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

Abstract

The invention provides a measurement system, a measurement method, a computer program product, and a smart device. In a system for measuring an object to be measured in a specimen using a test piece, the type of the specimen to be used is identified before the measurement. A measurement system is provided with: a test piece having an upstream-side introduction part into which a specimen is introduced; a downstream-side measurement unit to which a reaction reagent that reacts with an object to be measured included in the specimen is fixed; and a deployment unit for deploying the specimen from the introduction unit to the downstream of the measurement unit. A light source that irradiates the test piece into which the specimen is introduced with light of a predetermined wavelength; an imaging unit that acquires optical information of the test piece irradiated by the light source; and an analysis unit that determines the type of the specimen on the basis of the optical information of an upstream region, which is the upstream side of the expansion unit, among the optical information acquired by the imaging unit.

Description

Technical Field

[0001] The present invention relates to a technique for identifying the type of a sample to be used before measurement in a system for measuring a measurement object in a sample using a test strip. Background Art

[0002] Patent Document 1 discloses a technique for discriminating the type of a test solution based on a detection signal from a material portion on a chromatographic test piece to which the test solution has been added.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Laid-Open No. 2003-4743 Summary of the Invention

[0006] Problems to be solved by the invention

[0007] The standard curve used for specimen measurement changes depending on whether a specimen containing blood cell components (whole blood specimen) or a specimen not containing blood cell components (plasma or serum) is used as the specimen. Therefore, it is necessary to input the type of specimen to be dropped on the test piece into the measuring device as information in advance. In addition, when the type of specimen is dropped without confirming the type of the specimen, the measurement is sometimes performed with a standard curve of the wrong type. In addition, after the whole blood specimen reaches the measurement position, it is sometimes impossible to perform a correct measurement. Therefore, an embodiment of the present invention provides the following technology: in a system for measuring a measurement object in a specimen using a test piece, the type of specimen used is identified before the measurement.

[0008] Means for solving problems

[0009] A measurement system according to one embodiment of the present invention comprises: a test piece having: an introduction portion on the upstream side for introducing a specimen; a measurement portion on the downstream side on which a reaction reagent that reacts with a measurement object contained in the specimen is fixed; and a development portion for developing the specimen from the introduction portion to the downstream of the measurement portion; a light source for irradiating the test piece with the specimen introduced therein with light of a specified wavelength; an imaging portion for acquiring optical information of the test piece irradiated by the light source; and an analysis portion for determining the type of the specimen based on optical information acquired by the imaging portion, which is the optical information of the upstream side, i.e., the upstream area, in the development portion.

[0010] Effects of the Invention

[0011] According to an embodiment of the present invention, there is provided a technique for identifying the type of a sample to be used before measurement in a system for measuring a measurement object in a sample using a test strip. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1A holding portion used in the embodiment is shown in an upper perspective view.

[0013] Figure 2 The perspective view below shows an enlarged view of the vicinity of the insertion opening of the holding portion.

[0014] Figure 3A The test piece used in the embodiment is shown in a plan view.

[0015] Figure 3B Simplified representation Figure 3A of the test piece.

[0016] Figure 3C Schematically Figure 3A The structure of the test paper.

[0017] Figure 4 The upper perspective view shows a state where the test piece is attached to the holding portion.

[0018] Figure 5 Shown from a bird's-eye view Figure 4 status.

[0019] Figure 6 The placement portion used in the embodiment is shown in an upper perspective view.

[0020] Figure 7 The placing portion is shown as seen from below.

[0021] Figure 8 The housing of the embodiment is shown in an upper perspective view.

[0022] Figure 9 The above stereogram shows Figure 8 The test piece is mounted on the housing.

[0023] Figure 10 A smart device used in the embodiments is shown in an upward-looking manner.

[0024] Figure 11 The measuring system according to the embodiment is shown in an upper perspective view.

[0025] Figure 12 The above stereogram shows Figure 11 The measurement system is in a state where a portion of the outer wall is removed.

[0026] Figure 13 express Figure 12 Section XIII-XIII.

[0027] Figure 14 This is a functional block diagram of a measurement system according to an embodiment.

[0028] Figure 15 The control unit is represented by a block diagram.

[0029] Figure 16A This is a flowchart showing an outline of a method for measuring a measurement object in a measurement system according to an embodiment.

[0030] Figure 16B This is a flowchart showing an outline of a method for measuring a measurement object in a measurement system according to an embodiment.

[0031] Figure 17 An example of fluorescence intensity in a developed portion when a whole blood sample is measured as a sample is shown in a graph.

[0032] Figure 18 An example of fluorescence intensity in a developed area when measuring plasma as a sample is shown in a graph.

[0033] Description of Reference Numerals

[0034] 10 Measurement system

[0035] 42 light sources

[0036] 50 smart devices

[0037] 51 Camera Department

[0038] 60 test pieces

[0039] 63 Import Department

[0040] 70 Object Response Band

[0041] 71 Control Reaction Zone

[0042] 72 Measurement Department

[0043] 73 expansion

[0044] 74 upstream area

[0045] 75 control area

[0046] 76 benchmark area

[0047] 250 Analysis Department DETAILED DESCRIPTION

[0048] The following describes embodiments of the present invention with reference to the accompanying drawings. Identical reference numerals in the various figures indicate identical parts unless otherwise specified. The components and locations shown in the various figures are schematic and may not accurately represent the dimensions and positional relationships of the actual product.

[0049] (1) Holding part

[0050] Figure 1 The measuring system 10 of this embodiment is shown in the upper perspective view (see Figure 11 ) is a diagram of a holding portion 40 used in the measurement system 10 of the present invention. Figure 8 ) components, and may also include Figure 1 The holding portion 40 is shown in FIG. The holding portion 40 is box-shaped, and has two openings formed on the upper surface: an opening 43 for measurement and an opening 44 for identification. An optical filter 45 is embedded in the opening 43 for measurement. A sensor 47 for detecting light is also provided on the upper surface. A test piece 60 (see FIG. 4 ) is provided on the side of the holding portion 40 for the test piece 60 described later. Figure 3A ) is inserted into the insertion port 41. The internal space of the insertion port 41 is also connected to the measurement opening 43 and the identification opening 44 to form a receiving portion 46. The receiving portion 46 is a space for receiving a portion of the test piece 60.

