Determination device, determination method, and program

Abstract

To reduce the time spent on unnecessary decision-making. [Solution] The determination device of the embodiment comprises an acquisition unit, an estimation unit, and a determination unit. The acquisition unit acquires an index value relating to the number of labeled substances upstream of the detection position in the sample solution that is spread on the test paper and flows through the detection position on the test paper. The estimation unit estimates the number of labeled substances captured at the detection position based on the acquired index value. The determination unit determines the timing of the determination when performing a determination based on the number of labeled substances at the detection position when predetermined conditions are met, based on the estimated number of labeled substances.

Description

Technical Field

[0001] The embodiments disclosed in this specification and the drawings relate to a determination device, a determination method, and a program.

Background Art

[0002] In an immunochromatographic test, for example, it is determined whether a positive determination due to an antigen contained in a test sample fluid is positive or negative. In an immunochromatographic test, for example, a test sample fluid is dropped onto a test strip on which a labeling substance is arranged, and the test sample fluid is developed on the test strip for a certain period of time, for example, 15 minutes. On the test strip, a test line and a control line are set.

[0003] The test line develops color by capturing an antigen, and the control line develops color by capturing a labeling substance. The control line is set at a position farther from the test line than the position where the test sample fluid is dropped on the test strip. Therefore, when the control line develops color, the capture of the antigen on the test line is completed, and if the test line has developed color, it is determined as positive, and if not, it is determined as negative.

[0004] In an immunochromatographic test, there are individual differences between chips and between samples in the time until sufficient color development is obtained on the test line to determine the presence or absence of an antigen after dropping the test sample fluid. However, the time from dropping the test sample fluid until determining the color development of the test line is often set according to the individual with the slowest color development of the test line. Therefore, depending on individual tests, the test time may be taken longer than necessary, and extra time may occur until determination.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

[0006] The problem that the embodiments disclosed herein and in the drawings aim to solve is to reduce the time required for decision-making. However, the problems that the embodiments disclosed herein and in the drawings aim to solve are not limited to the above problem. Problems corresponding to the effects of each configuration shown in the embodiments described later can also be positioned as other problems. [Means for solving the problem]

[0007] The determination device of the embodiment comprises an acquisition unit, an estimation unit, and a determination unit. The acquisition unit acquires an index value relating to the number of labeled substances upstream of the detection position in the sample solution that is spread on the test paper and flows through the detection position on the test paper. The estimation unit estimates the number of labeled substances to be captured at the detection position based on the acquired index value. The determination unit determines the timing for performing a determination based on the number of labeled substances at the detection position when predetermined conditions are met, based on the estimated number of labeled substances. [Brief explanation of the drawing]

[0008] [Figure 1] A diagram showing an example of the configuration of the determination device according to the embodiment. [Figure 2] A diagram illustrating one example of the process by which test paper TP changes color. [Figure 3] This diagram illustrates an example of the process by which the test line TL and control line CL on test strip TP develop color. [Figure 4] A graph showing an example of the time evolution of the number of uncaptured particles in the upstream region. [Figure 5] This figure illustrates an example of calculating the estimated number of particles from the graph shown in Figure 4. [Figure 6] A graph showing an example of how the change in particle number changes over time. [Figure 7]A graph showing an example of the time-dependent change in the color intensity of the test line TL. [Figure 8] A graph showing another example of the time-dependent change in color intensity of the test line TL. [Figure 9] A flowchart showing an example of processing in the determination device 100. [Figure 10] A flowchart showing an example of processing in the determination device 100. [Figure 11] A graph showing another example of the time-dependent change in color intensity of the test line TL. [Figure 12] This figure shows the relationship between the color intensity of the test line TL and the number of particles before capture. [Figure 13] This figure shows the relationship between the color intensity of the test line TL and the number of particles before capture. [Modes for carrying out the invention]

[0009] The following describes the determination device, determination method, and program of the embodiment with reference to the drawings.

[0010] Figure 1 shows an example of the configuration of the judgment system 1 of the embodiment. The judgment system 1 is used for testing for antigens contained in a sample solution, such as determining a positive result in an immunochromatographic test. The judgment system 1 includes, for example, a camera 20 and a judgment device 100. In the judgment device 100, the judgment system 1 estimates the color development state of the control line CL and test line TL on the test strip TP based on the image transmitted by the camera 20. Based on the estimated color development state of the control line CL and test line TL, the judgment device 100 makes a positive determination for the antigen contained in the sample solution.

