなどの蓋の開閉を実行する。 Next, the control unit 24 performs a predetermined thermal cycle process on the PCR container 25A, and further controls the temperature control unit so that the amplification process for amplifying the gene is repeatedly performed. Every time one cycle of amplification processing is completed, the control unit 24 controls the optical unit 201 and the like so as to perform three-wavelength fluorescence detection while maintaining the liquid temperature in the PCR container 25A at 60°C. The opening/closing unit 205 opens and closes the lid of the reagent container 25B and the like when collecting the reagent as described above.
　増幅処理の繰り返しの過程で実施される３波長蛍光検出で得られたデータは、制御部２４において処理される。その処理結果が制御・処理装置３０に送られ、検査装置管理部３０１はその検査結果を表示部３３の画面上に表示する。その検査結果は、図１３（Ｂ）に一例を示すように、ＰＣＲ検査画面７０内の検査結果表示領域７１中に増幅曲線グラフ７２及びＣｔ値テーブル７３として示される。なお、検査結果のデータは、検体情報入力画面８０上の検査情報入力領域８１に含まれるファイル保存先として指定されたファイルに格納され、データベース３１又は制御・処理装置３０内の他の記憶装置に保存される。 The data obtained by the three-wavelength fluorescence detection performed in the process of repeating the amplification process is processed in the control unit 24. The processing result is sent to the control/processing device 30 , and the inspection device management section 301 displays the inspection result on the screen of the display section 33 . The test results are displayed as an amplification curve graph 72 and a Ct value table 73 in a test result display area 71 in a PCR test screen 70, as shown in FIG. 13(B). The test result data is stored in a file specified as a file storage destination included in the test information input area 81 on the sample information input screen 80, and stored in the database 31 or another storage device in the control/processing device 30. Saved.
　検査が終了すると、医師は上記のような表示部３３の画面上で検査結果を確認する（ステップＳ１６）。４個のプール検体に対しそれぞれ検査結果が得られる。そして、ウイルス感染の陽性であると判定され得るプール検体がない（ステップＳ１７においてＮｏである）場合には、個別検体についての再検査は不要であるので一連の作業を終了する。一方、ウイルス感染の陽性であると判定され得るプール検体がある場合には、ステップＳ１７からＳ１８へ進む。 When the examination is completed, the doctor confirms the examination results on the screen of the display unit 33 as described above (step S16). Test results are obtained for each of the four pooled specimens. Then, if there is no pooled specimen that can be determined to be positive for virus infection (No in step S17), retesting of individual specimens is unnecessary, and the series of operations is terminated. On the other hand, if there is a pool sample that can be determined to be positive for virus infection, the process proceeds from step S17 to step S18.
　陽性のプール検体がある場合、そのプール検体の調製元である複数の個別検体のうちの少なくとも一つが陽性である可能性が高い。そのため、例えば医師から指示を受けた担当者が、それら複数の個別検体についての再検査を実施する。その際には、検査装置２での検査対象は個別検体であるから、本来は、個別検体の検体情報を改めて入力する必要がある。それに対し、この検査システムでは、次のようにしてプール検体に対応する複数の個別検体の検体情報が自動的に入力される（ステップＳ１９）。 If there is a positive pooled specimen, it is highly likely that at least one of the multiple individual specimens from which the pooled specimen was prepared is positive. Therefore, for example, a person in charge who receives an instruction from a doctor reexamines the plurality of individual samples. In this case, since the object to be inspected by the inspection apparatus 2 is an individual sample, originally, it is necessary to input the sample information of the individual sample again. On the other hand, in this inspection system, specimen information of a plurality of individual specimens corresponding to pooled specimens is automatically input as follows (step S19).
　具体的には、担当者は、図１３（Ａ）に示すような、検査中及び検査終了後に表示されるＰＣＲ検査画面７０の検査結果表示領域７１において、陽性である検体（この例では検体１）のタブを開き、増幅曲線グラフ７２の領域内で右クリック操作を行う。或いは、過去の検査結果を確認するために任意のデータファイルを指定することで図１３（Ｂ）に示すような結果確認画面７１Ａを表示させ、担当者は、その画面７１Ａ内の増幅曲線グラフ７２上で右クリック操作を行う。すると、これらの操作に応じて検査装置管理部３０１は、作業メニューをドロップダウンメニューとして表示する。担当者はその中で「このプール検体に含まれる個別検体の検査を行う」の作業項目を選択する。なお、このドロップダウンメニューは、プール検査法の場合にのみ表示される。 Specifically, the person in charge displays a positive specimen (in this example, specimen 1 ) and right-click within the area of the amplification curve graph 72 . Alternatively, a result confirmation screen 71A as shown in FIG. 13B is displayed by designating an arbitrary data file to confirm the past test results, and the person in charge can check the amplification curve graph 72 in the screen 71A. Right click on it. Then, according to these operations, the inspection apparatus management unit 301 displays the work menu as a drop-down menu. Among them, the person in charge selects the work item of "Inspect individual samples contained in this pool sample". Note that this drop-down menu is displayed only for pooled assays.
