Body fluid analysis method and system

Abstract

To provide a technique capable of determining, detecting, and outputting the possibility of intentional substitution or falsification of a specimen, or unintentional mix-up or misidentification.SOLUTION: A body fluid analysis method (inspection method) is a method for analyzing a body fluid of a specimen collected from an inspection subject using a mass spectrometer being an inspection device. The mass spectrometer is a device having a function of introducing the specimen and measuring and analyzing the component amount of target component substances on the basis of the mass spectrometry. The body fluid analysis method includes: a determination step in which the mass spectrometer determines the possibility of substitution or mix-up of the specimen as the inappropriate specimen on the basis of the component amount of target component substances as a measurement result of the specimen of the mass spectrometer; and an output step in which a determination result in a case of determining as the inappropriate specimen is output.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to the technology of body fluid analysis, drug testing. [Background technology]

[0002] Various types of drug tests, or body fluid analyses, are conducted. For example, there are drug tests for entrants upon entry, alcohol and drug tests for drivers, and doping tests for athletes. In doping tests, detailed tests may be conducted using urine or blood as samples. Target drugs, or target substances, include illegal drugs such as narcotics, and prohibited substances stipulated in sports. Detailed tests take a relatively long time to produce results. Therefore, there is a high demand for simple tests that do not take a long time, or screening tests.

[0003] For various drug tests and body fluid analyses, mass spectrometers can be used as drug test devices, in other words, body fluid analyzers. During drug tests and body fluid analyses, for example, skin tissue is wiped from the skin of a test subject as a body fluid to be used as a specimen. In other words, a specimen is a specimen, a sample, an object to be tested, etc. Body fluids include sweat and saliva. A mass spectrometer measures and analyzes the constituent substances of a set and introduced specimen based on known mass analysis. From the results of the measurement and analysis, it is possible to detect and estimate whether the body fluid of the specimen contains a target substance, such as an illegal drug.

[0004] Mass spectrometry is a technology that ionizes samples at the atomic and molecular level, measures and analyzes their mass, and identifies and quantifies substances. Mass spectrometers ionize samples in a vacuum where high voltage is applied, and the ions flying due to electrostatic forces are separated according to their mass-to-charge ratio by electromagnetic action, and the separated components are detected. This type of measurement produces a mass spectrum (sometimes written as mass). In a mass spectrum, the horizontal axis represents the mass-to-charge ratio (m / z, m: mass, z: charge), and the vertical axis represents the signal intensity.

[0005] An example of a mass spectrometer capable of analyzing body fluids, in other words, a testing device, is disclosed in Japanese Patent No. 6368067 (Patent Document 1). Patent Document 1 describes that the device detects whether a sample is a substance in a body fluid component including at least one of urine, sweat, and saliva, or a solid substance.

[0006] Furthermore, Japanese Patent No. 7002637 (Patent Document 2) describes an example of a blood test support system, which describes managing the date and time of self-blood collection. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Patent No. 6368067 [Patent Document 2] Patent No. 7002637 Summary of the Invention [Problem to be solved by the invention]

[0008] In the case of a body fluid analyzer, which is a testing device, there may be cases where the sample to be tested and analyzed is intentionally replaced or counterfeited, or where there is unintentional mix-up or misidentification. In other words, there may be cases where the sample introduced into the testing device is not the body fluid of the test subject himself, but is made of some substance other than that of the subject himself. In such cases, the testing device cannot perform appropriate testing and analysis. In a system including a testing device, it is desirable to be able to judge, detect, and output the possibility that the sample is a sample other than that of the subject himself, in other words, the possibility that the sample has been intentionally replaced or unintentionally mixed up. In other words, it is desirable for a system including a testing device to have a function that can judge, detect, and output the above-mentioned possibility that the sample is not appropriate, in other words, that the sample is an inappropriate sample. The prior art example does not have such a function.

[0009] If, at the time of testing, the test confirmer, in other words the test implementer, collects a sample directly from the test subject, in other words the person being measured, and immediately performs the test on the spot using testing equipment, the possibility of the above-mentioned switching is low, so the above-mentioned function is not necessarily required.

[0010] On the other hand, when the location where the sample is collected from the test subject is different from the location where the test is performed with the testing device, there is a possibility of the above-mentioned swapping, etc., and therefore the above-mentioned function is necessary and effective. For example, a sample is collected from the test subject at a location such as an airport, port, checkpoint, or competition venue, and the collected sample is transported by mail or other means to another location where the testing device is located. The sample is then introduced into the testing device at that location and the test is performed. This type of test is sometimes called off-site monitoring, etc. In this case, the tester who performs the test at the testing device location does not meet the test subject, and it is uncertain whether the sample that is transported is made from a bodily fluid that was properly collected from the test subject himself / herself.

[0011] Examples of sample substitution or falsification include cases where a substance is taken from another person, animal, or any other object other than the test subject, such as a wall, desk, bag, clothing, food, drink, etc. Examples of sample mix-up or misidentification include cases where, even if the samples are properly collected, multiple samples from multiple test subjects are mistakenly swapped during the collection or mailing process.

[0012] If it were possible to determine, detect, and output the possibility that the sample was from someone other than the person in question or that it was inappropriate in the case of sample switching as described above, it would be possible to take measures such as rechecking the sample set in the testing device, re-examining the sample after collecting it again, or temporarily suspending the testing operation, etc. This would contribute to the optimization and efficiency of drug testing and body fluid analysis.

[0013] The purpose of the present disclosure is to provide technology that can determine, detect, and output the possibility of intentional switching or falsification of samples, or unintentional mix-ups or misidentifications, in relation to the above-mentioned bodily fluid analysis and drug testing technologies. [Means for solving the problem]

[0014] A representative embodiment of the present disclosure has the following configuration: The embodiment is a body fluid analysis method for analyzing body fluid of a specimen collected from a test subject using a mass spectrometer as a testing device, the mass spectrometer being a device having a function of introducing the specimen and measuring and analyzing the amount of a target component substance based on mass analysis, and the steps executed by the mass spectrometer include a determination step of determining the possibility of the specimen being swapped or mixed up as an inappropriate specimen based on the amount of the target component substance as a measurement result of the specimen by the mass spectrometer, and an output step of outputting a determination result when the specimen is determined to be an inappropriate specimen. Effect of the Invention

[0015] According to a representative embodiment of the present disclosure, the possibility of intentional substitution or falsification of samples, or unintentional mix-up or misidentification, etc., can be determined, detected, and output in relation to the above-mentioned body fluid analysis and drug testing technologies. Problems, configurations, effects, etc. other than those described above will be described in the description of the embodiment of the invention. [Brief description of the drawings]

[0016] [Figure 1] 1 is a diagram showing an example of the overall configuration of an inspection system that executes an inspection method according to a first embodiment. [Diagram 2] FIG. 4 is a sequence diagram of a simple drug testing service in the testing method and testing system of the first embodiment. [Diagram 3] FIG. 1 is a diagram showing an overview of a simple drug testing service using the testing method and testing system of the first embodiment. [Figure 4] 1 is a diagram showing an example of the external configuration of a mass spectrometer which is an inspection device in the inspection method and inspection system according to the first embodiment. [Diagram 5] FIG. 2 is a diagram showing a functional block configuration of a mass spectrometer which is an inspection device in the inspection method and inspection system according to the first embodiment. [Figure 6]1 is a diagram showing the configuration of a mass measurement unit of a mass spectrometer in the inspection method and inspection system of the first embodiment. [Figure 7] FIG. 2 is a diagram showing an example of a mass spectrum obtained by a mass spectrometer in the inspection method and inspection system according to the first embodiment. [Figure 8] FIG. 2 is a diagram showing an example of the configuration of a computer system constituting a PC of an inspection device in the inspection method and inspection system according to the first embodiment. [Figure 9] FIG. 2 is a diagram showing an example of the configuration of a computer system constituting a server in the inspection method and inspection system according to the first embodiment. [Figure 10] FIG. 2 is a diagram showing a flow of a sample inspection process in an inspection device in the inspection method and inspection system of the first embodiment. [Figure 11] FIG. 4 is a diagram showing an example of the structure of a questionnaire in the inspection method and inspection system of the first embodiment. [Figure 12] FIG. 4 is a diagram showing an example of the configuration of a questionnaire input screen in the inspection method and inspection system of the first embodiment. [Figure 13] FIG. 2 is a diagram showing an example of the configuration of a test subject information input screen in the testing method and testing system according to the first embodiment. [Figure 14] 4 is a diagram showing an example of the structure of a report form for notifying an inspection result in the inspection method and inspection system according to the first embodiment. FIG. [Figure 15] 4 is a diagram showing an example of the configuration of a report screen for notifying test results in the testing method and testing system according to the first embodiment. FIG. [Figure 16] 4 is a diagram showing an example of a customer ID management table in the inspection method and inspection system according to the first embodiment. [Figure 17] FIG. 13 is an explanatory diagram of a function of determining inappropriate samples in a PC of the testing device in the testing method and testing system of the first embodiment. [Figure 18] FIG. 2 is an explanatory diagram of the content of a function for determining an inappropriate specimen in the testing method and testing system according to the first embodiment. [Figure 19] FIG. 4 is a diagram showing an example of signal intensity of m / z in a mass spectrum as an example of the component amount of a target component substance in the inspection method and inspection system of the first embodiment. [Figure 20]FIG. 4 is a diagram showing an example of a mass spectrum when a large amount of impurities is contained in the inspection method and inspection system according to the first embodiment. [Figure 21] 4 is a diagram showing an example of processing for judgment condition 1 in the inspection method and inspection system according to the first embodiment. [Figure 22] 10 is a diagram showing an example of processing for judgment condition 2 in the inspection method and inspection system according to the first embodiment. [Diagram 23] FIG. 11 is a diagram showing an example of processing for judgment condition 3 in the inspection method and inspection system according to the first embodiment. [Figure 24] FIG. 4 is a diagram showing an example of component amounts and standard ranges in the inspection method and inspection system of the first embodiment. [Diagram 25] FIG. 13 is a diagram showing an example of a display screen on a PC of the inspection device in the inspection method and inspection system according to the modified example of the first embodiment. [Figure 26] FIG. 13 is a diagram showing an example of generating a reference range or the like in the inspection method and inspection system according to the modified example of the first embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Hereinafter, an embodiment of the present disclosure will be described in detail with reference to the drawings. In the drawings, the same parts are generally given the same reference numerals, and repeated explanations will be omitted. In the drawings, the representation of components may not represent the actual position, size, shape, range, etc., in order to facilitate understanding of the invention.

