Blood test aid

Abstract

To provide a blood test aid capable of adding a proper amount of blood to a blood test device by a simple operation. This blood test aid is provided with: a first base material in which a pool in which blood is disposed is formed; and a second base material that can be superimposed on the first base material, the second base material being provided with, on the side facing the pool, a guide indicating the position at which a blood test device is to be fixed to the second base material, and the second base material having formed therein an opening that exposes the observation window of the device when the blood test device is fixed in accordance with the guide.

Description

Blood test aids

[0001] The present invention relates to a blood test auxiliary device used in a blood test for measuring the presence or concentration of a specific substance in blood.

[0002] Blood tests that analyze the presence or concentration of specific substances in blood are widely used to diagnose the health condition of a subject. For example, by analyzing the content of various components in blood plasma, the organ function of the subject can be diagnosed.

[0003] In a typical blood test, the blood sample is separated into liquid components, such as plasma or serum, and solid components, such as cells, using a centrifuge, suction pump, or pressure pump. A certain amount of blood (e.g., 5 mL or more) is typically required for centrifugation, requiring a doctor, nurse, or clinical laboratory technician to draw blood from the subject. Therefore, typical blood tests can only be performed at medical institutions or specialized testing facilities equipped with expensive analytical equipment, such as centrifuges, and the power supply required to operate them. Furthermore, the burden on medical professionals who draw blood is significant. In other words, typical blood tests impose a significant burden on not only the subject but also the medical institution, resulting in high costs.

[0004] Meanwhile, from the perspective of preventive medicine and extending healthy life expectancy, awareness of taking responsibility for one's own health is spreading throughout society, and along with this, there is a growing need for simple testing devices that can perform quick tests and allow results to be determined visually.

[0005] If a simple testing device could be developed that could separate plasma or serum from blood without using expensive analytical equipment or a power source and that could accurately test for the presence or concentration of specific substances contained in the separated plasma or serum, even those not in well-equipped medical institutions or testing laboratories, or even ordinary people without specialized skills, could easily and inexpensively perform testing themselves using a small amount of self-collected blood. This would be useful not only for the daily health management of ordinary people, but also for the health management of people at home who have difficulty going out. Furthermore, testing would be possible even in countries or regions with weak medical systems or in areas where it is difficult to secure power, such as disaster areas. Therefore, there is a great social demand for the development of an easy-to-use and highly accurate testing device.

[0006] Patent document 1 discloses a reagent strip comprising a test pad formed from an anisotropic membrane containing a color-developing reagent system specific to the analyte and having a side with relatively small pores defining a test surface and an opposite side with relatively large pores defining a sample receiving surface, and a porous sample transfer medium attached to the sample receiving surface of the test pad, the transfer medium being capable of receiving a whole blood sample and transferring a detectable portion of the sample to the sample receiving surface.

[0007] Japanese Patent Application Publication No. 6-74953

[0008] Simple blood testing devices that observe a color reaction caused by permeating a reagent phase with plasma separated from blood have the following problems. Specifically, to obtain reliable and reproducible test results, a necessary and sufficient amount of plasma must be brought into contact with the entire surface of the reagent phase. If the amount of plasma is insufficient, the sensitivity of the color reaction resulting from contact between the plasma and the reagent phase may be reduced, potentially making the reaction impossible to observe. Alternatively, if the amount of plasma is insufficient, the reaction may become uneven in the reagent phase, reducing the reproducibility of the test. On the other hand, if the amount of plasma is too much, the plasma may overflow the reagent phase and wrap around the sides of the reagent phase, resulting in an uneven reaction. In other words, it is important to permeate the reagent phase with an appropriate amount of plasma. This allows for accurate color reactions corresponding to the concentrations of specific substances contained in the blood, with good reproducibility. To achieve this, an appropriate amount of blood must be added to the test device.

[0009] However, in a test device that allows general subjects to test themselves, it is not realistic to have the subjects measure the amount of self-collected blood using an instrument such as a pipette or capillary tube.

[0010] The present invention has been made in view of the above, and has an object to provide a blood test auxiliary tool that allows an appropriate amount of blood to be added to a blood test device with a simple operation.

[0011] In order to solve the above problems, a blood test auxiliary that is one aspect of the present invention is a blood test auxiliary that assists in tests using a blood test device, and the blood test device comprises: a first substrate having a blood addition section that is an opening through which blood is added, a second substrate having an observation window that is an opening for observing a color reaction, and a plasma separation membrane and a dry reagent phase that are laminated and arranged between the first and second substrates, and a first base material having a pool in which blood is placed; and a second base material that can be superimposed on the first base material, and which has a guide on the side facing the pool that indicates the position where the blood test device is fixed to the second base material, and which has an opening that exposes the observation window when the blood test device is fixed in accordance with the guide.

