Determination system, test piece and fluorescent reference piece

Abstract

To provide a determination system for correcting optical information related to measurement of a measurement object based on difference of an apparatus to be used.SOLUTION: A determination system includes: a fluorescence determination element arranged at a position predetermined by a plurality of predetermined fluorescent parts; a light source for irradiating the fluorescence determination element by one excitation light; and a control part including image acquisition means for photographing the fluorescence determination element irradiated by the light source to acquire calibration data being image data, and determination means for determining fluorescence information based on the calibration data.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] The technology of the present disclosure relates to a determination system that corrects optical information for determining the optical recognition state of an image acquisition means, and a test strip and a fluorescent reference strip used in the determination system. [Background technology]

[0002] In a measurement system that uses a test strip to which a reaction reagent is applied to detect the reaction between the substance to be measured in the sample and the reaction reagent using optical information such as luminescence intensity, differences in the color tone and intensity of the optical information detected by the device may occur, which may affect the measurement results.

[0003] The following Patent Documents 1 to 4 disclose techniques relating to color tone correction. Patent Document 1 discloses a technique relating to a color sample for a urine test strip observed under visible light. Patent Document 2 discloses a fluorescence correction technique that uses microparticles labeled with multiple fluorescent wavelengths. Patent Document 3 discloses a technique that uses two ultraviolet light sources to correct a target image based on the acquired fluorescence values ​​of a sample. Patent Document 4 discloses a technique that photographs a user wearing eyeglasses with multiple colors arranged in predetermined positions, and determines the user's skin color from image data capturing the color arrangement of the eyeglasses. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2022-518364 [Patent Document 2] Japanese Patent Application Laid-Open No. 2012-47462 [Patent Document 3] US 2010 / 0321681 A1 [Patent Document 4] Japanese Patent Publication No. 2022-2116 Summary of the Invention [Problem to be solved by the invention]

[0005] An embodiment of the present disclosure provides a determination system for determining optical information related to measurement of a measurement object based on differences in the equipment used. [Means for solving the problem]

[0006] The determination system of the present disclosure includes a control unit having a fluorescence determination element in which a plurality of predetermined fluorescent portions are arranged at predetermined positions, a light source that irradiates the fluorescence determination element with a single excitation light, an image acquisition means that photographs the fluorescence determination element irradiated by the light source to acquire calibration data, which is image data, and a determination means that determines fluorescence information based on the calibration data. [Effects of the Invention]

[0007] According to an embodiment of the present disclosure, a determination system is provided that determines optical information related to measurement of a measurement object based on differences in the equipment used. [Brief explanation of the drawings]

[0008] [Figure 1] 10 shows a top perspective view of a holding portion used in the embodiment. FIG. [Figure 2] 10 is an enlarged perspective view of the vicinity of the insertion opening of the holding portion. [Figure 3A] 1 shows a test specimen used in an embodiment in plan view. [Figure 3B] An example of a fluorescence determination element is shown in a schematic diagram. [Figure 4] FIG. 2 is a top perspective view showing a state in which a test piece is attached to the holder. [Figure 5] The state of FIG. 4 is shown in plan view. [Figure 6] 1 is a top perspective view of a placement unit used in an embodiment; [Figure 7] 1 shows the placement portion as viewed from the bottom. [Figure 8] 1 shows a top perspective view of an embodiment of a housing. [Figure 9]9 is a top perspective view showing a state in which a test piece is attached to the housing of FIG. 8. FIG. [Figure 10] 1 shows a bottom view of a mobile device used in an embodiment. [Figure 11] 1 is a top perspective view of a determination system according to an embodiment; [Figure 12] 12 is a top perspective view of the determination system of FIG. 11 with a portion of the outer wall portion removed. [Figure 13] 13 shows a cross section taken along line XIII-XIII in FIG. [Figure 14] FIG. 1 is a functional block diagram of a determination system according to an embodiment. [Figure 15] The control unit is shown in a block diagram. [Figure 16] 1 is a flowchart showing an outline of a method for measuring a measurement object in a determination system according to an embodiment. [Figure 17A] 10 is a flowchart illustrating an outline of calculation of correction information in a first example of a determination system according to an embodiment. [Figure 17B] 10 is a flowchart illustrating an outline of calculation of correction information in a second example of the determination system of the embodiment. [Figure 18] 10 is a flowchart illustrating an example of correcting measurement data. [Figure 19] 10 shows an example of measurement data and calibration data captured by the imaging unit. [Figure 20] An example of image data correction is shown in the form of a graph. [Figure 21] 10 shows a plan view of a fluorescent reference strip according to another embodiment. [Figure 22] 10 shows a top perspective view of a holding portion in yet another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. Common reference numerals in each drawing indicate the same parts unless otherwise specified. Furthermore, the components and parts shown in each drawing are merely schematic drawings, and the size and positional relationship of the actual product are not necessarily accurately depicted.