[0051] Figure 2 The lower perspective view shows the vicinity of the insertion port 41 of the holding portion 40 in an enlarged manner. The optical filter 45 is fitted into the measurement opening 43 (see FIG. Figure 1 ) is provided near the sensor 47. From the light source 42 (refer to Figure 13 ) irradiates light including light having a wavelength suitable for imaging the measurement region 61. The optical filter 45 has an optical characteristic of appropriately transmitting only light having a wavelength suitable for imaging.

[0052] (2) Test piece

[0053] Figure 3A The measuring system 10 of this embodiment is shown in a plan view (see Figure 11 ). 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 held by gripping it with a finger. A strip-shaped test paper 64 is housed inside the test strip 60 along the length of 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 the 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 object to be measured is performed. In addition, an identification area 62 on which information related to the test strip 60 is recorded is formed on the upper surface of the other end of the test strip 60, that is, the part farthest from the gripping portion 65. Hereinafter, with respect to the test strip 60, the side closer to the gripping portion 65 is referred to as the "upstream side", and the side closer to the identification area 62 is referred to as the "downstream side".

[0054] Test paper 64 is formed by coating a water-absorbing layer on the surface of a water-absorbing material such as filter paper or a synthetic resin substrate. A reaction reagent that reacts with the object to be measured and develops color is applied to the center portion of measurement area 61 of test paper 64. A specimen containing the object to be measured is dripped onto introduction portion 63. The specimen used in the present invention may be, for example, a specimen containing blood cell components (hereinafter referred to as a "whole blood specimen") or a specimen not containing blood cell components (for example, plasma or serum, hereinafter referred to as a "blood cell-free specimen"), or a specimen obtained by diluting these with an appropriate buffer.

[0055] Figure 3B For ease of explanation, Figure 3A The test piece 60 is simplified in FIG. That is, the structure other than the introduction portion 63 and the measurement area 61 is omitted. Figure 3A ) The visually recognized portion is the expansion section 73, where the specimen is expanded from the upstream side to the downstream side. As described later, expansion section 73 is divided into upstream region 74, an upstream area involved in specimen classification, and control region 75, an area beyond this region. The central portion of control region 75 serves as the measurement section 72, where a reagent that reacts with a substance contained in the specimen is immobilized.

[0056] Specifically, a reaction reagent that reacts specifically with the analyte is fixed to the downstream portion of the measuring section 72. When the analyte reacts with the reaction reagent, a target reaction zone 70 is generated. Furthermore, a control reagent that reacts non-specifically with the specimen regardless of the presence of the analyte is fixed to the upstream portion of the measuring 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 of the analyte. Specifically, the development section 73 includes a region that produces the target reaction zone 70, which is generated by a specific reaction with the analyte contained in the specimen, and a region that produces the control reaction zone 71, which is generated by a non-specific reaction with the specimen. The area of ​​the control region 75 excluding the region that produces the target reaction zone 70 and the region that produces the control reaction zone 71 serves as a reference region 76.

[0057] Figure 3C Schematically Figure 3A The test paper 64 has a structure in which a measuring area 61 (see Figure 3B) in length. Back plate 64E is formed of a moisture-impermeable material, such as polyvinyl chloride (PVC) or polystyrene (PS). The membrane 64A is formed of a material that can absorb liquids by capillary force and can immobilize reaction reagents and control reagents, such as a nitrocellulose membrane.

[0058] A sample pad 64B is fixed to the upstream side of the developing membrane 64A via a conjugation pad 64C. The sample pad 64B is located in the introduction portion 63 (see Figure 3B ). Sample pad 64B has a mesh structure that captures some of the blood cell components contained in the specimen, while allowing plasma components to pass downstream along with uncaptured blood cell components. As described later, the blood cell components that pass through sample pad 64B contribute to the identification of whether the specimen is a whole blood specimen or a blood cell-free specimen. Sample pad 64B is formed from a material such as glass fiber, polyethylene terephthalate resin (PET), or cellulose fiber.

[0059] Conjugate pad 64C allows the specimen that has passed through sample pad 64B to pass toward developing membrane 64A. Conjugate pad 64C may or may not have the same blood cell capturing function as sample pad 64B. In other words, the combination of sample pad 64B and conjugate pad 64C can achieve the desired blood cell capturing function. Conjugate pad 64C is formed from a material such as glass fiber, polyester fiber, or rayon.

[0060] An absorbent pad 64D is fixed to the downstream side of the extended film 64A. The absorbent pad 64D absorbs excess liquid that reaches the downstream end of the extended film 64A. The absorbent pad 64D is made of a material that absorbs liquid through capillary force, such as glass fiber, cellulose fiber, or cotton.

[0061] After the sample is dropped onto the introduction portion 63, it permeates from the sample pad 64B to the conjugate pad 64C and reaches the developing membrane 64A. The sample developed downstream of the developing membrane 64A is transferred to the measuring portion 72 (see Figure 3B ) reacts with the reagent. If the analyte is present, a target reaction zone 70 is generated. Regardless of the presence of the analyte, a control reaction zone 71 is generated. When the specimen contains blood cells, the blood cells that reach the developing membrane 64A can be retained in the upstream region 74 by appropriately adjusting the blood cell capture capacity of the sample pad 64B (and the conjugate pad 64C), the liquid permeability of the developing membrane 64A, the dimensions of the various components of the test strip 60, and the dilution concentration of the specimen. Optical information is then detected for the blood cell components retained in the upstream region 74, and the type of specimen, specifically, whether it is a whole blood specimen or a blood cell-free specimen, is identified based on the optical information detected in the upstream region 74. This will be described later.

[0062] Figure 4 The upper perspective view shows a state where the test piece 60 is mounted on the holding portion 40. Figure 5 This state is shown in a top-down manner. Figure 4 and Figure 5 As shown, the test piece 60 is inserted into the interior of the receiving portion 46 from the insertion port 41 with the downstream side first (see Figure 1 ). In this state, if Figure 5 As shown, the measurement area 61 (refer to Figure 3A ) is located at the same position as the measurement opening 43 in the plan view, and the identification region 62 is located at the same position as the identification opening 44 in the plan view.

[0063] In this state, when the sample is dropped onto the introduction portion 63, it flows downstream in the test paper 64 by capillary action, and a control reaction zone 71 (see FIG. 1 ) indicating the drop of the sample is generated on the upstream side of the measurement area 61. Figure 3B Furthermore, when the specimen contains the object to be measured, a target reaction zone 70 with an intensity corresponding to the concentration of the object to be measured is generated on the downstream side (see Figure 3B In the 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 of the center. The target reaction zone 70 is irradiated with light from the light source 42 (refer to FIG. Figure 13 ) and measures the intensity of the generated light, thereby measuring the concentration of the object to be measured. The identification area 62 contains information related to the test strip 60, such as the type of test paper 64 contained in the test strip 60, or identification information. Examples of the identification information include barcodes and QR codes (registered trademark).