[0012] In the above-mentioned blood test auxiliary device, at least one of the first and second base materials may be provided with a support portion that ensures a gap of a predetermined height between the poolside surface of the pool and the fixing surface of the blood test device on the second base material when the first base material and the second base material are overlapped.

[0013] In the above-mentioned blood test auxiliary tool, a protrusion that protrudes beyond a side surface of the pool may be formed on the first base material near the pool.

[0014] In the above-mentioned blood test auxiliary device, the first substrate and the second substrate may be formed from a sheet-like member that is continuous with each other, and the first substrate and the second substrate may be overlapped by folding the sheet-like member at the boundary line between the first substrate and the second substrate.

[0015] In the above-mentioned blood test auxiliary device, one of the first and second base materials may be provided with a convex portion having a protrusion formed on a wall surface, the other of the first and second base materials may be provided with a concave space into which the convex portion can fit, and a depression may be formed on the wall surface of the space at a position corresponding to the protrusion, and by fitting the convex portion into the space, the protrusion may fit into the depression, and the first base material and the second base material may be fixed in a superimposed state.

[0016] According to the present invention, by fixing the blood test device to the blood test auxiliary tool and placing blood in the pool, it becomes possible to add an appropriate amount of blood to the blood test device with a simple operation.

[0017] 1 is a plan view showing the inner surface side (unfolded state) of a blood test auxiliary according to an embodiment of the present invention. FIG. 2 is an end view taken along lines A-A to F-F in FIG. 1. FIG. 3 is a perspective view showing the inner surface side (unfolded state) of a blood test auxiliary according to an embodiment of the present invention. FIG. 4 is a perspective view showing the outer surface side (unfolded state) of a blood test auxiliary according to an embodiment of the present invention. FIG. 5 is a perspective view showing a blood test auxiliary (folded state) according to an embodiment of the present invention. FIG. 6 is an enlarged perspective view (blood addition section side) illustrating a blood test device used in an embodiment of the present invention. FIG. 7 is an enlarged perspective view (observation window side) illustrating a blood test device used in an embodiment of the present invention. FIG. 8 is an enlarged exploded perspective view illustrating a blood test device used in an embodiment of the present invention. FIG. 9 is a schematic diagram illustrating a method of using a blood test auxiliary according to an embodiment of the present invention. FIG. 10 is a schematic diagram illustrating a method of using a blood test auxiliary according to an embodiment of the present invention. FIG. 11 is a graph showing the colorimetric sensitivity of blood glucose in an example. FIG. 12 is a graph showing the colorimetric sensitivity of triglycerides in an example. FIG. 13 is a graph showing the colorimetric sensitivity of total cholesterol in an example. 14 is a graph showing blood glucose concentrations corresponding to the colorimetric sensitivities shown in Fig. 13. 15 is a graph showing triglyceride concentrations corresponding to the colorimetric sensitivities shown in Fig. 14. 16 is a graph showing total cholesterol concentrations corresponding to the colorimetric sensitivities shown in Fig. 15.

[0018] Hereinafter, blood test auxiliary devices according to embodiments of the present invention will be described with reference to the drawings. Note that the present invention is not limited to these embodiments. In addition, in the description of each drawing, the same parts are designated by the same reference numerals.

[0019] The drawings referred to in the following description merely show a rough outline of the shape, size, and positional relationship to the extent that the contents of the present invention can be understood. That is, the present invention is not limited to the shape, size, and positional relationship exemplified in each drawing. Furthermore, there may be parts in which the dimensional relationships and ratios differ between the drawings. Here, in this specification, a trace amount refers to a few μL to several tens of μL.

[0020] FIG. 1 is a plan view showing the inner surface (unfolded state) of a blood test auxiliary device according to an embodiment of the present invention. FIG. 2 is an end view taken along lines A-A to F-F shown in FIG. 1. Specifically, FIG. 2(a) shows the A-A end surface of FIG. 1, FIG. 2(b) shows the B-B end surface of FIG. 1, FIG. 2(c) shows the C-C end surface of FIG. 1, FIG. 2(d) shows the D-D end surface of FIG. 1, FIG. 2(e) shows the E1-E2-E3-E4 end surface of FIG. 1, and FIG. 2(f) shows the F-F end surface of FIG. 1. FIG. 3 is a perspective view showing the inner surface (unfolded state) of the blood test auxiliary device. FIG. 4 is a perspective view showing the outer surface (unfolded state) of the blood test auxiliary device. FIG. 5 is a perspective view showing the blood test auxiliary device (folded state).