[0010] (1) Holding part FIG. 1 is a top perspective view of a holder 40 used in a determination system 10 (see FIG. 11) of this embodiment. The determination system 10 of the present disclosure may include a holder 40 as shown in FIG. 1 as a component constituting the housing 20 (see FIG. 8). The holder 40 has a box-like shape, and two openings, a measurement opening 43 and an identification opening 44, are formed on the top surface. An optical filter 45 is fitted into the measurement opening 43. A sensor 47 that detects light is also provided on the top surface. An insertion opening 41 is opened on the side of the holder 40, through which a test strip 60 (see FIG. 3), described below, is inserted. The internal space of the insertion opening 41 is also connected to the measurement opening 43 and the identification opening 44, and forms a storage section 46, which is a space in which a portion of the test strip 60 is stored.

[0011] 2 is an enlarged perspective view from below of the vicinity of the insertion opening 41 of the holder 40. The sensor 47 is provided near the measurement opening 43 in the storage section 46, which is the internal space of the insertion opening 41. Light containing light rays of a wavelength suitable for photographing the measurement area 61 is emitted from the light source 42 (see FIG. 13) provided inside the storage section 46. The optical filter 45 has optical properties that allow only light rays of a wavelength suitable for photographing to pass through.

[0012] (2) Test piece FIG. 3A shows a plan view of a test strip 60 used in the determination system 10 (see FIG. 11 ) of this embodiment. The test strip 60 has a flat, rod-like shape. One end of the test strip 60 has a recessed grip portion 65 on the upper surface, which allows the test strip 60 to be grasped with the fingers. A test paper 64, which is elongated along the longitudinal direction of the test strip 60, is housed inside the test strip 60. The test paper 64 is exposed upward through two openings formed on the top surface of the test strip 60. Of these two openings, the one closer to the grip portion 65 is a sample application portion 63, and the one farthest from the grip portion 65 is a measurement region 61 where the measurement of the object to be measured is performed. Furthermore, an identification region 62 is formed on the other end of the test strip 60, i.e., the portion on the top surface farthest from the grip portion 65, in which information about the test strip 60 is recorded.

[0013] Furthermore, a fluorescence determination element 66 including multiple (six in the figure) fluorescent portions 66a-66f (see FIG. 3B) is provided near the opening of the measurement region 61. Each of the fluorescent portions 66a-66f has a predetermined number of color elements arranged at predetermined positions. The fluorescence determination element 66 is irradiated with a single excitation light from the light source 42. The color elements used in each of the fluorescent portions 66a-66f emit different fluorescence when irradiated with a single excitation light. The difference in fluorescence among the fluorescent portions 66a-66f may be fluorescence intensity or wavelength. Hereinafter, the side of the test strip 60 closer to the gripping portion 65 will be referred to as the "upstream side," and the side closer to the identification region 62 will be referred to as the "downstream side."

[0014] The test paper 64 is made of a water-absorbent material such as filter paper, or a synthetic resin substrate with a water-absorbent layer applied to its surface. The test paper 64 contains a reaction reagent that reacts with the analyte to emit fluorescence. A sample expected to contain the analyte is applied to the sample application section 63. Examples of samples include liquid specimens collected from living organisms, such as blood or urine, or diluted solutions of these specimens with an appropriate solvent, or solids or mucus collected from living organisms, or liquid specimens obtained by diluting or suspending these specimens in an appropriate solvent. Examples of analytes include components contained in the liquid specimen, or antigens derived from foreign microorganisms or viruses. While the test paper 64 of this embodiment is intended for use in fluorescent immunochromatography, it may also be used in general chromatography that does not emit fluorescence. It may also be used in other types of chromatography that do not rely on immune reactions, as long as it uses a reaction reagent that reacts with the analyte.

[0015] FIG. 4 is a top perspective view showing the state in which the test strip 60 is attached to the holder 40. FIG. 5 shows this state in plan view. As shown in FIGS. 4 and 5, the test strip 60 is inserted into the storage section 46 through the insertion port 41, with the downstream side first. In this state, as shown in FIG. 5, the measurement area 61 is in the same planar position as the measurement opening 43, and the identification area 62 is in the same planar position as the identification opening 44. Furthermore, the fluorescence determination element 66 provided on the test strip 60 can be seen through the measurement opening 43.