[0064] (3) Loading section

[0065] Figure 6 The measuring system 10 of this embodiment is shown in the upper perspective view (see Figure 11 ) used in the mounting portion 30. In addition, Figure 7 The figure shows the loading section 30 in a bottom-up manner. The loading section 30 is formed as a substantially rectangular parallelepiped carton with an open upper surface and a lower surface. The four side surfaces of the loading section 30 form an outer wall portion 34 vertically erected. A space is formed on the upper surface of the loading section 30 for loading a smart device 50 (see FIG. 1 ) described later. Figure 10 ) is a frame that is a loading frame 32. A box-shaped light shielding portion 33 is formed on one side of the interior of the loading portion 30 (hereinafter referred to as the "front side"), and the light shielding portion 33 has a window 31 and is closed on the upper surface and open on the lower surface (see Figure 7 ).

[0066] Here, of the four surfaces of the outer wall portion 34, the surface on the side where the light shielding portion 33 is located is designated as the front surface 34a, the surface opposite thereto is designated as the back surface 34b, the surface on the left side when viewed from the front surface 34a is designated as the left side surface 34c, and the surface opposite thereto is designated as the right side surface 34d. Furthermore, the interior of the receiving portion 30 is partitioned by a reinforcing portion 35 parallel to the front surface 34a and the back surface 34b. Furthermore, a rectangular cutout 36 is formed at the front lower edge of the left side surface 34c.

[0067] (4) Housing

[0068] like Figure 7 As shown, a gap is formed between the lower edge of the light shielding portion 33 and the lower edge of the outer wall portion 34, and the gap is used as the height. The space surrounded by the front surface 34a, the reinforcement portion 35, the left side 34c and the right side 34d is called the receiving area 37. When the holding portion 40 is installed in the receiving area 37, the Figure 8 In this state, the cutout portion 36 of the placement portion 30 is aligned with the insertion opening 41 of the holding portion 40. Figure 4 and Figure 5 The state where the test piece 60 is installed is as shown in FIG. Figure 9 As shown in the upper perspective view.

[0069] (5) Smart devices

[0070] Figure 10 The measuring system 10 (see FIG. Figure 11 ) is mounted on the housing 20. In this embodiment, a smartphone serves as the smart device 50, but a tablet terminal with a camera function can also be used as the smart device 50. A camera unit 51 configured as a camera and an illumination unit 52 configured as a flash lamp that emits visible light are provided on the bottom side (the so-called back side) of the smart device 50. The camera unit 51 obtains optical information of the test piece 60 illuminated by the light source 42 as an image. Furthermore, the top side (the so-called front side) of the smart device 50 serves as a display unit 53.

[0071] (6) Measurement system

[0072] make Figure 10 The smart device 50 is placed on the window 31 with the camera unit 51 and the lighting unit 52 aligned with the window 31 and the display unit 53 facing upward. Figure 9 The inner side of the mounting frame 32 of the housing 20 shown in FIG. Figure 11 The measuring system 10 of this embodiment is shown in the upper perspective view. Figure 12As shown in the upper perspective view, the measuring opening 43 and the identifying opening 44 of the holding portion 40 are covered by the light shielding portion 33, thereby preventing the entry of light from the outside. Figure 12 Indicates from Figure 11 The illustrated state is a state in which the front surface 34 a , the left side surface 34 c , and the right side surface 34 d of the outer wall portion 34 are removed.

[0073] In addition, as shown by the XIII-XIII section Figure 12 of Figure 13 As shown, the measurement opening 43 and optical filter 45 are located above the measurement area 61 of the test piece 60, while the identification opening 44 is located above the identification area 62. Furthermore, a light source 42 is provided below and slightly behind the identification opening 44 to illuminate the measurement area 61 from an obliquely upward direction. The window 31 of the mounting portion 30 is located directly above the measurement opening 43, allowing the camera unit 51 of the smart device 50 to view not only the measurement area 61 but also the identification area 62.

[0074] Figure 14 This is a diagram showing the measurement system 10 of this embodiment in a functional block diagram. Figure 10 The imaging unit 51 and the lighting unit 52 shown in FIG. Figure 11 The display unit 53 is shown, and the control unit 100 that controls them. The control unit 100 uses a CPU 110, a ROM 120, a RAM 130, and a storage device 150, which will be described later, as hardware resources of the computer, and functions as the following units.

[0075] That is, the control unit 100 functions as a lighting switching unit 200 that switches the lighting of the lighting unit 52 on / off (lit / extinguished). Specifically, the lighting switching unit 200 can be implemented as an application installed on the smart device 50, but can also be implemented as a unit that utilizes electrical or optical sensing with the holding unit 40, or as a wireless communication unit (e.g., Bluetooth (registered trademark)) with the holding unit 40. In addition, the control unit 100 functions as a shooting condition storage unit 210 that stores the shooting conditions of the camera unit 51. The conditions specified as shooting conditions include, for example, the standby time required for the reaction between the measurement object and the reagent. In addition, the control unit 100 functions as a dripping detection unit 220 that detects the dripping of the specimen onto the test strip 60 by the camera unit 51. In addition, the control unit 100 functions as a standby time measurement unit 230 that measures the standby time. Furthermore, the control unit 100 functions as an image storage unit 240 that stores images of the measurement area 61 captured by the camera 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.

[0076] like Figure 15 As shown in the hardware structure of FIG, the control unit 100 includes 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 via a bus 190 so as to be able to communicate with each other.

[0077] The CPU 110 is a central processing unit that executes various programs and controls various components. Specifically, the CPU 110 reads programs from the ROM 120 or storage device 150 and executes them using the RAM 130 as a work area. The CPU 110 controls the measurement system 10 according to the programs stored in the ROM 120 or storage device 150.

[0078] ROM 120 stores various programs and data. RAM 130 temporarily stores programs and data as a work area. Storage device 150 is configured as a memory based on an HDD (Hard Disk Drive), SSD (Solid State Drive), or flash memory, and stores various programs including the operating system and various data.

