Measurement cell and measurement cell manufacturing method

Abstract

The invention relates to a measuring cell and a method for manufacturing the measuring cell. The measurement means measures the characteristics of the biological sample. The measurement unit is provided with: a second solution containing a stimulant that activates the function of the biological sample and an organic solvent that dissolves the stimulant; a second container for accommodating the frozen second solution; and a sealing bag which accommodates the second container in a sealed internal space.

Description

[0001] This application claims priority based on Japanese Application No. 2024-188511, filed on October 25, 2024, and incorporates all the contents of that Japanese application. Technical Field

[0002] This disclosure relates to a measuring unit and a method for manufacturing the measuring unit. Background Technology

[0003] Techniques for measuring the properties of biological samples have been known for a long time (see, for example, Patent Document 1 (Japanese Patent Application Publication No. 2019-213464)). In such techniques, sometimes a biological sample collected from a test subject (e.g., a human body) is added to a preparative solution prepared by introducing multiple reagents into a container, and the light generated in the container's storage space is measured, thereby determining the properties of the biological sample. Summary of the Invention

[0004] In techniques like those described above, at least one of the reagents is prone to deterioration at room temperature. In such cases, it is desirable to perform the preparation of the solution and the introduction of the solution into the container before light measurement and near the test subject. However, performing these operations near the test subject can become cumbersome.

[0005] This disclosure provides a measuring unit and a method for manufacturing the measuring unit that can maintain the quality of the solution and perform simple operations.

[0006] The measuring unit disclosed herein is [1] "a measuring unit for measuring the properties of a biological sample, and comprising: a solution containing a stimulant that activates the function of the biological sample and an organic solvent that dissolves the stimulant; a container holding the frozen solution; and a sealed bag holding the container in a sealed internal space."

[0007] In the aforementioned assay unit, a solution containing a stimulant that activates the function of a biological sample is stored in a container in a frozen state. In this case, the assay unit can be transported to the vicinity of the test subject while the solution is frozen. Furthermore, after thawing the solution near the test subject, the thawed solution can be added to the solution containing the biological sample. Therefore, not only is the quality of the solution stored in the container maintained, but the process of introducing the solution into the container near the test subject is also eliminated. Additionally, the aforementioned assay unit includes a sealed bag for storing the container within a closed internal space. Organic solvents contained in solutions sometimes have hygroscopic properties, absorbing moisture from the air. In such cases, when the stimulant contained in the solution is dissolved by the organic solvent, the stimulant may lose its activity due to hydrolysis, leading to a deterioration in the quality of the solution. In contrast, when the container is stored in a sealed bag as in the aforementioned assay unit, moisture from the air surrounding the container can be prevented from being absorbed by the solution. This suppresses the degradation of solution quality caused by hydrolysis. Therefore, based on the aforementioned measurement unit, the operation of measuring the characteristics of biological samples while maintaining the quality of the solution becomes simple.

[0008] The measuring unit disclosed herein may also be [2] "the measuring unit according to [1] above, wherein it further comprises: a sealing member that blocks at least one of a first opening formed in the container and a second opening formed in the container at a position different from the first opening." In this case, it is possible to prevent moisture in the air from being absorbed by the solution, and therefore, it is possible to suppress the decrease in solution quality caused by hydrolysis.

[0009] The measuring unit disclosed herein can also be [3] "The measuring unit according to [1] above, further comprising: a first sealing member, the blockage of which is formed at a first opening of the container; and a second sealing member, the blockage of which is formed at a second opening in the container at a different position from the first opening." In this case, the interior of the container can be sealed using the first sealing member and the second sealing member. Thus, it is possible to effectively prevent moisture in the air surrounding the container from being absorbed by the solution inside the container.

[0010] The measuring unit disclosed herein may also be [4] "the measuring unit according to any one of [1] to [3] above, wherein it further comprises: a desiccant, which is housed together with the container in the internal space of the sealed bag to absorb moisture in the air." In this case, the desiccant can absorb moisture in the air, thus effectively preventing the moisture from being absorbed by the solution inside the container.

[0011] The measuring unit disclosed herein can also be [5] "the measuring unit according to any one of [1] to [4] above, wherein the container is housed in the internal space of the sealed bag." In this case, the measuring unit can be implemented with a simple structure.

[0012] The measuring unit disclosed herein may also be [6] "the measuring unit according to any one of [1] to [4] above, wherein it comprises a plurality of containers for respectively containing the frozen solution, and the plurality of containers are contained in the internal space of the sealed bag." In this case, when mass-producing the frozen containers, by centrally storing the plurality of containers in the internal space of the sealed bag, the costs required for the production and transportation of the measuring unit can be reduced.

[0013] The measuring unit disclosed herein may also be [7] "the measuring unit according to any one of [1] to [6] above, wherein it further comprises: a first solution containing an indicator that reacts with components produced by the biological sample; and a first container that holds the first solution, wherein the sealed bag holds the first container holding the first solution and the container holding the second solution, i.e., the second container, within the internal space." In this case, for example, by holding the first solution in the first container in a frozen state, the measuring unit can be transported to the vicinity of the test subject in the frozen state of the first solution, and the biological sample collected from the test subject can be added to the first solution after thawing the first solution near the test subject. Therefore, not only is the quality of the first solution maintained, but also, near the test subject, there is no need for operations such as the preparation of the first solution and the introduction of the first solution into the first container. Therefore, according to the structure described above [7], the operation for measuring the characteristics of the biological sample while maintaining the quality of the first solution and the second solution becomes simpler. In addition, in the structure described above [7], the first container and the second container can be transported together using a single sealed bag. Therefore, compared with the case where the first container and the second container are transported separately in different sealed bags, the transport cost of the measuring unit can be reduced and its availability improved.

[0014] The measuring unit of the present invention may also be [8] "The measuring unit according to any one of [1] to [6] above, wherein it further comprises: a first solution containing at least one of physiological saline and a buffer solution; a first container containing the first solution; a third solution containing an indicator that reacts with the components produced by the biological sample; and a third container containing the third solution, wherein the sealed bag contains: the first container containing the first solution; a second container as the container containing the second solution; and the third container containing the third solution." In this way, in the internal space of the sealed bag, when the first solution containing at least one of physiological saline and a buffer solution and the third solution containing the indicator are contained in different containers, compared with the case where physiological saline, buffer solution and indicator are contained in one container, the quality of the solutions contained in each container is less likely to deteriorate, and therefore, the quality of the solution can be maintained more reliably.

[0015] The measuring unit of this disclosure may also be [9] "the measuring unit according to [7] or [8] above, wherein the indicator is a fluorescent indicator." Sometimes, solutions containing fluorescent indicators require cryopreservation. As described above, cryopreservation of the first solution containing the fluorescent indicator is achieved by freezing the first solution containing the fluorescent indicator.

[0016] The measuring unit disclosed herein may also be

[10] "the measuring unit according to any one of [1] to [9] above, wherein the organic solvent is DMSO (Dimethyl sulfoxide)." DMSO has high hygroscopicity. Therefore, when dissolving the stimulant contained in the solution by DMSO, it is conceivable that the stimulant will undergo hydrolysis. In contrast, in the measuring unit described above, as mentioned above, it is possible to prevent the absorption of moisture from the air around the container by the solution, and to suppress the decrease in solution quality caused by hydrolysis, thus achieving the above-mentioned effects.

[0017] The measuring unit disclosed herein is

[11] "a measuring unit for measuring the properties of a biological sample, and comprising: a stimulant that activates the function of the biological sample; a container that holds the frozen stimulant; and a sealed bag that holds the container in a sealed internal space."

[0018] The aforementioned measuring unit contains a frozen stimulant in a container housed within a sealed bag. There is concern that the stimulant may hydrolyze due to humidity. Therefore, as with the aforementioned measuring unit, by housing the container within a sealed bag, it is possible to prevent the stimulant from absorbing moisture from the air surrounding the container, thereby suppressing the degradation of the stimulant's quality caused by hydrolysis. Therefore, the same effect as described above is obtained with the aforementioned measuring unit [1].