[0021] The blood test auxiliary device (hereinafter also simply referred to as auxiliary device) 1 according to this embodiment is an instrument that assists in testing blood self-collected by a subject. As shown in FIGS. 1 to 5 , auxiliary device 1 comprises a lower substrate (first substrate) 11 and an upper substrate (second substrate) 12 that can be stacked on top of each other. In this specification, the side that becomes the outer side when lower substrate 11 and upper substrate 13 are stacked on top of each other during use of auxiliary device 1 (see FIG. 5 ) is referred to as the outer surface side, and the side that becomes the inner side is referred to as the inner surface side. The detailed configuration of auxiliary device 1 will be described later.

[0022] (Configuration of Test Device) Fig. 6 is a perspective view (blood addition section side) illustrating a blood test device used in an embodiment of the present invention. Fig. 7 is a perspective view (observation window side) of the same blood test device. Fig. 8 is an exploded perspective view of the same blood test device.

[0023] The blood test device (hereinafter also referred to simply as test device) 2 shown in Figures 6 to 8 is intended to measure the presence or concentration of a specific substance contained in plasma based on a color reaction that occurs in a dry reagent phase by bringing plasma separated from blood into contact with the dry reagent phase impregnated with a reagent. Measurable test items are not particularly limited as long as they are components contained in plasma and show a color reaction with a specified reagent. Specific examples of test items include AST, ALT, γ-GT, triglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, blood glucose, HbA1c, etc., as well as minerals such as zinc and magnesium.

[0024] The test device 2 comprises a first substrate 21 and a second substrate 22 arranged opposite to each other, and a diffusion layer 23, a plasma separation section 24, and reagent phases 25a to 25c stacked between the first substrate 21 and the second substrate 22. There is no particular limit to the number of items that can be simultaneously tested in the test device 2. In this embodiment, by providing three reagent phases 25a to 25c, three test items (for example, total cholesterol, triglycerides, and blood glucose) can be simultaneously tested, but the number of items that can be tested (the number of reagent phases) may be one, two, or four or more.

[0025] The first substrate 21 and the second substrate 22 are formed of a thin sheet material, and may be made of any material that can maintain the shape of the testing device 2 and that does not allow the blood or plasma sample to penetrate or react with these liquids, such as a resin material such as PET (polyethylene terephthalate) or water-repellent cardboard.

[0026] A blood addition section 21a, which is an opening into which blood as a sample is added, is formed on first substrate 21. In this embodiment, blood addition section 21a is rectangular in shape, but this shape is not particularly limited, and various shapes such as an oval or elliptical shape can be used as long as the shape allows for the addition of blood.

[0027] Observation windows 22a to 22c, which are openings for observing the color reactions of the reagent phases 25a to 25c, are formed on the second substrate 22. The number of these observation windows 22a to 22c is also set according to the number of test items (i.e., the number of reagent phases 25a to 25c). In this embodiment, the shape of each of the observation windows 22a to 22c is square, but this shape is not particularly limited and may be circular, elliptical, or the like. Furthermore, alignment openings 27 may be formed in corresponding locations on the first substrate 21 and the second substrate 22.

[0028] The diffusion layer 23, the plasma separation section 24, and the reagent phases 25a to 25c are stacked in this order between the first substrate 21 and the second substrate 22. The first substrate 21 and the second substrate 22 may be formed from two separate plates as shown in Fig. 8, or may be formed by bending a single elongated plate. A spacer 26 may be disposed between the first substrate 21 and the second substrate 22 to form a space 20a having a height sufficient to accommodate the diffusion layer 23, the plasma separation section 24, and the reagent phases 25a to 25c.

[0029] Diffusion layer 23 is formed from a material in which hydrophilic fibers are woven into a sheet, and is disposed so that a portion thereof is exposed from blood addition section 21a provided on first substrate 21. Diffusion layer 23 quickly guides blood added to blood addition section 21a over a wide area in the planar direction by capillary action, and acts to uniformly soak the blood into one surface of plasma separation section 24. Diffusion layer 23 may be, for example, a plain-woven material made of hydrophilic polyester.

[0030] The plasma separation unit 24 is formed of a porous sheet material, and separates plasma by trapping cellular components from the blood that has soaked into one side and allowing liquid components to pass through in the membrane thickness direction. The plasma separation unit 24 can be made of a porous polymer membrane such as a polysulfone (PS) membrane or an asymmetric PS membrane.