　検査装置管理部３０１は、図１４に一例を示すような検体情報入力画面８０を表示部３３に表示する。また、検査装置管理部３０１は、データベース管理部３０２を通して、指示されたプール検体に関連付けられている複数の個別検体、つまりはそのプール検体の調製元である個別検体についての検体情報をデータベース３１から取得する。そして、その検体情報を検体情報テーブル８２の各欄に差し込む。つまり、番号がＰ１であるプール検体が陽性である場合には、図１４中に示すように、検体情報入力画面８０に重ねて表示される検体マップ６１中に点線で示す４個の個別検体についての検体情報が、自動的に検体情報テーブル８２の各欄に差し込まれる。これにより、再検査の対象である個別検体の検体情報の入力作業が簡略化される。また、担当者が誤った検体情報を入力することも回避することができる。なお、図１４中に示す検体マップ６１は、検体情報入力画面８０内に表示してもよいし或いは表示しなくてもよい。 The inspection apparatus management unit 301 displays a sample information input screen 80, an example of which is shown in FIG. 14, on the display unit 33. In addition, the testing apparatus management unit 301 acquires sample information about a plurality of individual samples associated with the designated pool sample, that is, the individual samples from which the pool samples are prepared, from the database 31 through the database management unit 302. get. Then, the sample information is inserted into each column of the sample information table 82 . In other words, when the pool sample with number P1 is positive, four individual samples indicated by dotted lines in the sample map 61 superimposed on the sample information input screen 80 are is automatically inserted into each column of the sample information table 82. This simplifies the work of inputting specimen information of individual specimens to be retested. In addition, it is possible to avoid inputting incorrect sample information by the person in charge. Note that the sample map 61 shown in FIG. 14 may or may not be displayed in the sample information input screen 80 .
　上述したように個別検体の検体情報の入力作業を終えたならば、担当者は、冷蔵庫からコンテナ５０を取り出し、陽性と判定されたプール検体に対応付けられている個別検体ラック５１Ａ－５１Ｄをコンテナ５０から取り出す。プール検体ラック５２において、陽性であったプール検体が収容されていたプール検体容器５５の容器保持部５２０の色は判明しているので、担当者は、それと同じ色が付与されている個別検体ラック５１Ａ－５１Ｄを取り出せばよい。これにより、検査結果が陽性ではないプール検体に対応する個別検体ラック５１Ａ－５１Ｄを担当者が取り出してしまうミスを低減することができる。 After completing the sample information input work for the individual samples as described above, the person in charge removes the container 50 from the refrigerator, and removes the individual sample racks 51A to 51D associated with the positively determined pool samples from the container. Take out from 50. In the pool sample rack 52, the color of the container holding portion 520 of the pool sample container 55 in which the positive pool sample was stored is known. 51A-51D should be taken out. As a result, it is possible to reduce the mistake of the person in charge taking out the individual sample racks 51A to 51D corresponding to pooled samples whose test results are not positive.
　担当者は、コンテナ５０から取り出した個別検体ラック５１にアダプターとしてのハンドルを装着し、ハンドルを把持して検査装置２まで搬送し該装置２にセットする（ステップＳ２０）。個別検体ラック５１を検査装置２にセットしたあとは、ステップＳ１３～Ｓ１６で述べたプール検体に対する検査及びその検査結果の確認と同様の手順で、個別検体ラック５１に保持されている４個の個別検体容器５４中の個別検体に対する検査をそれぞれ実行する（ステップＳ２１）。そして、医師が各個別検体に対する検査結果をそれぞれ確認する（ステップＳ２２）。それによって、いずれの個別検体が陽性であるのかを特定することができる。 The person in charge attaches a handle as an adapter to the individual sample rack 51 taken out of the container 50, grasps the handle, transports it to the inspection device 2, and sets it in the device 2 (step S20). After the individual sample rack 51 is set in the inspection apparatus 2, the four individual samples held in the individual sample rack 51 are inspected in the same manner as the inspection of the pooled samples and confirmation of the inspection results described in steps S13 to S16. Each individual sample in the sample container 54 is tested (step S21). Then, the doctor confirms the test results for each individual sample (step S22). Thereby, it is possible to identify which individual specimens are positive.
