Measurement system, measurement method, measurement program, and smart device

Abstract

To identify the type of a specimen to be used prior to measurement in a system for measuring, with a test piece, a measurement object in the specimen.SOLUTION: Provided is a measurement system comprising: a test piece having an introduction unit on the upstream side into which a specimen is introduced, a measurement unit on the downstream side to which a reaction agent is fixed that reacts with the measurement object included in the specimen, and an expansion unit for expanding the specimen from the instruction unit to downstream of the measurement unit; a light source for irradiating the test piece into which the specimen is introduced with light of a prescribed wavelength; an imaging unit for acquiring optical information on the test piece irradiated by the light source; and an analysis unit for determining the type of the specimen from optical information in an upstream region on the upstream side in the expansion unit, out of the optical information acquired by the imaging unit.SELECTED DRAWING: Figure 3B

Description

[Technical field]

[0001] The present disclosure relates to a technology for identifying the type of sample to be used prior to measurement in a system that measures a measurement target in a sample using a test strip. [Background technology]

[0002] Patent Document 1 discloses a technique for identifying the type of a test solution from a detection signal in a base portion of a chromatography test strip to which the test solution has been added. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2003-4743 A Summary of the Invention [Problem to be solved by the invention]

[0004] The calibration curve used for the sample measurement varies depending on whether a sample containing blood cell components (whole blood sample) or a sample not containing blood cell components (plasma or serum) is used as the sample. Therefore, it was necessary to input the type of sample to be applied to the test strip as information in advance into the measurement device. In addition, if the sample was applied without checking the type of sample, the measurement may be performed using the calibration curve of the wrong type. Furthermore, if the whole blood sample reached the measurement position, the correct measurement may not be possible. Therefore, an embodiment of the present disclosure provides a technology for identifying the type of sample to be used prior to measurement in a system that measures a measurement target in a sample using a test strip. [Means for solving the problem]

[0005] A measurement system of one embodiment of the present disclosure comprises a test strip having an upstream introduction section where a sample is introduced, a downstream measurement section where a reaction reagent that reacts with the substance to be measured contained in the sample is fixed, and a development section for developing the sample from the introduction section to downstream of the measurement section, a light source that irradiates light of a predetermined wavelength onto the test strip into which the sample has been introduced, an imaging section that acquires optical information of the test strip irradiated by the light source, and an analysis section that determines the type of sample from the optical information acquired by the imaging section, which is the optical information of an upstream region that is upstream of the development section. Effect of the Invention

[0006] According to an embodiment of the present disclosure, in a system that measures a measurement target in a sample using a test strip, a technique is provided for identifying the type of sample to be used prior to measurement. [Brief description of the drawings]

[0007] [Figure 1] FIG. 2 shows a top perspective view of a holding portion used in the embodiment. [Diagram 2] 1 is an enlarged perspective view of the vicinity of an insertion opening of a holding portion. [Figure 3A] 1 shows a test specimen used in an embodiment in plan view. [Figure 3B] 3B shows a simplified version of the test specimen of FIG. 3A. [Figure 3C] 3B is a schematic diagram showing the structure of the test paper of FIG. 3A. [Figure 4] FIG. 2 is a top perspective view showing a state in which a test piece is attached to the holder. [Diagram 5] The state of FIG. 4 is shown in plan view. [Figure 6] FIG. 2 is a top perspective view of a placement section used in the embodiment. [Figure 7] 1 shows a bottom view of the placement portion. [Figure 8] 1 shows a top perspective view of a housing according to an embodiment. [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 illustrates a bottom view of a smart device used in an embodiment. [Figure 11] 1 shows an embodiment of a measurement system in a top perspective view. [Figure 12] 12 is a top perspective view of the measurement 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 of FIG. [Figure 14] FIG. 2 is a functional block diagram of a measurement system according to an embodiment. [Figure 15] The control unit is shown in a block diagram. [Figure 16A] 4 is a flowchart showing an outline of a method for measuring a measurement object in the measurement system of the embodiment. [Figure 16B] 4 is a flowchart showing an outline of a method for measuring a measurement object in the measurement system of the embodiment. [Figure 17] 13 is a graph showing an example of the fluorescence intensity in the development area when a whole blood sample is measured as the sample. [Figure 18] An example of the fluorescence intensity in the development area when plasma is measured as a sample is shown in the graph. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Hereinafter, an embodiment of the present disclosure will be described with reference to the drawings. Common reference numerals in each drawing indicate the same parts without any special explanation. In addition, each member and each part shown in each drawing is merely a schematic drawing, and the size and positional relationship of the actual product are not necessarily accurately shown.

[0009] (1) Holding part FIG. 1 is a top perspective view of the holding part 40 used in the measurement system 10 (see FIG. 11) of this embodiment. In the measurement system 10 of the present disclosure, the holding part 40 as shown in FIG. 1 may be included as a member constituting the housing 20 (see FIG. 8). The holding part 40 has a box-like shape, and two openings, a measurement opening 43 and an identification opening 44, are formed on the upper surface. An optical filter 45 is fitted into the measurement opening 43. A sensor 47 that detects light is also provided on the upper surface. An insertion opening 41 is opened on the side of the holding part 40, into which a test piece 60 (see FIG. 3A) described later is inserted. The internal space of the insertion opening 41 is also connected to the measurement opening 43 and the identification opening 44, and serves as a storage part 46, which is a space in which a part of the test piece 60 is stored.

[0010] 2 is an enlarged perspective view of the vicinity of the insertion opening 41 of the holding part 40, seen from below. The sensor 47 is provided in the storage part 46, which is the internal space of the insertion opening 41, near the measurement opening 43 (see FIG. 1), in which the optical filter 45 is fitted. Light including 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 part 46. The optical filter 45 has optical properties that allow only light rays of a wavelength suitable for the photographing to be transmitted.