[0079] Meanwhile, the holding unit 40 includes a light source 42 that illuminates the measurement area 61; a sensor 47 that detects whether the illumination unit 52 is on or off; and a light source control unit 48 that illuminates the light source 42 upon receiving a signal from the sensor 47. The light source control unit 48, like the control unit 100 of the smart device 50, is configured as a computer hardware resource. Furthermore, the light source control unit 48 can control the illumination of the light source 42 regardless of the input method of the signal from the sensor 47 (e.g., wired or wireless), as long as it can control the illumination of the light source 42 during imaging of the measurement area 61, as described later. Furthermore, the light source control unit 48 can also control the extinguishing of the light source 42. Here, the light source 42 is a light source that irradiates the measurement area 61 with light of a predetermined wavelength suitable for detecting the measurement object. For example, if the substance that reacts with the measurement object in the target reaction zone 70 of the measurement area 61 absorbs ultraviolet light, the light source 42 can be set to emit ultraviolet light to enable appropriate imaging. Furthermore, this allows the light source 42 having a wavelength corresponding to the measurement object to be used for imaging the measurement area 61 , and the lighting unit 52 of the smart device 50 to be used as a light source for imaging the recognition area 62 .

[0080] As described above, the measurement system 10 of the present embodiment comprises: a test piece 60 having an introduction portion 63 on the upstream side for introducing a specimen, a measurement portion 72 on the downstream side on which a reaction reagent reacting with a measurement object contained in the specimen is fixed, and an expansion portion 73 for expanding the specimen from the introduction portion 63 to the downstream of the measurement portion 72; a light source 42 for irradiating the test piece 60 with light of a specified wavelength; an imaging portion 51 for acquiring optical information of the test piece 60 irradiated by the light source 42; and an analysis portion 250 for determining the type of the specimen based on the optical information acquired by the imaging portion 51, that is, the optical information of the upstream side, i.e., the upstream region 74, in the expansion portion 73.

[0081] In the measurement system 10 of this embodiment, the analysis unit 250 preferably determines the type of the specimen based on the optical information of the upstream region 74 relative to the reference value, which is based on the reference region 76 (see Figure 3B ), the reference area 76 is the area of ​​the control area 75 excluding the target reaction zone 70 and the control reaction zone 71, and the control area 75 is the area excluding the upstream area 74 in the expansion section 73. Here, with respect to the optical information, it is preferable to obtain optical information in a direction perpendicular to the longitudinal direction (specifically, at each predetermined position along the longitudinal direction of the expansion section 73) Figure 3BThe reference value is preferably the average value of the optical intensity at each predetermined position (in the width direction of the test strip 60 shown). Furthermore, the reference value is preferably the average value of the optical information in the reference area 76. Furthermore, the "predetermined position" referred to here is preferably determined based on the pixels of the image captured by the imaging unit 51. Furthermore, the predetermined wavelength with which the light source 42 irradiates the test strip 60 is preferably a wavelength absorbed by the blood cell components in the subject.

[0082] The measurement system 10 of this embodiment functions as follows. First, light of a predetermined wavelength (preferably ultraviolet light of a wavelength absorbed by the blood cell components in the subject) is irradiated from a light source to the test piece 60 into which the specimen is introduced. The 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 the photograph taken by the imaging unit 51) also includes optical information of the upstream area 74. The analysis unit 250 determines the type of the specimen (for example, a whole blood specimen or a blood cell-free specimen) based on the acquired optical information of the upstream area 74. The determination is preferably made based on the optical information in the control area 75, for example, based on the optical information of the upstream area 74 relative to a reference value, the reference value being determined as the average value of the optical information in the control area 75 (more preferably, the average value of the optical information in the reference area 76).

[0083] 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 specimen is determined based on the degree of deviation from the reference value. For example, if the specimen contains blood cells, the fluorescence intensity of the test strip 60, which is generated by 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 in the case where the specimen does not contain blood cells (i.e., the case where the specimen is a blood cell-free specimen). On the other hand, the fluorescence intensity in the reference region 76 is not affected by whether the specimen contains blood cells. Therefore, the degree of decrease in the optical information (i.e., fluorescence intensity) at each predetermined position in the upstream region 74 relative to the reference value based on the optical information (i.e., fluorescence intensity) in the reference region 76 determines whether the specimen is a whole blood specimen or a blood cell-free specimen.

[0084] For example, if the optical information at each predetermined position in the upstream region 74 contains optical information below a reference value for a predetermined ratio (e.g., 10%) or more, the specimen can be determined to be a whole blood specimen; otherwise, it can be determined to be a blood cell-free specimen. Alternatively, if the optical information at each predetermined position in the upstream region 74 contains optical information below the reference value for a predetermined number (e.g., 10) or more, the specimen can be determined to be a whole blood specimen; otherwise, it can be determined to be a blood cell-free specimen. As another determination method, if the optical information at each predetermined position in the upstream region 74 contains optical information below the reference value, and the optical information below the reference value continues from that point to the upstream end, the specimen can be determined to be a whole blood specimen; otherwise, it can be determined to be a blood cell-free specimen. As another method, if the rate of change of optical information (i.e., the ratio of the difference between the baseline value and the optical information relative to the baseline value) is lower than the baseline value in the upstream region 74, and if the rate of change of optical information is lower than the baseline value at more than a predetermined number of points (e.g., 10) in a row upstream from this point, the sample is determined to be a whole blood sample; otherwise, the sample is determined to be a blood cell-free sample.

[0085] It should be noted that by appropriately adjusting the structure of the test piece 60 (for example, the properties of the unfolding membrane 64A, the sample pad 64B and the binding pad 64C) and the dilution degree of the specimen, when the specimen contains blood cells, it is possible to configure the specimen to remain in the upstream area 74 of the unfolding portion 73 when the specimen is unfolded on the test piece 60.

[0086] In addition, if Figure 14 As shown, the smart device 50 includes an imaging unit 51 and an analysis unit 250. Specifically, the smart device 50 of this embodiment includes an upstream introduction unit 63 for introducing a specimen; a downstream measurement unit 72 containing a reaction reagent that reacts with a measurement target contained in the specimen; and a development unit 73 for developing the specimen from the introduction unit to the downstream side of the measurement unit 72. Furthermore, the smart device 50 includes the imaging unit 51 for acquiring optical information from an upstream region 74 in the development unit 73, upstream of the specimen, while irradiating the test strip 60 with light of a predetermined wavelength; and the analysis unit 250 for analyzing the optical information in the upstream region 74 to determine the specimen type. The determination of the specimen type by the analysis unit 250 has been described above.