　以上のように、本実施形態の検査システムによれば、検査担当者が関わる様々な作業を簡略化、省力化するとともに、作業上のミスやミスとまでは言えない注意不足等に起因する検体の取違いなどを防止し、信頼性の高いプール検査を行うことができる。 As described above, according to the inspection system of the present embodiment, various operations involving inspection personnel are simplified and labor-saving. A highly reliable pool inspection can be performed by preventing misunderstandings and the like.
　なお、上記実施形態は本発明の一例にすぎず、本発明の趣旨の範囲で適宜変形、追加、修正を行っても本願特許請求の範囲に包含されることは当然である。 It should be noted that the above-described embodiment is merely an example of the present invention, and it is a matter of course that any modification, addition, or modification within the spirit of the present invention will be included in the scope of the claims of the present application.
　例えば、上述した前処理装置１や検査装置２の具体的な構成は単に一例にすぎず、各装置１、２の構成を適宜に変更可能であることは当然である。 For example, the specific configurations of the pretreatment device 1 and the inspection device 2 described above are merely examples, and it goes without saying that the configurations of the respective devices 1 and 2 can be changed as appropriate.
　また、検体情報を入力するため又は検査結果を確認するための画面などにおける、各要素の配置や形状を含む表示の態様は、単に一例であり、適宜に変更することができることは当然である。また、そうした画面上での操作の手順や具体的な操作の内容も単に一例であって、適宜に変更することができることは当然である。 In addition, the display mode including the layout and shape of each element on the screen for entering sample information or checking test results is merely an example, and it is natural that it can be changed as appropriate. In addition, the procedure of operation on such a screen and the specific contents of operation are merely examples, and it is a matter of course that they can be changed as appropriate.
　　［種々の態様］
　上述した例示的な実施形態は、以下の態様の具体例であることが当業者により理解される。 [Various aspects]
It will be appreciated by those skilled in the art that the exemplary embodiments described above are specific examples of the following aspects.
　（第１項）本発明に係る検査方法の一態様は、複数の個別検体を混合してプール検体を調製する前処理装置と、プール検体又は個別検体を分析する検査装置と、前記前処理装置及び前記検査装置とそれぞれ通信可能である管理用端末と、前記管理用端末からアクセス可能であるデータベースと、表示部と、を備える検査システム、を用いた検体プール検査法による検査方法であって、
　前記前処理装置におけるプール検体の調製前に、前記管理用端末に搭載されている前処理装置管理用のソフトウェアにおいて、ユーザーの操作による個別検体及びプール検体に関する検体情報の入力を受け付ける検体情報入力工程と、
　前記検体情報入力工程で受け付けられた検体情報を前記データベースに保存する情報保存工程と、
　前記検査装置での一又は複数のプール検体に対する分析の結果を前記表示部に表示するプール検査結果表示工程と、
　前記プール検体の少なくとも一つが陽性であった場合に、前記管理用端末に搭載されている検査装置管理用のソフトウェアにおいて、特定のプール検体の指定又は選択を受け付ける検体指定工程と、
　前記検体指定工程で指定又は選択されたプール検体に関連付けられている複数の個別検体の検体情報を前記データベースから取得し、その取得した検体情報を、前記検査装置における検査対象の検体の検体情報を設定するための検体情報入力画面の所定位置に差し込んで前記表示部に表示する検体情報入力工程と、
　を有する。 (Section 1) One aspect of the testing method according to the present invention includes a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample, a testing device that analyzes the pooled sample or the individual samples, and the pretreatment device. and a management terminal that can communicate with the testing device, a database that can be accessed from the management terminal, and a display unit.
A sample information input step of accepting input of sample information related to individual samples and pooled samples by a user's operation in the pretreatment device management software installed in the management terminal before pool sample preparation in the pretreatment device. and,
an information storage step of storing the sample information received in the sample information input step in the database;
a pool test result display step of displaying the analysis results of one or more pool samples in the test device on the display unit;
a specimen designation step of accepting designation or selection of a specific pool specimen in software for testing device management installed in the management terminal when at least one of the pool specimens is positive;
acquiring sample information of a plurality of individual samples associated with the pool sample specified or selected in the sample specifying step from the database, and using the acquired sample information as the sample information of the sample to be inspected in the inspection apparatus; a sample information input step of inserting into a predetermined position of a sample information input screen for setting and displaying it on the display unit;
have
　第１項に記載の検査方法における検査の種類は特に限定されないが、一例として、ウイルス感染症の感染の有無の検査である。その場合、個別検体は被検者から採取された唾液、鼻咽腔拭い液、血液、尿などの生体試料由来の検体である。 The type of inspection in the inspection method described in paragraph 1 is not particularly limited, but one example is an inspection for the presence or absence of infection with a viral infection. In that case, an individual sample is a sample derived from a biological sample such as saliva, nasopharyngeal swab, blood, or urine collected from a subject.