[0019] The manufacturing method of the measuring unit disclosed herein is

[12] "A method for manufacturing a measuring unit, wherein the method manufactures a measuring unit for measuring the characteristics of a biological sample, and comprises: a step of preparing a solution comprising a stimulant that activates the function of the biological sample and an organic solvent that dissolves the stimulant, a container capable of containing the solution, and a sealed bag capable of containing the container; a step of freezing the solution while it is contained in the container; and a step of sealing the internal space of the sealed bag while the container is contained inside the sealed bag."

[0020] According to the above-described method for manufacturing the measuring unit, it is possible to manufacture a measuring unit that achieves the effect described in [1].

[0021] The manufacturing method of the measuring unit disclosed herein can also be

[13] "According to the manufacturing method of the measuring unit described in

[12] above, wherein, in the process of freezing the solution, the solution is frozen while the first opening formed in the container is blocked by the first sealing member, and the second opening formed in the container at a different position from the first opening is blocked by the second sealing member." In this case, the solution inside the container can be frozen while the inside of the container is sealed by the first sealing member and the second sealing member. Thus, it is possible to effectively prevent moisture in the air around the container from being absorbed by the solution inside the container.

[0022] The manufacturing method of the measuring unit disclosed herein can also be

[14] "The manufacturing method of the measuring unit according to

[12] or

[13] above, wherein, in the step of sealing the internal space of the sealed bag, the internal space is sealed while the desiccant that absorbs moisture from the air is housed together with the container in the internal space." In this case, in the step of sealing the internal space of the sealed bag, the desiccant can absorb moisture from the air, thus effectively preventing the moisture from being absorbed by the solution inside the container.

[0023] The manufacturing method of the measuring unit disclosed herein can also be

[15] "The manufacturing method of the measuring unit according to any one of

[12] to

[14] above, wherein a step of storing a first solution containing an indicator that reacts with the components produced by the biological sample in a first container is further included, and in the step of sealing the internal space of the sealed bag, the internal space is sealed while the first container containing the first solution and the container containing the second solution, i.e., the second container, are stored in the internal space." In this case, as described above, for example, by storing the first solution in the first container in a frozen state, the measuring unit can be transported to the vicinity of the test subject while the first solution is frozen, and the biological sample collected from the test subject can be added to the first solution after thawing the first solution near the test subject. Therefore, not only is the quality of the first solution maintained, but also, near the test subject, there is no need for operations such as the preparation of the first solution and the introduction of the first solution into the first container. Therefore, according to the structure described above

[15] , the operation of measuring the characteristics of the biological sample while maintaining the quality of the first solution and the second solution becomes simpler. In addition, in the structure described above

[15] , the first container and the second container can be transported together using a single sealed bag. Therefore, compared with the case where the first container and the second container are transported separately in different sealed bags, the transport cost of the measuring unit can be reduced and its availability improved.

[0024] The manufacturing method of the measuring unit of the present invention can also be

[16] "The manufacturing method of the measuring unit according to

[12] above, further comprising: a step of storing a first solution containing at least one of physiological saline and buffer in a first container; and a step of storing a third solution containing an indicator that reacts with components generated by the biological sample in a third container, wherein in the step of sealing the internal space of the sealed bag, the internal space is sealed while the first container containing the first solution, the second container containing the second solution as the container, and the third container containing the third solution are stored in the internal space." Thus, in the internal space of the sealed bag, when the first solution containing at least one of physiological saline and buffer and the third solution containing the indicator are stored in different containers, compared with the case where physiological saline, buffer, and indicator are stored in one container, the quality of the solutions stored in each container is less likely to deteriorate, and therefore, the quality of the solutions can be maintained more reliably.

[0025] The manufacturing method of the measuring unit disclosed herein may also be

[17] "The manufacturing method of the measuring unit according to any one of

[12] to

[16] above, wherein, in steps other than the steps of preparing the solution and introducing the solution into the container, the temperature around the container is maintained below the freezing point of the organic solvent." In this case, by maintaining the temperature around the container below the freezing point of the organic solvent, the hydrolysis of the stimulant caused by the organic solvent can be suppressed. Therefore, the decrease in solution quality caused by hydrolysis can be suppressed.

[0026] The manufacturing method of the measuring unit disclosed herein may also be

[18] "The manufacturing method of the measuring unit according to any one of

[12] to

[17] above, wherein, in the step of freezing the solution, the solution is frozen while a desiccant that absorbs moisture from the air is disposed around the container." In this case, during the step of freezing the solution, the desiccant can absorb moisture from the air, thus effectively preventing the moisture from being absorbed by the solution inside the container.

[0027] The manufacturing method of the measuring unit disclosed herein can also be

[19] "The manufacturing method of the measuring unit according to any one of

[12] to

[18] above, wherein, in the step of sealing the internal space of the sealed bag, the internal space of the sealed bag is sealed while the atmosphere of the internal space is replaced with a nitrogen atmosphere." In this case, the humidity of the internal space of the sealed bag can be reduced, and therefore, the absorption of moisture in the internal space by the solution inside the container can be effectively reduced.

[0028] The manufacturing method of the measuring unit disclosed herein can also be

[20] "The manufacturing method of the measuring unit according to any one of

[12] to

[18] above, wherein, in the step of sealing the internal space of the sealed bag, the internal space of the sealed bag is sealed while maintaining the internal space as a vacuum." In this case, the humidity of the internal space of the sealed bag can be reduced, and therefore, the absorption of moisture in the internal space by the solution inside the container can be effectively reduced.

[0029] According to this disclosure, a measuring unit capable of maintaining the quality of a solution and performing simple operations, and a method for manufacturing the measuring unit, can be provided. Attached Figure Description

[0030] Figure 1 This is a front view showing a measuring unit in one embodiment.

[0031] Figure 2 It means Figure 1 The front view of the first assay kit.

[0032] Figure 3 It is along Figure 2 A cross-sectional view of the first assay kit for line III-III.

[0033] Figure 4 It is along Figure 3 A cross-sectional view of the first assay kit for IV-IV lines.

[0034] Figure 5 It is along Figure 4 A cross-sectional view of the first assay kit for the VV line.

[0035] Figure 6 yes Figure 1 A cross-sectional view of the second assay kit.

[0036] Figure 7 It is Figure 6 An enlarged cross-sectional view of a portion of the second assay kit.

[0037] Figure 8 It means Figure 1 A flowchart of the manufacturing process of the measuring unit.

[0038] Figure 9 (a) is a side view of a cold storage box used to maintain the second solution at a certain temperature.

[0039] Figure 9 (b) is a side view showing a modified example of the cold storage box.

[0040] Figure 9 (c) is a side view showing another variation of the cold storage box.

[0041] Figure 10 This is a schematic diagram illustrating the process of freezing the second solution.

[0042] Figure 11 This is a schematic diagram illustrating the process of storing the first test kit, the second test kit, and the desiccant in a sealed bag.

[0043] Figure 12 It is a schematic cross-sectional view showing the measuring device.

[0044] Figure 13 It is a schematic cross-sectional view showing the measuring device.

[0045] Figure 14 It means that it was used. Figure 1 The flowchart shows the procedure for measuring biological samples in the measurement unit.

[0046] Figure 15 This is a front view showing a modified example of the measuring unit.

[0047] Figure 16 This is a front view showing another modified example of the measuring unit.

[0048] Figure 17 It means Figure 16 A cross-sectional view of the third container.

[0049] Figure 18 It means Figure 16 A flowchart of the manufacturing process of the measuring unit. Detailed Implementation

[0050] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. Furthermore, in the various figures, the same or equivalent parts are labeled with the same reference numerals, and repeated descriptions are omitted.