[0011] Figure 2 is a diagram for explaining an example of the process in which the test strip TP develops color. In the test strip TP, a labeling substance SN has been impregnated in the vicinity of the dropping position of the test body fluid in advance. When the test body fluid LQ is dropped at the dropping position of the test strip TP, the antigen AN contained in the test body fluid LQ binds to the labeling substance SN and flows on the test strip TP. The antigen AN is developed on the test strip TP together with the labeling substance SN. On the test strip TP, the labeling substance SN bound to the antigen AN and the labeling substance SN not bound to the antigen AN are flowing.

[0012] When the antigen AN flowing on the test strip TP reaches the test line region TLC, it is captured at the test line TL together with the bound labeling substance SN, causing the test line TL to develop color. The labeling substance SN not bound to the antigen AN is captured by the test strip TP in the control line region CLC, causing the control line CL to develop color.

[0013] When there is no or little antigen contained in the test body fluid, there is no or little labeling substance (hereinafter referred to as bound labeling substance) bound to the antigen captured by the test strip TP in the test line region TLC, and the test line TL is not developed or hardly developed. Therefore, when there is no or little antigen contained in the test body fluid, as shown in the upper right figure of Figure 2, the control line CL is in a developed state and the test line is not in a developed state.

[0014] On the other hand, when the test body fluid contains an amount of antigen that can be determined as positive, as shown in the lower right figure of Figure 2, when the control line CL is in a developed state, the test line TL is also in a developed state. The determination device 100 estimates whether the test line TL and the control line CL will be in a developed state before the test line TL and the control line CL actually become developed.

[0015] Figure 3 illustrates an example of the process by which the test line TL and control line CL on the test strip TP develop color. When the sample solution is dropped onto one end of the test strip TP, as shown in (A) of Figure 3, the sample solution LQ flows from the drop point to the other end of the test strip TP, and eventually, as shown in (B), the sample solution LQ spreads throughout the entire surface of the test strip TP.

[0016] As the sample solution LQ spreads across the entire surface of the test strip TP, as shown in (C), the bound labeling substance is contained in the upstream region FA upstream of the test line TL, and is captured by the test line TL, causing the test line TL to gradually change color. On the other hand, the labeling substance that is not bound to the antigen (hereinafter referred to as the unbound labeling substance) is captured by the control line CL, causing the control line CL to gradually change color.

[0017] As time progresses, the sample solution LQ gradually decreases across the entire area of ​​the test strip TP, as shown in (D) and (E). Additionally, the bound labeling substance in the upstream region FA is captured by the test line TL in the test area TA, increasing the color intensity of the test line TL, while the unbound labeling substance is further captured by the control line CL, increasing the color intensity of the control line CL.

[0018] Subsequently, as shown in (F) to (H), the sample solution LQ on the test strip TP evaporates or is absorbed and almost disappears, and the control line CL and test line TL become colored. In this example, the result of the positive test is positive, but if the result of the positive test is negative, the control line CL becomes colored, and the test line TL remains colorless.

[0019] Camera 20 images the test paper TP on which the sample solution has been dropped. The test paper TP is placed on a stand, for example, and camera 20 is positioned to view the test paper TP on the stand. Camera 20 is, for example, a digital camera. Camera 20 may also be an analog camera. Camera 20 transmits the captured image to the determination device 100. The illumination system of camera 20 may be natural light or light in a specific wavelength band. Camera 20 can be any type, but for example, an immunochromatograph may be used. The immunochromatograph may be an absorbance type or a fluorescence type.

[0020] The determination device 100 includes, for example, a communication interface 110, an input / output interface 120, a processing unit 130, and a memory 150. The communication interface 110 is implemented by, for example, a network card, a network adapter, or a NIC (Network Interface Controller). The communication interface 110 controls the transmission and communication of various data sent and received between the determination device 100 connected via a network.

[0021] The input / output interface 120 includes, for example, a touch panel. The input / output interface 120 displays a GUI (Graphical User Interface) image and various other images to receive user instructions. The input / output interface 120 receives instructions from the user who operates the GUI. An input interface and an output interface may be provided instead of the input / output interface 120.

[0022] In this case, the input interface can be implemented using GUI images, or by means of, for example, a mouse, keyboard, touch panel, trackball, switch, button, joystick, camera, infrared sensor, microphone, etc. In this specification, the input interface is not limited to those equipped with physical operating components such as a mouse or keyboard. For example, an electrical signal processing circuit that receives an electrical signal corresponding to an input operation from an external input device located separately from the device and outputs this electrical signal to a control circuit is also included as an example of an input interface.