　第１項に記載の検査方法において、管理用端末はパーソナルコンピューターを含むコンピューターである。前処理装置管理用のソフトウェア及び検査装置管理用のソフトウェアは、コンピューターに予めインストールされたそれぞれ異なるアプリケーションソフトウェア（コンピュータープログラム）である。 　In the inspection method described in paragraph 1, the management terminal is a computer including a personal computer. The software for managing the pretreatment device and the software for managing the inspection device are different application software (computer programs) pre-installed in the computer.
　また、データベースは管理用端末に内蔵されていても管理用端末とは別体であってもよい。つまり、コンピューターに内蔵されたハードディスドライブやソリッドステートドライブなどの記憶装置に上記データベースが構築されるようにしてもよいし、或いは、コンピューターとは別の記憶装置に上記データベースが構築されるようにしてもよい。 In addition, the database may be built into the management terminal or may be separate from the management terminal. In other words, the database may be constructed in a storage device such as a hard disk drive or solid state drive built into the computer, or the database may be constructed in a storage device separate from the computer. may
　第１項に記載の検査方法では、検体プール検査法による検査に際し、ユーザー（検査担当者）は、前処理装置でプール検体の調製を実施するのに先立って、管理用端末において前処理装置管理用のソフトウェア上のユーザーインターフェイスにより、混合される複数の個別検体や混合したあとのプール検体に関する検体情報を入力する。入力された検体情報はデータベースに保存される。前処理装置で調製されたプール検体は検査装置で分析されるが、その分析結果からプール検体は陽性である場合と陰性である場合とがある。 In the inspection method described in paragraph 1, in the inspection by the sample pool inspection method, the user (inspector) manages the pretreatment device on the management terminal before preparing the pooled sample with the pretreatment device. User interface on the software for entering sample information for multiple individual samples to be mixed and pooled samples after mixing. The input sample information is saved in the database. The pooled samples prepared by the pretreatment device are analyzed by the testing device, and the analysis results may indicate that the pooled samples are positive or negative.
　複数のプール検体のうちの或るプール検体が陽性であった場合、ユーザーは、管理用端末において検査装置管理用のソフトウェア上のユーザーインターフェイスにより、陽性であったプール検体を指定する又は選択する。この指定又は選択の操作は、例えばポインティングデバイスによるクリック操作で行えるようにすることができる。例えば複数のプール検体の中から或る一つのプール検体が選択されると、そのプール検体に関連付けられている複数の個別検体の検体情報がデータベースから読み出され、検体情報入力画面の所定位置に差し込まれて表示部に表示される。 　If a certain pooled specimen among multiple pooled specimens is positive, the user specifies or selects the positive pooled specimen through the user interface on the testing device management software on the management terminal. This designation or selection operation can be performed, for example, by a click operation using a pointing device. For example, when one pooled specimen is selected from among a plurality of pooled specimens, the specimen information of the plurality of individual specimens associated with the pooled specimen is read from the database and displayed at a predetermined position on the specimen information input screen. It is inserted and displayed on the display.
　即ち、第１項に記載の検査方法では、陽性であったプール検体を指定する又は選択するだけで、そのプール検体の元である複数の個別検体についての検体情報が、検査装置で検査の対象である検体の情報として自動的に設定される。これにより、検体プール検査法で個別検体を再検査する際における、検体情報の入力作業に掛かる検査担当者の負担を軽減し、検査効率の改善を図ることができる。また、陽性であるプール検体の元である個別検体の検体情報が間違い無く入力されるため、プール検体と個別検体との対応付けの誤りや個別検体の取違いなどのミスを防止することができ、検査の信頼性を高めることができる。 That is, in the testing method described in paragraph 1, simply by designating or selecting a positive pooled specimen, the specimen information about a plurality of individual specimens that are the source of the pooled specimen can be obtained by the testing apparatus. is automatically set as sample information. As a result, it is possible to reduce the burden on the person in charge of the inspection who is involved in the work of inputting the sample information when retesting the individual sample by the sample pool inspection method, and to improve the inspection efficiency. In addition, since the specimen information of the individual specimens that are the source of positive pooled specimens is entered without error, it is possible to prevent errors such as errors in association between pooled specimens and individual specimens and mix-up of individual specimens. , can increase the reliability of the inspection.