[0087] The measurement system 10 of the present embodiment described above can perform a measurement method having the following steps: irradiating a test piece 60 into which a specimen is introduced with light of a specified wavelength, wherein the test piece 60 has an upstream introduction portion 63 for introducing the specimen; a downstream measurement portion 72 carrying a reaction reagent that reacts with a measurement object contained in the specimen; and a development portion 73 for developing the specimen from the introduction portion 63 to the downstream of the measurement portion 72; obtaining optical information of the upstream side of the development portion, i.e., the upstream region 74, while irradiating with light of a specified wavelength; and analyzing the obtained optical information of the upstream region 74 to determine the type of the specimen.

[0088] The above-mentioned measurement method can be executed by a program, which enables a computer to function as the following units: a unit for irradiating a test piece with a specimen introduced therein with light of a specified wavelength, and the test piece has an upstream introduction portion for introducing the specimen; a downstream measurement portion, which carries a reaction reagent that reacts with a measurement object contained in the specimen; and a development portion for developing the specimen from the introduction portion to the downstream of the measurement portion; a unit for obtaining optical information of the upstream side, i.e., the upstream area, in the development portion under the condition of irradiating light of a specified wavelength; and a unit for analyzing the obtained optical information to determine the type of the specimen.

[0089] Reference Figure 16A as well as Figure 16B The flowcharts shown illustrate an example of the measurement method of the present embodiment described above. In these flowcharts, steps representing operations other than those directly performed by the smart device 50 are summarized in parentheses.

[0090] First, if Figure 11 As shown, the measuring system 10 is prepared, and the test piece 60 is inserted from the insertion port 41. In the measuring system 10, the smart device 50 is placed on the housing 20, and the holding part 40 is installed on the placement part 30 of the housing 20. In this step, when the operation display part 53 (refer to Figure 11 and Figure 14 ) screen appears, start the measurement application installed on the smart device 50 and start the measurement.

[0091] First, in step S100, the camera unit 51 captures an image of the recognition area 62 (see FIG. 1 ) with the illumination unit 52 turned on. Figure 3A ) image, based on which the control unit 100 refers to the shooting condition storage unit 210 (reference Figure 14 ), and obtain the imaging conditions for the measurement of the test piece 60. Detailed description of this step is omitted.

[0092] Next, in step S110, the tester inserts the test piece 60 into the introduction portion 63 (see Figure 3B) is dripped with an appropriate amount of sample. The dripped sample is passed through the test paper 64 (refer to Figure 3B ) expands toward the downstream side.

[0093] During this period, the dripping detection unit 220 (refer to Figure 14 In step S120, the image from the imaging unit 51 is continuously monitored to see whether an image indicating completion of drop attachment (e.g., a control reaction zone 71 (see FIG. 1 ) generated by a reaction with the object to be measured) is detected in the measurement area 61. Figure 3B )). When the image is detected, the process proceeds to step S130.

[0094] After the completion of the drop attachment is detected in step S120, the standby time measuring unit 230 (see Figure 14 ) continuously monitors whether the waiting time required for the reaction between the measurement object in the test paper 64 and the reagent in the imaging conditions acquired in the step shown in S100 has passed.

[0095] When the waiting time measuring unit 230 determines that the waiting time has elapsed in step S130 , the lighting switching unit 200 turns off the lighting unit 52 and turns on the light source 42 in step S140 .

[0096] When the light source 42 is turned on, in step S150, the imaging unit 51 captures the expanded portion 73 (see FIG. 1 ) including the target reaction zone 70 in the measurement region 61. Figure 3B ) to acquire optical information of the test strip 60. The target reaction zone 70 is observable due to the wavelength of the measurement light from the light source 42. After the optical information is acquired, the light source control unit 48 of the holding unit 40 turns off the light source 42 in step S160. Then, the type of the specimen is identified in step S170.

[0097] Figure 16B This is a flowchart showing the details of the sample identification process in step S170. First, in step S200, the analysis unit 250 measures the fluorescence intensity at each measurement site based on the optical information of the test piece 60 acquired by the imaging unit 51 in step S150. Figure 3B The image information of the expanded portion 73 is shown. This image information is a collection of pixels with the length direction of the test piece 60 as the X axis and the width direction as the Y axis, and each pixel is associated with information such as luminous intensity and color.

[0098] Figure 17 and Figure 18It is a graph obtained by graphing the fluorescence intensity at each position in the longitudinal direction based on the image information of the expansion portion 73 when whole blood and plasma are respectively dropped as specimens on the test piece 60. The horizontal axis of the two graphs represents the above-mentioned X-axis, specifically, the position on the image information in the longitudinal direction of the expansion portion is represented by the pixel number. In addition, in the two graphs, the pixel number is smaller on the downstream side, and the pixel number is larger on the upstream side. In addition, the vertical axis of the two graphs represents the average value of the fluorescence intensity along the above-mentioned Y-axis. In both graphs, a peak generated by the object reaction zone 70 caused by the measured object appears on the downstream side (left side in the figure), and a peak generated by the control reaction zone 71 appears on the upstream side. And, in Figure 17 In the figure, a decrease in fluorescence intensity was observed at the position corresponding to the upstream region 74, whereas a decrease in fluorescence intensity was observed at the position corresponding to the upstream region 74. Figure 18 In the figure, no decrease in fluorescence intensity was observed at the position corresponding to the upstream region 74.

[0099] After measuring the fluorescence intensity at each measurement site in step S200, the analysis unit 250 determines a reference value based on the fluorescence intensity of the reference region 76, which is an area of ​​the control region 75 excluding the target reaction zone 70 and the control reaction zone 71. Figure 17 and Figure 18 The reference value is determined based on the fluorescence intensity corresponding to the reference region 76. The reference value can be set to, for example, the average value of the fluorescence intensity of the reference region 76. Alternatively, the minimum fluorescence intensity in the reference region 76 can be used as the reference value.