[0051] Figure 1 The measurement unit 1 shown is used to measure the characteristics of a biological sample. The biological sample is, for example, the blood (e.g., whole blood) of a test subject (organism). The test subject is, for example, a human body. In this embodiment, the test subject is a hospital patient. The biological sample contains, for example, white blood cells. The characteristic of the biological sample is, for example, the activity of white blood cells. In this embodiment, the characteristic of the biological sample is the activity of neutrophils.

[0052] Neutrophils are a type of leukocyte. Their primary function is to prevent infection by phagocytizing and killing bacteria and fungi that enter the body. Neutrophils encapsulate bacteria and other microorganisms within their neutrophil membrane, forming phagocytic vesicles. When these vesicles fuse with the granules, the contents of the granule are released. Reactive oxygen species (superoxide, hydrogen peroxide) are produced by the NADPH oxidase system formed on the cell membrane (the membrane of the phagocytic vesicle), which kill bacteria. The enzymatic reaction of myeloperoxidase (EC code 1.11.2.2) within the granule contents, along with hydrogen peroxide (H₂O₂) and chloride ions (Cl₂), further contributes to the phagocytic vesicle's ability to kill bacteria. - The process generates hypochlorous acid (HOCl) (or its halogen equivalent), which kills bacteria and the like. Therefore, myeloperoxidase activity or superoxide production activity is used as an indicator to evaluate neutrophil activity. The measurement unit 1 in this embodiment is used to measure myeloperoxidase activity or superoxide production activity.

[0053] like Figure 1As shown, the measurement unit 1 includes a first test kit 2, a second test kit 3, a desiccant 10, and a sealing bag 100. The first test kit 2, the second test kit 3, and the desiccant 10 are housed in the internal space V of the sealing bag 100. The internal space V of the sealing bag 100 is sealed when the first test kit 2, the second test kit 3, and the desiccant 10 are contained. Sealing the internal space V means that the internal space V is airtightly sealed so that air from outside the sealing bag 100 cannot enter the internal space V. By sealing the internal space V, the exposure of the first test kit 2 and the second test kit 3, which are disposed in the internal space V, to the air outside the sealing bag 100 is reduced, that is, the contact between the first test kit 2 and the second test kit 3 and the moisture in the external air is reduced.

[0054] The sealing bag 100 is, for example, a metal bag made of a metal such as aluminum (e.g., an aluminum bag). When the sealing bag 100 is an aluminum bag, because aluminum bags have high light-blocking properties, the temperature rise of the aluminum bag itself and even the internal space V can be suppressed, and the increase in hygroscopicity caused by the temperature rise of the second solution 8 contained in the second assay kit 3 can be suppressed. Furthermore, because aluminum bags have high moisture-proof properties, the increase in humidity in the internal space V can be suppressed even during long storage periods. In addition, because aluminum bags have high thermal conductivity, the increase in hygroscopicity caused by the temperature rise of the second solution 8 during frozen storage, including transport, can be suppressed, and as a result, the deterioration of the properties of the second solution 8 can be suppressed. The material of the sealing bag 100 can also be other materials.

[0055] The desiccant 10 has hygroscopic properties, absorbing moisture from the surrounding air. Within the sealed internal space V, the desiccant 10 absorbs moisture present in the air within the internal space V. Therefore, within the sealed internal space V, the contact between the first assay kit 2 and the second assay kit 3 and moisture in the air is reduced. The desiccant 10 is, for example, a desiccant formed from zeolite or the like. The desiccant 10 can also be a dehumidifier or a water absorbent. The desiccant 10 can also be in the form of flakes, granules, blocks, fibers, or spheres.

[0056] The sealed bag 100 can also function as a desiccant 10. That is, the material of the sealed bag 100 can also contain the material of the desiccant 10. In this case, the sealed bag 100 functions as a desiccant 10, so it is not necessary to store the desiccant 10 in the internal space V of the sealed bag 100.

[0057] like Figure 2 and Figure 3 As shown, the first assay kit 2 has a first container 4, a rotor 5, and a first solution 6. The first container 4 is, for example, a rectangular plate. The first container 4 includes a first receiving space S1 and an opening 4a. The opening 4a communicates with the first receiving space S1.

[0058] The thickness (i.e., the length of the first container 4 in the Y-axis direction) T of the first container 4 is less than the width (i.e., the length of the first container 4 in the X-axis direction) W1. The thickness T of the first container 4 is, for example, less than 1 / 3 of the width W1 of the first container 4. The thickness T of the first container 4 is less than the height (i.e., the length of the first container 4 in the Z-axis direction) W2 of the first container 4. The thickness T of the first container 4 is, for example, less than 1 / 3 of the height W2 of the first container 4. The height W2 of the first container 4 is greater than the width W1 of the first container 4. The height W2 of the first container 4 is, for example, more than 1.1 times the width W1 of the first container 4. The thickness T of the first container 4 is, for example, 6 mm. The width W1 of the first container 4 is, for example, 28 mm. The height W2 of the first container 4 is, for example, 41 mm.

[0059] The first container 4 has a first component 41 and a second component 42. The first component 41 is, for example, a rectangular plate. The first component 41 includes main surfaces 41a and 41b and a storage space 41c. The main surfaces 41a and 41b face opposite sides in the Y-axis direction (i.e., the thickness direction of the first container 4). The storage space 41c opens at a first end E11 of the first component 41 in the Z-axis direction (i.e., the height direction of the first container 4). The storage space 41c reaches the first end E11 of the first component 41 in the Z-axis direction but does not reach the second end E12 of the first component 41 in the Z-axis direction. When viewed from the Y-axis direction, the storage space 41c is, for example, rectangular.

[0060] The first component 41 includes a recess 41d. The recess 41d is formed at a first end E11 of the first component 41 in the Z-axis direction. An opening 4a is formed at the first end E11 of the first component 41 in the Z-axis direction. The recess 41d extends from the opening 4a along the Z-axis direction. The width of the recess 41d in the X-axis direction is less than the maximum width of the storage space 41c in the X-axis direction. The two ends of the recess 41d in the X-axis direction are located inwardly than the two ends of the storage space 41c in the X-axis direction.

[0061] The second component 42 is disposed in the storage space 41c of the first component 41. For example... Figure 4 and Figure 5 As shown, the second component 42 is, for example, a rectangular plate. The shape of the second component 42 matches the shape of the storage space 41c. Specifically, the width of the second component 42 in the X-axis direction is the same as the width of the storage space 41c in the X-axis direction. The width of the second component 42 in the Y-axis direction is the same as the width of the storage space 41c in the Y-axis direction. The width of the second component 42 in the Z-axis direction is the same as the width of the storage space 41c in the Z-axis direction.

[0062] like Figure 5As shown, the second component 42 includes main surfaces 42a and 42b, a recess 421, a partition wall 422, and a support portion 423. Main surfaces 42a and 42b face opposite directions in the Y-axis direction. Main surface 42a faces the same direction as the main surface 41a of the first component 41. Main surface 42a contacts the inner surface of the storage space 41c. Main surface 42b faces the same direction as the main surface 41b of the first component 41. Main surface 42b contacts the inner surface of the storage space 41c. The recess 421 is formed on the main surface 42a. Figure 4 As shown, the recess 421 reaches the first end E21 of the second component 42 in the Z-axis direction, but does not reach the second end E22 of the second component 42 in the Z-axis direction.

[0063] like Figure 5 As shown, the partition wall 422 protrudes from the bottom surface 421a of the recess 421. The height of the partition wall 422 (i.e., its width in the Y-axis direction) is lower than the depth of the recess 421. The top surface 422a of the partition wall 422 is located between the main surfaces 42a and 42b. Figure 4 As shown, when viewed from the Y-axis direction, the partition wall 422 extends along the Z-axis direction. The two ends of the partition wall 422 in the Z-axis direction are located inside the two ends of the recess 421 in the Z-axis direction. The partition wall 422 is a part of the second component 42.