[0016] When a sample is applied to the sample application section 63 in this state, the test strip 64 flows downstream due to capillary action, and a control reaction zone 70 (see FIG. 19) indicating the application of the sample appears downstream in the measurement area 61. Furthermore, if the sample contains a target substance, a target reaction zone 71 (see FIG. 19) with an intensity corresponding to the target substance's concentration appears upstream. In this embodiment, the control reaction zone 70 and target reaction zone 71 are visualized as fluorescence generated by excitation light emitted from the light source 42. The determination system 10 of this embodiment measures the concentration of the target substance by irradiating the target reaction zone 71 with excitation light emitted from the light source 42 and measuring the intensity of the generated fluorescence. The identification area 62 stores information about the test strip 60, such as the type of test strip 64 contained therein. Examples of the identification area 62 include a barcode and a QR code (registered trademark).

[0017] (3) Placement section FIG. 6 is a top perspective view of the placement unit 30 used in the determination system 10 (see FIG. 11) of this embodiment. FIG. 7 is a bottom view of the placement unit 30. The placement unit 30 is configured as a roughly rectangular parallelepiped paper box with open top and bottom faces. The four sides of the placement unit 30 form vertically erected outer walls 34. A placement frame 32 is formed on the top face of the placement unit 30, and is a frame on which a mobile device 50 (see FIG. 10), which will be described later, is placed. One side (hereinafter referred to as the "front side") of the interior of the placement unit 30 is formed with a box-shaped light-shielding section 33 that is closed at the top while opening a window 31 and is open at the bottom (see FIG. 7).

[0018] Of the four faces of the outer wall 34, the face on which the light-shielding portion 33 is located is referred to as the front face 34a, the face opposite thereto as the back face 34b, the face on the left side as viewed from the front face 34a as the left face 34c, and the face opposite thereto as the right face 34d. The interior of the mounting portion 30 is divided by a reinforcing portion 35 that is parallel to the front face 34a and the back face 34b. Furthermore, a rectangular notch 36 is formed in the front lower edge of the left face 34c.

[0019] (4) Housing As shown in FIG. 7, a gap is formed between the lower edge of the light-shielding portion 33 and the lower edge of the outer wall portion 34. The space defined by this gap and surrounded on all four sides by the front surface 34a, the reinforcing portion 35, the left side surface 34c, and the right side surface 34d is referred to as the storage area 37. When the holder 40 is attached to this storage area 37, the housing 20 shown in FIG. 8 is formed. In this state, the notch 36 of the mounting portion 30 and the insertion opening 41 of the holder 40 are aligned. The state in which the test piece 60 is attached to the insertion opening 41 in this state, as shown in FIGS. 4 and 5, is shown in the top perspective view of FIG. 9.

[0020] (5) Mobile devices FIG. 10 shows a bottom view of a mobile device 50 used in the determination system 10 (see FIG. 11) of this embodiment, placed on a housing 20. In this embodiment, a smartphone is used as the mobile device 50, but a tablet terminal with a camera function may also be used as the mobile device 50. On the bottom side (so-called backside) of the mobile device 50, there are provided a photographing unit 51 configured as a camera and an illumination unit 52 configured as a flash that irradiates visible light, next to it. The top side (so-called front side) of the mobile device 50 is a display unit 53 (see FIG. 11).

[0021] (6) Judgment system The determination system 10 of this embodiment, as shown in the top perspective view of Fig. 11, is configured by placing the mobile device 50 shown in Fig. 10 inside the mounting frame 32 of the housing 20 shown in Fig. 9 with the image capturing unit 51 and the illumination unit 52 aligned with the window 31 and the display unit 53 facing upward. As shown in the top perspective view of Fig. 12, which shows the state in which the front surface 34a, the left side surface 34c, and the right side surface 34d of the outer wall 34 are removed from this state, the measurement opening 43 and the identification opening 44 of the holder 40 are covered with the light-shielding unit 33, preventing light from entering from the outside.

[0022] As shown in FIG. 13 , which is a cross-sectional view of FIG. 12 taken along the line XIII-XIII of FIG. 12 , the measurement opening 43 and optical filter 45 are located above the measurement region 61 of the test strip 60, and the identification opening 44 is located above the identification region 62. Furthermore, a light source 42 is installed slightly rearward of and below the measurement opening 43, illuminating the measurement region 61 from an obliquely upward direction. More specifically, a light source installation plate 42A extends obliquely from the lower edge of the storage unit rear wall 46A, which corresponds to the rear side of the storage unit 46, toward the rear edge 43A of the measurement opening 43. The light source 42 is installed on the underside of the light source installation plate 42A, allowing the light source 42 to illuminate the measurement region 61 obliquely from the rear side (i.e., perpendicular to the extension direction of the light source installation plate 42A). The light source 42 irradiates the test strip 60 on which the reagent is placed with excitation light, and also irradiates the fluorescence determination element 66 attached to the test strip 60 with excitation light. Directly above the measurement opening 43 is located the window 31 of the mounting portion 30, through which the photographing portion 51 of the mobile device 50 can view not only the measurement area 61 but also the identification area 62 and the fluorescence determination element 66.