[0011] (2) Test piece FIG. 3A shows a plan view of a test strip 60 used in the measurement system 10 (see FIG. 11) of this embodiment. The test strip 60 has a flat rod-like shape. A gripping portion 65 with a recessed upper surface is formed at one end of the test strip 60, and the test strip 60 can be gripped with the fingers by holding this portion. A test paper 64 having a long shape along the longitudinal direction of the test strip 60 is contained inside the test strip 60. The test paper 64 is exposed upward at two openings formed on the upper surface of the test strip 60. Of these two openings, the one closer to the gripping portion 65 is the introduction portion 63, and the one farther from the gripping portion 65 is the measurement area 61 where the measurement of the measurement object is performed. Furthermore, an identification area 62 in which information about the test strip 60 is recorded is formed on the other end side of the test strip 60, i.e., on the upper surface at the location farthest from the gripping portion 65. 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."

[0012] The test paper 64 is an absorbent such as filter paper, or a synthetic resin substrate with an absorbent layer applied to its surface. A reaction reagent that reacts with the object to be measured and develops a color is applied to the middle part of the measurement area 61 of the test paper 64. A sample that is assumed to contain the object to be measured is applied to the introduction part 63. As the sample in the present disclosure, for example, a sample containing blood cell components (hereinafter referred to as a "whole blood sample") or a sample not containing blood cell components (for example, plasma or serum, hereinafter referred to as a "blood cell-free sample"), or a sample diluted with an appropriate buffer is used.

[0013] Figure 3B shows the test strip 60 of Figure 3A in a simplified form for ease of explanation. That is, components other than the introduction section 63 and the measurement area 61 are omitted. The part of the test paper 64 that is visible in the measurement area 61 (see Figure 3A) is the development section 73 where the sample is developed from the upstream side to the downstream side. The development section 73 is divided into an upstream area 74, which is an upstream area involved in identifying the type of sample as described below, and a control area 75, which is the other area. The middle part of the control area 75 is the measurement section 72 where a reagent that reacts with a substance contained in the sample is fixed.

[0014] Specifically, a reaction reagent that reacts specifically with the object to be measured is fixed to the downstream portion of the measurement section 72. When the object to be measured reacts with the reaction reagent, a target reaction zone 70 is generated. In addition, a control reagent that reacts nonspecifically with the specimen, regardless of the presence or absence of the object to be measured, is fixed to the upstream portion of the measurement section 72. When the specimen reacts with the control reagent, a control reaction zone 71 is generated. The generation of the control reaction zone 71 indicates that the specimen has been correctly developed, regardless of the presence or absence of the object to be measured. In other words, the development section 73 includes a region where the target reaction zone 70 is generated by specifically reacting with the object to be measured contained in the specimen, and a region where the control reaction zone 71 is generated by nonspecifically reacting with the specimen. The region of the control region 75 excluding the region where the target reaction zone 70 is generated and the region where the control reaction zone 71 is generated is set as the reference region 76.

[0015] Fig. 3C is a schematic diagram showing the structure of the test paper 64 in Fig. 3A. The test paper 64 has a spreading membrane 64A, the length of which is sufficient to cover the measurement area 61 (see Fig. 3B), fixed to the middle of a backing sheet 64E, the length of which is almost the entire length of the test strip 60. The backing sheet 64E is made of a material that is impermeable to moisture, such as polyvinyl chloride resin (PVC) or polystyrene resin (PS). The spreading membrane 64A is made of a material that can absorb liquid by capillary force and can immobilize the reaction reagent and the control reagent, such as a nitrocellulose membrane.

[0016] A sample pad 64B is fixed to the upstream side of the developing membrane 64A via a conjugate pad 64C. The sample pad 64B is located directly below the introduction section 63 (see FIG. 3B). The sample pad 64B has a mesh structure and has the function of capturing some of the blood cell components contained in the specimen and allowing the plasma components to permeate downstream together with the uncaptured blood cell components. The blood cell components that permeate the sample pad 64B are involved in identifying whether the specimen is a whole blood specimen or a blood cell-free specimen, as described below. The sample pad 64B is formed of a material such as glass fiber, polyethylene terephthalate resin (PET), or cellulose fiber.

[0017] The conjugate pad 64C has a function of allowing the specimen that has permeated the sample pad 64B to permeate to the developing membrane 64A. The conjugate pad 64C may or may not have a function of capturing blood cells like the sample pad 64B. In other words, the sample pad 64B and the conjugate pad 64C may be combined to achieve a desired blood cell capturing function. The conjugate pad 64C is formed of a material such as glass fiber, polyester fiber, or rayon.

[0018] An absorbent pad 64D is fixed to the downstream side of the spreading membrane 64A. The absorbent pad 64D has a function of absorbing excess liquid that reaches the downstream end of the spreading membrane 64A. The absorbent pad 64D is made of a material capable of absorbing liquid by capillary force, such as glass fiber, cellulose fiber, or cotton.

[0019] When a sample is applied to the introduction section 63, it permeates from the sample pad 64B to the conjugate pad 64C and reaches the developing membrane 64A. The sample developed downstream by the developing membrane 64A reacts with a reagent in the measurement section 72 (see FIG. 3B), and a target reaction zone 70 is generated if the measurement target is present, and a control reaction zone 71 is generated regardless of the presence or absence of the measurement target. At this time, if the sample contains blood cells, the blood cells that have reached the developing membrane 64A can be made to stay in the upstream region 74 by appropriately adjusting the blood cell capturing ability of the sample pad 64B (and the conjugate pad 64C), the liquid permeation speed of the developing membrane 64A, the size of each part of the test piece 60, and the dilution concentration of the sample. Then, the blood cell components that have stayed in the upstream region 74 are detected as optical information, and the type of sample, specifically, whether it is a whole blood sample or a blood cell-free sample, is identified from the optical information of the detected upstream region 74. This point will be described later.

[0020] Fig. 4 is a top perspective view showing the state in which the test strip 60 is attached to the holding portion 40. Fig. 5 shows this state in a plan view. As shown in Figs. 4 and 5, the test strip 60 is inserted into the storage portion 46 from the insertion port 41 with the downstream side first (see Fig. 1). In this state, as shown in Fig. 5, the measurement area 61 (see Fig. 3A) 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.