[0064] like Figure 4 As shown, the recess 421 includes a first region 42c, a second region 42d, and an intermediate region 42e. The first region 42c is located between the partition wall 422 and the first end E21 of the second component 42 in the Z-axis direction. When viewed from the Y-axis direction, the first region 42c is, for example, rectangular. The first region 42c opens at the first end E21 of the second component 42 in the Z-axis direction. The second region 42d is located between the partition wall 422 and the second end E22 of the second component 42 in the Z-axis direction. When viewed from the Y-axis direction, the width of the second region 42d in the X-axis direction gradually decreases from the first end E21 of the second component 42 towards the second end E22 in the Z-axis direction. That is, the recess 421 includes a curved inner surface 42f. When viewed from the Y-axis direction, the inner surface 42f curves towards the side opposite to the partition wall 422.

[0065] The intermediate region 42e is located between the first region 42c and the second region 42d. The intermediate region 42e is connected to both the first region 42c and the second region 42d. Viewed from the Y-axis direction, the intermediate region 42e is, for example, rectangular. Viewed from the Y-axis direction, the position of the first end of the intermediate region 42e in the Z-axis direction coincides with the position of the first end of the partition wall 422 in the Z-axis direction. The position of the second end of the intermediate region 42e in the Z-axis direction coincides with the position of the second end of the partition wall 422 in the Z-axis direction.

[0066] The support portion 423 is located in the second region 42d. For example... Figure 5 As shown, the support portion 423 protrudes from the bottom surface 421a of the recess 421. The surface of the support portion 423 is, for example, curved. The support portion 423 is a part of the second component 42.

[0067] like Figure 3 and Figure 4 As shown, the second component 42 includes an inclined region 42g. The inclined region 42g is parallel to the X-axis direction and inclined relative to the XZ plane. The inclined region 42g is formed in the bottom surface 421a of the recess 421 in the Z-axis direction relative to one side of the partition wall 422. The inclined region 42g is inclined in such a way that it approaches the main surface 42b as it moves toward the opening 4a. The first end of the inclined region 42g in the Z-axis direction reaches the main surface 42b. The first end of the inclined region 42g in the Z-axis direction is located inside the opening 4a. The second end of the inclined region 42g in the Z-axis direction coincides with the position of the first end of the partition wall 422 in the Z-axis direction. The width of the inclined region 42g in the X-axis direction is the same as the width of the recess 421 in the X-axis direction.

[0068] The first storage space S1 is the space in the storage space 41c excluding the second component 42. The opening 4a of the first container 4 is formed by the opening of the storage space 41c and the opening of the recess 421. The first container 4 includes a light-transmitting region 4b. When viewed from the Y-axis direction, the light-transmitting region 4b is the area in the first component 41 that overlaps with the first storage space S1 (i.e., the recess 421). The light-transmitting region 4b is the portion of the first component 41 located on the opposite side of the main surface 41b relative to the first storage space S1. Light generated in the first storage space S1 passes through the light-transmitting region 4b. Therefore, the light-transmitting region 4b has light transmittance that allows light generated in the first storage space S1 to pass through. The light-transmitting region 4b only needs to allow at least a portion of the light generated in the first storage space S1 to pass through. In this embodiment, the first component 41 and the second component 42 are light-transmitting as a whole. The materials of the first component 41 and the second component 42 are, for example, transparent resin.

[0069] A recognition surface 41e is formed on the main surface 41b of the first component 41. The recognition surface 41e is parallel to the Z-axis direction and inclined relative to the main surface 41b. The recognition surface 41e reaches both ends of the first component 41 in the Z-axis direction. Based on the recognition surface 41e, the main surface 41a, including the light-transmitting region 4b, can be easily identified. The first component 41 is integrally formed from the same material. As a result, leakage of the first solution 6 housed in the housing space 41c is reduced.

[0070] Rotor 5 is disposed in the second region 42d. Rotor 5 is, for example, rod-shaped. Rotor 5 is, for example, magnetic. The diameter of rotor 5 is, for example, 1 mm or less. The length of rotor 5 is, for example, 10 mm or less. Rotor 5 has, for example, a core material and a plating formed on the surface of the core material. The core material is, for example, magnetic. The plating material is, for example, gold. Rotor 5 rotates with the rotation of the rotating device disposed outside the first container 4. When supported by the support portion 423, rotor 5 rotates with a line parallel to the Y-axis direction as its axis.

[0071] The first solution 6 is housed in the first storage space S1. The first solution 6 fills a portion of the first region 42c, the intermediate region 42e, and the second region 42d. The surface 6a of the first solution 6 is located between the first end of the partition wall 422 and the opening 4a in the Z-axis direction. That is, the first solution 6 does not reach the opening 4a. The first solution 6 impregnates the rotor 5. In other words, the rotor 5 is housed in the first storage space S1 by being impregnated in the first solution 6. The rotor 5 is also buried in the first solution 6. Figure 4 and Figure 5 The illustration of the first solution 6 is omitted in the text.

[0072] The first solution 6 is a mixture of multiple reagents. The first solution 6 contains at least one of, for example, physiological saline and a buffer solution, as well as a fluorescent indicator, among other reagents. Physiological saline has the function of maintaining the osmotic pressure of the cells contained in the biological sample at a state close to the isotonic state within the biological body. This inhibits cell damage or modification during the assay. The buffer solution has the function of maintaining the pH of the first solution 6 within a specified range. The activity of the biological sample is sometimes pH-dependent; therefore, by using a buffer solution to stabilize the pH, the reliability and reproducibility of the assay can be improved. The fluorescent indicator reacts with components (HOCl) produced by the biological sample. The fluorescent indicator is, for example, aminophenylfluorescein (APF). Commercially available fluorescent indicators can also be used. The fluorescent indicator can also react with components produced by the biological sample, such as reactive oxygen species, superoxide, and nitric oxide. The fluorescent indicator can also be, for example, DCFH-DA, BES-So, and DAF-2.

[0073] The first solution 6 is frozen while contained within the first storage space S1. In this embodiment, the case where the first solution 6 is frozen while contained within the first storage space S1 is exemplified; however, the first solution 6 may also be cooled to an unfrozen state while contained within the first storage space S1. The first solution 6 may be frozen entirely or partially. Freezing the first solution 6 means freezing at least a portion of the first solution 6. The temperature of the first solution 6 is below the freezing point of any reagent contained in the first solution 6. That is, the temperature of the first solution 6 may be the same as or lower than the freezing point of any reagent contained in the first solution 6. In this embodiment, the temperature of the first solution 6 is below the freezing point of the reagent with the largest volume among the plurality of reagents contained in the first solution 6. The temperature of the first solution 6 may also be below the freezing point of the reagent with the lowest freezing point among the plurality of reagents contained in the first solution 6. In this embodiment, the temperature of the first solution 6 is below the freezing point of the buffer solution contained in the first solution 6. The temperature of the first solution 6 may also be below the freezing point of the fluorescent indicator contained in the first solution 6. In this embodiment, the overall temperature of the first assay kit 2 is below the freezing point of any reagent contained in the first solution 6. The temperature of the first solution 6 is, for example, -20°C. In this embodiment, "temperature" refers to temperature at atmospheric pressure.

[0074] like Figure 6 As shown, the second assay kit 3 includes a second container 7, a second solution 8, a first sealing member 31, and a second sealing member 32. The second container 7 is, for example, a cone shaped with a line parallel to the Z-axis as its center. The second container 7 is, for example, elastic. Figure 6 As shown, the second container 7 includes a second receiving space S2, an opening 7a (second opening), and an opening 7b (first opening). Openings 7a and 7b are formed at different locations within the second container 7. Specifically, openings 7a and 7b are formed at locations facing opposite sides within the second container 7. For example, opening 7b is formed at the first end E1 of the second container 7 in the Z-axis direction. Opening 7a is formed at the second end E2 of the second container 7 in the Z-axis direction. Openings 7a and 7b are respectively connected to the second receiving space S2. The second receiving space S2 is, for example, conical. The cross-sectional area of ​​the second receiving space S2 decreases as it moves from opening 7b toward opening 7a. The diameter of opening 7a is smaller than the diameter of opening 7b. Opening 7a serves as the outlet of the second container 7. Opening 7a can also function as the suction inlet of the second container 7. The second container 7 is, for example, a straw end.