[0023] Fig. 14 is a functional block diagram of the determination system 10 of this embodiment. The mobile device 50 is provided with an image capturing unit 51 and an illumination unit 52 shown in Fig. 10, a display unit 53 shown in Fig. 11, and a control unit 100 that controls these. The control unit 100 functions as each of the following means by using a CPU 110, a ROM 120, a RAM 130, and a storage device 150, which will be described later, as computer hardware resources.

[0024] That is, the control unit 100 functions as an illumination switching means 200 that switches the illumination by the illumination unit 52 on / off (on / off). Specifically, the illumination switching means 200 can be implemented as an application installed on the mobile device 50. Alternatively, the illumination switching means 200 can be implemented as a means utilizing electrical or optical sensing between the holding unit 40 or as a wireless communication means (e.g., Bluetooth (registered trademark)) between the holding unit 40. The control unit 100 also functions as an imaging condition storage means 210 that stores the conditions for imaging by the imaging unit 51. The imaging conditions include, for example, the waiting time required for the reaction between the measurement object and the reagent. The control unit 100 also functions as a drop detection means 220 that detects the drop of the sample onto the test strip 60 via the imaging unit 51. The control unit 100 also functions as a waiting time measurement means 230 that measures the waiting time. The control unit 100 also functions as image acquisition means 235 that acquires calibration data, which is image data obtained by photographing the fluorescence determination elements 66 illuminated by the light source 42, and measurement data, which is image data obtained by photographing the test piece 60 illuminated by the light source 42. The control unit 100 also functions as image storage means 240 that stores images of the measurement area 61 photographed by the photographing unit 51. The control unit 100 also functions as determination means 245 that determines fluorescence information determined from multiple pieces of fluorescence data included in the calibration data based on the arrangement of the fluorescence determination elements 66. The control unit 100 also functions as analysis means 250 that calculates correction information by comparing the fluorescence information determined by the determination means 245 with multiple reference values ​​that serve as standards for each of the fluorescent elements 66a to 66f, and corrects the measurement data based on the correction information.

[0025] 15, the control unit 100 has a CPU (Central Processing Unit) 110, a ROM (Read Only Memory) 120, a RAM (Random Access Memory) 130, and a storage device 150. Each component is connected to each other via a bus 190 so as to be able to communicate with each other.

[0026] The CPU 110 is a central processing unit that executes various programs that can be realized as installed applications and controls each part. That is, the CPU 110 reads programs from the ROM 120 or the storage device 150 and executes the programs using the RAM 130 as a work area. The CPU 110 controls the determination system 10 in accordance with the programs recorded in the ROM 120 or the storage device 150.

[0027] The ROM 120 stores various programs and various data. The RAM 130 temporarily stores programs or data as a working area. The storage device 150 is configured as storage using an HDD (Hard Disk Drive), SSD (Solid State Drive), or flash memory, and stores various programs including an operating system, and various data.

[0028] Meanwhile, the holding unit 40 includes a light source 42 that illuminates the measurement area 61, a sensor 47 that detects the on / off (on / off) of the illumination unit 52, and a light source control unit 48 that turns on the light source 42 when a signal is input from the sensor 47. The light source control unit 48 is configured as a hardware resource of a computer, similar to the control unit 100 of the mobile device 50. Note that the light source control unit 48 can turn on the light source 42 regardless of the input mode of the signal from the sensor 47 (for example, wired or wireless), as long as it can control the turning on of the light source 42 when photographing the measurement area 61 (described later). The light source control unit 48 can also control the turning off of the light source 42.

[0029] As described above, the determination system 10 of this embodiment includes a control unit 100 having a fluorescence determination element 66 with a predetermined number of fluorescent light sources 66a-66f arranged at predetermined positions, a light source 42 that irradiates the fluorescence determination element 66 with a single excitation light, an image acquisition unit 235 that photographs the fluorescence determination element 66 illuminated by the light source 42 to acquire calibration data, which is image data, and a determination unit 245 that determines fluorescence information based on the calibration data. In other words, the present disclosure is a technology for determining fluorescence information, regardless of whether or not subsequent measurements are performed. Examples of cases in which subsequent measurements are not performed include when the system is used in a system for determining the performance of the image acquisition unit 235, or when the system is used in a system that appropriately displays an error message or notifies the user by voice or other means based on the results of the performance determination of the image acquisition unit 235.