[0021] In this state, when a sample is applied to the introduction section 63, the test paper 64 flows downstream due to capillary action, and a control reaction zone 71 (see FIG. 3B) indicating the application of the sample is generated upstream in the measurement area 61. Furthermore, when the sample contains a measurement target, a target reaction zone 70 (see FIG. 3B) having an intensity corresponding to the concentration of the measurement target is generated downstream. In this test paper 64, the control reaction zone 71 is located in the center of the measurement area 61, and the target reaction zone 70 is located downstream away from the center. The measurement system 10 of this embodiment measures the concentration of the measurement target by irradiating the target reaction zone 70 with light of a predetermined wavelength emitted from the light source 42 (see FIG. 13) and measuring the intensity of the generated light. In the above-mentioned identification area 62, identification information, which is information about the test strip 60, such as what type of test paper 64 is contained in the test strip 60, is recorded. Examples of identification information include barcodes and QR codes (registered trademark).

[0022] (3) Placement section FIG. 6 is a top perspective view of the placement unit 30 used in the measurement 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 substantially rectangular parallelepiped paper box with an open top and bottom. The four sides of the placement unit 30 are outer walls 34 that are vertically erected. On the top surface of the placement unit 30, a placement frame 32 is formed, which is a frame on which a smart device 50 (see FIG. 10) described later is placed. On one side (hereinafter referred to as the "front side") of the interior of the placement unit 30, a box-shaped light-shielding section 33 is formed, which has a window 31 open, a closed top, and an open bottom (see FIG. 7).

[0023] Here, 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 opposite face is referred to as the back face 34b, the face on the left side as viewed from the front face 34a is referred to as the left side face 34c, and the opposite face is referred to as the right side face 34d. The inside of the mounting portion 30 is divided by a reinforcing portion 35 parallel to the front face 34a and the back face 34b. Furthermore, a rectangular cutout portion 36 is formed on the front lower edge of the left side face 34c.

[0024] (4) Housing As shown in Fig. 7, a gap is generated between the lower edge of the light-shielding portion 33 and the lower edge of the outer wall portion 34, and the space surrounded by the front surface 34a, the reinforcing portion 35, the left side surface 34c, and the right side surface 34d on all four sides with the gap as the height is referred to as the accommodation area 37. When the holding portion 40 is attached to this accommodation area 37, the housing 20 shown in Fig. 8 is formed. In this state, the notch 36 of the placement portion 30 and the insertion opening 41 of the holding portion 40 are aligned. In this state, the test piece 60 is attached to the insertion opening 41 as shown in Figs. 4 and 5, as shown in the top perspective view of Fig. 9.

[0025] (5) Smart devices FIG. 10 shows a smart device 50 used in the measurement system 10 (see FIG. 11) of this embodiment in a bottom view in a state where it is placed on the housing 20. In this embodiment, a smartphone is used as the smart device 50, but a tablet terminal with a camera function may also be used as the smart device 50. An imaging unit 51 configured as a camera and an illumination unit 52 configured as a flash that irradiates visible light are provided on the bottom side (so-called back side) of the smart device 50. The imaging unit 51 acquires optical information of the test piece 60 illuminated by the light source 42 as an image. The top side (so-called front side) of the smart device 50 is a display unit 53.

[0026] (6) Measurement system The measurement system 10 of this embodiment is configured as shown in the top perspective view of Fig. 11 by placing the smart device 50 shown in Fig. 10 inside the mounting frame 32 of the housing 20 shown in Fig. 9 with the imaging unit 51 and the lighting 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 portion 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 portion 33, preventing the entry of light from the outside world.

[0027] 13, which shows a cross section of FIG. 12 taken along the line XIII-XIII, the measurement opening 43 and the optical filter 45 are located above the measurement area 61 of the test piece 60, and the identification opening 44 is located above the identification area 62. Furthermore, a light source 42 is installed slightly behind and below the identification opening 44 to irradiate the measurement area 61 from above. A window 31 of the mounting unit 30 is located directly above the measurement opening 43, and through this, the imaging unit 51 of the smart device 50 can view the identification area 62 in addition to the measurement area 61.

[0028] Fig. 14 is a functional block diagram of the measurement system 10 of this embodiment. The smart device 50 is provided with an imaging 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 them. 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 described later as computer hardware resources.

[0029] That is, the control unit 100 functions as an illumination switching means 200 that switches on / off (on / off) the illumination by the illumination unit 52. Specifically, the illumination switching means 200 can be realized as an application installed in the smart device 50, but can also be realized as a means using electrical or optical sensing with the holding unit 40, or as a wireless communication means (for example, Bluetooth (registered trademark) or the like) with the holding unit 40. The control unit 100 also functions as an imaging condition storage means 210 that stores the conditions of imaging by the imaging unit 51. The conditions defined as the imaging conditions include, for example, a waiting time required for the reaction between the measurement object and the reagent. The control unit 100 also functions as a spotting detection means 220 that detects the spotting of the sample on the test piece 60 through 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 an image storage means 240 that stores the image of the measurement area 61 captured by the imaging unit 51. Furthermore, the control unit 100 functions as an analysis unit 250 that analyzes the image captured by the imaging unit 51 as optical information.

[0030] 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.

[0031] The CPU 110 is a central processing unit that executes various programs and controls each part. That is, the CPU 110 reads the programs from the ROM 120 or the storage device 150, and executes the programs using the RAM 130 as a working area. The CPU 110 controls the measurement system 10 according to the programs recorded in the ROM 120 or the storage device 150.

[0032] 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 a storage device using a hard disk drive (HDD), a solid state drive (SSD), or a flash memory, and stores various programs including an operating system, and various data.

[0033] On the other hand, the holding unit 40 includes a light source 42 that irradiates 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 smart device 50. Note that the light source control unit 48 can realize turning 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 turning on the light source 42 when photographing the measurement area 61 described later. In addition, the light source control unit 48 can also control turning off the light source 42. Here, the light source 42 is a light source that irradiates light of a predetermined wavelength suitable for detecting the measurement target in the measurement area 61. For example, when a substance that reacts with the measurement target in the target reaction zone 70 of the measurement area 61 has absorption of ultraviolet light, the light source 42 can be set to ultraviolet light to perform appropriate photographing. In this way, the light source 42 with a wavelength corresponding to the object to be measured can be used to capture an image of the measurement area 61, and the lighting unit 52 of the smart device 50 can be used as a light source to capture an image of the identification area 62.