[0075] The second solution 8 is housed in the second storage space S2. The second solution 8 fills a portion of the second storage space S2. A temporary storage space S3 exists between the second solution 8 and the opening 7a, and a space S4 exists between the second solution 8 and the opening 7b. Specifically, the second solution 8 is located further inward than each of the openings 7a and 7b. Figure 7 As shown, the second solution 8 includes a surface 8a facing the opening 7a and a surface 8b facing the opening 7b. Surface 8a is away from the opening 7a. Surface 8b is away from the opening 7b.

[0076] The volume of the temporary storage space S3 is greater than or equal to the volume of the second solution 8. The length of the temporary storage space S3 in the Z-axis direction (i.e., the distance between the opening 7a and the surface 8a) is greater than or equal to the length of the second solution 8 in the Z-axis direction (i.e., the distance between the surfaces 8a and 8b). The volume of the space S4 is greater than or equal to the volume of the second solution 8. The length of the space S4 in the Z-axis direction (i.e., the distance between the opening 7b and the surface 8b) is greater than or equal to the length of the second solution 8 in the Z-axis direction. The volume of the space S4 may also be less than the volume of the second solution 8. The length of the space S4 in the Z-axis direction may also be less than the length of the second solution 8 in the Z-axis direction. The volume of the space S4 is greater than or equal to the volume of the temporary storage space S3. The length of the space S4 in the Z-axis direction is greater than or equal to the length of the temporary storage space S3 in the Z-axis direction. The volume of the space S4 may also be less than the volume of the temporary storage space S3. The length of the space S4 in the Z-axis direction may also be less than the length of the temporary storage space S3 in the Z-axis direction.

[0077] The second solution 8 is a mixture of multiple reagents. These reagents include, for example, stimulants and organic solvents. The stimulant is a reagent used to functionally activate the biological sample. For example, the stimulant mimics the stimulation of neutrophils in the biological sample. When neutrophils are mimicked, a natural immune response (biological defense response) is elicited. The stimulant is, for example, fMLP (N-formyl-L-methionyl-L-leucyl-phenylalanine) or PMA (4β-phorbol-12-myristate-13-acetate). The organic solvent is a reagent used to dissolve the stimulant in powder form or to dilute the stimulant in liquid form. The organic solvent is, for example, DMSO (dimethyl sulfoxide).

[0078] The second solution 8 is frozen while it is contained within the second receiving space S2. The second solution 8 is also frozen while a temporary receiving space S3 exists between the second solution 8 and the opening 7a, and a space S4 exists between the second solution 8 and the opening 7b. The second solution 8 can be frozen entirely or partially. Freezing the second solution 8 means freezing at least a portion of the second solution 8.

[0079] The temperature of the second solution 8 is below the freezing point of any of the reagents contained in the second solution 8. That is, the temperature of the second solution 8 may be the same as or lower than the freezing point of any of the reagents contained in the second solution 8. In this embodiment, the temperature of the second solution 8 is below the freezing point of the reagent with the largest volume among the plurality of reagents contained in the second solution 8. The temperature of the second solution 8 may also be below the freezing point of the reagent with the lowest freezing point among the plurality of reagents contained in the second solution 8.

[0080] In this embodiment, the temperature of the second solution 8 is below the freezing point of the organic solvent contained in the second solution 8. In this embodiment, the overall temperature of the second assay kit 3 is below the freezing point of any reagent contained in the second solution 8. The temperature of the second solution 8 is, for example, the same as the temperature of the first solution 6. That is, the temperature of the second solution 8 is, for example, -20°C. The temperature of the second solution 8 may also be lower than the temperature of the first solution 6. The temperature of the second solution 8 may, for example, be below -30°C, below -40°C, or below -80°C.

[0081] In this embodiment, the second solution 8 does not contain a buffer solution. Therefore, the degradation of the stimulant caused by the buffer solution is suppressed. Specifically, stimulants diluted with a buffer solution tend to degrade more over a longer period until the second solution 8 is frozen. When the second solution 8 does not contain a buffer solution, for example, even if the period until the second solution 8 is frozen is longer, the degradation of the stimulant can be suppressed.

[0082] Furthermore, the second solution 8 may also contain a buffer solution. The buffer solution is a reagent used to dilute the organic solvent. Because the organic solvent is diluted in the second solution 8, the organic solvent can be prevented from damaging the biological sample even when the second solution 8 is applied directly to the biological sample. Commercially available products can be used for example as the stimulant, organic solvent, and buffer solution. However, when the organic solvent is diluted with the buffer solution, the stimulant dissolved in the organic solvent may sometimes degrade. In contrast, by keeping the temperature of the second solution 8 lower than that of the first solution 6 (by setting it to ultra-low temperature), even if the organic solvent is diluted with the buffer solution for direct application of the second solution 8 to the biological sample, the second solution 8 can be preserved while maintaining a state that inhibits the degradation of the stimulant dissolved in the organic solvent.

[0083] like Figure 6 As shown, the first sealing member 31 is configured to block the opening 7b of the second container 7. The first sealing member 31 completely covers the opening 7b of the second container 7 without gaps. The first sealing member 31 may or may not contact the first end E1 of the second container 7. That is, the first sealing member 31 does not necessarily need to contact the first end E1 of the second container 7. The first sealing member 31 is detachably mounted relative to the second container 7. The first sealing member 31 is, for example, a cover, a silicone cord, or a filter attached to the end of a straw.

[0084] The second sealing member 32 is configured to block the opening 7a of the second container 7 located on the opposite side of the opening 7b. The second sealing member 32 may or may not contact the second end E2 of the second container 7. That is, the second sealing member 32 does not necessarily need to contact the second end E2 of the second container 7. A space may also be formed between the second sealing member 32 and the second end E2 of the second container 7. The second sealing member 32 may also completely cover the opening 7a of the second container 7 without gaps. The second sealing member 32 is detachably mounted relative to the second container 7. The second sealing member 32 may be, for example, a cover, a silicone cord, or a filter attached to the end of a straw.

[0085] By blocking the openings 7a and 7b of the second container 7 with the first sealing member 31 and the second sealing member 32 respectively, the second storage space S2 of the second container 7 is sealed. Sealing the second storage space S2 means that the openings 7b and 7a of the second container 7 are completely blocked by the first sealing member 31 and the second sealing member 32, preventing outside air from entering the second storage space S2. Figure 1 When the second test kit 3 is stored in the internal space V of the sealed bag 100 shown, the frozen second solution 8 is stored in the second storage space S2, and the openings 7b and 7a are blocked by the first sealing member 31 and the second sealing member 32, the second test kit 3 is stored in the internal space V.

[0086] In this way, the second solution 8 is stored in the second container 7 in its frozen state. In this case, the measuring unit 1 can be moved to the vicinity of the test subject while the second solution 8 is frozen. Furthermore, after thawing the second solution 8 near the test subject, the thawed second solution 8 can be added to the first solution 6 containing the biological sample. Therefore, not only is the quality of the second solution 8 stored in the second container 7 maintained, but also, the operation of introducing the second solution 8 into the second container 7 near the test subject is eliminated.

[0087] However, the temperature of the second solution 8 after freezing significantly affects its quality. For example, maintaining the temperature of the second solution 8 at -80°C can preserve its quality for approximately 3 months or more after freezing. Furthermore, maintaining the temperature of the second solution 8 at -30°C can sometimes preserve its quality for approximately 1 month after freezing. On the other hand, maintaining the temperature of the second solution 8 at -20°C can only preserve its quality for approximately 5 days after freezing. Therefore, from the viewpoint of maintaining the quality of the second solution 8 over a long period, ultra-low temperatures, such as maintaining the temperature of the second solution 8 below -80°C, are considered.