[0030] Furthermore, in the determination system 10 of this embodiment, the fluorescent portions 66a to 66f emit different fluorescence when irradiated with excitation light, the calibration data includes a plurality of fluorescence data corresponding to the respective fluorescence emitted by the plurality of fluorescent portions 66a to 66f, the light source 42 irradiates the excitation light not only to the fluorescence determination element 66 but also to the test piece 60 on which the reagent is placed, the image acquisition means 235 acquires, in addition to the calibration data, measurement data which is image data obtained by photographing the test piece 60 irradiated by the light source 42, and the determination means 245 calculates correction information by comparing the fluorescence information determined from the plurality of fluorescence data with a plurality of reference values ​​that serve as standards for each of the fluorescent portions 66a to 66f, and it is desirable to further include analysis means 250 that corrects the measurement data based on the correction information. Furthermore, in the determination system 10 of this embodiment, the light source 42 irradiates excitation light not only to the fluorescent determination element 66 but also to the test piece 60 on which the reagent is placed, and the image acquisition means 235 acquires measurement data, which is image data obtained by photographing the test piece 60 irradiated by the light source 42, in addition to the calibration data, and it is desirable that the analysis means 250 corrects the measurement data based on the correction information.

[0031] Here, it is preferable that the image acquisition means 235 captures an image of the fluorescence determination element 66 and the test piece 60 illuminated by the light source 42 as a single image data, and acquires calibration data and measurement data from the single image data. Furthermore, it is preferable that the determination means 245 determines fluorescence information from the calibration data based on the arrangement of the fluorescence determination element 66. Furthermore, the fluorescence of the multiple fluorescent portions 66a-66f may differ from one another in fluorescence intensity as fluorescence information, or the fluorescence of the multiple fluorescent portions 66a-66f may differ from one another in wavelength as fluorescence information.

[0032] It is preferable that the determination system 10 of this embodiment further includes a mobile device 50 having a camera as the photographing unit 51, and that the central processing unit 110 of the mobile device 50 is configured to function as the control unit 100. It is preferable that the determination system 10 of this embodiment further includes a housing 20 to which the test piece 60 is attached, and that the housing 20 includes a mounting unit 30 that holds the mobile device 50, and a holding unit 40 to which the test piece 60 is inserted, a light source 42 is provided, and the holding unit 40 is attached to the mounting unit 30.

[0033] The fluorescence determination element 66 may be provided on the test strip 60. The test strip 60 provided with the fluorescence determination element 66 is used in the determination system 10 of this embodiment. Alternatively, the fluorescence determination element 66 may be provided on the housing 20. Alternatively, the fluorescence determination element 66 may be provided on a fluorescent reference strip 60A (see FIG. 21 ), which has substantially the same shape as the test strip 60 and is dedicated to obtaining calibration data, as described below. The fluorescent reference strip 60A provided with the fluorescence determination element 66 is used in the determination system 10 of this embodiment.

[0034] (7) Measurement method of the measurement object using the judgment system An example of a method for measuring an object to be measured using the determination system 10 of this embodiment will be described with reference to the flowchart in Fig. 16. In this flowchart, steps showing operations other than those directly performed by the mobile device 50 are outlined in parentheses.

[0035] First, as shown in Fig. 11, the determination system 10 is prepared by placing the mobile device 50 in the housing 20, which has the holder 40 attached to the placement part 30, and inserting the test strip 60 through the insertion port 41. At this stage, when the screen of the display part 53 (see Figs. 11 and 14) is operated, the measurement application installed on the mobile device 50 is launched and measurement begins.

[0036] First, in a step shown in S100, the illumination switching means 200 (see FIG. 14) turns on the illumination unit 52. At this step, the light source 42 of the holder 40 is turned off. Next, in a step shown in S110, the photographing unit 51 photographs the identification area 62 using the illumination unit 52 as a light source. When the photographing is completed, the process proceeds to a step shown in S120.

[0037] At the stage shown in S120, the control unit 100 acquires the photographing conditions for measurement using the test piece 60 from the photographed image of the identification region 62 by referring to the photographing condition storage means 210 (see FIG. 14).

[0038] Next, in step S130, the operator applies an appropriate amount of sample to the sample application portion 63 (see FIG. 3) of the test strip 60. The applied sample is spread downstream inside the test strip 60 by the test paper 64 (see FIG. 3A).