[0023] The processing unit 130 includes, for example, an acquisition function 131, an estimation function 132, and a decision function 133. The processing unit 130 realizes these functions, for example, by having a hardware processor execute a program stored in a memory device (memory circuit). A hardware processor refers to circuits such as a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), an Application Specific Integrated Circuit (ASIC), or a programmable logic device (e.g., a Simple Programmable Logic Device (SPLD) or a Complex Programmable Logic Device (CPLD), or a Field Programmable Gate Array (FPGA)). Instead of storing the program in memory 150, the program may be directly incorporated into the circuit of the hardware processor. In this case, the hardware processor realizes its functions by reading and executing the program incorporated into the circuit. The hardware processor is not limited to being configured as a single circuit; it may be configured as a single hardware processor by combining multiple independent circuits to realize each function. Alternatively, multiple components may be integrated into a single hardware processor to realize each function.

[0024] Memory 150 stores the test paper database (hereinafter referred to as DB) 151. The test paper DB 151 stores the thickness, length (area), and characteristic coefficient for each test paper TP. The thickness is the thickness of the test paper TP. The length is the length from the upstream end of the test line TL on the test paper TP to the test line TL.

[0025] The area of ​​the test paper TP (the area from the upstream end of the test line TL to the test line TL) is obtained by multiplying the length from the upstream end of the test line TL to the test line TL by the width of the test paper TP. The intrinsic coefficient is a value corresponding to the labeling substance impregnated into the test paper TP. Memory 150 stores the test paper DB151, as well as the first threshold TH1, the second threshold TH2, and the set maximum test time.

[0026] The acquisition function 131 acquires the brightness upstream of the test line TL on the test strip where the sample solution containing the antigen and labeling substance, which is spread on the test strip TP and flows along the test line TL, is spread. The test line region TLC where the test line TL is formed on the test strip TP is an example of the detection position. The brightness upstream of the test line TL on the test strip where the sample solution is spread is an example of an index value related to the number of labeling substances. The acquisition function 131 is an example of an acquisition unit.

[0027] In the following explanation, the side of the test strip TP where the sample solution is dropped from the test line TL is referred to as the upstream side. Therefore, the control line CL is located downstream of the test line TL. Also, the labeling substance is sometimes referred to as a particle.

[0028] The acquisition function 131 processes images transmitted by, for example, the camera 20. Based on the results of the image processing, the acquisition function 131 calculates the brightness of the upstream region FA on the test paper TP, for example, upstream of the test line TL. The acquisition function 131 further measures the test line TL and the control line CL based on the results of the image processing.

[0029] The acquisition function 131 calculates the color intensity of the test line TL and the control line CL based on the measurement results. The control line region CLC, where the control line CL is formed on the test paper TP, is an example of a predetermined measurement position. The color intensity of the control line CL is an example of a predetermined condition index value.

[0030] The acquisition function 131 refers to the test paper DB 151 stored in the memory 150 and reads out the thickness, length, and intrinsic coefficient of the test paper TP to be used for immunochromatographic testing (hereinafter referred to as "test"). The acquisition function 131 substitutes the brightness calculated based on the image processing results and the thickness, length, and intrinsic coefficient of the test paper TP read from the memory 150 into (1) below to calculate and acquire the number of pre-captured particles out of the number of labeled substances (particles) (hereinafter referred to as "particle count"). Number of particles before capture = luminance × length × thickness × eigenfactor ... (1)

[0031] Figure 4 is a graph showing an example of the time change in the number of particles before capture in the upstream region. In Figure 4, the graph shows the change in the number of particles over time after the sample solution is dropped in the upstream region upstream of the test line TL. The labeling substance that counts the number of particles includes both bound and unbound labeling substances.

[0032] The number of particles in the upstream region before capture is maximized when the sample solution is dropped into the upstream region, causing the particles to spread there. The number of particles in the upstream region before capture then gradually decreases as the particles flow downstream from the upstream region. After a sufficient amount of time has elapsed, the number of particles in the upstream region before capture settles at a constant value corresponding to the baseline.

[0033] The estimation function 132 estimates the number of particles flowing into the test line TL from that point in time, based on the brightness of the test paper TP acquired by the acquisition function 131. The estimation function 132 is an example of an estimation unit. Here, the number of particles located upstream of the test line TL and estimated to flow into the test line TL (hereinafter referred to as the estimated number of particles) will be explained with reference to Figure 5.

[0034] Figure 5 illustrates an example of calculating the estimated number of particles from the graph shown in Figure 4. For example, from the first time t1 to the determination time t b The estimated number of particles up to this point is calculated from the number of particles P1 at the first time step t1 to the baseline number of particles P b This is the number obtained by subtracting [a certain value]. Estimated function 132 is calculated using the first time step t1 and the baseline particle number P in the graph shown in Figure 4. b By reading this, the number of particles P1 and the baseline number of particles P at the first time step t1 can be determined. b These are estimated as the estimated number of particles.