[0100] After determining the reference value in step S210, the analysis unit 250 determines in step S220 whether the fluorescence intensity of the upstream region 74 is lower than the reference value. Regarding the criteria for determining whether the fluorescence intensity of the upstream region 74 is lower than the reference value, for example, if the fluorescence intensity at each predetermined location in the upstream region 74 is lower than the reference value by a predetermined ratio (e.g., 10%) or more, the fluorescence intensity of the upstream region 74 can be determined to be lower than the reference value. Alternatively, if the fluorescence intensity at each predetermined location in the upstream region 74 is lower than the reference value by a predetermined number (e.g., 10) or more, the fluorescence intensity of the upstream region 74 can be determined to be lower than the reference value. Alternatively, if the fluorescence intensity at each predetermined location in the upstream region 74 is lower than the reference value, and the lower fluorescence intensity continues from that location to the upstream end, the sample can be determined to be whole blood; otherwise, the sample can be determined to be blood cell-free. Alternatively, if the rate of change of fluorescence intensity (i.e., the ratio of the difference between the reference value and the fluorescence intensity relative to the reference value) is lower than the reference value in the upstream region 74, and if the fluorescence intensity is lower than the reference value at more than a predetermined number of points (e.g., 10) in the upstream direction, the sample can be determined to be a whole blood sample; otherwise, the sample can be determined to be a blood cell-free sample. For example, Figure 17 As shown in FIG, when it is considered that the fluorescence intensity is lower than the reference value in the upstream region 74, the analyzing unit 250 determines that the specimen is a whole blood specimen. Figure 18 As shown, when the fluorescence height of the upstream region 74 is not considered to be lower than the reference value, the analyzing unit 250 determines that the specimen is a blood cell-free specimen.

[0101] The storage device 150 of the control unit 100 pre-stores information on calibration curves obtained by measuring whole blood samples containing a known concentration of the analyte, and information on calibration curves obtained by measuring blood-free samples (e.g., plasma samples) containing a known concentration of the analyte. If, in step S220, the fluorescence intensity of the upstream region 74 is determined to be below the reference value, the analysis unit 250 selects the calibration curve for the whole blood sample stored in the storage device 150 in step S230. On the other hand, if, in step S220, the fluorescence intensity of the upstream region 74 is not determined to be below the reference value, the analysis unit 250 selects the calibration curve for the blood-free sample stored in the storage device 150 in step S240.

[0102] Then, in case of any standard curve selected, Figure 16A In the step S180 of each embodiment, the analyzing unit 250 measures the concentration of the measurement target in the sample by applying the peak value (ie, fluorescence intensity) of the target reaction zone 70 to the selected calibration curve.

[0103] As described above, according to the measurement system 10 and the measurement method of this embodiment, even when it is unknown in advance whether the sample is a whole blood sample or a blood cell-free sample, the measurement object in the sample can be measured using an appropriate calibration curve by simply dropping the sample on the test strip 60 .

[0104] The specimens that can be measured using the measurement system 10 and measurement method of this embodiment are not limited to the whole blood specimens or blood cell-free specimens described above. For example, if it is unclear whether a specimen assumed to contain a measurement target contains a specific particulate matter, the measurement target in the specimen can be measured in the same manner as described above if information on standard curves related to the concentration of the measurement target is stored in advance in the storage device 150 for specimens containing the particulate matter and for specimens not containing the particulate matter.

[0105] [Example]

[0106] Next, an example of a test strip constructed as follows will be studied as an embodiment: under specific conditions, when a whole blood sample dropped onto the test strip 60 is spread over the test paper 64, blood cell components remain in the upstream area 74. In this embodiment, Figure 3B and Figure 3C The test piece 60 of the structure shown, Figure 3B and Figure 3C The dimensions of the various parts shown in are shown in Table 1 below.

[0107] [Table 1]

[0108] Part Dimensions (mm) α 15 β 17.5 γ 25 δ 10 ε 17 ζ 22 η 5 θ 64.7 ι 2 κ 2.3 λ 20.7

[0109] That is, in the test piece 60 of the present embodiment, the length of the developed portion 73 is the aforementioned λ (20.7 mm).

[0110] Four types of immunochromatographic membranes, IAB090, IAB120, IAB135, and IAB180 (all ADVANTEC), were used as the developing membrane 64A of the test piece 60. Their liquid permeation rates at a length of 4 cm were 90 seconds, 120 seconds, 135 seconds, and 180 seconds, respectively.

[0111] As specimens to be dropped onto the test strip 60, whole blood samples were prepared by suspending the amounts listed in Table 2 below in 130 μL of a diluent (specifically, a buffer solution containing a surfactant, sugar, and an anti-adhesive agent such as bovine serum albumin). 90 μL of these specimens were dropped onto the introduction section 63 of the test strip 60 equipped with the four developing membranes 64A described above, and the results of the development are shown in Table 2 below. The evaluation results shown in Table 2 are as follows.

[0112] A: There is no effect on the measurement and the specimen type can be identified.

[0113] B: By changing the shape of the measurement piece, the type of the specimen can be identified.

[0114] C1: There is a possibility of affecting the measurement.

[0115] C2: Unable to identify the specimen type.

[0116] [Table 2]

[0117]

[0118] First, in Table 2 above, the combination rated "A" can retain blood cell components in the upstream region 74 in the test piece 60 of this embodiment having the dimensions shown in Table 1 above, and therefore is found to be preferred in this embodiment. Furthermore, while the combination rated "B" is not suitable for the test piece 60 of this embodiment, it is believed that by changing the dimensions of the various parts of the test piece 60, blood cell components can be retained in the upstream region 74.

[0119] On the other hand, in the combination evaluated as "C1," the blood cell components exceeded the upstream region 74 and reached the measurement section 72, and were therefore judged to be inappropriate because they hindered detection of the target reaction zone 70. Furthermore, in the combination evaluated as "C2," the blood cell components did not reach the expansion section 73, and were therefore judged to be incapable of identifying the type of the specimen.

[0120] From the above, it can be seen that by using a nitrocellulose membrane with a desired permeation rate as the developing membrane, and by appropriately diluting the whole blood sample and adjusting the shape of the test piece, blood cells contained in the sample can be retained in the upstream area of ​​the developing section.

[0121] [Preferred embodiment]

[0122] Preferred embodiments of the present invention are listed below.

[0123] <1> A measurement system comprising:

[0124] A test strip comprising: an upstream introduction portion for introducing a specimen; a downstream measurement portion having fixed thereto a reaction reagent that reacts with a measurement object contained in the specimen; and a development portion for developing the specimen from the introduction portion to a downstream portion of the measurement portion;

[0125] a light source for irradiating the test piece into which the specimen is introduced with light of a predetermined wavelength;

[0126] an imaging unit that acquires optical information of the test piece illuminated by the light source; and

[0127] An analyzing unit determines the type of the specimen based on the optical information of an upstream region on the upstream side of the developing unit, among the optical information acquired by the imaging unit.

[0128] <2> exist <1> In the measurement system, the optical information is obtained by obtaining, at each predetermined position along the longitudinal direction of the development portion, an average value of the optical information at each predetermined position along a direction perpendicular to the longitudinal direction.

[0129] <3> exist <2> In the above-mentioned measurement system, the predetermined position is determined based on pixels of a picture taken by the imaging unit.