[0039] During this time, the spotting detection means 220 (see FIG. 14) of the control unit 100 continues to monitor, at the step shown in S140, whether an image indicating completion of spotting (for example, a control reaction zone 70 formed by a reaction with the measurement object) is detected in the measurement area 61 through the image from the photographing unit 51. If such an image is detected, the process proceeds to the step shown in S150.

[0040] At the step S150, after detecting the completion of spot application at the step S140, the waiting time measurement means 230 (see FIG. 14) of the control unit 100 continues to monitor whether the waiting time required for the reaction between the measurement object and the reagent on the test paper 64, among the photographing conditions acquired at the step S120, has elapsed.

[0041] When the standby time measurement means 230 determines at a stage shown in S150 that the standby time has elapsed, the illumination switching means 200 turns off the illumination unit 52 at a stage shown in S160.

[0042] Meanwhile, in the stage shown in S170, when the light source control unit 48 of the holding unit 40 detects that the illumination unit 52 has been turned off via the sensor 47 (see FIGS. 1 and 14), the light source 42 is turned on.

[0043] When the light source 42 is turned on, in the step shown in S180, the photographing unit 51 photographs each of the fluorescent zones 66a to 66f in the fluorescence determination element 66 excited by the wavelength of the measurement light from the light source 42 as calibration data, and also photographs the measurement site including the target reaction zone 71 and the control reaction zone (see FIG. 19B) that are excited by the wavelength of the measurement light from the light source 42 and visualized in the measurement area 61 as measurement data. Specifically, RGB pixel values ​​(e.g., 0 to 255) obtained for each pixel of the image data photographed by the photographing unit 51 of the mobile device 50 are obtained as primary data, and fluorescence intensities at specific wavelengths are measured from this primary data and acquired as measurement data or calibration data for each site.

[0044] The calibration data of the measurement area 61 photographed at this stage is, for example, as shown in Fig. 19. The multiple fluorescent portions 66a-66f in the fluorescence determination element 66 photographed with this calibration data emit different fluorescent light from one another. When the photographing is completed, at the stage shown in S190, the light source control unit 48 of the holding unit 40 turns off the light source 42. Then, the process proceeds to the stage shown in S195, where correction information is calculated.

[0045] As a first example, consider a case where each fluorescent unit 66a-66f is coated with paint that emits fluorescence of different intensities at the same fluorescent wavelength. In this first example, the memory device 150 (see FIG. 15) of the control unit 100 stores, as data, 40, 80, 120, 160, 200, and 240 as reference values ​​of the fluorescent intensities corresponding to the fluorescent units 66a, 66b, 66c, 66d, 66e, and 66f, respectively, from upstream to downstream, as shown in Table 1 below.

[0046] [Table 1]

[0047] In the first example, at the stage shown in S180, the determination means 245 of the control unit 100 determines, based on the arrangement of the fluorescent portions 66a-66f and the calibration data shown in FIG. 19, a plurality of pieces of fluorescence data as fluorescence information associated with each of the fluorescent portions 66a-66f. Then, at the stage shown in S195a of FIG. 17A, the fluorescence intensity is measured as an actual measurement value as shown in Table 1 above for each of the fluorescent portions 66a-66f from the associated fluorescence information. Next, at the stage shown in S195b, the analysis means 250 compares the actual measurement value of the fluorescence intensity measured for each of the fluorescent portions 66a-66f with the reference value for the corresponding fluorescent portion 66a-66f. For example, as shown in Table 1 above, the analysis means 250 calculates how many times the reference value is compared with the actual measurement value, and sets this as the comparison value.

[0048] Next, at step S195c, the analysis means 250 calculates correction information for correcting the actually measured fluorescence intensity from the comparison value obtained at step S195b, and then at step S195d, the analysis means 250 stores this correction information in the storage device 150.

[0049] For example, the average of the comparison values ​​(1.094 in Table 1 above) can be used as correction information, and the sensitivity of the fluorescence intensity of the imaging unit 51 can be adjusted by uniformly multiplying this correction information (1.094) by the actual measured value of the fluorescence intensity of the image data captured by the imaging unit 51 (first example A).

[0050] Alternatively, the sensitivity of the fluorescence intensity of the photographing unit 51 may be adjusted by calculating the average of adjacent comparison values ​​and using this as correction information, and multiplying it by 1.089 as correction information if the actual measured value of the fluorescence intensity photographed by the photographing unit 51 is in the range of less than 75, 1.079 as correction information if it is in the range of 75 or more but less than 110, 1.090 as correction information if it is in the range of 110 or more but less than 147, 1.103 as correction information if it is in the range of 147 or more but less than 179, or 1.104 as correction information if it is in the range of 179 or more, as shown in Table 1 above (first example B).