[0035] Particle number P1 and baseline particle number P at the first time step t1 b These may be determined by other methods. Particle number P1 at the first time step t1 and baseline particle number P b This can be determined, for example, based on the time evolution of the particle number change. Figure 6 is a graph showing an example of the time evolution of the particle number change. The estimation function 132 is calculated from the first time t1 to the determination time t b By calculating the integral of the particle number change dP / dt up to , the particle number P1 at the first time t1 and the baseline particle number P b This can be used as the estimated number of particles.

[0036] The determination function 133 determines whether predetermined conditions are met for determining whether the test environment of the test paper TP is in a state where determination based on the number of particles is possible. The determination function 133 determines that the state is undeterminable when the predetermined conditions are not met, for example, when the color intensity of the control line CL is less than the second threshold TH2. The determination function 133 determines that the state is determinable when the predetermined conditions are met, for example, when the color intensity of the control line CL is equal to or greater than the second threshold TH2.

[0037] The determination function 133, when in a determination-ready state, determines the timing of the determination in the inspection based on the number of particles captured on the test line TL, based on the estimated number of particles estimated by the estimation function 132. For example, the determination function 133 determines the determination timing to be when the result of the determination does not change even if the estimated number of particles is captured on the test line TL. The determination function 133 is an example of a determination unit.

[0038] The decision function 133 determines, for example, whether the estimated number of particles estimated by the estimation function 132 affects the result of the judgment. If the decision function 133 determines that the estimated number of particles does affect the result of the judgment, it is not yet the judgment timing, and the decision timing is determined to be when it determines that the estimated number of particles does not affect the result of the judgment.

[0039] The determination function 133 calculates the Δparticle count based on equation (2) below. The Δparticle count is, for example, the total number of particles in the upstream region FA. The determination function 133 calculates the Δparticle count without distinguishing between bound and unbound labeled substances. The Δparticle count can also be said to be the number of particles that can be captured by the test line TL. The determination function 133 calculates the Δparticle count for example at measurement times that are spaced apart by a fixed amount of time. ΔParticle number = Particle capture rate x Estimated number of particles (2)

[0040] The particle capture rate is calculated based on the following equation (3). Particle capture rate = number of captured particles / (number of downstream particles + number of captured particles) ···(3) In equation (3) above, the number of captured particles is the number of particles captured at the test line TL, and the number of downstream particles is the number of particles downstream of the test line TL. The number of captured particles can also be considered as the value obtained by subtracting the number of downstream particles from the total number of particles that passed through the test line, and then dividing that value by the total number of particles that passed through the test line TL.

[0041] The determination function 133 substitutes the calculated Δ number of particles (x = Δ number of particles) into the function F(x), which represents the change in the effect of the number of particles captured by the test line TL on the color intensity of the test line TL, and generates the maximum color intensity increase value F(Δ number of particles). The determination function 133 uses the generated maximum color intensity increase value F(Δ number of particles), the "T line" generated by the acquisition function 131, and the first threshold TH1 among the thresholds stored in memory 150 to determine the result of a positive test.

[0042] The "T line" is a line that shows the change in the color intensity of the test line TL over time. The first threshold TH1 is the color intensity that is used as the criterion for determining that the test result is positive. Figure 7 is a graph showing an example of the change in the color intensity of the test line TL over time. The decision function 133 determines that the test result is positive when the color intensity of the test line TL is equal to or greater than the first threshold TH1.

[0043] The "T line" is generated by the acquisition function 131 by tracking the time change in the color intensity of the test line TL, which is calculated based on the image obtained by image processing of an image captured by the camera 20. Similarly, the "C line," which shows the color intensity of the control line CL, is generated by the acquisition function 131 by tracking the time change in the color intensity of the control line CL, which is calculated based on the image obtained by image processing of an image.

[0044] The determination function 133 calculates the particle capture rate using equation (3) above, and then calculates the Δ number of particles using equation (2) above. The Δ number of particles is shown, for example, by a straight line extending from the "T line" in Figure 7. The determination function 133 determines whether the sum of the color intensity shown by the "T line" at a predetermined time plus the maximum color intensity increase value F (Δ number of particles) (hereinafter referred to as the Δ number sum) exceeds the first threshold TH1.

[0045] As long as the Δparticle count sum exceeds the first threshold TH1, the number of particles before capture will affect the positive result. However, once the "T line" reaches the first threshold TH1, a positive result is determined, and the number of particles before capture no longer affects the positive result. The determination function 133 determines the time tm1 when the "T line" reaches the first threshold TH1 while the Δparticle count sum exceeds the first threshold TH1 as the determination timing. In this case, the determination function 133 determines the positive result of the test to be positive.