[0130] <4> exist <1> ~ <3> In any one of the measurement systems described, the analyzing unit determines the type of the specimen based on the optical information of the upstream area relative to a reference value, and the reference value is determined based on the optical information of a control area, which is an area other than the upstream area in the expansion section.

[0131] <5> exist <4> In the measurement system, the control area includes an area for producing a target reaction zone and an area for producing a control reaction zone, wherein the target reaction zone is produced by specifically reacting with the measurement object contained in the specimen, and the control reaction zone is produced by non-specifically reacting with the specimen, and

[0132] The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region where the subject reaction band is generated and a region where the control reaction band is generated.

[0133] <6> exist <5> In the measurement system, the reference value is an average value of the optical information in the reference area.

[0134] <7> exist <6> In the measurement system, the optical information at each predetermined position along the longitudinal direction of the development portion in the upstream region is compared with the reference value.

[0135] <8> exist <7> In the measurement system, the type of the specimen is determined based on whether the number of optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region exceeds a predetermined ratio.

[0136] <9> exist <7> In the measurement system, the type of the specimen is determined based on whether or not there are more than a predetermined number of optical information having a value lower than the reference value among the optical information at each predetermined position in the upstream region.

[0137] <10> exist <1> ~ <9> In any one of the measurement systems , the predetermined wavelength is a wavelength absorbed by blood cell components in the specimen.

[0138] <11> A determination method comprising the following steps:

[0139] Irradiating a test strip with light of a predetermined wavelength, the test strip comprising: an upstream introduction portion for introducing a specimen; a downstream measurement portion having fixed thereto a reaction reagent that reacts with a measurement object contained in the specimen; and a development portion for developing the specimen from the introduction portion to a downstream portion of the measurement portion;

[0140] acquiring optical information of the irradiated test piece;

[0141] The type of the specimen is determined based on the optical information of the upstream region on the upstream side in the development section, among the acquired optical information.

[0142] <12> exist <11> In the above-mentioned measurement method, regarding the optical information, at each predetermined position along the longitudinal direction of the developed portion, an average value of the optical information at each predetermined position along a direction perpendicular to the longitudinal direction is obtained.

[0143] <13> exist <12> In the above-mentioned measuring method, the predetermined position is determined based on pixels of a picture taken by the imaging unit.

[0144] <14> exist <11> ~ <13> In any one of the measurement methods described, in the step of determining the type of the specimen, the type of the specimen is determined based on the optical information of the upstream area relative to a baseline value, and the baseline value is determined based on the optical information of a control area, which is an area outside the upstream area in the expansion section.

[0145] <15> exist <14> In the above-mentioned measurement method, the control area includes an area for producing a target reaction zone and an area for producing a control reaction zone, wherein the target reaction zone is produced by specifically reacting with the measurement object contained in the specimen, and the control reaction zone is produced by non-specifically reacting with the specimen, and

[0146] The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region where the subject reaction band is generated and a region where the control reaction band is generated.

[0147] <16> exist <15> In the above-mentioned measurement method, the reference value is an average value of the optical information in the reference area.

[0148] <17> exist <16> In the above-mentioned measuring method, the optical information at each predetermined position along the longitudinal direction of the development portion in the upstream region is compared with the reference value.

[0149] <18> exist <17> In the measurement method, the type of the specimen is determined based on whether the optical information having a value lower than the reference value exceeds a predetermined ratio in the optical information at each predetermined position in the upstream region.

[0150] <19> exist <17> In the measurement method, the type of the specimen is determined based on whether or not there are more than a predetermined number of optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region.

[0151] <20> exist <11> ~ <19> In any one of the measurement methods described above, the predetermined wavelength is a wavelength absorbed by blood cell components in the specimen.

[0152] <21> A measurement program that causes a computer to function as the following unit:

[0153] A unit for irradiating a test strip with light of a predetermined wavelength, the test strip comprising: an upstream introduction portion for introducing a specimen; a downstream measurement portion having fixed thereto a reaction reagent that reacts with a measurement object contained in the specimen; and a development portion for developing the specimen from the introduction portion to a downstream portion of the measurement portion;

[0154] a unit for acquiring optical information of the irradiated test piece; and

[0155] A means for determining the type of the specimen based on the optical information of the upstream region on the upstream side in the developing section, among the acquired optical information.

[0156] <22> exist <21> In the measurement procedure, the optical information is obtained by obtaining, at each predetermined position along the longitudinal direction of the developed portion, an average value of the optical information at each predetermined position along a direction perpendicular to the longitudinal direction.

[0157] <23> exist <22> In the measurement program, the predetermined position is determined based on pixels of a picture taken by the imaging unit.

[0158] <24> exist <21> ~ <23> In any one of the measurement procedures described, in the unit for determining the type of the specimen, the type of the specimen is determined based on the optical information of the upstream area relative to a reference value, and the reference value is determined based on the optical information of a control area, which is an area other than the upstream area in the expansion section.

[0159] <25> exist <24> In the measurement procedure, the control area includes an area for producing a target reaction zone and an area for producing a control reaction zone, the target reaction zone being produced by a specific reaction with the measurement object contained in the specimen, and the control reaction zone being produced by a non-specific reaction with the specimen, and

[0160] The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region where the subject reaction band is generated and a region where the control reaction band is generated.

[0161] <26> exist <25> In the measurement procedure, the reference value is an average value of the optical information in the reference area.

[0162] <27> exist <26> In the measurement procedure, the optical information at each predetermined position along the longitudinal direction of the development portion in the upstream region is compared with the reference value.

[0163] <28> exist <27> In the measurement program, the type of the specimen is determined based on whether the number of optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region exceeds a predetermined ratio.

[0164] <29> exist <27> In the measurement program, the type of the specimen is determined based on whether or not there are more than a predetermined number of optical information having a value lower than the reference value among the optical information at each predetermined position in the upstream region.

[0165] <30> exist <21> ~ <29> In any one of the measurement procedures described above, the predetermined wavelength is a wavelength absorbed by blood cell components in the specimen.

[0166] <31> A smart device comprising:

[0167] an imaging unit for acquiring optical information of a test piece while irradiating the test piece with light of a predetermined wavelength, the test piece comprising: an upstream introduction unit for introducing a specimen; a downstream measurement unit on which a reaction reagent that reacts with a measurement object contained in the specimen is fixed; and a development unit for developing the specimen from the introduction unit to a downstream portion of the measurement unit; and

[0168] An analyzing unit determines the type of the specimen based on the optical information of an upstream region on the upstream side of the developing unit, among the optical information acquired by the imaging unit.