　（第２項）第１項に記載の検査方法において、前記検査装置はＰＣＲ検査装置であり、該検査装置による分析の結果はＰＣＲの増幅曲線であるものとすることができる。 (Section 2) In the inspection method described in Section 1, the inspection device may be a PCR inspection device, and the result of analysis by the inspection device may be a PCR amplification curve.
　第２項に記載の検査方法によれば、ＰＣＲ検査を効率的に且つ正確に実施することができる。 According to the inspection method described in paragraph 2, PCR inspection can be performed efficiently and accurately.
　（第３項）第１項又は第２項に記載の検査方法は、前記検体情報入力画面に配置されている所定のボタンがクリック操作されたのに応じて、前記検査装置における分析を開始する分析実行工程、をさらに有するものとすることができる。 (Section 3) In the examination method according to the first or second section, the analysis in the examination apparatus is started in response to clicking of a predetermined button arranged on the sample information input screen. an analysis execution step.
　例えば、上記検体情報入力工程が実行されることで、検体情報入力画面に検査対象である複数の個別検体の検体情報が設定され、ユーザーがそれに対応する個別検体を検査装置にセットしたうえで、検体情報入力画面内の所定のボタンをクリックする操作を行うと、検査装置ではセットされた複数の個別検体に対する分析が開始される。これにより、ユーザーは個別検体をセットするという作業を除き、検体情報入力画面に自動的に設定された検体情報を確認し、同じ画面上のボタンをクリックするというごく簡単な操作を行うだけで、個別検体の再検査の実行を指示することができる。 For example, by executing the sample information input step, the sample information of a plurality of individual samples to be inspected is set on the sample information input screen, and the user sets the corresponding individual samples in the inspection apparatus, When a predetermined button in the sample information input screen is clicked, the inspection apparatus starts analyzing the set individual samples. As a result, except for the work of setting individual samples, the user can check the sample information automatically set on the sample information input screen and perform a very simple operation of clicking a button on the same screen. It is possible to instruct execution of retesting of individual specimens.
　（第４項）第１項～第３項のいずれか１項に記載の検査方法において、前記検体指定工程では、特定のプール検体の検査結果の指定又は選択を受けて該プール検体が指定又は選択されたものと判断することができる。 (Section 4) In the test method according to any one of paragraphs 1 to 3, in the specimen designation step, the pool specimen is designated or selected in response to designation or selection of test results of a specific pool specimen. can be determined as selected.
　通常、ＰＣＲ検査では増幅曲線が陽性、陰性の判断に利用される。第４項に記載の検査方法では、例えば増幅曲線が表示されている画面上において陽性であるプール検体を選択することができるので、作業に無駄な操作がなくなり、作業効率を向上させるのに有利である。 In PCR tests, amplification curves are usually used to determine positive or negative. In the test method described in paragraph 4, for example, positive pool specimens can be selected on the screen where the amplification curve is displayed, which eliminates unnecessary operations and is advantageous for improving work efficiency. is.
　（第５項）第１項～第４項のいずれか１項に記載の検査方法において、前記検体情報入力工程では、前記取得した検体情報が差し込まれた検体情報入力画面内に又は該画面とともに、前記前処理装置において個別検体が収容された個別検体容器と調製後のプール検体が収容されるプール検体容器とがセットされる作業面に対応した容器配置情報、を表示することができる。 (Item 5) In the inspection method according to any one of items 1 to 4, in the sample information input step, the sample information input screen into which the acquired sample information is inserted or together with the screen and container arrangement information corresponding to a working surface on which individual sample containers containing individual samples and pool sample containers containing prepared pool samples are set in the pretreatment device.
　第５項に記載の検査システムでは、ユーザーは、検体情報入力画面に差し込まれた検体情報に対応する個別検体が置かれていた位置を、容器配置情報で確認することができる。これにより、例えば差し込まれた検体情報が一つのプール検体を調製するのに使用された個別検体に対応しているか否かを確認することができ、容器の搬送やセット等で発生し得る個別検体の取違いをより一層確実に回避することができる。 In the inspection system described in paragraph 5, the user can confirm the position where the individual sample corresponding to the sample information inserted in the sample information input screen was placed by the container placement information. This makes it possible, for example, to check whether or not the inserted specimen information corresponds to the individual specimens used to prepare one pooled specimen. misunderstanding can be more reliably avoided.