[0088] However, maintaining the temperature of the second solution 8 at ultra-low temperatures such as below -30°C requires a special freezer. This increases the transportation costs required to maintain the temperature of the second solution 8, necessitating the user to prepare such a special freezer, thus reducing its availability. Maintaining the temperature of the second solution 8 above -20°C eliminates the need for a special freezer, thus reducing transportation costs and improving availability. However, the issue of not being able to maintain the quality of the second solution 8 for extended periods as described above remains.

[0089] Regarding this problem, the inventors conducted in-depth research on the main reasons for the deterioration of the quality of the second solution 8 when its temperature is maintained at approximately -20°C. The results showed that the moisture absorbed by the second solution 8 can significantly affect its quality. The organic solvent DMSO contained in the second solution 8 has high hygroscopicity; that is, DMSO readily absorbs moisture from the surrounding air. Furthermore, the stimulant PMA contained in the second solution 8 loses its activity due to hydrolysis. Therefore, when PMA is dissolved in DMSO, it loses its activity due to hydrolysis with the moisture absorbed by the DMSO, potentially deteriorating the quality of the second solution 8. Additionally, DMSO has a melting point of 19°C; therefore, while the second solution 8 is in a solid state when maintained at -20°C, the aforementioned hydrolysis may still occur slightly within the second solution 8.

[0090] Therefore, in this embodiment, to prevent the absorption of moisture into the second solution 8, the second container 7 is housed in the sealed bag 100. By housing the second container 7 within the sealed space V of the sealed bag 100, contact between the air outside the sealed bag 100 and the second solution 8 inside the second container 7 can be prevented, thus preventing the absorption of moisture from the air by the second solution 8. This suppresses the degradation of the quality of the second solution 8 caused by hydrolysis.

[0091] As in this embodiment, the measuring unit 1 may also include a first sealing member 31 that blocks the opening 7b of the second container 7 and a second sealing member 32 that blocks the opening 7a of the second container 7. In this case, the interior of the second container 7 can be sealed using the first sealing member 31 and the second sealing member 32. This effectively prevents moisture in the air surrounding the second container 7 from being absorbed by the second solution 8 inside the second container 7. Depending on the temperature of the second solution 8, the first sealing member 31 may sometimes detach from the opening 7b of the second container 7. Therefore, the measuring unit 1 may also be without the first sealing member 31 that blocks the opening 7b of the second container 7. That is, when the second container 7 is contained in the internal space V of the sealed bag 100, the opening 7b of the second container 7 may remain open without being blocked by the first sealing member 31.

[0092] As in this embodiment, the measuring unit 1 may also include a desiccant 10 for absorbing moisture from the air, which is stored together with the second container 7 in the internal space V of the sealed bag 100. In this case, the desiccant 10 can absorb moisture from the air, thus effectively preventing the moisture from being absorbed by the second solution 8 inside the second container 7.

[0093] As in this embodiment, a second container 7 can also be housed within the internal space V of the sealed bag 100. In this case, the measuring unit 1 can be implemented with a simple structure.

[0094] As in this embodiment, the sealing bag 100 can also house the first container 4 and the second container 7 within its internal space V. In this case, the first solution 6 is stored in the first container 4 in a frozen state. Therefore, the measurement unit 1 can be transported to the vicinity of the test subject while the first solution 6 is frozen, and the biological sample collected from the test subject can be added to the first solution 6 after thawing near the test subject. Therefore, not only is the quality of the first solution 6 maintained, but also, the preparation of the first solution 6 and the introduction of the first solution 6 into the first container 4 are not required near the test subject. Therefore, according to this embodiment, the operation of measuring the characteristics of the biological sample while maintaining the quality of the first solution 6 and the second solution 8 becomes simpler. In addition, in this embodiment, the first container 4 and the second container 7 can be transported together using a single sealing bag 100. Therefore, compared with the case where the first container 4 and the second container 7 are transported separately in different sealing bags, the transportation cost of the measurement unit 1 can be reduced and its usability improved.

[0095] As in this embodiment, the biological sample may also contain leukocytes. Sometimes, the first solution 6 used to determine the characteristics of leukocytes requires cryopreservation. As described above, cryopreservation of the first solution 6 is achieved because the first solution 6 is frozen.

[0096] As in this embodiment, the indicator can also be a fluorescent indicator. Sometimes, the first solution 6 containing the fluorescent indicator needs to be frozen. As described above, because the first solution 6 containing the fluorescent indicator is frozen, the frozen preservation of the first solution 6 containing the fluorescent indicator is achieved.

[0097] As in this embodiment, the organic solvent can also be DMSO. As mentioned above, DMSO has high hygroscopicity. Therefore, when dissolving the stimulant contained in the second solution 8 using DMSO, it is conceivable that the stimulant undergoes hydrolysis. In contrast, in the measuring unit 1 of this embodiment, as described above, it is possible to prevent moisture in the air surrounding the second container 7 from being absorbed by the second solution 8, and to suppress the decrease in the quality of the second solution 8 caused by hydrolysis, thus achieving the aforementioned effects.

[0098] The aforementioned sealing bag 100, desiccant 10, first sealing member 31, and second sealing member 32 function as moisture-proof parts to prevent moisture contained in the air outside the second container 7 from contacting the second solution 8 inside the second container 7. When the measuring unit 1 has such moisture-proof parts, the moisture absorption rate of the second solution 8 can be reduced. The moisture absorption rate can be defined, for example, by a ratio that is the ratio of the mass of the second solution 8 after being frozen and placed inside the second container 7 for a certain period of time to the mass of the second solution 8 before being frozen and placed inside the second container 7 for a certain period of time.

[0099] Next, the manufacturing method of measuring unit 1 will be described. The manufacturing process of measuring unit 1 includes, for example, the following steps: Figure 8 The steps S11 to S19 are shown. In at least one of these steps, except for step S16 (preparation of the second solution 8) and step S17 (introduction of the second solution 8 into the second container 7), which require the second solution 8 to be in a liquid state, the temperature of the second solution 8 is maintained below the freezing point (19°C) of DMSO, which is the organic solvent.

[0100] To maintain the temperature of the second solution 8 below the freezing point of DMSO, for example, one can use... Figure 9 The cold storage box B1 shown in (a) is, for example, a rectangular box-shaped container. Three refrigerants P1, P2, and P3 are disposed inside the cold storage box B1. Refrigerant P1 is disposed on the bottom surface Ba of the interior of the cold storage box B1. Refrigerants P2 and P3 are disposed on the two sides Bb and Bc, respectively, standing upright from the bottom surface Ba, inside the cold storage box B1. With refrigerants P1, P2, and P3 disposed inside the cold storage box B1 in this manner, at least one step in the manufacturing process of the measuring unit 1 is performed, thereby maintaining the temperature of the second solution 8 below the freezing point of DMSO (19°C).

[0101] like Figure 9 As shown in (b), only the refrigerant P1 can be placed inside the cold storage box B1. Figure 9 As shown in (c), a cold storage box B2, which is lower in height than cold storage box B1, can also be used. Alternatively, only the cold insulation agent P1 can be placed inside cold storage box B2. The inventors confirmed the temperature change of the buffer solution by introducing 750 μl of cryopreserved buffer solution into the interiors of cold storage boxes B1 and B2. The results showed that when using… Figure 9 In the case of cold storage unit B1 (a), the temperature rise of the buffer solution is best suppressed. Specifically, the temperature of the frozen buffer solution changes from 5.7°C to 6.5°C after 3 minutes, to 7.1°C after 15 minutes, and to 7.0°C after 30 minutes. Furthermore, when using... Figure 9 In the case of cold storage box B1 (b), the temperature of the buffer solution changed from 6.0°C to 12.5°C after 3 minutes, to 17.8°C after 15 minutes, and to 18.8°C after 30 minutes. When using... Figure 9 In the case of cold storage box B2 (c), the temperature of the buffer solution changed from 6.6°C to 16.7°C after 3 minutes, to 21.8°C after 15 minutes, and to 18.8°C after 30 minutes.