[0034] As described above, the measurement system 10 of this embodiment comprises a test piece 60 having an upstream introduction section 63 where a sample is introduced, a downstream measurement section 72 where a reaction reagent that reacts with the substance to be measured contained in the sample is fixed, and a development section 73 for developing the sample from the introduction section 63 to downstream of the measurement section 72, a light source 42 that irradiates light of a predetermined wavelength onto the test piece 60 into which the sample has been introduced, an imaging section 51 that acquires optical information of the test piece 60 irradiated by the light source 42, and an analysis section 250 that determines the type of sample from the optical information acquired by the imaging section 51, of an upstream region 74 that is upstream of the development section 73.

[0035] In the measurement system 10 of this embodiment, it is preferable that the analysis section 250 determines the type of the specimen based on the optical information of the upstream region 74 relative to a reference value based on the optical information of the reference region 76 (see FIG. 3B), which is a region excluding the target reaction zone 70 and the control reaction zone 71 in the control region 75, which is a region other than the upstream region 74 in the development section 73. Here, it is preferable that the optical information is obtained as an average value of the optical intensity at each predetermined position along the longitudinal direction of the development section 73 in a direction perpendicular to the longitudinal direction (specifically, the width direction of the test piece 60 shown in FIG. 3B). In addition, it is preferable that the reference value is an average value of the optical information in the reference region 76. Note that the "predetermined position" here is preferably determined based on the pixels of the photograph taken by the imaging section 51. Furthermore, it is preferable that the predetermined wavelength at which the light source 42 irradiates the test piece 60 is a wavelength that is absorbed by blood cell components in the specimen.

[0036] The measurement system 10 of this embodiment operates as follows. First, a light source irradiates the test piece 60 into which a specimen has been introduced with light of a predetermined wavelength (preferably ultraviolet light having a wavelength absorbed by blood cell components in the specimen). Optical information of the irradiated test piece 60 is acquired by the imaging unit 51. The optical information acquired by the imaging unit 51 (preferably pixel information of a photograph taken by the imaging unit 51) also includes optical information of the upstream region 74. The analysis unit 250 determines the type of specimen (e.g., whether it is a whole blood specimen or a blood cell-free specimen) from the acquired optical information of the upstream region 74. This determination is preferably made based on the optical information in the control region 75, for example, based on the optical information of the upstream region 74 relative to a reference value defined as the average value of the optical information in the control region 75 (more preferably, the average value of the optical information in the reference region 76).

[0037] More specifically, the optical information (i.e., pixel information) at each predetermined position in the upstream region 74 is compared with a reference value, and the type of the sample is determined based on the degree of deviation from the reference value. For example, if the sample contains blood cells, the intensity of the fluorescence emitted by the test strip 60 upon absorption of the irradiated ultraviolet light is lower in the region where blood cells are assumed to be present (i.e., the upstream region 74) than when the sample does not contain blood cells (i.e., when the sample is a blood cell-free sample). On the other hand, the fluorescence intensity in the reference region 76 is not affected by whether the sample contains blood cells or not. Therefore, whether the sample is a whole blood sample or a blood cell-free sample is determined based on the degree of decrease in the optical information (i.e., fluorescence intensity) at each predetermined position in the upstream region 74 relative to a reference value based on the optical information (i.e., fluorescence intensity) in the reference region 76.

[0038] For example, if the optical information for each predetermined position in the upstream region 74 is lower than the reference value at a predetermined rate (e.g., 10%) or more, the sample can be determined to be a whole blood sample, and if not, the sample can be determined to be a blood cell-free sample. Alternatively, if the optical information for each predetermined position in the upstream region 74 is lower than the reference value at a predetermined number (e.g., 10) or more, the sample can be determined to be a whole blood sample, and if not, the sample can be determined to be a blood cell-free sample. As another determination method, if the optical information for each predetermined position in the upstream region 74 is lower than the reference value and the optical information lower than the reference value continues from that point to the upstream end, the sample can be determined to be a whole blood sample, and if not, the sample can be determined to be a blood cell-free sample. As yet another method, if there is a point in the upstream region 74 where the rate of change of the optical information (i.e., the ratio of the difference between the reference value and the optical information) is below the reference value, and if a predetermined number of consecutive points (e.g., 10 points) upstream from that point are below the reference value, it can be determined to be a whole blood sample, and if not, it can be determined to be a blood cell-free sample.

[0039] Furthermore, by appropriately adjusting the structure of the test strip 60 (for example, the properties of the spreading membrane 64A, the sample pad 64B and the conjugate pad 64C) and the degree of dilution of the sample, when the sample contains blood cells, it is possible to configure the test strip 60 so that the blood cells are retained in the upstream region 74 of the spreading section 73 when the sample is spread on the test strip 60.

[0040] 14, the smart device 50 includes an imaging unit 51 and an analysis unit 250. That is, the smart device 50 of this embodiment includes an introduction unit 63 on the upstream side where the specimen is introduced, a measurement unit 72 on the downstream side where a reaction reagent that reacts with a measurement target contained in the specimen is placed, and a development unit 73 for developing the specimen from the introduction unit to downstream of the measurement unit 72, and includes an imaging unit 51 that acquires optical information of an upstream region 74 on the upstream side of the development unit 73 in a state where light of a predetermined wavelength is irradiated onto the test piece 60 into which the specimen has been introduced, and an analysis unit 250 that analyzes the optical information of the upstream region 74 to determine the type of specimen. The determination of the type of specimen by the analysis unit 250 is as described above.