　（第６項）また、本発明に係る検査システムの一態様は、検体プール検査法による検査を行う検査システムであって、
　複数の個別検体を混合してプール検体を調製する前処理装置と、
　プール検体又は個別検体を分析する検査装置と、
　前記前処理装置及び前記検査装置とそれぞれ通信可能であって、入力部及び表示部を含み、前記前処理装置及び前記検査装置における各々の動作を独立に制御する制御装置と、
　前記制御装置からアクセス可能であるデータベースと、
　表示部と、
を備え、前記制御装置は、
　前記前処理装置でのプール検体の調製前に、前記入力部を通した、複数の個別検体及びプール検体に関する検体情報の入力を受け付けるとともに、受け付けられた検体情報を前記データベースに保存する前処理装置管理部と、
　前記検査装置での一又は複数のプール検体に対する分析の結果を前記表示部に表示し、前記入力部を通した、陽性であったプール検体の指定又は選択を受け付け、指定又は選択されたプール検体に関連付けられている複数の個別検体の検体情報を前記データベースから取得して、取得した検体情報を、前記検査装置における検査対象の検体の検体情報を設定するための検体情報入力画面の所定位置に差し込んで前記表示部に表示する検査装置管理部と、
　を備える。 (Section 6) In addition, one aspect of the inspection system according to the present invention is an inspection system that performs an inspection by a sample pool inspection method,
a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample;
a testing device that analyzes pool samples or individual samples;
a control device capable of communicating with the preprocessing device and the inspection device, respectively, including an input unit and a display unit, and independently controlling operations of the preprocessing device and the inspection device;
a database accessible from the controller;
a display unit;
wherein the control device comprises
A pretreatment device that receives input of specimen information regarding a plurality of individual specimens and pooled specimens through the input unit and stores the received specimen information in the database before pooled specimens are prepared by the pretreatment device. management department and
display the results of analysis of one or more pooled samples by the testing device on the display unit, accept designation or selection of positive pooled samples through the input unit, and designate or select the pooled samples acquires sample information of a plurality of individual samples associated with the database from the database, and places the acquired sample information in a predetermined position of a sample information input screen for setting sample information of a sample to be inspected in the inspection device. an inspection device management unit that is inserted and displayed on the display unit;
Prepare.
　第６項に記載の検査システムを利用することで、第１項に記載の検査方法を実施することができ、検査担当者に掛かる負担を軽減しながら、効率的に検体プール検査を遂行することができる。また、プール検体で陽性が発生した場合でも、的確に且つ迅速に陽性である個別検体を特定することができ、検体プール検査の信頼性を高めることができる。 By using the inspection system described in paragraph 6, the inspection method described in paragraph 1 can be performed, and the specimen pool inspection can be performed efficiently while reducing the burden on the person in charge of inspection. can be done. In addition, even if a positive test occurs in a pooled sample, it is possible to accurately and quickly identify a positive individual sample, thereby increasing the reliability of the sample pool test.
１…前処理装置
　１０…分注ユニット
　　１００…シリンジ
　　１０１…ノズル
　１１、１３…移動部
　１２…作業テーブル
　　１２０…コンテナ収納部
　　１２０ａ…位置規制片
　　１２１…分注チップ保持部
　　１２２…チップ廃棄部
　１４…制御部
２…検査装置
　２０…検査部
　　２０１…光学ユニット
　　２０２…分注ユニット
　　　２０３…シリンジ
　　　２０４…ノズル
　　２０５…開閉ユニット
　２１、２２…移動部
　２３…保持部
　　２３１…温調保持部
　　２３２…非温調保持部
　２４…制御部
　２５…容器
　　２５Ａ…ＰＣＲ容器
　　２５Ｂ…試薬容器
　　２５Ｃ…分注チップ
３０…制御・処理装置
　３００…前処理装置管理部
　３０１…検査装置管理部
　３０２…データベース管理部
３１…データベース
３２…操作部
３３…表示部
４…バーコードリーダー
５…通信線
５０…コンテナ
５００、５００Ａ～５００Ｄ、５０１…個別検体ラック収納部
５０２…プール検体ラック収納部
５０３…色標識部
５１、５１Ａ～５１Ｅ…個別検体ラック
５１０、５２０…容器保持部
５２…プール検体ラック
５３…ハンドル
５４…個別検体容器
５５…プール検体容器
５６…分注チップ
６０…検体情報入力画面
　６１…検体マップ
　６２…管理テーブル
　６３…「開始」ボタン
　６５…「最初期化」ボタン
７０…ＰＣＲ検査画面
　７１…検査結果表示領域
　７１Ａ…結果確認画面
　７２…増幅曲線グラフ
　７３…Ｃｔ値テーブル
　７４…「検体情報入力」ボタン
８０…検体情報入力画面
　８１…検査情報入力領域
　８２…検体情報テーブル
９０…検体選択画面
　９１…管理検体一覧テーブル