[0018] For the sake of explanation, when describing processing by a program, the program, functions, processing units, etc. may be described as the main components, but the main hardware components of these are the processor, or a controller, device, computer, system, etc. that is configured with the processor. The computer executes processing according to the program read into the memory by the processor, appropriately using resources such as memory and communication interfaces. This realizes predetermined functions, processing units, etc. The processor is configured with semiconductor devices such as a CPU / MPU or GPU, for example. Processing is not limited to software program processing, and can also be implemented by dedicated circuits. Dedicated circuits such as FPGA, ASIC, CPLD, etc. can be used.

[0019] The program may be pre-installed as data in the target computer, or may be distributed as data from a program source to the target computer. The program source may be a program distribution server on a communication network, or a non-transient computer-readable storage medium, such as a memory card or a disk. The program may be composed of multiple modules. The computer system may be composed of multiple devices. The computer system may be composed of a client-server system, a cloud computing system, an IoT system, etc. Various data and information are composed of structures such as, for example, tables and lists, but are not limited to these. Expressions such as identification information, identifiers, IDs, names, and numbers are mutually replaceable.

[0020] <Embodiment 1> A testing method and testing system according to embodiment 1 of the present disclosure will be described with reference to FIG. 1 and subsequent figures. The testing method according to embodiment 1 is, in other words, a body fluid analysis method. The testing method according to embodiment 1 is a method having steps executed in the testing system according to embodiment 1 (in other words, a body fluid analysis system). As shown in FIG. 1, FIG. 3, FIG. 10, FIG. 17, etc., the testing method according to embodiment 1 includes, as a characteristic function in the testing, a function 1200 in the testing device 1 for determining, detecting, and outputting whether a sample is an inappropriate sample not collected from the person in question.

[0021] In the first embodiment, the processing of the characteristic functions is mainly performed by the PC 403 (FIG. 4) of the inspection device 1, but is not limited to this. For example, the inspection result data of the inspection device 1 may be acquired by another computer, such as the server 30 or the management terminal 20 (FIG. 1), and the processing of the characteristic functions may be performed by the server 30 or the management terminal 20. Furthermore, the processing may be shared and coordinated among a plurality of computers, such as the PC 403 and the server 30.

[0022] In the first embodiment, a simple drug test / screening test is provided to customers as a service via mail and communication, where the location where the sample is taken (location 1) is different from the location where the test is carried out (location 2) (Fig. 1). For example, simple tests / screening tests for illegal drugs are carried out on people entering the country, drivers, athletes, employees, etc. who are the test subjects. Such tests contribute to ensuring occupational safety and health management. Such tests can be carried out at a predetermined timing depending on the customer taking the test, for example, as a pre-employment test, a regular test, a post-accident test, etc.

[0023] [Inspection system] FIG. 1 shows the overall configuration of a system including a testing system (body fluid analysis system) of embodiment 1. The system of FIG. 1 is also referred to as the testing system. The testing system of FIG. 1 is a system that provides a simple drug testing service to a customer establishment 100. The testing system of FIG. 1 is a system in which the system of the customer establishment 100, the system of an intermediary business 300, and the system of a testing establishment 200 of a business that performs the testing are interconnected via a communication network 900. Note that there may be multiple customer establishments 100 that are customers that receive the service. The communication network 900 includes the Internet, etc., and a mailing system, etc.

[0024] The customer establishment 100 is at a location 1 as one location, and the testing establishment 200 is at a location 2 as another location. The customer establishment 100 has one or more test subjects U1 who undergo testing. At the customer establishment 100, a customer worker U2 performs the task of collecting a specimen 5 from the test subject U1. In a specific example, the worker U2 wipes skin tissue from the skin of the test subject U1's neck with gauze and stores the gauze in a specimen holder 6 (or a plastic bag). The specimen holder 6 may be a dedicated container that can be set in the testing device 1, or may be another container, for example, a plastic bag. The worker U2 operates a work terminal 10 such as a PC in the customer system and can access a web page 31 of the intermediary business operator 300. The worker U2 can request a test, input a questionnaire 7, view a report 8 of the test results, and the like on the web page 31 from the work terminal 10.

[0025] A testing device 1 is installed at location 2 of the testing business facility 200. A sample holder 6 for a sample 5 is delivered by mail from the customer facility 100 to location 2 of the testing business facility 200. A tester U3 at the testing business facility 200 uses the testing device 1 to perform testing of the sample 5. When the sample holder 6 containing the sample 5 is delivered by mail, the tester U3 sets the sample holder 6 in the testing device 1 and causes the testing device 1 to perform testing processing. In another embodiment, when a plastic bag containing the sample 5 is delivered by mail, the tester U3 removes gauze from the plastic bag and stores it in the sample holder 6.

[0026] The inspection implementer U3 can operate the management terminal 20 of the system of the inspection business establishment 200 to access the web page 31 of the intermediary business operator 300. From the management terminal 20, the inspection implementer U3 can accept inspections, obtain input information for a questionnaire 7, upload a report 8 of the inspection results, and the like, on the web page 31.

[0027] As a mass spectrometer, the testing device 1 has a basic function of testing and analyzing a specimen 5 and, in particular, in the first embodiment, has a function 1200 for determining whether a specimen is inappropriate. This function 1200 determines, detects, and outputs whether the specimen 5 to be tested is an inappropriate specimen or a specimen collected from someone other than the person in question. The testing device 1 outputs the test results to the management terminal 20 or server 30. The management terminal 20 or server 30 creates a report 8 from the test results to notify the customer of the test results. The report 8 is sent to the customer facility 100.

[0028] The intermediary business 300 mediates between the customer business 100 that will take the test and the testing business 200 that will perform the test. The intermediary business 300 cooperates with the testing business to provide a simple drug testing service. The system of the intermediary business 300 includes a server 30 and the like on a communication network 900, and the server 30 and the like provide services as an input / output interface, a graphical user interface (GUI), and a contact point for the simple drug testing service. The services include accepting tests, inputting questionnaires, and notifying test results. The intermediary business 300 provides a web page 31 as a GUI 31 by the server 30 and the like. In the embodiment, the GUI 31 (web page 31) by the server 30 and the like enables acceptance of tests, inputting questionnaires, and notifying test results.

[0029] The intermediary business 300 and the testing business (testing business 100) may be integrated. In the system of the testing business 200, the management terminal 20 and the testing device 1 are provided separately, but these may be integrated. The management terminal 20 manages information for the testing work of the tester U3 as data, but such data management may be integrated into the PC 403 of the testing device 1.

[0030] The server 30 and the test device 1 (particularly the PC 403 in FIG. 4) are appropriately connected via communication. Alternatively, the test device 1 may be connected via communication to the management terminal 20 of the test implementer U3, and the management terminal 20 and the server 30 may be connected via communication.

[0031] The questionnaire 7 is basically completed by filling out a questionnaire form and mailing it, but is not limited to this and in the first embodiment, the questionnaire data can be input on the screen of the Web page 31 of the server 30. The report 8 is basically completed by filling out a report form and mailing it, but is not limited to this and can be output as a report on the screen of the Web page 31 of the server 30. The form is not limited to the Web page 31 and may be e-mail or the like. When the customer uses the Web page 31, there is no need to mail a form, etc.

[0032] When the questionnaire 7 is in the form of paper, the questionnaire is mailed from the inspection business establishment 200 or the intermediary business 300 to the customer business establishment 100, and the customer (e.g., worker U2) fills in the questionnaire and mails it to the inspection business establishment 200 or the intermediary business 300. The inspection business establishment 200 or the intermediary business 300 acquires the information written on the questionnaire. The system of the inspection business establishment 200 or the intermediary business 300 may input the information written on the questionnaire into an inspection subject information screen described below and convert it into data. This allows the questionnaire information, in other words, the inspection subject information to be obtained. The questionnaire information, in other words, the inspection subject information, is transmitted to the management terminal 20 of the inspection business establishment 200 or the PC 403 of the inspection device 1.