[0046] Figure 8 is a graph showing another example of the time-dependent change in the color intensity of the test line TL. When the time-dependent change in the color intensity of the test line TL is weak, the change (degree of increase) of the "T line" becomes small. In this case, the Δ particle count sum indicated by the "T line" at a given time gradually decreases, and the Δ particle count sum becomes smaller than the first threshold TH1 before the "T line" reaches the first threshold TH1.

[0047] When the Δparticle count sum is greater than or equal to the first threshold TH1 before the "T line" reaches the first threshold TH1, the number of particles before capture affects the positive result. However, when the Δparticle count sum becomes less than the first threshold TH1, the number of particles before capture no longer affects the positive result. Therefore, the determination function 133 determines the time tm2 as the determination timing when the Δparticle count sum becomes less than the first threshold TH1 before the "T line" reaches the first threshold TH1. In this case, the determination function 133 determines the result of the test to be negative.

[0048] Similar to the "T line," the determination function 133 generates the color intensity of the control line CL (hereinafter referred to as "C line") by tracing the time change of the color intensity of the control line CL calculated based on the image acquired by the acquisition function 131 through image processing of the image captured by the camera 20. Based on the estimated number of particles estimated by the estimation function 132, the determination function 133 calculates the Δ number of particles and the maximum color intensity increase value F (Δ number of particles) in the control line CL.

[0049] The determination function 133 uses the maximum color intensity increase value F (Δ number of particles) of the generated control line CL, the color intensity of the control line CL calculated by the acquisition function 131, and the second threshold TH2 among the thresholds stored in memory 150 to determine whether the test environment of the test paper TP is in a state where it can be judged. The second threshold TH2 is the color intensity that serves as the criterion for determining whether the test environment of the test paper TP is in a state where it can be judged.

[0050] The determination function 133 determines that the test environment of the test paper TP is in a state where it can be judged if the generated "C line" is equal to or greater than the second threshold TH2. If the generated "C line" is less than the second threshold TH2, the determination function 133 calculates the Δ particle count sum value at the control line CL at regular time intervals.

[0051] If the Δparticle count sum at the control line CL is equal to or greater than the second threshold TH2, the test environment of the test paper TP may then become a judging state, so the process should proceed. If the Δparticle count sum at the control line CL becomes less than the second threshold TH2, the test environment of the test paper TP will not become a judging state, so it should be determined that an abnormality occurred in the test (test error).

[0052] Next, the processing in the determination device 100 will be described. Figures 9 and 10 are flowcharts showing an example of the processing in the determination device 100. The determination device 100 starts processing from the time the test is started by dropping the sample solution onto the test paper TP. In the acquisition function 131, the determination device 100 measures the control line CL based on the results of image processing on the image transmitted by the camera 20, as shown in Figure 9 (step S101).

[0053] Next, the acquisition function 131 calculates the "C line" based on the measurement results of the control line CL and determines whether the "C line" is equal to or greater than the second threshold TH2 (step S103). If it is determined that the "C line" is not equal to or greater than the second threshold TH2 (i.e., less than the second threshold TH2), the estimation function 132 estimates the number of particles in the control line CL (step S105).

[0054] Next, the determination function 133 calculates the Δ particle count and the maximum color intensity increase value F(Δ particle count) in the control line CL based on the estimated particle count estimated in step S105. Subsequently, the determination function 133 calculates the Δ particle count sum value by adding the "C line" value and the maximum color intensity increase value F(Δ particle count), and determines whether the Δ particle count sum value is equal to or greater than the second threshold TH2 (step S107). If it is determined that the Δ particle count sum value is equal to or greater than the second threshold TH2, the test environment of the test paper TP may then become ready for determination. For this reason, the determination function 133 waits for a certain period of time (step S109).

[0055] Next, the decision function 133 determines whether the total test time elapsed since the start of the test (hereinafter referred to as the total test time) exceeds the set maximum test time (step S111). The set maximum time is set, for example, to the maximum time at which the "T line" reaches the first threshold TH1 when the test result is positive.

[0056] If the determination function 133 determines that the total inspection time has exceeded the set maximum inspection time, the determination device 100 outputs an inspection error via the communication interface 110 or the input / output interface 120 (step S113). In this way, the determination device 100 terminates the process shown in Figure 9.

[0057] Furthermore, if it is determined that the total inspection time does not exceed the set maximum inspection time (i.e., it is less than or equal to the set maximum inspection time), the process returns to step S101. In addition, if it is determined in step S107 that the Δ particle count sum is not equal to or greater than the second threshold TH2, the test environment of the test paper TP is no longer in a state where it can be judged. For this reason, the judgment device 100 outputs an inspection error via the communication interface 110 or the input / output interface 120 (step S113). In this way, the judgment device 100 terminates the process shown in Figure 9.