[0031] The reagent phases 25a to 25c are dry reagent phases made by impregnating filter paper (such as chromatography paper) with a reagent appropriate for the test item and then drying the same, and are arranged so that a portion of each is exposed from the observation windows 22a to 22c. The reagent phases 25a to 25c react with a predetermined substance contained in the plasma that has passed through the plasma separation unit 24 and develop a color. This color reaction can be visually observed from the observation windows 22a to 22c side when the plasma has sufficiently permeated the reagent phases 25a to 25c.

[0032] The diffusion layer 23, the plasma separation section 24, and the reagent phases 25a to 25c are adhered to the first substrate 21 or the second substrate 22 using double-sided tape or the like. The first substrate 21 and the second substrate 22 are also adhered to each other using double-sided tape or the like, or are adhered via a spacer 26.

[0033] 1 to 5, the lower base material 11 and the upper base material 13 of the auxiliary device 1 are formed by vacuum molding using a resin material such as polyethylene terephthalate (PET) or polyethylene (PE). However, the method and material for forming the lower base material 11 and the upper base material 13 are not limited to these. For example, a composite material of pulp and resin or a material in which cardboard has been treated with a water-repellent finish may be used, or the lower base material 11 and the upper base material 13 may be formed using press processing or pulp molding technology.

[0034] In this embodiment, the assisting device 1 is configured such that the lower base material 11 and the upper base material 13 are integrally formed and are superimposed on each other by folding along the boundary line 15 between the lower base material 11 and the upper base material 13. However, the lower base material 11 and the upper base material 13 may also be formed separately from each other.

[0035] 1 to 3, a pool 111 in which blood is placed is formed on the inner surface side of the lower base material 11. The capacity of the pool 111 is determined based on the appropriate amount of blood to be added to the test device 2 (for example, 30 μL to 40 μL) so that when the pool 111 is filled with blood so that the blood rises slightly above the upper surface of the pool 111 (i.e., the pool side surface 112) due to surface tension, the volume will be approximately appropriate.

[0036] The size of the opening surface of the pool 111 is preferably approximately the same as or slightly smaller than the blood addition section 21a of the testing device 2. Even if the opening surface of the pool 111 is smaller than the blood addition section 21a, by bringing the blood into contact with a part of the blood addition section 21a, the blood can be widely diffused over the entire surface of the plasma separation section 24 by the diffusion layer 23. Furthermore, the shape of the opening surface of the pool 111 may be the same as or different from that of the blood addition section 21a. In this embodiment, the blood addition section 21a is rectangular, while the opening surface of the pool 111 is elliptical.

[0037] A protrusion 113 that protrudes inward beyond the pool side surface 112 is formed near the pool 111. This protrusion 113 functions as a support that ensures a gap G (see FIG. 2C ) of a predetermined height between the pool side surface 112 and the fixing surface 13a of the upper substrate 12 for the test device 2 when the lower substrate 11 and the upper substrate 12 are overlapped. The height of this gap G is preferably set to be approximately the same as the thickness of the test device 2 or slightly smaller than the thickness of the test device 2. By appropriately setting the gap G, when the lower substrate 11 and the upper substrate 12 are overlapped, the blood addition section 21a of the test device 2 can be brought into contact with the blood placed in the pool 111 without the user having to apply external force to the holder 1, and the test device 2 can be maintained in a moderately compressed state without being strongly crushed.

[0038] The protrusion 113 can also be used as a guide for the user to check the amount of blood to be added when adding it to the pool 111. Furthermore, a mark (for example, an arrow) 114 indicating the position of the pool 111 may be placed near the pool 111.

[0039] A guide 131 is provided on the inner surface of the upper base material 13 (i.e., the side facing the pool 111) to indicate the position at which the test device 2 is fixed to the upper base material 13. In this embodiment, the guide 131 is provided so as to protrude more toward the inner surface than the fixing surface 13a of the test device 2. By abutting the end side of the test device 2 against the inner wall of the guide 131, the test device 2 can be attached in the appropriate position for the blood test device 2. Note that the guide 131 may simply be a printed mark that indicates the attachment position of the test device 2.

[0040] The upper base material 13 has openings 132 formed therein that expose the observation windows 22a to 25c when the testing device 2 is fixed in place in accordance with the guides 131. The upper base material 13 may also have alignment openings 133 formed therein that correspond to the alignment openings 27 of the testing device 2.