[0041] The measurement system 10 of the present embodiment described above can perform a measurement method having an upstream introduction section 63 where a sample is introduced, a downstream measurement section 72 where a reaction reagent that reacts with the substance to be measured contained in the sample is placed, and a development section 73 for developing the sample from the introduction section 63 to downstream of the measurement section 72, and including the steps of irradiating light of a predetermined wavelength onto the test piece 60 into which the sample has been introduced, acquiring optical information of an upstream region 74, which is the upstream side of the development section, while the light of the predetermined wavelength is irradiated, and analyzing the acquired optical information of the upstream region 74 to determine the type of sample.

[0042] The above-mentioned measurement method can be executed by a measurement program that causes a computer to function as: a means for irradiating light of a predetermined wavelength onto a test piece having an upstream introduction section where a sample is introduced, a downstream measurement section where a reaction reagent that reacts with the substance to be measured contained in the sample is placed, and a development section for developing the sample from the introduction section to downstream of the measurement section, a means for acquiring optical information of an upstream region that is upstream of the development section while the test piece is irradiated with light of the predetermined wavelength; and a means for analyzing the acquired optical information to determine the type of sample.

[0043] An example of the measurement method of the present embodiment described above will be described with reference to the flowcharts shown in Figures 16A and 16B. Note that in these flowcharts, the outline of the steps showing operations other than those directly performed by the smart device 50 is shown in parentheses.

[0044] First, as shown in Fig. 11, the measurement system 10 is prepared by placing the smart device 50 on the housing 20 having the holder 40 attached to the placement part 30, and the test piece 60 is inserted through the insertion opening 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 smart device 50 is started, and the measurement is started.

[0045] First, in the step shown in S100, the illumination unit 52 is turned on and the imaging unit 51 captures an image of the identification area 62 (see FIG. 3A), and based on this, the control unit 100 refers to the imaging condition storage means 210 (see FIG. 14) and acquires the imaging conditions for measurement using the test piece 60. Details of this step will be omitted.

[0046] Next, in the step shown in S110, the operator applies an appropriate amount of sample to the introduction portion 63 (see FIG. 3B) of the test strip 60. The applied sample is spread downstream inside the test strip 60 by the test paper 64 (see FIG. 3B).

[0047] During this time, the spotting detection means 220 (see FIG. 14) of the control unit 100 continues to monitor whether an image indicating completion of spotting (for example, a control reaction zone 71 (see FIG. 3B) generated by a reaction with the measurement object) is detected in the measurement area 61 through the image from the imaging unit 51 at the stage shown in S120. If such an image is detected, the process proceeds to the stage shown in S130.

[0048] At the stage shown in S130, after the completion of application is detected at the stage shown in S120, the waiting time measurement means 230 (see Figure 14) of the control unit 100 continues to monitor whether the waiting time required for the reaction between the measurement object in the test paper 64 and the reagent has elapsed, among the shooting conditions acquired at the stage shown in S100.

[0049] When the standby time measurement means 230 determines at a stage shown in S130 that the standby time has elapsed, the illumination switching means 200 turns off the illumination unit 52 and turns on the light source 42 at a stage shown in S140.

[0050] When the light source 42 is turned on, at the stage shown in S150, the imaging unit 51 captures an image of the development portion 73 (see FIG. 3B) including the target reaction zone 70 visualized in the measurement region 61 by the wavelength of the measurement light from the light source 42, and acquires this as optical information of the test strip 60. When acquisition of the optical information is completed, at the stage shown in S160, the light source control unit 48 of the holder 40 turns off the light source 42. Then, at the stage shown in S170, identification of the type of sample is performed.

[0051] Fig. 16B is a flow chart showing details of specimen identification at the stage shown in S170. First, at the stage shown in S200, the analysis unit 250 measures the fluorescence intensity for each measurement site from the optical information of the test strip 60 acquired by the imaging unit 51 at the stage shown in S150. Here, the optical information of the test strip 60 is actually image information of the development section 73 shown in Fig. 3B. This image information is a collection of pixels with the longitudinal direction of the test strip 60 as the X-axis and the width direction as the Y-axis, and each pixel is associated with information such as luminescence intensity and color.

[0052] 17 and 18 are graphs of the fluorescence intensity at each position in the longitudinal direction from the image information of the development section 73 when whole blood and plasma are applied to the test piece 60 as specimens, respectively. The horizontal axis of both figures represents the X-axis, and specifically, the position on the image information in the longitudinal direction of the development section is represented by pixel numbers. In both figures, the smaller pixel numbers are the downstream side, and the larger pixel numbers are the upstream side. The vertical axis of both figures represents the average value of the fluorescence intensity along the Y-axis. In both figures, a peak originating from the target reaction zone 70 originating from the measurement target appears on the downstream side (left side in the figure), and a peak originating from the control reaction zone 71 appears on the upstream side. Furthermore, while a decrease in fluorescence intensity is observed at the position corresponding to the upstream region 74 in FIG. 17, no decrease in fluorescence intensity is observed at the position corresponding to the upstream region 74 in FIG. 18.

[0053] After measuring the fluorescence intensity for each measurement site in the step shown in S200, in the step shown in S210, the analysis unit 250 specifies a reference value from the fluorescence intensity of the reference region 76, which is the region of the control region 75 excluding the target reaction zone 70 and the control reaction zone 71. That is, the reference value is specified based on the fluorescence intensity corresponding to the reference region 76 shown in Figs. 17 and 18. The reference value may be, for example, the average value of the fluorescence intensity of the reference region 76. Alternatively, the minimum fluorescence intensity in the reference region 76 may be used as the reference value.