[0058] Furthermore, if the determination device 100 determines in step S103 that the "C line" is equal to or greater than the second threshold TH2, it proceeds to measure the "T line" (step S115). In this way, the determination device 100 completes the process shown in Figure 9.

[0059] In the process shown in Figure 10, first, the acquisition function 131 measures the test line TL based on the image processing results of the image transmitted by the camera 20 (step S201). Next, the acquisition function 131 calculates the "T line" based on the measurement result of the test line TL and determines whether the "T line" is greater than or equal to the first threshold TH1 (step S203). If it is determined that the "T line" is not greater than or equal to the first threshold TH1 (less than the first threshold TH1), the estimation function 132 estimates the number of particles in the test line TL (step S205).

[0060] Next, the determination function 133 calculates the Δ particle count and the maximum color intensity increase value F(Δ particle count) in the test line TL based on the estimated number of particles estimated in step S205. Subsequently, the determination function 133 calculates the Δ particle count sum value by adding the color intensity shown by "T line" and the maximum color intensity increase value F(Δ particle count), and determines whether the Δ particle count sum value is greater than or equal to the first threshold TH1 (step S207). If it is determined that the Δ particle count sum value is greater than or equal to the first threshold TH1, the positive result may then become positive. For this reason, the determination function 133 waits for a certain period of time (step S209).

[0061] Next, the determination function 133 determines whether the total test time exceeds the set maximum test time (step S211). If the determination function 133 determines that the total test time exceeds the set maximum test time, it determines that it is time for a determination and determines the positive result as negative. The input / output interface 120 reads the determination result determined by the determination function 133 and displays the read negative result on the touch panel or outputs it as sound through the speaker (step S213). In this way, the determination device 100 completes the process shown in Figure 10.

[0062] Furthermore, if it is determined that the total test time does not exceed the set maximum test time (i.e., it is less than or equal to the set maximum test time), the process returns to step S201. In addition, if it is determined in step S207 that the Δparticle count sum is not greater than or equal to the first threshold TH1, then the test line TL no longer exceeds the first threshold TH. Therefore, when the determination function 133 determines that the Δparticle count sum is not greater than or equal to the first threshold TH1, it determines that it is time for a determination and determines the positive determination result as negative. The input / output interface 120 reads the determination result determined by the determination function 133 and displays the read negative determination result on the touch panel or outputs it as sound through the speaker (step S213). In this way, the determination device 100 completes the process shown in Figure 10.

[0063] Furthermore, in step S203, if the "T line" is determined to be greater than or equal to the first threshold TH1, the determination function 133 determines that it is time for a determination and determines the positive determination result to be positive. The input / output interface 120 reads the determination result determined by the determination function 133 and displays the read positive determination result on the touch panel or outputs it as sound through the speaker (step S213). In this way, the determination device 100 completes the process shown in Figure 10.

[0064] The determination device 100 of this embodiment determines the color intensity of the test line TL based on the brightness of the upstream region FA upstream of the test line TL, and determines the result of a positive test as positive when the color intensity becomes equal to or greater than the first threshold TH1. Furthermore, it determines the result of a positive test as negative when the Δ particle sum value becomes less than the first threshold TH1. Therefore, for example, the determination timing can be set to a time before the color intensity of the test line TL obtained by image processing of an image captured by the camera 20 becomes equal to or greater than the first threshold TH1. Consequently, the unnecessary determination time can be reduced.

[0065] In the above embodiment, the determination timing is determined when the color intensity of the test line TL becomes equal to or greater than the first threshold, or when the Δ particle sum becomes less than the first threshold TH1. However, future determination timings (measurement timings) may be determined based on the estimated number of particles. An example of estimating future determination timings based on the estimated number of particles is described below.

[0066] Figure 11 is a graph showing another example of the time evolution of the color intensity of the test line TL. In this example, the determination function 133 predicts, for example, the color intensity of the test line TL at a future determination timing tm. Following the same procedure as in the embodiment described above, the acquisition function 131 acquires the color intensity of the test line TL, and the estimation function 132 estimates the estimated number of particles (F(Δparticle count)) at time tn and calculates the Δparticle count sum value by adding it to the color intensity of the test line TL ("T line(n)").

[0067] Next, the decision function 133 calculates the difference between the Δparticle count sum and the first threshold TH1, and based on the calculated difference, predicts the probability (hereinafter referred to as the predicted positive probability) that the color intensity of the test line TL at time tm will be greater than or equal to the first threshold TH1, resulting in a positive test result. The predicted positive probability increases as the Δparticle count sum is greater than the first threshold TH1 and the difference is larger. If the Δparticle count sum is less than the first threshold TH1, the predicted positive probability is 0%.