[0041] The lower substrate 11 is formed with support portions 115 and 116 that protrude inward from the floor surface of the lower substrate 11. When the upper substrate 13 is superimposed on the lower substrate 11, the top surface of the support portion 115 abuts against the floor surface 134 of the upper substrate 13, and the top surface of the support portion 116 abuts against the floor surface 135 of the upper substrate 13. When the upper substrate 13 is superimposed on the lower substrate 11, these support portions 115 and 116 can also function as a means for ensuring a gap G of a predetermined height between the pool side surface 112 of the pool 111 provided on the lower substrate 11 and the fixing surface 13a of the testing device 2 on the upper substrate 13.

[0042] It is also possible to provide only one of the support portions 115 and 116. Alternatively, a support portion protruding toward the inner surface may be provided on the upper substrate 13, with its top surface abutting the floor surface of the lower substrate 11. Alternatively, both the lower substrate 11 and the upper substrate 13 may be provided with support portions that protrude toward the inner surface and abut against each other at their top surfaces. Furthermore, if the protrusion 113 is provided, it is not necessary to provide the support portions 115 and 116. Conversely, the protrusion 113 may be omitted, and either or both of the support portions 115 and 116 may be provided. The key point is that when the upper substrate 13 is superimposed on the lower substrate 11, it is sufficient that a gap G is secured between the pool side surface 112 and the fixing surface 13a.

[0043] The upper substrate 13 has two convex portions 136 protruding from the floor surface toward the inner side. Protrusions 137 are formed on the outer wall surfaces of these convex portions 136. Meanwhile, the lower substrate 11 has two convex portions 121 protruding from the floor surface. The spaces between these convex portions 121 and the outer periphery 120 form spaces 122 into which the two convex portions 136 can fit. In the inner wall surfaces of the outer periphery 120 and the outer wall surfaces of the convex portions 121 that form each space 122, depressions 123 and 124 are formed at positions corresponding to the protrusions 137 of the upper substrate 13. By overlapping the upper substrate 13 on the lower substrate 11 and fitting the convex portions 136 of the upper substrate 13 into the spaces 122 of the lower substrate 11, the protrusions 137 on the convex portion 136 side fit into the depressions 123 and 124 on the space 122 side, and the lower substrate 11 and the upper substrate 13 can be fixed in a closed state.

[0044] In addition, as a configuration for fixing the lower substrate 11 and the upper substrate 13 in a closed state, a convex portion with a protrusion on the outer wall surface may be provided on the lower substrate 11, and a space with a recess formed on the wall surface may be provided on the upper substrate 13.

[0045] 4 and 5, a guide 141 may be formed on the outer surface of the upper substrate 13, protruding from the surface on which the opening 132 is formed. The guide 141 can be used to align a card-shaped color sample (colorimetric card) used when observing the color reactions of the reagent phases 25a to 25c with the opening 132. Furthermore, the test items corresponding to the reagent phases 25a to 25c exposed through the opening 132 may be displayed around the opening 132 on the outer surface of the upper substrate 13 by printing or by using a sticker.

[0046] 9 to 12 are schematic diagrams for explaining how to use the blood test auxiliary device according to this embodiment. In Fig. 12, "TCHD (total cholesterol)," "TG (triglycerides)," and "GLU (blood glucose)" are displayed around opening 132 on the outer surface of upper base material 13 as examples of test items corresponding to reagent phases 25a to 25c exposed from opening 132.

[0047] First, as shown in Figure 9, the test device 2 is attached to the inner surface of the upper base material 13 of the auxiliary tool 1. At this time, the alignment opening 27 of the test device 2 is aligned with the alignment opening 133 of the upper base material 13, the blood addition section 21a is faced to the inner surface, and the test device 2 is placed inside the guide 131. There are no particular limitations on the means for attaching the test device 2, and for example, double-sided tape can be used.

[0048] Next, the subject places blood collected by puncturing their fingertip or the like into the pool 111. At this time, the blood can be transferred to the pool 111 by directly contacting the blood pool formed on the fingertip or the like with the pool 111. The amount of blood is preferably such that the surface of the blood 3 rises above the pool side surface 112 due to surface tension, as shown in FIG. 10(a). At this time, the subject can check whether the amount of blood 3 is sufficient by using the protrusion 113 as a guide. If the surface of the blood 3 is lower than the pool side surface 112, as shown in FIG. 10(b), the blood 3 may not contact the diffusion layer 23 inside the blood addition section 21a, and the blood volume may be insufficient. Furthermore, even if the surface of the blood 3 rises above the pool side surface 112, as shown in FIG. 10(c), the blood volume may still be insufficient if the entire pool 111 is not filled with blood.