　９２…絞り込み条件選択領域 DESCRIPTION OF SYMBOLS 1... Pretreatment apparatus 10... Dispensing unit 100... Syringe 101... Nozzle 11, 13... Moving part 12... Work table 120... Container storage part 120a... Position control piece 121... Dispensing tip holding part 122... Tip disposal part 14... Control part 2... Inspection device 20... Inspection part 201... Optical unit 202... Dispensing unit 203... Syringe 204... Nozzle 205... Opening/ closing unit 21, 22... Moving part 23... Holding part 231... Temperature control holding part 232... Non temperature control Holding unit 24 Control unit 25 Container 25A PCR container 25B Reagent container 25C Dispensing tip 30 Control/processing device 300 Pretreatment device management unit 301 Inspection device management unit 302 Database management unit 31 Database 32 Operation unit 33 Display unit 4 Barcode reader 5 Communication line 50 Containers 500, 500A to 500D, 501 Individual sample rack storage unit 502 Pool sample rack storage unit 503 Color indicator units 51, 51A to 51E Individual sample racks 510, 520 Container holding unit 52 Pool sample rack 53 Handle 54 Individual sample container 55 Pool sample container 56 Dispense tip 60 Sample information input screen 61 Sample map 62 Management table 63 "START" button 65... ``Initialize'' button 70... PCR test screen 71... Test result display area 71A... Result confirmation screen 72... Amplification curve graph 73... Ct value table 74... "Specimen information input" button 80... Specimen information input Screen 81... Examination information input area 82... Specimen information table 90... Specimen selection screen 91... Management specimen list table 92... Narrowing condition selection area

Claims (6)

  1. 　複数の個別検体を混合してプール検体を調製する前処理装置と、プール検体又は個別検体を分析する検査装置と、前記前処理装置及び前記検査装置とそれぞれ通信可能である管理用端末と、前記管理用端末からアクセス可能であるデータベースと、表示部と、を備える検査システム、を用いた検体プール検査法による検査方法であって、
    　前記前処理装置におけるプール検体の調製前に、前記管理用端末に搭載されている前処理装置管理用のソフトウェアにおいて、ユーザーの操作による個別検体及びプール検体に関する検体情報の入力を受け付ける検体情報入力工程と、
    　前記検体情報入力工程で受け付けられた検体情報を前記データベースに保存する情報保存工程と、
    　前記検査装置での一又は複数のプール検体に対する分析の結果を前記表示部に表示するプール検査結果表示工程と、
    　前記プール検体の少なくとも一つが陽性であった場合に、前記管理用端末に搭載されている検査装置管理用のソフトウェアにおいて、特定のプール検体の指定又は選択を受け付ける検体指定工程と、
    　前記検体指定工程で指定又は選択されたプール検体に関連付けられている複数の個別検体の検体情報を前記データベースから取得し、その取得した検体情報を、前記検査装置における検査対象の検体の検体情報を設定するための検体情報入力画面の所定位置に差し込んで前記表示部に表示する検体情報入力工程と、
    　を有する検査方法。     a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample, an inspection device that analyzes the pooled sample or the individual samples, a management terminal capable of communicating with the pretreatment device and the inspection device, respectively; A testing method according to a specimen pool testing method using a testing system comprising a database accessible from a management terminal and a display unit,
    A sample information input step of accepting input of sample information related to individual samples and pooled samples by a user's operation in the pretreatment device management software installed in the management terminal before pool sample preparation in the pretreatment device. and,
    an information storage step of storing the sample information received in the sample information input step in the database;
    a pool test result display step of displaying the analysis results of one or more pool samples in the test device on the display unit;
    a specimen designation step of accepting designation or selection of a specific pool specimen in software for testing device management installed in the management terminal when at least one of the pool specimens is positive;
    acquiring sample information of a plurality of individual samples associated with the pool sample specified or selected in the sample specifying step from the database, and using the acquired sample information as the sample information of the sample to be inspected in the inspection apparatus; a sample information input step of inserting into a predetermined position of a sample information input screen for setting and displaying it on the display unit;
    inspection method.