[0033] When obtaining the questionnaire 7 in the form of a Web page 31, a worker U2 at the customer establishment 100 accesses the Web page 31 from the work terminal 10 and inputs the questionnaire information on the screen of the Web page 31. The server 30 transmits the questionnaire information via communication to the management terminal 20 of the inspection establishment 200 or the PC 403 of the inspection device 1. In other words, the management terminal 20 or the PC 403 refers to and obtains the questionnaire information from the server 30. The management terminal 20 may transfer the questionnaire information to the PC 403.

[0034] Function 1200 of PC 403 of testing device 1 uses the questionnaire information and the measurement results (mass measurement data) obtained from sample 5 by testing device 1 to determine whether the sample is inappropriate, and stores and outputs determination result information. PC 403 may transmit the determination result information to management terminal 20 or server 30. Management terminal 20 may transmit the determination result information to server 30. Server 30 may create report 8 based on the determination result information.

[0035] It is desirable for information about the sample 5 to be written on the sample holder 6. The written information includes, for example, a personal ID that represents the test subject U1.

[0036] [Sequence of rapid drug testing service] Figure 2 shows the sequence of a simple drug testing service between the components in Figure 1. In step A1, for example, a worker U2 at a customer establishment 100 requests, or in other words places an order for, a simple drug test from a testing business 200 on a work terminal 10, using a web page 31 of a GUI 31 of an intermediary business 300 as a window. A test implementer U3 at the testing establishment 200 accepts the request through the web page 31.

[0037] In step A2, an inspection person U3 at the inspection establishment 200 receives an inspection request from the customer establishment 100 through the Web page 31. An operator U2 at the customer establishment 100 confirms and completes the inspection order through the Web page 31.

[0038] In step A3, the testing establishment 200 mails a test kit for collecting a specimen 5 to the customer establishment 100 through the intermediary business 300. The customer establishment 100 receives the test kit. The test kit is a set of tools for collecting the specimen 5, and includes a specimen holder 6 or a plastic bag. A questionnaire may be mailed together with the test kit.

[0039] In step A4, a worker U2 at the customer facility 100 uses a test kit to collect a specimen 5 from a test subject U1 and stores the specimen in a specimen holder 6 or a plastic bag. The worker U2 similarly collects specimens 5 from one or more test subjects U1.

[0040] In step A5, the operator U2 submits, for example, the sample holder 6 after collection, for example by mail, via the intermediary business 300 to the testing facility 200. The testing facility 200 receives the sample 5.

[0041] In step A6, the worker U2 at the customer establishment 100 writes the survey information on a questionnaire. Alternatively, the worker U2 accesses the Web page 31 on the work terminal 10 and inputs the survey information on the screen of the Web page 31. In the case of a questionnaire, the questionnaire is mailed to the inspection establishment 100 via the intermediary business operator 300.

[0042] In step A7, at the testing facility 200, a tester U3 uses the testing device 1 to perform testing of a sample 5. The tester U3 sets a sample holder 6 in the testing device 1, which then introduces the sample holder 6 inside and performs the test. The PC 403 of the testing device 1 obtains the test results. During the testing process of the testing device 1, a judgment is also made by the function 1200 that judges whether a sample is inappropriate.

[0043] In step A8, the PC 403 of the testing device 1 transmits the test result data to the management terminal 20 or the server 30 of the intermediary business 300. The test result data includes the judgment result by the function 1200 for judging inappropriate samples. The management terminal 20 may transmit the test result data to the server 30. The server 30 creates a report 8 for notifying the test result from the test result data. The PC 403 or the management terminal 20 may create the report 8 from the test result data. The server 30 transmits the report 8 to the customer establishment 100. If the report 8 is a report form, it is sent by mail. If it is report data, it may be viewed on the web page 31 or may be sent by email, etc. An operator U2 at the customer establishment 100 receives the report 8 and can check the test results, etc.

[0044] [Overview of the Simple Drug Testing Service] FIG. 3 shows an overview of the simple drug testing service, and in particular shows branching according to the results. In step S1, a sample 5 is collected from a test subject U1 at a customer establishment 100 in location 1. An operator U2 wipes away body fluids containing sebum from the neck of the test subject U1 with gauze (in other words, a wiper) and collects the body fluids as the sample 5. For example, the gauze is stored in a sample holder 6 or a plastic bag. The operator wears gloves or the like when performing the wiping and other operations.

[0045] In step S2, the sample holder 6 storing the sample 5 is transported by mail or the like from location 1 to the testing facility 100 at location 2. Also in step S2, information about the test subject U1 is entered into a questionnaire 7, and if the questionnaire 7 is paper, it is mailed to the testing facility 100 together with the sample 5. Alternatively, the input information for the questionnaire 7, in other words, the test subject information, can be obtained via a web page 31.

[0046] In step S3, the testing establishment 200 in location 2 acquires the specimen 5 (specimen holder 6) and questionnaire input information from the customer establishment 100.

[0047] In step S4, at the testing facility 200, a sample holder 6 storing a sample 5 is introduced into a mass spectrometer, which is the testing device 1, based on an operation by a tester U3, and testing and analysis of the sample 5 are performed. In the first embodiment, this testing includes a determination of an inappropriate sample as a process by the characteristic function 1200. In a specific example, a PC 403, which will be described later, performs the process by the characteristic function 1200.

[0048] Step S5 is the output of the test result of the testing device 1, and branches depending on the test result. Step S6 is broadly classified as one of the judgment results, where it is judged that the sample is appropriate. Step S7 is broadly classified as the other judgment result, where it is judged that the sample is inappropriate, in other words, where it is judged that the sample was not collected from the person in question, or that there is a possibility that the sample was swapped or mixed up.

[0049] In the case of step S6, the test results are either the test result in step S8 = OK, in which case illegal drugs or the like are not detected as a component substance of the specimen 5, or the test result in step S9 = NG, in which case illegal drugs or the like are detected as a component substance of the specimen 5. If the result in step S9 is NG, then in step S10, a detailed test is required.

[0050] On the other hand, if the sample is determined to be inappropriate in step S7, then as a countermeasure, a request is made in step S11 to confirm the sample and to retest. Sample confirmation is a request to the tester U3 to reconfirm the sample 5 set in the testing device 1. A request for retesting includes a request / recommendation to the customer facility 100 to collect the sample 5 again from the test subject U1 and to retest.

[0051] In any branch (S8, S10, S11), finally, in step S12, a result notification is sent to the customer establishment 100 according to the respective case. The testing establishment 200 creates a test result notification report 8 including the judgment result, and transmits it to the customer establishment 100. The report 8 may be a report form sent by mail, or the intermediary business 300 may provide report data on its web page 31. The customer establishment 100 receives the result notification report 8. This completes the series of sequences.

[0052] In the case of the detailed examination in step S10, the detailed examination may be performed at another testing establishment or specialized institution (e.g., a hospital) other than the testing establishment 200. In that case, when a detailed examination is requested, the other testing establishment or specialized institution is introduced.

[0053] In one test, a plurality of predetermined target components can be analyzed. This test can also detect if the test subject U1 has used illegal drugs in the past, for example, from one month ago.

[0054] On the GUI 31, the web page 31 can also confirm a series of schedules for the drug simple test as shown in Figures 2 and 3 above. For example, the deadline for mailing the sample and the time when the result report 8 will be issued can be confirmed.

[0055] Although FIG. 1 shows only one test subject U1, if there are multiple test subjects U1 at the customer business 100, it is possible to request testing of samples 5 from multiple people all at once by mail, etc., and the test results for multiple people can be obtained together as a report 8.

[0056] [Exterior of the inspection device] FIG. 4 shows an example of the external configuration of the inspection device 1. The inspection device 1 includes a main body 401, a cover 402, a PC 403, etc. FIG. 4(A) shows a state in which the cover 402 is closed during normal use, and a PC (computer) 403 is placed on the cover 402, using the cover 402 as a base. FIG. 4(B) shows a state in which the cover 402 is opened during maintenance work or the like, and components 404 (described later) placed inside the main body 401 are visible. The PC 403 is a computer that serves as a controller for operating and inputting / outputting the inspection device 1, has a data processing function, and provides a GUI when the inspection implementer U3 (FIG. 1) or the like operates the inspection device 1.

[0057] The tester U3 can operate the PC 403 to switch the operation of the test device 1 on / off, execute tests, perform settings, and perform maintenance. The PC 403 can be, but is not limited to, a general notebook PC. The PC 403 includes a processor, memory, a communication interface, an input device, an output device, and the like, and processes detection signals obtained from the main body 401 to obtain mass measurement data and test result data. The PC 403 holds data such as mass measurement data in its memory and transmits it to the outside at the appropriate time.

[0058] The PC 403 of the testing device 1 refers to the questionnaire input information, in other words, the test subject information, as information related to the testing of the sample 10 from the server 30 or the management terminal 20. The PC 403 compiles the test results of the testing device 1 and the judgment results of the function 1200. The test result data also includes judgment result data. The PC 403 transmits the test result data to the management terminal 20 or the server 30 in a timely manner.

[0059] The PC 403 of the testing device 1 may perform control so as to temporarily halt the testing process in the main body when the function 1200 for determining whether a sample is inappropriate determines that the sample is inappropriate.