[0054] After the reference value is specified at the stage shown in S210, at the stage shown in S220, the analysis unit 250 judges whether or not the fluorescence intensity of the upstream region 74 is lower than the reference value. The criterion for judging whether or not the fluorescence intensity of the upstream region 74 is lower than the reference value may be, for example, that the fluorescence intensity of the upstream region 74 is lower than the reference value when a predetermined percentage (e.g., 10%) or more of the fluorescence intensities at each predetermined position in the upstream region 74 are lower than the reference value. Alternatively, the fluorescence intensity of the upstream region 74 can be judged to be lower than the reference value when a predetermined number (e.g., 10) or more of the fluorescence intensities at each predetermined position in the upstream region 74 are lower than the reference value. Alternatively, when the fluorescence intensities at each predetermined position in the upstream region 74 are lower than the reference value and the fluorescence intensities lower than the reference value continue from that point to the upstream end, the sample is judged to be a whole blood sample, and when this is not the case, the sample is judged to be a blood cell-free sample. Alternatively, if there is a point in the upstream region 74 where the rate of change of the fluorescence intensity (i.e., the ratio of the difference between the reference value and the fluorescence intensity) is below the reference value, and if a predetermined number of consecutive points (e.g., 10 points) upstream from that point are below the reference value, the sample can be determined to be a whole blood sample, and if not, the sample can be determined to be a blood cell-free sample. For example, as shown in FIG. 17, if a fluorescence intensity lower than the reference value is observed in the upstream region 74, the analysis unit 250 determines that the sample is a whole blood sample. On the other hand, as shown in FIG. 18, if the fluorescence intensity in the upstream region 74 is not found to be lower than the reference value, the analysis unit 250 determines that the sample is a blood cell-free sample.

[0055] Here, the memory device 150 of the control unit 100 stores in advance information on a calibration curve obtained by measuring a whole blood sample containing a known concentration of a measurement target substance and information on a calibration curve obtained by measuring a blood cell-free sample (e.g., a plasma sample) containing a known concentration of a measurement target substance. If it is determined in the step shown in S220 that the fluorescence intensity in the upstream region 74 is lower than the reference value, the analysis unit 250 selects the calibration curve of the whole blood sample stored in the memory device 150 in the step shown in S230. On the other hand, if it is not determined in the step shown in S220 that the fluorescence intensity in the upstream region 74 is lower than the reference value, the analysis unit 250 selects the calibration curve of the blood cell-free sample stored in the memory device 150 in the step shown in S240.

[0056] Regardless of which calibration curve is selected, at the stage shown in S180 of FIG. 16A, the analysis unit 250 measures the concentration of the substance to be measured in the sample by applying the peak value (i.e., fluorescence intensity) of the target reaction zone 70 to the selected calibration curve.

[0057] As described above, according to the measurement system 10 and measurement method of this embodiment, even if it is unknown in advance whether the sample is a whole blood sample or a blood cell-free sample, by similarly applying the sample to the test strip 60, it is possible to measure the measurement target in the sample with an appropriate calibration curve.

[0058] Note that samples that can be measured by the measurement system 10 and the measurement method of this embodiment are not limited to whole blood samples or blood cell-free samples as described above. For example, even if it is unknown whether a sample that is assumed to contain a measurement target contains a specific particulate matter, if information on a calibration curve relating to the concentration of the measurement target in a sample containing the particulate matter and a sample not containing the particulate matter is stored in advance in the storage device 150, it is possible to measure the measurement target in the sample in the same manner as described above. EXAMPLES

[0059] Below, an example will be considered in which a test strip 60 is configured so that blood cell components remain in the upstream region 74 after a whole blood sample applied to the test strip 60 has been developed on the test paper 64 under specific conditions. In this example, a test strip 60 configured as shown in Figures 3B and 3C was used, and the sizes of each portion shown in Figures 3B and 3C are as shown in Table 1 below.

[0060] [Table 1]

[0061] That is, in the test piece 60 of this embodiment, the length of the development portion 73 was the above-mentioned λ (20.7 mm).

[0062] Four types of immunochromatographic membranes, IAB090, IAB120, IAB135, and IAB180 (all manufactured by ADVANTEC), were used as the spreading membrane 64A of the test piece 60. The liquid permeation speeds of these membranes over a length of 4 cm were 90 seconds, 120 seconds, 135 seconds, and 180 seconds, respectively.

[0063] The specimens to be spotted on the test strip 60 were prepared by suspending the amounts of whole blood shown in Table 2 below in 130 μL of dilution solution (specifically, a buffer solution containing a surfactant, sugar, and a blocking agent such as bovine serum albumin). 90 μL of these specimens were spotted on the introduction section 63 of the test strip 60 equipped with the above-mentioned four types of spreading membrane 64A, and the spreading results are shown in Table 2 below. The evaluation results shown in Table 2 below are as follows.

[0064] A: There is no effect on the measurement and it is possible to identify the sample type. B: By changing the shape of the test strip, it is possible to identify the type of sample. C1: There is a possibility that it may affect the measurement. C2: It is impossible to identify the sample type.

[0065] [Table 2]

[0066] First, in Table 2 above, it was found that the combination with evaluation "A" is suitable for this embodiment because it can keep blood cell components in the upstream region 74 in the test strip 60 of this embodiment having the size shown in Table 1 above. Also, the combination with evaluation "B" is not suitable for the test strip 60 of this embodiment, but it is believed that it will be possible to keep blood cell components in the upstream region 74 by changing the size of each part of the test strip 60.

[0067] On the other hand, the combination with the evaluation "C1" was judged to be inappropriate because the blood cell components passed through the upstream region 74 and reached the measurement section 72, hindering the detection of the target reaction zone 70. Also, the combination with the evaluation "C2" was judged to be inappropriate because the blood cell components did not reach the development section 73, making it impossible to identify the type of sample.

[0068] From the above, by using a nitrocellulose membrane with the desired permeation rate as the development membrane, by appropriately diluting the whole blood sample, and by appropriately adjusting the shape of the test piece, it is possible to retain the blood cells contained in the sample in the upstream region of the development section.

[0069] [Preferred embodiment] Preferred embodiments of the present disclosure are listed below.