[0049] 11, the upper base material 13 is folded along the boundary line 15 and overlapped with the lower base material 11. At this time, the convex portion 136 of the upper base material 13 is fitted into the space 122 of the lower base material 11. This allows the assisting device 1 to be maintained in a closed state without the subject having to press down on it.

[0050] As described above, the height of the gap G between the pool-side surface 112 of the lower substrate 11 and the fixing surface 13a of the upper substrate 13 is approximately the same as the thickness of the test device 2. Therefore, by closing the auxiliary tool 1, the first substrate 21 of the test device 2 comes into almost contact with the pool-side surface 112. As a result, the surface of the blood 3 filled in the pool 111 comes into contact with the diffusion layer 23 inside the blood addition section 21a. As a result, almost all of the blood 3 in the pool 111 is sucked in by capillary action and added to the test device 2.

[0051] Here, when the assisting tool 1 is closed, it is acceptable for there to be a small gap between the test device 2 and the pool side surface 112. Because the blood 3 fills the pool 111 in a raised state due to surface tension (see FIG. 10(a)), if a portion of the surface of the blood 3 can come into contact with the diffusion layer 23, the blood will be sucked in from that point.

[0052] Furthermore, there is no problem even if blood 3 accumulates in pool 111 in an amount exceeding the appropriate amount for test device 2. This is because when auxiliary tool 1 is closed, excess blood 3 escapes through pool side surface 112, so ultimately only an amount slightly exceeding the capacity of pool 111 is added to test device 2. Furthermore, because blood that escapes through pool side surface 112 also remains within auxiliary tool 1, contamination of the surrounding area due to blood leakage can be prevented.

[0053] The blood that has spread over the entire surface of the diffusion layer 23 soaks into the plasma separation section 24. Then, the plasma separated by the plasma separation section 24 soaks into the reagent phases 25a-25c. After a predetermined time has passed since the auxiliary tool 1 was closed, the color of the reagent phases 25a-25c in which the color reaction has occurred is compared with a reference color to estimate the concentration of the test item.

[0054] For example, a color comparison card 4 shown in FIG. 12 can be used to estimate the concentration. The color comparison card 4 displays scales 41-43 consisting of color samples that can be displayed by the reagent phases 25a-25c for each test item (e.g., total cholesterol (TCHO), triglycerides (TG), blood glucose (GLU)). The scales 41-43 display numerical values ​​that indicate the concentration of the component corresponding to each color (or the stage corresponding to the concentration). Furthermore, openings 44-46 are formed within the area of ​​each scale 41-43, corresponding to the positions of the reagent phases 25a-25c that appear in the opening 132 of the assisting tool 1.

[0055] 12, the values ​​displayed on each scale 41 to 43 indicate the concentration (mg / dL) in the range detectable by a simple test in stages. Specifically, the concentration of total cholesterol is shown in seven stages, the concentration of triglycerides is shown in five stages, and the concentration of blood glucose is shown in seven stages.

[0056] By placing the color comparison card 4 in alignment with the guide 141 of the assisting tool 1 and sliding it in the direction of the arrow shown in Figure 12, the reagent phases 25a to 25c appear sequentially in the openings 44 to 46. The subject can visually determine the test results (concentration of each component) by comparing the colors of the reagent phases 25a to 25c appearing in the openings 44 to 46, respectively, with the color samples in the scales 41 to 43.

[0057] After the test is completed, the auxiliary tool 1 can be disposed of as is without opening it, thereby preventing contamination by the tested blood.

[0058] As described above, according to this embodiment, the test is performed by fixing the test device 2 to the auxiliary tool 1, placing blood in the pool 111 of the auxiliary tool 1, and closing the auxiliary tool 1, so that an appropriate amount of blood can be added to the blood test device with a simple operation.

[0059] Furthermore, according to this embodiment, a protrusion 113 that protrudes from the pool side surface 112 is provided near the pool 111, so that when the subject places blood in the pool 111, it can be used as a guide for the amount of blood.

[0060] Furthermore, according to this embodiment, the test is performed with the test device 2 attached to the assisting tool 1, so that the test device 2 can be easily handled.

[0061] Furthermore, according to this embodiment, the reaction in the test device 2 begins when the auxiliary tool 1 is closed after the blood 3 is placed in the pool 111, making it easy to control the test time. In other words, the waiting time from when blood is added to the test device 2 until a sufficient reaction is observed in the reagent phases 25a to 25c can be accurately counted.

[0062] Furthermore, according to this embodiment, by attaching the test device 2 to the auxiliary tool 1 in accordance with the guide 131, the color reaction of the reagent phases 25a to 25c can be observed from the outer surface of the auxiliary tool 1.