  2. 　前記検査装置はＰＣＲ検査装置であり、該検査装置による分析の結果はＰＣＲ増幅曲線である、請求項１に記載の検査方法。 　The inspection method according to claim 1, wherein the inspection device is a PCR inspection device, and the analysis result by the inspection device is a PCR amplification curve.
  3. 　前記検体情報入力画面に配置されている所定のボタンがクリック操作されたのに応じて、前記検査装置における分析を開始する分析実行工程、をさらに有する、請求項１に記載の検査方法。 　The inspection method according to claim 1, further comprising an analysis execution step of starting analysis in the inspection device in response to clicking of a predetermined button arranged on the sample information input screen.
  4. 　前記検体指定工程では、特定のプール検体の検査結果の指定又は選択を受けて該プール検体が指定又は選択されたものと判断する、請求項１に記載の検査方法。 　The inspection method according to claim 1, wherein, in the specimen designation step, it is determined that the pool specimen has been designated or selected in response to designation or selection of the test results of a specific pool specimen.
  5. 　前記検体情報入力工程では、前記取得した検体情報が差し込まれた検体情報入力画面内に又は該画面とともに、前記前処理装置において個別検体が収容された個別検体容器と調製後のプール検体が収容されるプール検体容器とがセットされる作業面に対応した容器配置情報、を表示する、請求項１に記載の検査方法。 In the sample information input step, an individual sample container in which an individual sample is stored and a pool sample after preparation are stored in the sample information input screen in which the acquired sample information is inserted or together with the screen. 2. The inspection method according to claim 1, wherein the container placement information corresponding to the work surface on which the pool sample container is set is displayed.
  6. 　検体プール検査法による検査を行う検査システムであって、
    　複数の個別検体を混合してプール検体を調製する前処理装置と、
    　プール検体又は個別検体を分析する検査装置と、
    　前記前処理装置及び前記検査装置とそれぞれ通信可能であって、入力部及び表示部を含み、前記前処理装置及び前記検査装置における各々の動作を独立に制御する制御装置と、
    　前記制御装置からアクセス可能であるデータベースと、
    　表示部と、
    を備え、前記制御装置は、
    　前記前処理装置でのプール検体の調製前に、前記入力部を通した、複数の個別検体及びプール検体に関する検体情報の入力を受け付けるとともに、受け付けられた検体情報を前記データベースに保存する前処理装置管理部と、
    　前記検査装置での一又は複数のプール検体に対する分析の結果を前記表示部に表示し、前記入力部を通した、陽性であったプール検体の指定又は選択を受け付け、指定又は選択されたプール検体に関連付けられている複数の個別検体の検体情報を前記データベースから取得して、取得した検体情報を、前記検査装置における検査対象の検体の検体情報を設定するための検体情報入力画面の所定位置に差し込んで前記表示部に表示する検査装置管理部と、
    　を備える検査システム。     An inspection system for performing inspection by a sample pool inspection method,
    a pretreatment device that mixes a plurality of individual samples to prepare a pooled sample;
    a testing device that analyzes pool samples or individual samples;
    a control device capable of communicating with the preprocessing device and the inspection device, respectively, including an input unit and a display unit, and independently controlling operations of the preprocessing device and the inspection device;
    a database accessible from the controller;
    a display unit;
    wherein the control device comprises
    A pretreatment device that receives input of specimen information regarding a plurality of individual specimens and pooled specimens through the input unit and stores the received specimen information in the database before pooled specimens are prepared by the pretreatment device. management department and
    display the results of analysis of one or more pooled samples by the testing device on the display unit, accept designation or selection of positive pooled samples through the input unit, and designate or select the pooled samples acquires sample information of a plurality of individual samples associated with the database from the database, and places the acquired sample information in a predetermined position of a sample information input screen for setting sample information of a sample to be inspected in the inspection device. an inspection device management unit that is inserted and displayed on the display unit;
    inspection system.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000275249A (en) * 1999-03-24 2000-10-06 Hitachi Ltd Automatic analyzer
JP2001159635A (en) * 1999-11-30 2001-06-12 Aloka Co Ltd Specimen treatment system
JP2014224749A (en) * 2013-05-16 2014-12-04 バイオテック株式会社 Automatic specimen process device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000275249A (en) * 1999-03-24 2000-10-06 Hitachi Ltd Automatic analyzer
JP2001159635A (en) * 1999-11-30 2001-06-12 Aloka Co Ltd Specimen treatment system
JP2014224749A (en) * 2013-05-16 2014-12-04 バイオテック株式会社 Automatic specimen process device

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