[0060] [Inspection equipment functional blocks] Fig. 5 shows an example of the functional block configuration of the testing device 1. The cover 402 is omitted in Fig. 5. Fig. 5 also shows a tester U3. For example, in the case of a simple drug test in off-site monitoring, the tester U3 sets a sample holder 6 (in other words, a wiper holder) in which a sample 5 is stored, in a wiper loader 520. The testing device 1 in Fig. 5 shows a case where the testing device 1 is an ion trap type mass spectrometer equipped with a mass measurement unit 501 with an automatic positive / negative polarity switching function.

[0061] Inspection apparatus 1 includes, in main body 401, a vacuum chamber 510, a wiper loader 520, a wiper loader (WL) control unit 530, a mass flow controller (MFC) 540, a power supply unit 550, a exhaust pump (DP) 560, and a He gas cylinder 570. Vacuum chamber 510 includes a mass measurement unit (in other words, a mass analysis unit) 501, an ion source 502, a turbo molecular pump 503, a He control unit 504, a control board 505, and the like.

[0062] The wiper loader 520 is a specimen introduction section that introduces a specimen holder 6 that stores a wipe-type specimen 5, and has an input port that opens to the front of the device and a fan, and introduces the specimen holder 6 that holds the specimen 5. From the introduced specimen holder 6, a sample gas corresponding to the specimen 5 is introduced into the vacuum chamber 510.

[0063] Wiper loader (WL) control unit 530 is a unit that includes a PLC (programmable logic controller) and controls the operation of wiper loader 520 .

[0064] The mass flow controller (MFC) 540 is a unit that controls the flow of gases such as sample gas and buffer gas (e.g., He gas). The MFC 540 is connected to the control board 505, and controls the air pump, flow rate, pressure, and the like based on the control from the control board 505. The MFC 540 has a filter that opens on the front of the device, and exhausts excess sample gas to the outside.

[0065] The turbo molecular pump 503 is connected to the mass measurement unit 501 and performs vacuum evacuation. The exhaust pump (DP) 560 is connected to the turbo molecular pump 503 and performs vacuum evacuation to the outside based on the control from the control board 505.

[0066] He gas cylinder 570 supplies He gas through piping to He control unit 504. Although He gas cylinder 570 is illustrated as a component of inspection apparatus 1, it may be regarded as an installation outside inspection apparatus 1. He control unit 504 supplies He gas supplied from He gas cylinder 570 to mass measurement unit 501.

[0067] The power supply unit 550 generates DC power based on an external AC power input, and supplies the necessary power to each unit.

[0068] In the vacuum chamber 510, the control board 505 controls the components of the vacuum chamber 510. The control board 505 corresponds to a controller that mainly controls the measurement of the inspection device 1. The control board 505 receives instructions from the PC 403. The PC 403 can give instructions to the WL control unit 530, the control board 505 of the vacuum chamber 510, and the like.

[0069] A mass measurement unit (mass analysis unit) 501, the details of which will be described later, measures the mass spectrum of an ionized sample gas supplied through an ion source 502. A signal of the mass spectrum measured by the mass measurement unit 501 is sent to the PC 403 for data processing.

[0070] An overview of mass measurement in the testing device 1 is as follows. A tester U3 introduces a specimen holder 6 into the wiper loader 520. The wiper loader 520 supplies a sample gas corresponding to the specimen 5 to the ion source 502 in the vacuum chamber 510 under the control of the WL control unit 530. In detail, the wiper loader 520 generates a sample gas 603 from the specimen 5 on the gauze (wiper) 602 of the specimen introducer 601 (FIG. 6), and the sample gas 603 is supplied to the ion source 502 in the vacuum chamber 510 through piping under the control of the MFC 540.

[0071] In the ion source 502, the sample gas 603 is ionized. The ionized sample gas 604 is supplied into the chamber of the mass measurement unit 501. Excess sample gas is exhausted to the outside through the MFC 540. In the mass measurement unit 501, the introduced ionized sample gas 604 is subjected to mass separation and structural analysis. Details are shown in FIG. 6.

[0072] A mass spectrum measurement signal is obtained by measurement in the mass measurement unit 501. The measurement signal (in other words, the detection signal) is sent to the PC 403, where data processing is performed to obtain mass spectrum measurement data (mass measurement data). In the PC 403, the target component substance of the specimen 5 is identified based on the mass measurement data and internal database information, and test result data is generated.

[0073] [Mass measurement part of the inspection device] FIG. 6 shows a configuration example of the mass measurement unit 501 and the like in FIG. 5. The mass measurement unit 501 and the ion source 502 constitute an ion optical system 600. The mass measurement unit 501 has end cap electrodes 605 and 607 (in other words, lens electrodes) and a ring electrode 606 in its chamber. Ionized sample gas 604 (in other words, ions) introduced into the chamber passes through the end cap electrode 605, the ring electrode 606, and the end cap electrode 607 in this order and is detected as a detection signal by a detector 608. A high-frequency voltage is applied to the end cap electrodes 605 and 607. A high-frequency voltage is applied to the ring electrode 502. In this configuration example, an ion trap type having a ring electrode 606 is shown, but a linear ion trap type in which the electrodes are linear may also be used.

[0074] In this configuration example, ions 609 are held in a trap formed by end cap electrodes 605, 607 and a ring electrode 606. When the radio frequency voltage of the ring electrode 606 is increased, ions 609 with small m / z are released and detected by a detector 608. In this manner, a mass spectrum is obtained by separation according to the m / z of the ions 609 corresponding to the components.

[0075] [Mass spectrum] FIG. 7 shows an example of a mass spectrum obtained as a result of measurement and analysis by the mass measurement unit 501 of the inspection device 1. FIG. 7(A) shows an example of a mass spectrum obtained by measurement in the form of a waveform. The horizontal axis is m / z, and the vertical axis is signal intensity. Since the sample gas contains multiple component substances, the mass spectrum contains a mixture of multiple peaks (e.g., peaks 701, 702). For example, by comparing the integrated value of the signal intensity within the measurement range centered on the m / z peak value with a threshold value, it is possible to determine whether or not a specific target component substance is present.

[0076] 7B is another example of a mass spectrum. In this example, for example, peak 703 and peak 704 can be observed. Peak 703 is near m / z 200, and peak 704 is near m / z 230. An example of a component substance corresponding to peak 703 is trichlorophenol. An example of a component substance corresponding to peak 704 is tetrachlorophenol.

[0077] [Computer system: PC] Fig. 8 shows an example of the configuration of a computer system related to the PC 403 of the inspection device 1. The computer system in Fig. 8 has a computer 1000, and an input device 1005 and an output device 1006 that are externally connected to the computer 1000. A specific user U3, here an inspection implementer U3, utilizes the functions of the PC 403, which is a computer system, by operating the input device 1005 and the output device 1006, or the management terminal 20 as a client terminal.

[0078] The computer 1000 includes a processor 1001, a memory 1002, a communication interface device 1003, an input / output interface device 1004, and the like, which are connected to each other via an architecture such as a bus. The processor 1001 includes, for example, a CPU, a ROM, a RAM, and the like. The memory 1002 includes a non-volatile storage device, an auxiliary storage device, and the like. The communication interface device 1003 includes a communication interface with the communication network 900 and a communication interface corresponding to the control board 505 of the main body 401 of the inspection device 1, and the like. An input device 1005 and an output device 1006 are connected to the input / output interface device 1004. Examples of the input device 1005 include a keyboard and a mouse, and examples of the output device 1006 include a display and a printer. The input device 1005 and the output device 1006 may be configured as a touch panel.

[0079] The memory 1002 stores, for example, a control program 1011, setting information 1012, a database (DB) 1013, screen data 1014, and the like. The control program 1011 is a program that realizes a predetermined function. The processor 1001 realizes the predetermined function as an execution module by executing processing according to the control program 1011 read from the memory 1002. The setting information 1012 is system setting information and user setting information related to the control program 1011. The DB 1013 is a database that stores, for example, data for analysis of target component substances and test result data. The screen data 1014 is data to be displayed on the screen of a display device that is the output device 1006.

[0080] A client-server system may be configured by connecting the PC 403 as a server to the management terminal 20 of Fig. 1 as a client terminal via a LAN. Each device in Fig. 1 may be similarly configured as a computer system as shown in Fig. 8.

[0081] [Computer system: Server] Fig. 9 shows an example of the configuration of a computer system related to server 30. The computer system in Fig. 9 has a computer 3000, and an input device 3005 and an output device 3006 that are externally connected to computer 3000. A specific user U4, here an administrator U4 of intermediary business operator 300, uses the functions of server 30, which is a computer system, by operating input device 3005 and output device 3006, or a client terminal.

[0082] The computer 3000 includes a processor 3001, a memory 3002, a communication interface device 3003, an input / output interface device 3004, etc., which are interconnected via an architecture such as a bus. The processor 3001 includes, for example, a CPU, a ROM, a RAM, etc. The memory 3002 includes a non-volatile storage device, an auxiliary storage device, etc. The communication interface device 3003 includes a communication interface with the communication network 900. An input device 3005 and an output device 3006 are connected to the input / output interface device 3004.

[0083] The memory 3002 stores, for example, a control program 3011, setting information 3012, a database (DB) 3013, screen data 3014, and the like. The control program 3011 is a program that realizes a predetermined function. The processor 3001 realizes the predetermined function as an execution module by executing processing in accordance with the control program 3011 read from the memory 3002. The setting information 3012 is system setting information and user setting information related to the control program 3011. The DB 3013 is a database that stores data such as a questionnaire 7 and a report 8. The screen data 3014 is data for displaying the Web page 31.