[0063] Furthermore, according to this embodiment, when the lower substrate 11 and the upper substrate 13 are overlapped, support portions 115, 116 are provided to ensure a gap G of a predetermined height between the pool side surface 112 and the fixing surface 13a, so that the testing device 2 can be held without being crushed.

[0064] Furthermore, according to this embodiment, the upper substrate 13 can be fixed to the lower substrate 11 and maintained in a closed state by fitting the convex portion 136 having the protrusions 137 formed on the wall surface into the space 122 having the recesses 123 and 124 formed on the wall surface. Therefore, contamination of the surroundings by blood can be prevented during the waiting time for the color reaction, during observation using the color comparison card 4, and even at the time of disposal.

[0065] (Modification) In the above embodiment, the outer peripheral shape and size of the lower substrate 11 and the upper substrate 13 are the same (see FIG. 5 ), but the outer peripheral shape or size of the two may be different. For example, a notch may be formed in a portion of the upper substrate 13. In this case, after placing the auxiliary tool 1 on a desk and placing blood in the pool 111, the upper substrate 13 can be placed over the lower substrate 11 while holding down the portion of the lower substrate 11 corresponding to the notch and keeping the lower substrate 11 horizontal. This makes it easier to handle the auxiliary tool 1.

[0066] Furthermore, a tongue portion protruding outward from the outer periphery may be formed on either the lower substrate 11 or the upper substrate 13. When a tongue portion is formed on the lower substrate 11, the tongue portion can be pressed down to place the upper substrate 13 over the lower substrate 11. Conversely, when a tongue portion is formed on the upper substrate 13, the tongue portion can be pinched to place the lower substrate 11 over the upper substrate 13. Alternatively, tongue portions may be formed on both the lower substrate 11 and the upper substrate 13 at mutually different positions.

[0067] (Example) An experimental test device having the same configuration as test device 2 was created, and an experiment was carried out as follows to measure the colorimetric sensitivity in the reagent phase by changing the amount of blood placed in auxiliary tool 1.

[0068] 1. Preparation of experimental test devices Fifteen experimental test devices were prepared, each having a reagent phase, a plasma separation part, and a diffusion layer made of the following materials, arranged between two substrates each having an opening for the blood addition part and an opening for the observation window. (1) Reagent phase: Material: Test paper impregnated with glucose concentration measurement reagents (components: piperazine-1,4-bis(2-ethanesulfonic acid) (PIPES), N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline sodium (DAOS), 4-aminoantipyrine (4-AA), mutarotase, peroxidase (POD), glucose oxidase) and dried. Size: 5 mm (short side of device) x 2.5 mm (longitudinal side of device), thickness 0.17 mm. (2) Plasma separation section: Material: Asymmetric polysulfone. Size: 5 mm (short side of device) x 10 mm (longitudinal side of device), thickness 0.33 mm. (3) Diffusion layer: Material: Plain woven sheet of hydrophilic polyester. Size: 5 mm (short side of device) x 10 mm (longitudinal side of device), thickness 0.12 mm.

[0069] 2. Experimental Method (1) A blood test device was attached to a designated location on the support tool. (2) Experimental blood (whole blood) was dropped into the pool of the support tool. Three blood volumes were used: 30 μL, 35 μL, and 40 μL. In all cases, the surface of the blood was raised above the poolside surface due to surface tension. (3) Five minutes after closing the support tool, the reagent phase exposed in the observation window was photographed with an optical camera, and the colorimetric sensitivity of each reagent phase was estimated based on the image. Furthermore, the CV value of the colorimetric sensitivity was calculated. (4) The concentration (mg / dL) of each component was calculated based on the colorimetric sensitivity.

[0070] 3. Experimental Results Figure 13 is a graph showing the colorimetric sensitivity of blood glucose in the example. Figure 14 is a graph showing the colorimetric sensitivity of triglycerides in the same example. Figure 15 is a graph showing the colorimetric sensitivity of total cholesterol in the same example. Figure 16 is a graph showing the blood glucose concentration corresponding to the colorimetric sensitivity shown in Figure 13. Figure 17 is a graph showing the triglyceride concentration corresponding to the colorimetric sensitivity shown in Figure 14. Figure 18 is a graph showing the total cholesterol concentration corresponding to the colorimetric sensitivity shown in Figure 15. In Figures 13 to 15, the horizontal axis represents the amount of blood dropped into the pool, and the vertical axis represents the colorimetric sensitivity. In Figures 16 to 18, the horizontal axis represents the colorimetric sensitivity, and the vertical axis represents the concentration of each component (mg / dL).