[0102] like Figure 8 As shown, when manufacturing the measuring unit 1, firstly, in step S11, a first container 4 is prepared. In step S11, the first container 4 is prepared to house the rotor 5 in the first storage space S1.

[0103] Next, in step S12, a first solution 6 is prepared. In step S12, multiple reagents (at least one of physiological saline and buffer solution, and a fluorescent indicator, etc.) are mixed on the outside of the first receiving space S1. The volume of the first solution 6 prepared in step S12 is several times or more the volume of the first receiving space S1. That is, in step S12, a large amount of the first solution 6 is prepared compared to the volume of the first receiving space S1. Next, in step S13, the pre-prepared first solution 6 is introduced into the first receiving space S1. In step S13, the first solution 6 is sequentially introduced into the first receiving space S1 of multiple first containers 4.

[0104] Next, in step S14, the first solution 6 is cooled while contained in the first storage space S1. In this embodiment, the first solution 6 is frozen while contained in the first storage space S1. In step S14, the first solution 6 is frozen while the rotor 5 contained in the first storage space S1 is immersed in the first solution 6. In step S14, the first assay kit 2, containing the rotor 5 and the first solution 6 in the first container 4, is placed in the cooling space of the cooling device. The temperature of the cooling space is, for example, -20°C. The first assay kit 2 is placed in this cooling space for, for example, about 2 hours. Thus, the first assay kit 2 after the first solution 6 has been frozen is manufactured. The first assay kit 2 can also be stored in this cooling space. In step S14, the opening 4a of the first container 4 can also be sealed by a sealing component such as a sealing film or a rubber plug.

[0105] Next, in step S15, the second container 7 is prepared. Next, in step S16, the second solution 8 is prepared. In step S16, multiple reagents (stimulants and organic solvents, etc.) are mixed on the outside of the second receiving space S2. The volume of the second solution 8 prepared in step S16 is several times the volume of the second receiving space S2. That is, in step S16, a large amount of the second solution 8 is prepared compared to the volume of the second receiving space S2.

[0106] Next, in step S17, the pre-prepared second solution 8 is introduced into the second storage space S2. In step S17, after the second solution 8 is drawn into the second storage space S2 through the opening 7a, air is further drawn into the second storage space S2 through the opening 7a.

[0107] Specifically, in step S17, a predetermined amount of the second solution 8 is placed in a preparation container such as a microtube or microplate. Next, a suction nozzle is inserted into the opening 7b of the second container 7. Then, the second container 7 is positioned so that its opening 7a is in contact with the second solution 8. Next, the predetermined amount of the second solution 8 is drawn into the second receiving space S2 via the opening 7a using the suction force of the suction nozzle. Next, air is drawn into the second receiving space S2 via the opening 7a. Thus, a temporary receiving space S3 is formed between the opening 7a and the second solution 8. The volume of air drawn in step S17 is greater than or equal to the volume of the second solution 8 drawn in step S17. Alternatively, in step S17, the second solution 8 placed in, for example, one preparation container, may be simultaneously introduced into the second receiving spaces S2 of multiple second containers 7.

[0108] Next, in step S18, the second solution 8 is frozen while it is contained in the second storage space S2. In step S18, the suction nozzle is pulled out from the opening 7b of the second container 7. Then, with the temporary storage space S3 existing between the opening 7a and the second solution 8, and space S4 existing between the opening 7b and the second solution 8, the second container 7 is placed in the cooling space of the cooling device. In this embodiment, utilizing... Figure 6 The first sealing component 31 and the second sealing component 32 shown block the openings 7b and 7a of the second container 7. The second assay kit 3 is stored together with other second assay kits 3 in the container. Figure 10 The cooling container 200 shown is configured in the cooling space of the cooling equipment. The cooling container 200 is, for example, a suction head holder. Two desiccant 11 are respectively stored on the bottom and top surfaces of the cooling container 200.

[0109] The desiccant 11 is, for example, the same agent as the desiccant 10. Therefore, the desiccant 11, like the desiccant 10, has the hygroscopic property of absorbing moisture from the surrounding air. Inside the cooling container 200, the desiccant 11 absorbs moisture from the air surrounding the second assay kit 3. Therefore, it reduces the contact between the moisture in the air surrounding the second assay kit 3 and the second solution 8 of the second assay kit 3. The desiccant 11 is, for example, a desiccant formed from zeolite or the like. The desiccant 11 can also be a dehumidifier or a water absorbent. The desiccant 11 can also be in the form of flakes, granules, blocks, fibers, or spheres.

[0110] The second assay kit 3 is prepared, for example, in the cooling space of a cooling device for about 1 hour. The temperature of this cooling space is, for example, -80°C. Thus, the second assay kit 3 is prepared by freezing the second solution 8. The second assay kit 3 can also be stored in this cooling space.

[0111] Next, in step S19, as Figure 11As shown, the first assay kit 2 and the second assay kit 3, together with the desiccant 10, are housed in the internal space V of the sealed bag 100. The atmosphere of the internal space V of the sealed bag 100 can also be replaced with a nitrogen atmosphere. Specifically, the atmosphere of the internal space V can be replaced with a nitrogen atmosphere by repeatedly evacuating the internal space V and introducing nitrogen (N2). The internal space V of the sealed bag 100 can also be maintained as a vacuum. Then, with the first assay kit 2, the second assay kit 3, and the desiccant 10 housed in the internal space V of the sealed bag 100, the internal space V is sealed. Thus, an assay unit 1 is manufactured that houses a first assay kit 2, a second assay kit 3, and a desiccant 10 in the sealed internal space V. The first assay kit 2 and the second assay kit 3 can also be stored in a cooling space while housed in the internal space V of the sealed bag 100.

[0112] Within the sealed internal space V, the first solution 6 of the first assay kit 2 and the second solution 8 of the second assay kit 3 are in a frozen state. In this state, the openings 7b and 7a of the second container 7 of the second assay kit 3 are blocked by the first sealing member 31 and the second sealing member 32, respectively. Additionally, frost may sometimes adhere to the first container 4 when the first solution 6 of the first assay kit 2 is frozen. In this case, the first assay kit 2 and the second assay kit 3 can also be stored in separate, mutually separated spaces inside the sealed bag 100. That is, the space for storing the first container 4 and the space for storing the second container 7 can be separated from each other inside the sealed bag 100. For example, the sealed bag 100 can be pre-separated using a sealing machine or the like. The second assay kit 3 can also be stored in a sealed bag smaller than the sealed bag 100. In this case, the desiccant 10 can also be stored in the same space as the second assay kit 3. The desiccant 10 may also not be placed inside the sealed bag 100.

[0113] At least one of steps S15 to S18 may be performed simultaneously with at least one of steps S11 to S14. The order of steps S11 to S19 is not limited. Figure 8 The example shown can be modified arbitrarily. For example, steps S14 (freezing the first solution 6) and S18 (freezing the second solution 8) can also be performed after step S19 (storing the first assay kit 2 and the second assay kit 3 into the sealed bag 100). That is, the first assay kit 2 containing the unfrozen first solution 6 and the second assay kit 3 containing the unfrozen second solution 8 can also be frozen after being stored together with the desiccant 10 in the internal space V of the sealed bag 100. In step S14, the first solution 6 can also be cooled to an unfrozen state while stored in the first storage space S1.

[0114] According to this manufacturing method, it is possible to manufacture a measuring unit 1 that achieves the above-mentioned effects.