[0070] <1> a test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section in which a reaction reagent that reacts with a substance to be measured contained in the specimen is immobilized, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; a light source that irradiates the test piece into which the specimen has been introduced with light of a predetermined wavelength; an imaging unit that acquires optical information of the test piece illuminated by the light source; and an analysis unit that determines the type of the sample from the optical information of an upstream region that is upstream of a development section, among the optical information acquired by the imaging unit. <2> The optical information is obtained as an average value of optical information for each predetermined position along the longitudinal direction of the development portion, the average value being obtained for each predetermined position along a direction perpendicular to the longitudinal direction. <1> A measurement system as described in <3> The predetermined position is determined based on pixels of a photograph captured by the imaging unit. <2> A measurement system as described in <4> the analysis unit determines the type of the sample based on optical information of the upstream region relative to a reference value determined based on optical information of a control region, which is a region other than the upstream region in the development section. <1> ~ <3> 13. The measurement system according to claim 12, <5> The control region includes a region in which a target reaction zone is generated by specifically reacting with a measurement target contained in the sample, and a region in which a control reaction zone is generated by non-specifically reacting with the sample, The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region in which the target reaction zone occurs and a region in which the control reaction zone occurs. <4> A measurement system as described in <6> The reference value is an average value of the optical information in the reference area. <5> A measurement system as described in <7> The optical information for each predetermined position along the longitudinal direction of the deployment portion in the upstream region is compared with the reference value. <6> A measurement system as described in <8> the type of the sample is determined based on whether or not a predetermined ratio of the optical information for each of the predetermined positions in the upstream region has a value lower than the reference value. <7> A measurement system as described in <9> the type of the sample is determined based on whether or not a number of pieces of the optical information for each of the predetermined positions in the upstream region that have a value lower than the reference value is greater than a predetermined number. <7> A measurement system as described in <10> the predetermined wavelength is a wavelength that is absorbed by a blood cell component in the sample; <1> from <9> 2. The measurement system according to claim 1 .

[0071] <11> a step of irradiating light of a predetermined wavelength onto a test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section in which a reaction reagent that reacts with a substance to be measured contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; acquiring optical information of the illuminated specimen; determining a type of the sample from the acquired optical information of an upstream region that is an upstream side of a development section; A measuring method comprising: <12> The optical information is obtained as an average value of optical information for each predetermined position along the longitudinal direction of the development portion, the average value being obtained for each predetermined position along a direction perpendicular to the longitudinal direction. <11> The measurement method described in <13> The predetermined position is determined based on pixels of a photograph captured by the imaging unit. <12> The measurement method described in <14> In the step of determining the type of the sample, the type of the sample is determined based on optical information of the upstream region relative to a reference value determined based on optical information of a control region, which is a region other than the upstream region in the development section. <11> ~ <13> 13. The measurement method according to claim 12, <15> The control region includes a region in which a target reaction zone is generated by specifically reacting with a measurement target contained in the sample, and a region in which a control reaction zone is generated by non-specifically reacting with the sample, The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region in which the target reaction zone occurs and a region in which the control reaction zone occurs. <14> The measurement method described in <16> The reference value is an average value of the optical information in the reference area. <15> The measurement method described in <17> The optical information for each predetermined position along the longitudinal direction of the deployment portion in the upstream region is compared with the reference value. <16> The measurement method described in <18> the type of the sample is determined based on whether or not a predetermined ratio of the optical information for each of the predetermined positions in the upstream region has a value lower than the reference value. <17> The measurement method described in <19> the type of the sample is determined based on whether or not a number of pieces of the optical information for each of the predetermined positions in the upstream region that have a value lower than the reference value is greater than a predetermined number. <17> The measurement method described in <20> the predetermined wavelength is a wavelength that is absorbed by a blood cell component in the sample; <11> from <19> 2. The measurement method according to claim 1 ,

[0072] <21> Computer, a means for irradiating light of a predetermined wavelength onto a test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section in which a reaction reagent that reacts with a substance to be measured contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; a means for acquiring optical information of the illuminated specimen; and a means for determining the type of the sample from the acquired optical information of an upstream region that is on the upstream side of the development section; A measurement program to function as a. <22> The optical information is obtained as an average value of optical information for each predetermined position along the longitudinal direction of the development portion, the average value being obtained for each predetermined position along a direction perpendicular to the longitudinal direction. <21> The measurement program according to claim 1. <23> The predetermined position is determined based on pixels of a photograph captured by the imaging unit. <22> The measurement program according to claim 1. <24> the means for determining the type of the sample determines the type of the sample based on optical information of the upstream region relative to a reference value determined based on optical information of a control region, which is a region other than the upstream region in the development section. <21> ~ <23> The measurement program according to any one of the preceding claims. <25> The control region includes a region in which a target reaction zone is generated by specifically reacting with a measurement target contained in the sample, and a region in which a control reaction zone is generated by non-specifically reacting with the sample, The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region in which the target reaction zone occurs and a region in which the control reaction zone occurs. <24> The measurement program according to claim 1. <26> The reference value is an average value of the optical information in the reference area. <25> The measurement program according to claim 1. <27> The optical information for each predetermined position along the longitudinal direction of the deployment portion in the upstream region is compared with the reference value. <26> A measurement system as described in <28> the type of the sample is determined based on whether or not a predetermined ratio of the optical information for each of the predetermined positions in the upstream region has a value lower than the reference value. <27> The measurement program according to claim 1. <29> the type of the sample is determined based on whether or not a number of pieces of the optical information for each of the predetermined positions in the upstream region that have a value lower than the reference value is greater than a predetermined number. <27> The measurement program according to claim 1. <30> the predetermined wavelength is a wavelength that is absorbed by a blood cell component in the sample; <21> from <29> The measurement program according to any one of claims 1 to 5.