[0071] The CV values ​​of the colorimetric sensitivity were 1.61% for blood glucose, 2.42% for triglycerides, and 2.44% for total cholesterol.

[0072] 4. Discussion The blood volumes used in the experiment were 30 μL, 35 μL (approximately a 17% increase), and 40 μL (approximately a 14% increase). As shown in Figures 13 to 15, although there was some variation depending on the component, the colorimetric sensitivity generally fell within a range of Δ0.02 regardless of the amount of blood dropped. Furthermore, the CV value of the colorimetric sensitivity fell within 3% for all components. Therefore, it can be said that the variation in colorimetric sensitivity due to the amount of blood dropped is small.

[0073] 16 to 18, it can be seen that the variations in colorimetric sensitivity shown in FIGS. 13 to 15 do not significantly affect the concentrations of the respective components. Here, in the colorimetric card 4 shown in FIG. 12, blood glucose levels are generally rated at 80 mg or more and less than 120 mg per dL, triglycerides are generally rated at 70 mg or more and less than 100 mg per dL, and total cholesterol levels are generally rated at 180 mg or more and less than 220 mg per dL. Thus, in a simple test in which a user visually determines a color reaction, even if there is variation in colorimetric sensitivity to the extent shown in the examples, this falls within the same range when converted to concentration, and does not affect the determination results.

[0074] From the above, it was found that even if the amount of blood dropped into the pool was changed, the same blood sample was detected at roughly the same concentration in the blood test device. This indicates that a roughly constant amount of blood was added to the blood test device regardless of the amount of blood dropped into the pool. Therefore, it can be said that by using the assisting tool 1 according to this embodiment, an appropriate amount of blood was able to be added to the test device 2.

[0075] The present invention described above is not limited to the above-described embodiment and modifications, and various inventions can be formed by appropriately combining the multiple components disclosed in the above-described embodiment and modifications. For example, some components may be excluded from all the components shown in the above-described embodiment and modifications, or the components shown in the above-described embodiment and modifications may be appropriately combined to form various inventions.

[0076] 1...blood test auxiliary part (auxiliary tool), 2...blood test device (test device), 3...blood, 4...colorimetric card, 11...lower substrate, 13...upper substrate, 13a...fixing surface, 15...boundary line, 20a...space, 21...first substrate, 21a...blood addition part, 22...second substrate, 22a-22c...observation window, 23...diffusion layer, 24...plasma separation part, 25a-25c...reagent phase, 26...spacer, 27...position Alignment opening, 41 to 43...scale, 44 to 46...opening, 111...pool, 112...pool side surface, 113...projection portion, 114...mark, 115, 116...support portion, 120...periphery, 121...projection portion, 122...space, 123...recess, 131...guide, 132...opening, 133...alignment opening, 134, 135...floor surface, 136...projection portion, 137...projection, 141...guide

Claims

1. A blood test auxiliary tool that assists a test using a blood test device, The blood test device comprises a first substrate formed with a blood application section which is an opening into which blood is applied, a second substrate formed with an observation window which is an opening for observing a color reaction, and a plasma separation membrane and a dry reagent phase laminated and disposed between the first and second substrates; a first substrate having a pool formed thereon in which blood is placed; a second substrate that can be superimposed on the first substrate, the second substrate having a guide on the side facing the pool that indicates the position at which the blood test device is fixed to the second substrate, and an opening that exposes the observation window when the blood test device is fixed in accordance with the guide; A blood testing aid comprising:

2. 2. The blood test auxiliary tool according to claim 1, wherein at least one of the first and second base materials has a support section that ensures a gap of a predetermined height between the pool side surface of the pool and a fixing surface of the blood test device on the second base material when the first base material and the second base material are overlapped.

3. 3. The blood test auxiliary tool according to claim 1, wherein a protrusion that protrudes beyond a side surface of the pool is formed on the first base material near the pool.

4. the first substrate and the second substrate are formed of continuous sheet-like members, 3. The blood test auxiliary device according to claim 1, wherein the first substrate and the second substrate are overlapped by folding the first substrate and the second substrate at a boundary line between the first substrate and the second substrate.

5. a protrusion having a wall surface formed with a projection is provided on one of the first and second base materials; a recessed space into which the protrusion can be fitted is provided on the other of the first and second embodiments, a recess is formed in a wall surface of the space at a position corresponding to the protrusion, By fitting the convex portion into the space, the protrusion fits into the recess, and the first base material and the second base material are fixed in a superposed state. The blood test auxiliary device according to claim 1 or 2.