[0084] [Inspection flow using inspection equipment] 10 shows the flow of testing (in other words, measurement, analysis, etc.) in the testing device 1. In step S101, testing of a sample 5 is started in the testing device 1. For example, a tester U3 checks information about the sample 5 to be tested on the screen of the PC 403, sets the sample holder 6 in the testing device 1, and then presses a measurement start button on the screen of the PC 403.

[0085] In step S102, the inspection device 1, as described above (FIGS. 5 and 6), controls the mechanism to measure the mass spectrum of the specimen 5, thereby obtaining mass measurement data. That is, data on the signal intensity of m / z, as shown in the example of FIG. 7, is obtained as the component amount related to the target component substance. The PC 403 obtains the mass measurement data and stores it in memory.

[0086] In step S103, the PC 403 executes processing by the function 1200 for determining whether a sample is inappropriate. Details will be described later. When making this determination, the PC 403 also refers to questionnaire input information (in other words, test subject information) necessary for the determination and information on the reference range for each determination condition. The determination in step S103, which will be described later, is such that for each determination condition, the component amount of the measurement result is compared with the reference range, and if it is within the reference range, the determination condition is cleared.

[0087] Step S104 is a branch according to the judgment result of function 1200. If the sample is judged to be inappropriate (NG), the process proceeds to step S105, where the sample is confirmed and a retest is requested. If the sample is judged to be appropriate (OK), in other words, if the judgment conditions for an inappropriate sample are not met, the process proceeds to step S106.

[0088] In step S106, the test result of the simplified drug test is judged. For example, if the amount of an illegal drug detected as the target component substance exceeds a threshold, the test result is NG, that is, drugs are detected. Step S7 is a branch according to the test result. If drugs are detected, the process proceeds to step S108, where a detailed test is requested. If drugs are not detected, the process proceeds to step S109.

[0089] In step S109, the inspection of the specimen 5 by the inspection device 1 is completed. The inspection device 1 outputs the inspection result of the specimen 5 (including the judgment result of the function 1200). If there are other specimens 5 among the multiple specimens 5 at the customer establishment 100, the inspection is repeated in the same manner. In step S110, the PC 403 of the inspection device 1, or the management terminal 20, or the server 30 creates a report 8 based on the inspection result data. In this example, the server 30 creates the report 8 based on the inspection results. The intermediary business 300 sends a report form corresponding to the report 8 to the customer establishment 100 by mail. Alternatively, the intermediary business 300 posts a web page 31 corresponding to the report 8, and the customer establishment 100 views the report 8 on the web page 31.

[0090] [questionnaire] The information in the questionnaire 7 may be acquired by providing a questionnaire form along with the test kit and having the person fill it out and return it, or by having the person fill it out on a questionnaire on the web page 31. In the former case, the information written on the questionnaire form may be read by OCR or the like and acquired as questionnaire input information, or the information written on the questionnaire form may be entered by a person at the intermediary business operator 300 on a screen described below. In either case, the acquired questionnaire input information, in other words, test subject information, is input into the PC 403 of the testing device 1.

[0091] FIG. 11 shows an example of the structure of a questionnaire as an example of the structure of the questionnaire 7. The questionnaire in FIG. 11 has columns for entering the personal ID, age, and sex corresponding to the test subject U1. The questionnaire in FIG. 11 also has columns for entering the current medical history, past medical conditions, and medication history. The questionnaire in FIG. 11 also has a question 1, "Have you used the following drugs in the past month?", and a column for entering yes / no for each drug, such as tobacco, alcohol, marijuana, and stimulants. The questionnaire in FIG. 11 also has a column for entering the frequency of use of the substance as question 2, if question 1 indicates that the drug has been used.

[0092] Fig. 12 shows an example of the configuration of a questionnaire input screen on a web page 31, as an example of the configuration of the questionnaire 7. The screen in Fig. 12 has the same items as in Fig. 11, and input can be made using GUIs such as check boxes, list boxes, or text boxes.

[0093] [Inspection subject information input screen] Fig. 13 shows an example of the configuration of an inspection subject information input screen when inspection subject information is input based on questionnaire information in the system of intermediary business operator 300. Intermediary business operator 300 inputs inspection subject information into a screen like that shown in Fig. 13 based on the questionnaire information acquired from customer establishment 100. Note that if the questionnaire information has been input from the beginning in a web format like that shown in Fig. 12, input on this screen may be omitted and that questionnaire information may be used as is.

[0094] In the inspection target information input screen in Fig. 13, for example, an administrator U4 of the intermediary business operator 300 inputs inspection target information based on questionnaire information. The screen in Fig. 13 has the same items as the questionnaire information in Fig. 11 and Fig. 12. The basic input method allows the necessary information to be easily input by checking each item on the screen by clicking the check box or by selecting from options defined in a list box.

[0095] If the test subject U1 has a history of current illnesses, medications, or drug intake, the information can also be entered in the remarks column. If a detailed examination is required due to the detection of illegal drugs, the test subject information can be provided and used on this screen.

[0096] Function 1200 for determining whether a sample is inappropriate handles target component substances from each viewpoint under multiple determination conditions described below. For this purpose, attribute information of test subject U1 corresponding to the sample 5 is required. Therefore, this testing system acquires questionnaire input information as attribute information of test subject U1 along with the sample 5 prior to testing. The questionnaire input information includes, for example, age, sex, smoking, and drinking habits. This testing system uses the acquired questionnaire information, in other words, test subject information, for making a determination in function 1200. Function 1200 makes a determination using the questionnaire information together with mass measurement data, which is the measurement result of the test.

[0097] The questionnaire information obtained through this testing system can also be provided and used during detailed testing.

[0098] In addition, when there is no input information in the questionnaire 7, even if the information of the test subject U1 is not entered on the test screen, the test can be performed by the test device 1. In this case, the related process is skipped for the items for which there is no input.

[0099] [Report] FIG. 14 shows an example of the configuration of a report form as an example of the report 8 for notifying the test result. The report form in FIG. 14 lists information such as the order number, the date of receipt of the specimen, and the number of specimens received. The report form in FIG. 14 also lists information such as the date of the test, the total number of people tested, the number of people for whom drugs were not detected, and the number of people for whom drugs were detected, as "Test Results (Summary)". The report form in FIG. 14 also lists information such as the result, detected components, %, and request for each individual ID of the test subject U1, as "Test Results (List)". In the result item, the test result of illegal drugs, etc. is listed as "detected" (NG) or "not detected" (OK). In the result item, when the test result of the function 1200 for determining an inappropriate sample is determined to be an inappropriate sample, "inappropriate sample" is listed. In the detected components item, the detected component substances are listed when illegal drugs, etc. are detected. In the % item, information on the accuracy of detection when illegal drugs, etc. are detected, for example, information on an estimated period in the past when the drug was taken, is listed. The requirements section includes requests based on the results, such as a request for detailed testing in the case of a "detection" and a request for retesting in the case of an "inappropriate specimen."

[0100] FIG. 15 shows an example of the configuration of a report data screen on a Web page 31 as an example of a test result notification report 8. The screen of FIG. 15 displays information on the same items as in FIG. 14. In addition, in the screen of FIG. 15, for example, a Details button is provided in the request item, and when the user presses the Details button, detailed information is displayed and can be confirmed. For example, when the Details button is pressed in a row in which the result is "inappropriate sample," the judgment result of "inappropriate sample" and a comment regarding the request for "retest" are displayed as shown in the figure. The comment is, for example, a message such as "This is an inappropriate sample. There is a possibility that the sample has been replaced or mixed up. Please collect the sample again and perform a retest." In addition, the Details button may be used to transition to a screen for requesting a retest.

[0101] Regarding function 1200, it is possible to use functions other than the example of the alert output of "inappropriate specimen" shown in FIG. 14 or FIG.

[0102] [Customer ID management] The system of the intermediary business 300 or the testing business 200 manages customer IDs. This is to prevent the business from mixing up the samples 5. The system of the intermediary business 300 or the testing business 200, for example, the server 30, manages data including information identifying the customer business 100 (customer business ID) and information identifying the test subject U1 (test subject ID, the above-mentioned personal ID).

[0103] Fig. 16 shows an example of a customer ID management table on the business side. The customer ID management table 1600 in Fig. 16 has, as items, customer establishment IDs for multiple customer establishments 100, test subject IDs for multiple test subjects U1, sample acquisition date, sample testing date, and presence or absence of inappropriate sample. The sample acquisition date is the date and time that the testing establishment acquired the sample 5. The sample testing date is the date and time that the testing establishment tested the sample 5. The presence or absence of inappropriate sample refers to whether the sample was determined to be inappropriate with respect to function 1200.

[0104] A business operator, for example, server 30, associates various data including the above-mentioned customer ID management table 1600, questionnaire information (in other words, test subject information) 1601, and test result data 1602 (or report data) and manages the data in a DB (database) or the like.

[0105] [Function to determine inappropriate samples] Fig. 17 shows an overview of a function 1200 for determining an inappropriate sample as a characteristic function of the PC 403, which is the controller of the testing device 1. The PC 403 realizes the testing function 1100 and the function 1200 for determining an inappropriate sample by the processor 1001 executing processing in accordance with the control program on the memory 1002 based on the base configuration as shown in Fig. 8 described above.