[0073] <31> an imaging unit that acquires optical information of a test strip in a state where the test strip is irradiated with light of a predetermined wavelength, the test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section to which a reaction reagent that reacts with a measurement target contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; and an analysis unit that determines the type of the sample from the optical information acquired by the imaging unit, the optical information being from an upstream region that is upstream of the development section. <32> The optical information is obtained as an average value of optical information for each predetermined position along the longitudinal direction of the development portion, the average value being obtained for each predetermined position along a direction perpendicular to the longitudinal direction. <31> A smart device as described in. <33> The predetermined position is determined based on pixels of a photograph captured by the imaging unit. <32> A smart device as described in. <34> the analysis unit determines the type of the sample based on optical information of the upstream region relative to a reference value determined based on optical information of a control region, which is a region other than the upstream region in the development section. <31> ~ <33> 2. A smart device according to claim 1 , <35> The control region includes a region in which a target reaction zone is generated by specifically reacting with a measurement target contained in the sample, and a region in which a control reaction zone is generated by non-specifically reacting with the sample, The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region in which the target reaction zone occurs and a region in which the control reaction zone occurs. <34> A smart device as described in. <36> The reference value is an average value of the optical information in the reference area. <35> A smart device as described in. <37> The optical information for each predetermined position along the longitudinal direction of the deployment portion in the upstream region is compared with the reference value. <36> A smart device as described in. <38> the type of the sample is determined based on whether or not a predetermined ratio of the optical information for each of the predetermined positions in the upstream region has a value lower than the reference value. <37> A smart device as described in. <39> the type of the sample is determined based on whether or not a number of pieces of the optical information for each of the predetermined positions in the upstream region that have a value lower than the reference value is greater than a predetermined number. <37> A smart device as described in. <40> the predetermined wavelength is a wavelength that is absorbed by a blood cell component in the sample; <31> from <39> A smart device according to any one of claims 1 to 4. [Industrial Applicability]

[0074] INDUSTRIAL APPLICABILITY The present invention can be used as a system and a measuring device for measuring a measurement target substance in a sample using a test strip. [Explanation of symbols]

[0075] 10 Measurement System 42 Light source 50 Smart Devices 51 Imaging unit 60 Test Pieces 63 Introduction 70 Target reaction zone 71 Control reaction zone 72 Measuring part 73 Development Section 74 Upstream region 75 Control Region 76 Reference area 250 Analysis Department

Claims

1. a test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section in which a reaction reagent that reacts with a substance to be measured contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; a light source that irradiates the test piece into which the specimen has been introduced with light of a predetermined wavelength; an imaging unit that acquires optical information of the test piece illuminated by the light source; and an analysis unit that determines the type of the sample from the optical information of an upstream region that is upstream of a development section, out of the optical information acquired by the imaging unit.

2. The measurement system according to claim 1 , wherein the optical information is obtained for each predetermined position along the longitudinal direction of the deployment portion as an average value of optical information for each predetermined position along a direction perpendicular to the longitudinal direction.

3. The measurement system according to claim 1 , wherein the analysis section determines the type of the sample based on optical information of the upstream region relative to a reference value determined based on optical information in a control region, which is a region other than the upstream region in the development section.

4. The measurement system according to claim 2 , wherein the analysis section determines the type of the sample based on optical information of the upstream region relative to a reference value determined based on optical information in a control region, which is a region other than the upstream region in the development section.

5. The control region includes a region in which a target reaction zone is generated by specifically reacting with a measurement target contained in the sample, and a region in which a control reaction zone is generated by non-specifically reacting with the sample, The measurement system according to claim 3 , wherein the reference value is determined based on optical information in a reference area, which is an area of ​​the control area excluding the area in which the target reaction zone occurs and the area in which the control reaction zone occurs.

6. The control region includes a region in which a target reaction zone is generated by specifically reacting with a measurement target contained in the sample, and a region in which a control reaction zone is generated by non-specifically reacting with the sample, The measurement system according to claim 4, wherein the reference value is determined based on optical information in a reference area, which is an area of ​​the control area excluding the area in which the target reaction zone occurs and the area in which the control reaction zone occurs.

7. The measurement system of claim 5 , wherein the reference value is an average value of the optical information in the reference area.

8. The measurement system of claim 6 , wherein the reference value is an average value of the optical information in the reference area.

9. The measurement system according to claim 7 , wherein the optical information for each predetermined position along the longitudinal direction of the deployment in the upstream region is compared with the reference value.

10. The measurement system of claim 8 , wherein the optical information for each of the predetermined locations in the upstream region is compared to the reference value.

11. The measurement system according to claim 9 , wherein the type of the specimen is determined based on whether or not a predetermined proportion of the optical information for each of the predetermined positions in the upstream region has a value lower than the reference value.

12. The measurement system according to claim 10 , wherein the type of the specimen is determined based on whether or not a predetermined proportion of the optical information for each of the predetermined positions in the upstream region has a value lower than the reference value.

13. The measurement system according to claim 9 , wherein the type of the specimen is determined based on whether or not a number of the optical information pieces for each of the predetermined positions in the upstream region that have values ​​lower than the reference value is greater than a predetermined number.

14. The measurement system according to claim 10 , wherein the type of the specimen is determined based on whether or not a number of pieces of the optical information for each of the predetermined positions in the upstream region that have a value lower than the reference value is greater than a predetermined number.

15. The measurement system according to claim 2 , wherein the predetermined position is determined based on pixels of a photograph taken by the imaging unit.

16. The measurement system according to claim 9 , wherein the predetermined position is determined based on pixels of a photograph taken by the imaging unit.

17. The measurement system according to claim 1 , wherein the predetermined wavelength is a wavelength that is absorbed by a blood cell component in the sample.

18. a step of irradiating light of a predetermined wavelength onto a test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section in which a reaction reagent that reacts with a substance to be measured contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; acquiring optical information of the illuminated specimen; determining a type of the sample from the acquired optical information of an upstream region that is an upstream side of a development section; A measuring method comprising:

19. Computer, a means for irradiating light of a predetermined wavelength onto a test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section in which a reaction reagent that reacts with a substance to be measured contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; a means for acquiring optical information of the illuminated specimen; and a means for determining the type of the sample from the acquired optical information of an upstream region that is on the upstream side of the development section; A measurement program to function as a.

20. an imaging unit that acquires optical information of a test strip in a state where the test strip is irradiated with light of a predetermined wavelength, the test strip having an upstream introduction section into which a specimen is introduced, a downstream measurement section to which a reaction reagent that reacts with a measurement target contained in the specimen is fixed, and a development section for developing the specimen from the introduction section to a section downstream of the measurement section; and an analysis unit that determines the type of the sample from the optical information acquired by the imaging unit, the optical information being from an upstream region that is upstream of the development section.

Images