WO2023007805A1 - Procédé de test et système de test - Google Patents

Procédé de test et système de test 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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English (en)
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/JP7509322B2/ja
Publication of WO2023007805A1 publication Critical patent/WO2023007805A1/fr

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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

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Abstract

Un mode de réalisation du procédé de test selon la présente invention est effectué par regroupement d'échantillons en utilisant les éléments suivants : un système de test équipé d'un dispositif de prétraitement pour mélanger une pluralité d'échantillons individuels afin de préparer un échantillon regroupé ; un dispositif de test pour analyser l'échantillon regroupé ou un échantillon individuel ; un terminal de gestion capable de communiquer avec chacun du dispositif de prétraitement et du dispositif de test ; une base de données à laquelle on peut accéder depuis le terminal de gestion, et une unité d'affichage. Le mode de réalisation du procédé comprend les étapes suivantes : avant la préparation de l'échantillon groupé, le logiciel pour la gestion du dispositif de prétraitement installé dans le terminal de gestion possède une étape pour recevoir l'entrée d'informations d'échantillon relatives aux échantillons individuels et à l'échantillon groupé par une opération de l'utilisateur ; une étape pour sauvegarder les informations sur l'échantillon reçu dans la base de données ; et une étape pour afficher les résultats de l'analyse d'un ou d'une pluralité d'échantillons groupés sur l'unité d'affichage (S16) ; et lorsqu'au moins un échantillon groupé est positif, le logiciel pour la gestion des dispositifs de test installé dans le terminal de gestion comporte une étape de désignation d'échantillon (S18) pour recevoir la désignation ou la sélection d'un échantillon groupé spécifique, et une étape de saisie d'informations sur les échantillons (S19) pour obtenir des informations sur les échantillons concernant la pluralité d'échantillons individuels associés à l'échantillon groupé désigné ou sélectionné à partir de la base de données, pour insérer les informations obtenues sur les échantillons à une position prescrite dans une image d'écran de saisie d'informations sur les échantillons pour définir les informations sur les échantillons sur un échantillon à tester, et pour afficher les informations sur les échantillons sur l'unité d'affichage.
PCT/JP2022/009372 2021-07-30 2022-03-04 Procédé de test et système de test WO2023007805A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000275249A (ja) * 1999-03-24 2000-10-06 Hitachi Ltd 自動分析装置
JP2001159635A (ja) * 1999-11-30 2001-06-12 Aloka Co Ltd 検体処理システム
JP2014224749A (ja) * 2013-05-16 2014-12-04 バイオテック株式会社 自動検体処理装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000275249A (ja) * 1999-03-24 2000-10-06 Hitachi Ltd 自動分析装置
JP2001159635A (ja) * 1999-11-30 2001-06-12 Aloka Co Ltd 検体処理システム
JP2014224749A (ja) * 2013-05-16 2014-12-04 バイオテック株式会社 自動検体処理装置

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