[0106] The inspection device 1 includes a basic inspection function 1100. The inspection function 1100 is a function that, when a predetermined illegal drug or the like is treated as a target component substance and the component amount of the target component substance (the signal intensity of m / z in the mass spectrum described above) exceeds a predetermined value (in other words, a reference value, an upper limit value, or the like), determines that the illegal drug or the like may have been taken, gives a test result of NG (detected), and requests a detailed inspection.

[0107] During the inspection process, the inspection function 1100 obtains mass measurement data 1701 as measurement result data based on a detection signal (in other words, a measurement signal) from the control board 505 of the inspection device 1. The inspection function 1100 determines the inspection result based on the mass measurement data 1701 and preset target component substance data 1702, and creates inspection result data 1703.

[0108] During the test process, the function 1200 for determining whether a sample is inappropriate refers to mass measurement data 1701, test subject information 1704, which is questionnaire information, and reference range information 1705, and determines whether the sample is inappropriate. The function 1200 enters the determination result in the test result data 1703 generated by the test function 1100.

[0109] The PC 403 stores the inspection result data 1703 including the judgment result of the function 1200, and outputs it to the management terminal 20 or the server 30. Note that the inspection result data by the inspection function 1100 and the judgment result data by the function 1200 may be generated separately or integrally.

[0110] The function 1200 for determining whether a sample is inappropriate is, in other words, a sample determination function, and is a function for determining the possibility of switching or mix-up. This function 1200 includes at least four functions, in other words, determination conditions. This function 1200 has a function 1201 for determining whether a sample is consistent with attributes such as age and sex as determination condition 1, a function 1202 for determining whether a sample was collected from a person as determination condition 2, a function 1203 for determining whether a sample is consistent with the effects of smoking as determination condition 3, and a function 1204 for determining whether a sample is consistent with the effects of drinking alcohol as determination condition 4.

[0111] In the first embodiment, the function 1200 judges the four judgment conditions of the above four functions, respectively, and judges the sample to be inappropriate if at least one judgment result corresponds, i.e., if it is outside the reference range described below. In other words, if all judgment results do not correspond to the four judgment conditions, i.e., if they are within the reference range, the sample is judged to be appropriate. In other words, an inappropriate sample is a presumption that the sample was not collected from the individual in question, or that there is a possibility that it has been swapped or mixed up.

[0112] [Function to judge inappropriate samples: Judgment conditions] 18 shows the contents of four functions 1201 to 1204 for four determination conditions as the contents of a function 1200 for determining whether a specimen is inappropriate. The contents of each function are as follows.

[0113] Judgment condition 1: Function 1201 for judging whether the sample is consistent with attributes such as age and sex: This function 1201 refers to attribute information such as the age and sex of the test subject U1 corresponding to the target sample 5 from the questionnaire information 1704. This function 1201 obtains the hormone component amount ratio as the measurement result of the sample 5 from the mass measurement data 1701. This function 1201 refers to the reference range of the hormone component amount ratio corresponding to the age and sex of the sample 5 from the reference range information 1705. This function 1201 compares the hormone component amount ratio of the measurement result with the reference range, and judges that the sample is inappropriate if it is outside the reference range. In other words, the judgment result by this function 1201 corresponds to an estimation that the measured sample 5 is not consistent with the age, sex, etc. of the test subject U1.

[0114] For example, the types and balance of hormones differ between men and women. Also, the types and balance of hormones differ between men in their teens and men in their fifties. If sample 5 is collected from a person with attributes different from the subject, this will appear as a difference in the amount of the target component substance. Therefore, in function 1201, by examining the ratio of hormone component amounts, it can be estimated whether sample 5 is consistent with the attributes of the test subject, and whether it may have been collected from a person with attributes different from the subject.

[0115] Judgment condition 2: Function 1202 for judging whether the sample is collected from a human: This function 1202 obtains, from the mass measurement data 1701, a component amount ratio in which a component substance specific to human body fluids (in other words, a substance derived from a human) is used as a target component substance as a measurement result of the sample 5. This function 1201 refers to the reference range of the component amount ratio of the target component substance derived from a human from the reference range information 1705. This function 1202 compares the component amount ratio of the target component substance derived from a human in the measurement result with the reference range, and judges that the sample is inappropriate if it is outside the reference range. In other words, the judgment result by this function 1202 corresponds to an estimation that the measured sample 5 is not a sample collected from a human.

[0116] In the case of a sample collected from any object other than the human test subject, for example, a sample wiped from a wall, desk, bag, clothing, animal, food, drink, etc., the amount of human-derived components in the sample is often 0 or small, and the sample often contains a large amount of impurities other than human-derived components. Therefore, function 1202 can estimate whether sample 5 was collected from the human test subject by examining the amount of human-derived components and the amount of impurities.

[0117] Judgment condition 3: Function 1203 for judging whether the sample is compatible with the influence of smoking: This function 1203 refers to information on the situation of the test subject U1 corresponding to the target sample 5, such as whether or not the test subject U1 smokes, from the questionnaire information 1704. This function 1203 obtains the component amount ratio of tobacco as the target component substance as the measurement result of the sample 5 from the mass measurement data 1701. This function 1203 refers to the reference range of the component amount ratio of tobacco as the target component substance in the sample 5 from the reference range information 1705. This function 1203 compares the component amount ratio of tobacco as the target component substance of the measurement result with the reference range, and judges that the sample is inappropriate if it is outside the reference range. In other words, the judgment result by this function 1203 corresponds to an estimation that the measured sample 5 is not compatible with the influence of smoking of the test subject U1.

[0118] Judgment condition 4: Function 1204 for judging whether the sample is consistent with the influence of alcohol: This function 1204 refers to information on the situation of the test subject U1 corresponding to the target sample 5, such as whether or not the test subject U1 has drunk alcohol, from the questionnaire information 1704. This function 1204 obtains the component amount ratio of alcohol as the target component substance from the mass measurement data 1701 as the measurement result of the sample 5. This function 1204 refers to the reference range of the component amount ratio of alcohol as the target component substance of the sample 5 from the reference range information 1705. This function 1204 compares the component amount ratio of alcohol as the target component substance of the measurement result with the reference range to be referred to, and judges that the sample is inappropriate if it is outside the reference range. In other words, the judgment result by this function 1204 corresponds to an estimation that the measured sample 5 is not consistent with the influence of alcohol of the test subject U1.

[0119] The effects of tobacco and alcohol intake are manifested as related substances being included in some of the bodily fluids. Therefore, in function 1203 and function 1204, by examining the amounts of tobacco-related substances and alcohol-related substances, it is possible to estimate whether sample 5 is consistent with the smoking and drinking habits of the test subject, and whether it may have been collected from someone with different smoking and drinking habits than the test subject.

[0120] [Amount of target ingredient] FIG. 19 shows an example of the signal intensity of the mass-to-charge ratio (m / z) of the mass spectrum as the component amount of the target component substance. In the example of FIG. 19, the detection result of a specific component derived from a human, contained in a sample obtained by collecting skin tissue as a human body fluid, is shown as the target component substance. For example, in the function 1202 of the judgment condition 2, such a component derived from a human can be used as the target substance. The mass spectrum of (A) shows a part of the m / z range with negative ion polarity, and the mass spectrum of (B) shows a part of the m / z range with positive ion polarity. In (A), lactic acid is detected with a signal intensity peak near m / z 90. In (B), urea is detected near m / z 60, glycine propionate near 74, 3-methylbutane near 102, and n-heptanal near 115.

[0121] [impurities] FIG. 20 shows a case where impurities are present at all m / z positions in the mass spectrum. Such a case is referred to as impurities. Impurities are substances other than human body fluids. When a large amount of impurities are detected in the measurement results like this, even if there is a peak at the m / z position of the target component substance, it is doubtful whether the sample was collected from a human. Therefore, function 1202 of judgment condition 2 also takes into account the amount of impurities. In function 1202, for example, all points where a certain level of signal intensity is present are counted as impurities, and the total amount of impurities is calculated. In function 1202, if the total amount of impurities exceeds a predetermined value, it is presumed that the sample was not collected from a human.

[0122] In the first embodiment, the function 1200 implements all of the above judgment conditions 1 to 4, but is not limited to this and may implement at least one of them. When multiple judgment conditions are judged, the judgment accuracy can be improved.

[0123] [Judgment condition 1] FIG. 21 shows a specific example of the determination of whether a specimen is age- and sex-matched in the function 1201 of the determination condition 1. In the processing example of the determination condition 1, the component amount ratio of multiple types of hormones, which are target component substances, is used. Examples of hormones, which are target component substances, include testosterone and estradiol. Hormone secretion differs according to age and sex, and the component amount ratio of hormones differs. For example, the component amount ratio of testosterone to estradiol differs. The m / z of testosterone is 289, and the m / z of estradiol is 272. In the function 1201 of the determination condition 1, multiple categories are set, for example, males in their teens and females in their teens, and a reference range is set for each category.