[0068] The decision function 133 may output the calculated predicted positive probability to the input / output interface 120. The output method of the predicted positive probability can be anything. For example, the decision function 133 may output the predicted positive probability as a numerical value, or it may output "positive" if the predicted positive probability exceeds a predetermined prediction threshold, for example, 80%, or it may output "high positive probability."

[0069] The decision function 133 may output the predicted positive probability along with the judgment timing or the time until the judgment timing. For example, it may output that there is a XX% probability of being judged positive after x minutes. The prediction threshold may be adjusted, for example, by the difference between the current time tn and the future judgment timing tm. For example, the prediction threshold may be set to increase as the difference between the current time tn and the future judgment timing tm increases. The prediction threshold may also be determined by using the standard deviation σ of the negative control and multiplying the standard deviation σ of the negative control by time x.

[0070] Alternatively, the timing of the determination may be determined based on the color intensity of the test line TL and the number of particles before capture. Figure 12 shows the relationship between the color intensity of the test line TL and the number of particles before capture. A third threshold TH3 is set in relation to the color intensity of the test line TL and the number of particles before capture.

[0071] The third threshold TH3 may be, for example, a straight line obtained using a positive control containing X times the detection limit of the strongly positive control antigen. In the determination, a positive result may be determined when it is ασ, for example, 10σ (α=10), or greater than the third threshold TH3. In the determination, a positive result may be definitively determined, a positive probability may be determined to be high, or the probability of becoming positive after a predetermined time elapsed may be P%, etc. The third threshold TH3 may be set to threshold + x%, for example.

[0072] The determination function 133 determines the timing of the determination when the color intensity (hereinafter referred to as the determination color intensity) CFL of the test line TL reaches the specified number of particles HN and the third threshold TH3 or higher, and determines the result of the test as positive. The determination function 133 determines the result of the test as negative when the determination color intensity CFL falls below the third threshold TH3.

[0073] Furthermore, for strongly positive sample solutions, the third threshold may be set higher than the threshold used for normal negative / positive determination in order to obtain a rapid result. In this case, the determination function 133 may continue the determination even if the determination color intensity CFL falls below the third threshold. Thus, the timing of the determination and the positive determination in the test may be made using the relationship between the color intensity of the test line TL and the number of particles before capture.

[0074] Alternatively, when setting a third threshold TH3 to determine a positive result, the timing of the determination may be determined according to the number of particles before capture. Figure 13 shows the relationship between the color intensity of the test line TL and the number of particles before capture. Here, too, the third threshold TH3 is set based on the relationship between the color intensity of the test line TL and the number of particles before capture.

[0075] Here, when the line of the third threshold TH3 is drawn, the method for determining the judgment timing described in the embodiment is available when the number of particles before capture is greater than or equal to a certain specified value BN, and is unavailable when it is less than the specified value BN. When it is less than or equal to the specified value BN, the method for determining the judgment timing may be changed to another method, or an error may be output. Alternatively, a fourth threshold TH4 and a fifth threshold TH5 may be set in relation to the color intensity of the test line TL and the number of particles before capture, and the method for determining the judgment timing may be changed when the number of particles before capture is less than the fourth threshold TH4, and an error may be output when the number of particles before capture is less than the fifth threshold TH5.

[0076] Alternatively, the number of particles upstream and downstream of the test line TL may be measured, the number of background particles on the test line TL may be estimated from the distribution of these measurements, and the number of background particles on the test line TL may be calculated based on the estimated distribution. In this case, the color intensity of the test line TL can be determined, for example, by equation (4) below. Color intensity of the test line TL = (number of particles on the test line TL at each point) - (average number of particles in the background) ... (4) The number of particles on the test line TL and the number of particles in the background can be calculated, for example, based on their respective brightness levels.

[0077] Alternatively, a portion of the test line TL, for example, an adjacent region, may be partially omitted, and the number of particles in the omitted region adjacent to the test line TL may be subtracted as background to calculate the color intensity of the test line TL. In this case, the color intensity of the test line TL can be determined, for example, by the following equation (5). Color intensity of test line TL = (luminance of partially missing test line TL) - (luminance of area adjacent to test line TL) ... (5)

[0078] Furthermore, although there is one test line TL in each of the above embodiments, there may be two or more test lines. Here, for example, a first test line TL1, a second test line TL2, and a control line CL are set downstream from the drop position of the sample solution.

[0079] In this case, the determination timing for the first test line TL1 is determined in the same way as the determination timing for the test line TL shown in the above embodiment. To determine the determination timing for the first test line TL1, first, the number of particles in the region upstream of the first test line TL1 (hereinafter referred to as the first measurement region) and the region downstream of the first test line TL1 and upstream of the second test line TL2 (hereinafter referred to as the second measurement region) are measured. Next, the sum of the number of particles in the first measurement region and the second measurement region is calculated as the number of particles before capture in the second test line TL2. After that, the estimated number of particles in the second test line TL2 can be calculated using the procedure shown in the above embodiment.