[0051] Alternatively, the sensitivity of the fluorescence intensity of the imaging unit 51 may be adjusted by calculating a regression line as correction information when the actual measured value of the fluorescence intensity is x and the reference value is y, and then applying the actual measured value x to this correction information to obtain the reference value y (first example C). In the case of Table 1 above, the regression line is as shown in the following formula (1).

[0052] y=1.1024x+0.9214 (1)

[0053] Next, as a second example, consider a case where each of the fluorescent portions 66a to 66f is coated with a paint that emits fluorescence of a different wavelength. In the second example, as shown in Table 2 below, from upstream to downstream, the fluorescent portions 66a and 66b are associated with reference values ​​of 640 nm and 620 nm, respectively, which correspond to a color tone R with an assumed wavelength peak value of 630 nm; the fluorescent portions 66c and 66d are associated with reference values ​​of 540 nm and 520 nm, respectively, which correspond to a color tone G with an assumed wavelength peak value of 530 nm; and the fluorescent portions 66e and 66f are associated with reference values ​​of 470 nm and 450 nm, respectively, which correspond to a color tone B with an assumed wavelength peak value of 460 nm, and these data are stored in the memory device 150 (see FIG. 15) of the control portion 100.

[0054] [Table 2]

[0055] In the second example, at the stage shown in S180, the determination means 245 of the control unit 100 determines, from the calibration data shown in Fig. 19, a plurality of pieces of fluorescence data as fluorescence information associated with each of the fluorescent units 66a-66f based on the arrangement of the fluorescent units 66a-66f. Then, at the stage shown in S195e of Fig. 17B, the wavelength is measured as an actual measurement value as shown in Table 2 above, from the associated fluorescence information for each of the fluorescent units 66a-66f. Next, at the stage shown in S195f, the analysis means 250 compares the actual measurement value of the wavelength measured for each of the fluorescent units 66a-66f with the reference value for the corresponding fluorescent unit 66a-66f.

[0056] Then, the analysis means 250 calculates correction information for correcting the measured wavelengths at the step shown in S195g. For example, in the case of Table 2 above, the averages of the measured values ​​corresponding to the color tones R, G, and B are calculated, and these are used as the correction information.

[0057] Then, the analysis means 250 stores this correction information in the storage device 150 at a step shown in S195h.

[0058] After the step shown in S195 of FIG. 16B, in the step shown in S200, the analysis means 250 corrects the captured measurement data using the correction information calculated in the step shown in S195c (in the first example) or the step shown in S195g (in the second example).

[0059] Specifically, at the step S200a in Fig. 18, the image acquisition means 235 measures the luminescence intensity for each measurement site in the captured measurement image. Next, at the step S200b, the analysis means 250 corrects each luminescence intensity in the measurement image by applying the correction information calculated at the step S195c (in the first example) or the step S195g (in the second example) to the luminescence intensity for each measurement site in the measurement image.

[0060] For example, in the case of the first example A, the analysis means 250 corrects the luminescence intensity by uniformly multiplying the luminescence intensity for each measurement site by the average of the comparison values ​​(specifically, 1.094) as shown in Table 1 as correction information.

[0061] In the case of the first example B, the analysis means 250 corrects the luminescence intensity for each measurement site by multiplying the luminescence intensity by the average of two adjacent values ​​as shown in Table 1 corresponding to the range to which the luminescence intensity belongs, as correction information.

[0062] In the case of the first example C, the analysis means 250 corrects the emission intensity by substituting the emission intensity for each measurement site as value X into the formula (1) as correction information to obtain value Y.

[0063] In the second example, the analysis means 250 corrects the fluorescence spectrum recorded as pixel information in the pixels corresponding to each measurement site so that the average wavelength of the corresponding two values ​​shown in Table 2 as correction information is regarded as the peak value for each of RGB. That is, for color tone R, the peak value is corrected to be the emission intensity at 632 nm, the average value of the actual measurements, rather than 630 nm. Similarly, for color tone G, the peak value is corrected to be the emission intensity at 532 nm, the average value of the actual measurements, rather than 530 nm. Furthermore, for color tone B, the peak value is corrected to be the emission intensity at 460.5 nm, the average value of the actual measurements, rather than 460 nm.

[0064] After the luminescence intensity for each measurement site is corrected in S200b, in the step shown in S200c, the luminescence intensity for each measurement site of the corrected measurement image is stored in the memory device 150 (see Figure 15), and then the measurement object is measured by being used to calculate the content of the measurement object by the analysis means 250.

[0065] An example of the emission intensity after correction in the measurement data is represented by the graph shown by the solid line in Fig. 20. That is, the graph of emission intensity before correction shown by the dashed line becomes the graph shown by the solid line after correction.