[0124] For example, testosterone is A, estradiol is B, and the ratio of the amounts of the components is expressed as A:B. In this case, for example, in the male teens category, the reference value of the ratio of the amounts of the components is A1:B1, and in the female teens category, the reference value of the ratio of the amounts of the components is A2:B2. Note that although the ratio of the amounts of the components is expressed as a ratio (A:B) here (where the colon ":" indicates a ratio), it may also be expressed as a ratio (R=A / B) (where the slash " / " indicates division). In addition, a range (for example, a lower limit and an upper limit) is set for the reference value. For example, for the ratio of A1:B1 (R1=A1 / B1), the lower limit is set as R1min and the upper limit is set as R1max.

[0125] Based on the information of Questionnaire 7, assume that the person being tested, U1, is, for example, a male in his teens. In Function 1201, a reference range corresponding to males in their teens, for example, {R1min~R1max}, is referred to. In Function 1201, the component quantity ratio of hormones A and B in the measurement result, for example, ratio R1 = A1 / B1, is obtained. In Function 1201, the ratio R1 of the component quantity ratio is compared with the reference range {R1min~R1max}. If it is outside the reference range, that is, if R1 is less than the lower limit value R1min (R1 < R1min), or (OR), if R1 exceeds the upper limit value R1max (R1 > R1max), the test sample is judged as an inappropriate sample as the judgment result. If the sample 5 submitted by the person being tested, U1, is a sample collected from another person, for example, a female in her twenties, the measurement result does not match the characteristics of the hormones of a male in his teens, so the test sample is judged as an inappropriate sample as the judgment result.

[0126] [Judgment Condition 2] Figure 22 shows a specific example of the judgment of whether a sample is collected from a person in Function 1202 of Judgment Condition 2. In the processing example of Judgment Condition 2, the total value of the component quantities of the components derived from a person and the total value of the impurity quantities are used. As the component derived from a person that is the target component substance, for example, nonanal, lactic acid, 3-methylbutane, urea, etc., as shown in FIG. 19, can be used. The m / z of nonanal is 140, the m / z of lactic acid is 90, the m / z of 3-methylbutane is 102, and the m / z of urea is 60.

[0127] In Function 1202, a reference range is provided for each component substance derived from a person that is the target component substance, or with respect to the total amount of the components derived from a person. In Function 1202, the component quantity for each component substance derived from a person and their total value are calculated. In Function 1202, it is also possible to compare with the reference range for each component substance derived from a person, or as a simpler judgment, use the total value of the component quantities of the component substances derived from a person and compare with the reference range regarding the total value.

[0128] In this example, the human-derived components are nonenal as substance a, lactic acid as substance b, 3-methylbutane as substance c, and urea as substance d, and the respective component amounts are a1, b1, c1, and d1. The total component amount of these four types of substances is SH=a1+b1+c1+d1. A reference range may be set for each human-derived component. For example, for substance a, a reference range {a1min to a1max} is set with a lower limit a1min and an upper limit a1max. Furthermore, a reference range {SHmin to SHmax} is set with a lower limit SHmin and an upper limit SHmax as the reference range for the total value SH.

[0129] When judging for each individual component, for example, if the component amount a1 of substance a in the measurement result of sample 5 is less than the lower limit a1min of the reference range, the sample is judged to be inappropriate. Similarly, if the component amount b1 of substance b is less than the lower limit b1min, if the component amount c1 of substance c is less than the lower limit c1min, or if the component amount d1 of substance d is less than the lower limit d1min, the sample is judged to be inappropriate. When judging by the total value, for example, if the total value SH of the component amounts of four types of substances in the measurement result of sample 5 is less than the lower limit SHmin of the reference range, the sample is judged to be inappropriate.

[0130] Furthermore, function 1202 may further make a judgment using the amount of impurity components in the measurement results of sample 5. Impurities are substances other than human-derived components. When making this impurity judgment, function 1202, for example, calculates the total amount of impurity components. The total amount of impurity components is set as SI. Function 1202 sets, for example, a lower limit SImin and an upper limit SImax as a reference range for the total amount of impurity components. Function 1202 judges the sample to be inappropriate when the total amount of impurity components SI in the measurement results of sample 5 exceeds, for example, the upper limit SImax.

[0131] If the sample 5 submitted by the test subject U1 is, due to substitution or other reasons, not a bodily fluid taken from the test subject U1 but from a non-living object, the measurement results will not match the components derived from a human being, and the sample will be determined to be inappropriate.

[0132] Furthermore, in function 1202 of judgment condition 2, attributes such as age and sex of judgment condition 1 may be combined. For example, function 1202 may refer to the age and sex of the sample based on questionnaire information, and refer to the standard range of human-derived constituent substances that differs according to the age and sex classification. For example, in the case of a middle-aged man, the standard range of a specific substance (such as nonenal) corresponding to a middle-aged man may be referred to.

[0133] [Criteria 3] FIG. 23 shows a specific example of the determination of whether a specimen is consistent with the influence of smoking in the function 1203 of the determination condition 3. From the questionnaire information, it is assumed that the test subject U1 has a habit of smoking and drinking, for example. In the determination condition 3, for example, nicotine, benzofuran, D-limonene, and 4-ethylpyridine are handled as target component substances related to tobacco, and these four types of substances are substances e, f, g, and h, the amounts of each component are e1, f1, g1, and h1, and the total amount thereof is ST=e1+f1+g1+h1. In the function 1203, a reference range is set for each individual substance. For example, it is set as {e1min to e1max} for the substance e. In addition, a reference range for the total value of the component amounts of the four types of substances is set as {STmin to STmax}. These reference ranges are set as different values ​​depending on, for example, the presence or absence of smoking.

[0134] For example, since the test subject U1 has a smoking habit, the reference range corresponding to smoking is referenced in function 1203. In the case of individual judgment, if the component amount of the target component substance in the measurement result of the sample 5, for example e1, is less than the lower limit e1min, the sample is judged to be inappropriate. In the case of total value judgment, if the total value ST of the component amounts of the four target components is less than the lower limit STmin, the sample is judged to be inappropriate.

[0135] In the case of another test subject U1, if the test subject U1 does not smoke, the reference range corresponding to non-smoking is referred to. In the case of individual judgment, if the component amount of the target component substance in the measurement result, for example e1, exceeds the upper limit value e1max, the sample is judged to be inappropriate. In the case of total value judgment, if the total value ST of the component amounts of the four target component substances exceeds the upper limit value STmax, the sample is judged to be inappropriate.

[0136] If the sample 5 submitted by the test subject U1 is a bodily fluid collected from a person with a different smoking status due to switching or the like, the measurement result is determined to be an inappropriate sample because it does not match the smoking status (e.g., smoking). For the function 1204 of the judgment condition 4, the same processing example as that of the judgment condition 3 above can be applied.

[0137] [Component amounts and standard ranges] FIG. 24 shows an example of a comparison between the component amount of the above measurement result and the reference range as a supplement. In this example, the target component substance is lactic acid in FIG. 19(A). The m / z signal intensity is used as the component amount of lactic acid. In the case of lactic acid, the signal intensity peak value is near m / z 90. 2401 is the mass axis, which corresponds to the m / z peak value. 2402 is the signal intensity peak value. 2403 indicates the location of the peak of the waveform. 2404 is the mass width. 2405 is the intermediate mass width. In the embodiment, for example, the signal intensity peak value 2402 is used as the component amount of the target component substance. Not limited to this, the component amount may be various parameter values ​​(for example, intermediate mass width, resolution, integrated value, etc.) obtained from the waveform of the mass spectrum.

[0138] Regarding the signal intensity peak value 2402, which is the component amount, there is a reference range 2410 from a lower limit value Xmin to a lower limit value Xmax. Note that the reference range may also be expressed as a range having a width above and below the reference value as a center.

[0139] The parameter values ​​used to calculate the component amounts and the reference ranges can be set as control settings. The setting values ​​can be set in the control program of function 1200.

[0140] [Example of display screen on inspection device PC] FIG. 25 shows an example of a display screen on the PC 403 of the testing device 1. This example is an example in which, during the testing work by the tester U3, the results of the judgment by the function 1200 for judging inappropriate specimens are displayed as work support information on the screen of the PC 403. The tester U3 sequentially sets specimens in the testing device 1 according to the support information on the screen and performs the testing work. When a specimen is judged or detected as inappropriate by the function 1200 for judging inappropriate specimens during the test, an alert is output on the screen as "inappropriate specimen". In addition, detailed comments may be displayed by pressing the details button for "inappropriate specimen". For example, the comment may be a message such as "This is an inappropriate specimen. There is a possibility that the specimen has been replaced or mixed up. Please recheck the specimen that has been set." The alert output is not limited to display only, and may also be combined with voice output or message notification. The tester U3 receives the alert output "inappropriate specimen" on the screen and checks the specimen 5 (specimen holder 6) set in the testing device 1.

[0141] Also, the function 1200 for determining whether a sample is inappropriate can be turned on or off on the screen. For example, when a sample 5 is directly collected from a test subject U1 and the sample 5 is used for testing on-site using a testing device 1, the possibility of switching samples is low, so the test can be performed with the function 1200 turned off. In this case, there is no need to refer to or obtain questionnaire information. Step S103 in FIG. 10 is skipped.

[0142] The target constituent substances vary depending on the type of test, such as illegal drug testing, doping testing, etc., and data (target constituent substance data 1702 in FIG. 17) is set in advance in the testing device 1. Although not shown, by specifying the type of test on the screen of PC 403, it is possible to make a judgment regarding the target constituent substance corresponding to the type of test.