[0080] Alternatively, after measuring the number of particles in the first and second measurement areas, the estimated number of particles in the second test line TL2 is calculated by considering the number of particles captured in the first test line TL1. In this case, the estimated number of particles in the second test line TL2 can be calculated, for example, by equation (6) below. Second estimated particle number = {(First particle number) × (Brightness of second measurement area) / (Brightness of second measurement area) + (Brightness of first test line TL1)} + Second particle number ... (6) In equation (6), the first particle count is the number of particles in the first measurement area, and the second particle count is the number of particles in the second measurement area.

[0081] Furthermore, by determining the brightness of the second measurement region and the region downstream of the second measurement region, and correcting the calculation result of equation (6), the second estimated number of particles can be estimated with greater accuracy.

[0082] According to at least one embodiment described above, the device includes an acquisition unit that acquires an index value relating to the number of labeled substances upstream of the detection position in a sample solution that is spread on a test strip and flows through the detection position on the test strip; an estimation unit that estimates the number of labeled substances to be captured at the detection position based on the acquired index value; and a determination unit that determines the timing of a determination when performing a determination based on the number of labeled substances at the detection position when predetermined conditions are met, based on the estimated number of labeled substances. This makes it possible to shorten the time required for determination.

[0083] While several embodiments have been described, these embodiments are presented as examples only and are not intended to limit the scope of the invention. These embodiments can be carried out in a variety of other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their variations are included in the scope and spirit of the invention, as well as in the claims and their equivalents. [Explanation of symbols]

[0084] 1. Judgment System 20 cameras 100 Judgment device 110 Communication Interface 120 Input / Output Interfaces 130 Processing Unit 131 Acquisition function 132 Estimated Function 133 Decision Function 150 memory 151 Test strip DB CL Control Line TL Test Line

Claims

1. An acquisition unit that is deployed on a test strip and acquires an index value relating to the number of labeled substances contained in the sample solution flowing through the test strip that are upstream of the detection position, An estimation unit that estimates the number of labeled substances captured at the detection position based on the acquired index value, The system includes a determination unit that determines the timing of a determination when performing a determination based on the number of labeled substances captured at the detection position when predetermined conditions are met, based on the estimated number of labeled substances. Judgment device.

2. The determination unit determines the determination timing to be the time when the result of the determination does not change even if the estimated number of the labeled substance is captured at the detection position. The determination device according to claim 1.

3. The labeling substance is spread on the test paper together with the labeling substance provided on the test paper. The determination device according to claim 1.

4. The acquisition unit acquires a predetermined condition index value relating to the number of labeled substances at a predetermined measurement position downstream of the detection position. The estimation unit estimates the number of labeled substances captured at the predetermined measurement position based on the predetermined condition index value. The determination unit determines whether the predetermined conditions are met based on the number of labeled substances captured at the estimated predetermined measurement position. The determination device according to claim 1.

5. The predetermined conditions include whether the test environment of the test paper is in a state where determination is possible based on the number of labeled substances. The determination device according to claim 1.

6. The detection position is the position of the test line that captures the labeled substance. The determination based on the number of the aforementioned labeling substances is a positive determination caused by the antigen contained in the sample solution. The determination unit determines that the result of the positive judgment is positive when the color intensity of the test line becomes equal to or greater than the first threshold. The determination device according to claim 1.

7. The predetermined conditions include the color intensity of the control line downstream of the test line being equal to or greater than a second threshold. The determination device according to claim 6.

8. The estimation unit estimates the number of antigens captured by the control line based on the number of antigens upstream of the control line. The determination unit determines the test environment for the positive result on the test strip based on the estimated number of antigens. The determination device according to claim 7.

9. Computers The test strip is unfolded, and an index value is obtained relating to the number of labeled substances contained in the sample solution flowing through the test strip that are upstream of the detection position. Based on the acquired index value, the number of labeled substances captured at the detection location is estimated. The timing of the determination when performing a determination based on the number of labeled substances captured at the detection position when predetermined conditions are met is determined based on the estimated number of labeled substances. Judgment method.

10. On the computer, The test strip is unfolded, and an index value is obtained relating to the number of labeled substances contained in the sample solution flowing through the test strip that are upstream of the detection position. Based on the acquired index value, the number of labeled substances captured at the detection location is estimated. The timing of the determination when performing a determination based on the number of labeled substances captured at the detection position when predetermined conditions are met is determined based on the estimated number of labeled substances. program.

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