[0169] <32> exist <31> In the smart device, regarding the optical information, at each predetermined position along the longitudinal direction of the extended portion, an average value of the optical information at each predetermined position along a direction perpendicular to the longitudinal direction is obtained.

[0170] <33> exist <32> In the smart device, the predetermined position is determined based on pixels of a photo taken by the camera unit.

[0171] <34> exist <31> ~ <33> In any one of the smart devices described, the analyzing unit determines the category of the specimen based on the optical information of the upstream area relative to a baseline value, and the baseline value is determined based on the optical information of a control area, which is an area outside the upstream area in the expansion section.

[0172] <35> exist <34> In the smart device, the control area includes an area for generating a target reaction zone and an area for generating a control reaction zone, wherein the target reaction zone is generated by specifically reacting with the measurement object contained in the specimen, and the control reaction zone is generated by non-specifically reacting with the specimen, and

[0173] The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region where the subject reaction band is generated and a region where the control reaction band is generated.

[0174] <36> exist <35> In the smart device, the reference value is an average value of the optical information in the reference area.

[0175] <37> exist <36> In the smart device, the optical information at each predetermined position along the longitudinal direction of the expansion portion in the upstream area is compared with the reference value.

[0176] <38> exist <37> In the smart device, the type of the specimen is determined based on whether the optical information having a value lower than the reference value exceeds a predetermined ratio among the optical information at each predetermined position in the upstream area.

[0177] <39> exist <37> In the smart device, the type of the specimen is determined based on whether or not there are more than a predetermined number of optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream area.

[0178] <40> exist <31> ~ <39> In any one of the smart devices described above, the predetermined wavelength is a wavelength absorbed by blood cell components in the specimen.

[0179] Industrial Application Possibilities

[0180] The present invention provides a system and a measuring device capable of measuring a measurement object in a specimen using an action test strip.

Claims

1. A measurement system comprising: A test piece, the test piece comprising: an introduction section on the upstream side for introducing a sample; a measurement section on the downstream side, on which a reaction reagent that reacts with a measurement object contained in the sample is fixed; and a development section for developing the sample from the introduction section to the downstream of the measurement section; a light source for irradiating the test piece into which the specimen is 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 analyzing unit determines the type of the specimen based on the optical information on the upstream side, that is, the upstream region, in the developing unit, among the optical information acquired by the imaging unit.

2. The assay system according to claim 1, wherein: Regarding the optical information, at each predetermined position along the longitudinal direction of the development portion, an average value of the optical information at each predetermined position along a direction perpendicular to the longitudinal direction is obtained.

3. The assay system according to claim 1, wherein: The analyzing unit determines the type of the specimen based on optical information of the upstream region relative to a reference value determined based on optical information of a control region that is a region other than the upstream region in the developing unit.

4. The assay system according to claim 2, wherein: The analyzing unit determines the type of the specimen based on optical information of the upstream region relative to a reference value determined based on optical information of a control region that is a region other than the upstream region in the developing unit.

5. The measuring system according to claim 3, wherein: The control region includes a region for producing a subject reaction zone produced by a specific reaction with a measurement object contained in the specimen and a region for producing a control reaction zone produced by a non-specific reaction with the specimen, and The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region where the subject reaction band is generated and a region where the control reaction band is generated.

6. The measuring system according to claim 4, wherein The control region includes a region for producing a subject reaction zone produced by a specific reaction with a measurement object contained in the specimen and a region for producing a control reaction zone produced by a non-specific reaction with the specimen, and The reference value is determined based on optical information in a reference region, which is a region of the control region excluding a region where the subject reaction band is generated and a region where the control reaction band is generated.

7. The measuring system according to claim 5, wherein: The reference value is an average value of the optical information in the reference area.

8. The measuring system according to claim 6, wherein: The reference value is an average value of the optical information in the reference area.

9. The measuring system according to claim 7, wherein: The optical information at each prescribed position along the length direction of the development portion in the upstream region is compared with the reference value.

10. The measuring system according to claim 8, wherein The optical information of each of the prescribed positions in the upstream area is compared with the reference value.

11. The assay system according to claim 9, wherein: The type of the specimen is determined based on whether the optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region exceeds a predetermined ratio.

12. The measuring system according to claim 10, wherein: The type of the specimen is determined based on whether the optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region exceeds a predetermined ratio.

13. The measuring system according to claim 9, wherein: The type of the specimen is determined based on whether or not the number of optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region exceeds a predetermined number.

14. The measuring system according to claim 10, wherein: The type of the specimen is determined based on whether or not the number of optical information having a value lower than the reference value among the optical information at each of the predetermined positions in the upstream region exceeds a predetermined number.

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

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

17. The measurement system according to any one of claims 1 to 16, wherein: The predetermined wavelength is a wavelength absorbed by blood cell components in the specimen.

18. A determination method comprising the following steps: Irradiating a test piece with light of a predetermined wavelength, the test piece comprising: an introduction portion on the upstream side for introducing a sample; a measurement portion on the downstream side, on which a reaction reagent that reacts with a measurement object contained in the sample is fixed; and a development portion for developing the sample from the introduction portion to the downstream of the measurement portion; acquiring optical information of the irradiated test piece; The type of the specimen is determined based on the optical information of the upstream region on the upstream side in the development section among the acquired optical information.

19. A computer program product comprising a program for causing a computer to function as: A unit for irradiating a test piece with light of a predetermined wavelength, the test piece comprising: an introduction section on the upstream side for introducing a sample; a measurement section on the downstream side, on which a reaction reagent that reacts with a measurement object contained in the sample is fixed; and a development section for developing the sample from the introduction section to the downstream of the measurement section; a unit for acquiring optical information of the irradiated test piece; and A means for determining the type of the specimen based on the optical information of the upstream region on the upstream side in the developing section among the acquired optical information.

20. A smart device comprising: An imaging unit that acquires optical information of a test piece while irradiating the test piece with light of a predetermined wavelength, the test piece comprising: an introduction unit on an upstream side for introducing a specimen; a measurement unit on a downstream side to which a reaction reagent that reacts with a measurement object contained in the specimen is fixed; and a development unit for developing the specimen from the introduction unit to a downstream side of the measurement unit; and An analyzing unit determines the type of the specimen based on the optical information on the upstream side, that is, the upstream region, in the developing unit, among the optical information acquired by the imaging unit.

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