[0143] [Variations] In the first embodiment, a form has been described in which attribute information such as the age of the test subject U1 is referenced from the questionnaire input information (in other words, the test subject information) in order to determine whether a sample is inappropriate in the function 1200. As a modified example, a sample may be determined to be inappropriate using only the mass measurement data without using the questionnaire input information (in other words, the test subject information).

[0144] In another modified example, the reference range for the component amount is not limited to a static set value, but may be a dynamically updated set value. FIG. 26 shows an example of generating a reference range in the modified example. In this modified example, the testing system, for example, the intermediary business 300 or the testing business 200, stores information on the results of many past tests and questionnaires in DB2501. Test result data 2502 including mass measurement data and questionnaire information 2503 are stored in DB2501. The testing system generates and updates a reference range for the component amount of the target component substance by statistics and learning 2504 based on the data in DB2501. A reference range 2506 and a learning model 2507 are stored in DB2505. When learning is used, the learning model 2507 is trained using, for example, unsupervised machine learning or supervised machine learning. In learning, for example, mass measurement data and questionnaire information (in other words, test subject information) are input, and whether or not the sample is inappropriate is output, and the parameter values ​​of the learning model 2507 are adjusted.

[0145] During testing by the testing device 1, when making a judgment using the function 1200, the judgment may be made by referring to the reference range 2506 obtained from past statistics. In addition, if a trained learning model 2507 is available, by inputting mass measurement data and questionnaire information to the learning model 2507, a judgment result as to whether or not the sample is inappropriate can be output as a result of inference by the learning model 2507.

[0146] [Effects of the embodiment] As described above, according to the testing method etc. of the first embodiment, the possibility of intentional swapping or falsification of a sample, or unintentional mix-up or misidentification, can be judged, detected and output as an inappropriate sample, which contributes to the optimization and efficiency of testing. According to the first embodiment, when a simplified testing service is provided to a customer via mail, an alert can be output to the effect that the sample is an inappropriate sample that is not a bodily fluid collected from the customer.

[0147] In the first embodiment, the testing device 1 is installed at location 2 of a testing business 200 that is remote from location 1 of a customer business 100, and the testing business 200 can provide simple drug testing services to the customer business 100 of a plurality of customers. The testing device 1 is used with function 1200 for determining whether a sample is inappropriate for a sample 5 submitted by a customer in an on-state. However, when the testing device 1 is installed at location 1 of the customer business 100, it may be used with function 1200 in an off-state.

[0148] In the first embodiment, a case has been described in which a simplified testing service is provided to a customer's business establishment 100 by cooperation between the system of the intermediary business 300 and the system of the testing facility 200, but the present invention is not limited to this. The system of the intermediary business 300 and the system of the testing facility 200 may be configured as an integrated system. A function 1200 for determining inappropriate samples may be implemented in a computer other than the testing device 1.

[0149] In a modified example, the server 30 may be equipped with a function 1200 for determining whether a sample is inappropriate. In this case, the server 30 acquires measurement result data and the like from the testing device 1 via communication. The server 30 determines whether a sample is inappropriate based on the questionnaire input information and the measurement result data, and if it determines that the sample is inappropriate, it outputs an alert or a report to the customer facility 100 and the testing facility 200 that the sample is inappropriate.

[0150] In the first embodiment, function 1200 provides a binary judgment result of the possibility that the sample is from someone other than the subject, i.e., presence or absence, but this is not limited to the above, and a multi-value judgment result is also possible. For example, by setting multiple thresholds in the comparison between the component amount and the reference range, it is possible to provide the judgment result in three or more levels or degrees. For example, the judgment result may be expressed as "There is a medium level of possibility that the sample is from someone other than the subject," or "The possibility is 80%."

[0151] The function 1200 in the first embodiment is implemented and used with four types of judgment conditions as shown in FIG. 18, but is not limited to this, and may be implemented and used with at least one judgment condition. In the case of only one judgment condition, if the judgment condition is met, the judgment result is an inappropriate sample. In the case of using a plurality of judgment conditions in combination, one method is to determine the judgment result as an inappropriate sample if any one of the judgment conditions is met. In another method, a comprehensive judgment may be made from the judgment results of the plurality of judgment conditions. For example, a comprehensive judgment result may be determined from the judgment results of the four judgment conditions described above by logical operations or other calculations. As an example, when the judgment results of each judgment condition are values ​​representing the degree of possibility, a comprehensive index value or evaluation value may be obtained by adding or multiplying the values ​​of the four judgment results.

[0152] The influence of tobacco and alcohol is reflected in samples collected from the surface of human skin and skin tissue. In addition, skin gases emitted from the human body are present on the surface of human skin, and the state of the skin gases is related to the physical and physiological state of the person. The influence of these substances can be taken into account as the component amounts of the measurement results of the sample, and it is possible to determine whether the sample is inappropriate or not depending on whether it is consistent with the characteristics of the test subject U1.

[0153] As another modification, information such as the current medical history of the test subject U1 based on the questionnaire information may be used to determine whether the sample is inappropriate. For example, in the case of diabetes, acetone is one of the substances in the skin gas that is closely related to diabetes. If acetone is treated as the target component substance and the amount of acetone is, for example, below a lower limit, it is possible to estimate that the sample is not the subject's.

[0154] Although the embodiments of the present disclosure have been specifically described above, they are not limited to the above-described embodiments and can be modified in various ways without departing from the gist of the present disclosure. In each embodiment, components can be added, deleted, or replaced, except for essential components. Unless otherwise specified, each component can be singular or plural. A combination of each embodiment and its modified examples is also possible. [Explanation of symbols]

[0155] 1...testing equipment, 5...sample, 6...sample holder, 7...questionnaire, 8...report, 10...work terminal, 20...management terminal, 30...server, 31...GUI (web page), 100...customer establishment, 200...testing establishment, 300...intermediary business operator, 900...communication network, 1200...function for determining whether or not a sample is inappropriate, U1...person to be tested, U2...worker, U3...person conducting the test.

Claims

1. A body fluid analysis method for analyzing a body fluid of a sample collected from a test subject using a mass spectrometer that is a testing device, comprising: The mass spectrometer is a device having a function of introducing the sample and measuring and analyzing the amount of a target component substance based on mass analysis, The steps performed by the mass spectrometer include: a determining step of determining whether the sample is an inappropriate sample based on the amount of the target component substance as a measurement result of the sample by the mass spectrometer, based on the possibility of substitution or mix-up of the sample; an output step of outputting a determination result when the sample is determined to be inappropriate; A body fluid analysis method comprising the steps of:

2. The method for analyzing body fluid according to claim 1, The location where the sample is collected from the test subject is different from the location where the test device that tests the sample is installed, a step of requesting a detailed examination when the amount of the detection target substance as the target component substance is equal to or greater than a reference value based on the measurement result; A step of requesting re-examination by collecting the sample again when the sample is determined to be inappropriate; A body fluid analysis method comprising the steps of:

3. The method for analyzing body fluid according to claim 1, The determination step includes determining the sample as inappropriate when a ratio of component amounts of a plurality of specific substances corresponding to the test subject as the target component substances of the sample is outside a reference range for the ratio. Body fluid analysis methods.

4. The method for analyzing body fluid according to claim 3, The specific substances according to the test subject are specific substances according to attributes including age and sex of the test subject. Body fluid analysis methods.

5. The method for analyzing body fluid according to claim 1, The determination step includes determining that the sample is inappropriate when a total value of component amounts of specific substances contained in the body fluid collected from a human being as the target component substances of the sample is outside a reference range for the total value. Body fluid analysis methods.

6. The method for analyzing body fluid according to claim 1, The determination step includes determining the sample as an inappropriate sample when a total value of the amount of impurities other than a specific plurality of substances contained in the body fluid collected from a human being as the target component substance of the sample is outside a reference range for the total value. Body fluid analysis methods.

7. The method for analyzing body fluid according to claim 1, The determination step includes determining the sample as an inappropriate sample when an amount of a specific substance related to smoking, which is the target component of the sample and corresponds to a smoking status of the test subject, is outside a reference range for the amount of the specific substance. Body fluid analysis methods.

8. The method for analyzing body fluid according to claim 1, The determination step includes determining the sample as an inappropriate sample when an amount of a specific substance related to alcohol consumption, which is the target component substance of the sample and corresponds to the drinking situation of the test subject, is outside a reference range for the amount of the substance. Body fluid analysis methods.

9. The method for analyzing body fluid according to claim 1, Acquiring information on a questionnaire containing information on the test subject in association with the acquisition of the sample; The determining step includes making the determination using information of the questionnaire. Body fluid analysis methods.

10. The method for analyzing body fluid according to claim 1, outputting a report of the test result of the sample, including the determination result when the sample is determined to be an inappropriate sample, to a customer including the test subject; Body fluid analysis methods.

11. A body fluid analysis system that analyzes body fluids of a sample collected from a test subject using a mass spectrometer that is a testing device, comprising: The mass spectrometer is a device having a function of introducing the sample and measuring and analyzing the amount of a target component substance based on mass analysis, The mass spectrometer is determining whether the sample is an inappropriate sample based on the amount of the target component substance as a measurement result of the sample by the mass spectrometer, and outputting a determination result when the sample is determined to be inappropriate; Body fluid analysis system.

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