[0066] With the above configuration, in the determination system 10 of the present disclosure, the measurement data measured by the mobile device 50 used is corrected using the fluorescence information obtained from the fluorescence determination element 66, thereby making it possible to avoid variations in the measurement results due to differences in the mobile device 50 used.

[0067] (8) Other In the above example, the fluorescence determination element 66 was provided on the test strip 60, but as shown in another example in Figure 21, the fluorescence determination element 66 can be provided on a fluorescent reference strip 60A dedicated to obtaining calibration data, separate from the test strip 60. In this case, the fluorescent reference strip 60A is first attached to the housing 20, correction information is obtained, the fluorescent reference strip 60A is then removed, and the test strip 60 is then attached to the housing 20 again, thereby obtaining measurement data.

[0068] 22, a fluorescent determination element 66 may be provided inside the storage compartment 46 of the holder 40. In this example, the notch on the side of the test strip 60 is larger than in the example shown in FIG. 3A. When the test strip 60 is inserted into the storage compartment 46 of the holder 40, the position of this notch coincides with the position of the fluorescent determination element 66. This allows the test strip 64 and the fluorescent determination element 66 to fit within the same field of view of the imaging unit 51. [Industrial Applicability]

[0069] The technology of the present disclosure can be used in a measurement system in which an object to be measured in a sample is developed on a test strip and optically detected. [Explanation of symbols]

[0070] 10 Judgment System 20. Housing 30 Placement section 40 Holding part 42 Light source 50 Mobile Devices 60 test specimens 60A Fluorescent Reference Block 66 Fluorescence Determination Elements 66a~66f Fluorescent part 100 control section 110 CPU (Central Processing Unit) 235 Image Acquisition Method 245 Judgment means 250 Analysis Means

Claims

1. a fluorescence determination element having a predetermined number of fluorescent portions arranged at predetermined positions; a light source that irradiates the fluorescence determination element with an excitation light; a control unit including an image acquisition means for acquiring calibration data, which is image data, by photographing the fluorescence determination element illuminated by the light source, and a determination means for determining fluorescence information based on the calibration data; A judgment system comprising:

2. the fluorescent units emit different fluorescent lights when irradiated with the excitation light, the calibration data includes a plurality of pieces of fluorescence data corresponding to the respective fluorescence emitted by the plurality of fluorescent portions, The determination system according to claim 1 , further comprising an analysis means for calculating correction information by comparing the fluorescence information determined by the determination means from the plurality of fluorescence data with a plurality of reference values ​​serving as standards for each fluorescent portion.

3. the light source irradiates the excitation light onto the fluorescence determination element and also onto a test piece on which a reagent is placed; The image acquisition means acquires measurement data, which is image data obtained by capturing an image of the test piece illuminated by the light source, in addition to the calibration data, and The determination system according to claim 2 , wherein the analysis means corrects the measurement data based on the correction information.

4. The determination system according to claim 3 , wherein the image acquisition means captures an image of the fluorescent determination element and the test piece illuminated by the light source as a single image data, and acquires the calibration data and the measurement data from the single image data.

5. The determination system according to claim 2 , wherein the determination means determines the fluorescence information based on the arrangement of the fluorescence determination elements from the calibration data.

6. The determination system according to claim 2 , wherein the fluorescence intensities of the fluorescence emitted from the plurality of fluorescent parts are different from one another as the fluorescence information.

7. The determination system according to claim 2 , wherein the fluorescence of each of the plurality of fluorescent parts has a wavelength different from each other as the fluorescence information.

8. The image acquisition means further includes a mobile device having a camera, The determination system according to claim 2 , wherein a central processing unit of the mobile device functions as the control unit.

9. The image acquisition means further includes a mobile device having a camera, The determination system according to claim 3 , wherein a central processing unit of the mobile device functions as the control unit.

10. a housing in which the test strip is mounted; The housing includes: a mounting portion for holding the mobile device; a holder into which the test strip is inserted and in which the light source is provided, the holder being attached to the placement part; The determination system according to claim 9 , comprising:

11. 11. The determination system according to claim 3, wherein the fluorescent determination element is provided on the test piece.

12. 11. The determination system according to claim 3, wherein the fluorescence determination element is provided on a fluorescent reference piece that has substantially the same shape as the test piece and is dedicated to obtaining the calibration data.

13. The determination system according to claim 10 , wherein the fluorescence determination element is provided in the holder.

14. A test strip provided with the fluorescent determination element, for use in the determination system according to claim 11.

15. A fluorescent reference strip provided with the fluorescent determination element, for use in the determination system according to claim 12.

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