[0115] As in this embodiment, in step S18, the second solution 8 can also be frozen while the opening 7b of the second container 7 is blocked by the first sealing member 31 and the opening 7a of the second container 7 is blocked by the second sealing member 32. In this case, the second solution 8 inside the second container 7 can be frozen while the inside of the second container 7 is sealed by the first sealing member 31 and the second sealing member 32. This effectively prevents moisture in the air surrounding the second container 7 from being absorbed by the second solution 8 inside the second container 7.

[0116] As in this embodiment, in step S19, the internal space V can be sealed while the desiccant 10, which absorbs moisture from the air, is housed together with the second container 7 within the internal space V. In this case, the desiccant 10 can absorb moisture from the air in step S19, thus effectively preventing the moisture from being absorbed by the second solution 8 inside the second container 7.

[0117] As in this embodiment, in step S19, the internal space V can be sealed while the first container 4 and the second container 7 are housed within it. In this case, as described above, the first solution 6 is housed in the first container 4 in a frozen state. Therefore, the measurement unit 1 can be transported to the vicinity of the test subject while the first solution 6 is frozen, and the biological sample collected from the test subject can be added to the first solution 6 after thawing it near the test subject. Therefore, not only is the quality of the first solution 6 maintained, but also, the preparation of the first solution 6 and the introduction of the first solution 6 into the first container 4 are not required near the test subject. Therefore, according to this embodiment, the operation of measuring the characteristics of the biological sample while maintaining the quality of the first solution 6 and the second solution 8 becomes simpler. In addition, in this embodiment, the first container 4 and the second container 7 can be transported together using a single sealed bag 100. Therefore, compared with the case where the first container 4 and the second container 7 are transported separately in different sealed bags, the transportation cost of the measurement unit 1 can be reduced and its usability improved.

[0118] As in this embodiment, in steps other than S16 and S17, the temperature around the second container 7 can also be maintained below the freezing point of the organic solvent (DMSO). In this case, by maintaining the temperature around the second container 7 below the freezing point of the organic solvent, the hydrolysis of the stimulant caused by the hygroscopicity of the organic solvent can be suppressed. Therefore, the degradation of the quality of the second solution 8 caused by hydrolysis can be suppressed.

[0119] As in this embodiment, in step S18, the second solution 8 can also be frozen while the desiccant 11, which absorbs moisture from the air, is placed around the second container 7. In this case, in step S18, the desiccant 11 can absorb moisture from the air, thus effectively preventing the moisture from being absorbed by the second solution 8 inside the second container 7.

[0120] As in this embodiment, in step S19, the internal space V of the sealed bag 100 can also be sealed while the atmosphere of the internal space V is replaced with a nitrogen atmosphere. In this case, the humidity of the internal space V of the sealed bag 100 can be reduced, and therefore, the absorption of moisture in the internal space V by the second solution 8 inside the second container 7 can be effectively reduced.

[0121] As in this embodiment, in step S19, the internal space V of the sealed bag 100 can also be sealed while maintaining the internal space V under vacuum. In this case, the humidity of the internal space V of the sealed bag 100 can be reduced, thus effectively reducing the absorption of moisture from the internal space V by the second solution 8 inside the second container 7.

[0122] Next, the method for measuring biological samples using measurement unit 1 will be described. First, the measurement apparatus will be described. Figure 12 and Figure 13 As shown, the measuring device 9 includes a support member 91, a heater 92, a nozzle 93, a rotating device 94, and a light device 95. The support member 91 includes a mounting space (slot) 91a and an opening 91b. The opening 91b extends through the side wall of the support member 91. The opening 91b communicates with the mounting space 91a. The first measuring kit 2 is mounted in the mounting space 91a with the light-transmitting region 4b opposite to the opening 91b. The heater 92 is disposed on the side wall of the support member 91. When viewed along the Y-axis direction, the heater 92 is disposed on both sides of the mounting space 91a in the X-axis direction. The heat generated by the heater 92 is transferred to the first measuring kit 2 through the support member 91. The position of the heater 92 is not limited to the example described above. For example, the heater 92 may also be disposed on the measuring surface of the measuring unit 1, or on the side opposite to the measuring surface. The heater 92 may also be disposed on both the measuring surface of the measuring unit 1 and the side opposite to the measuring surface.

[0123] Nozzle 93 is positioned vertically above support member 91. Nozzle 93 ejects air, for example. Opening 7b of second container 7 is attached to nozzle 93. When air is ejected from nozzle 93, the pressure in space S4 is greater than the pressure in temporary storage space S3. Due to the pressure difference between space S4 and temporary storage space S3, thawed second solution 8 is discharged from opening 7a. The second solution 8 discharged from opening 7a is added to the first storage space S1 of first container 4.

[0124] The rotating device 94 is positioned opposite the opening 91b to the mounting space 91a. The rotating device 94 is, for example, a magnetic stirrer. The rotating device 94 rotates the rotor 5 of the first assay kit 2.

[0125] The light device 95 is disposed on the side opposite to the rotating device 94, relative to the mounting space 91a. The light device 95 includes an excitation section 96, an optical system 97, and a light-receiving section 98. The excitation section 96 has a light-emitting element, such as a laser diode or a light-emitting diode. The excitation section 96 emits excitation light. The optical system 97 is disposed between the excitation section 96 and the mounting space 91a, and between the light-receiving section 98 and the mounting space 91a. The optical system 97 is, for example, a lens that focuses light. The light-receiving section 98 has a photoelectric conversion element, such as a photodiode. The light-receiving section 98 detects incident light. The excitation light emitted from the excitation section 96 reaches the first receiving space S1 via the optical system 97, the opening 91b, and the light-transmitting region 4b. As a result, the substance generated by the reaction of the components produced by the biological sample with the fluorescent indicator in the first solution 6 is excited, resulting in fluorescence. This fluorescence reaches the light-receiving section 98 via the light-transmitting region 4b, the opening 91b, and the optical system 97. The fluorescence was detected by the light-receiving part 98.

[0126] like Figure 14 As shown, in the biological sample determination method, firstly, in step S21, the determination unit 1 is prepared.

[0127] Next, in step S22, the first solution 6 is thawed. In step S22, the first assay kit 2 is installed in the installation space 91a. In step S22, the first solution 6 is heated using the heater 92 until it is thawed. The heat from the heater 92 is conducted to the first solution 6 via the support member 91 and the first container 4. In step S22, the first solution 6 is continuously heated to bring its temperature to a suitable temperature (optimal temperature) for the biological sample. The suitable temperature for the biological sample is, for example, 37°C. In step S22, the first solution 6 is heated to a temperature of, for example, 36.5°C to 37.5°C. In step S22, the first solution 6 is heated for, for example, 5 to 10 minutes. Thus, the first solution 6 is heated relatively slowly, thereby suppressing the degradation of its function.

[0128] In step S22, the first solution 6 is heated while the rotor 5 rotates. Specifically, in step S22, the first solution 6 is thawed, and after it becomes flowable, the rotor 5 is rotated. As the rotor 5 rotates, the first solution 6 flows sequentially to one side of the first region 42c, the middle region 42e, the second region 42d, and the other side of the middle region 42e, and flows from the other side of the middle region 42e through the area between the partition wall 422 and the inner surface of the first component 41 to one side of the middle region 42e. This promotes thermal movement in the first solution 6, improving the thawing efficiency of the first solution 6. In step S22, the rotating device 94 can also be started before the first solution 6 becomes flowable (e.g., before the first assay kit 2 is installed in the installation space 91a). In this case, the rotor 5 rotates while the first solution 6 becomes flowable.

[0129] Next, in step S23, the biological sample is added to the first storage space S1 through the opening 4a. In step S23, a small amount (2 μL to 3 μL) of capillary blood collected from the finger of the subject, for example by a blood collection device such as a lancet, is added to the first storage space S1 as a biological sample.

[0130] Next, in step S24, the temperature of the first solution 6 is adjusted. In step S24, the first solution 6 is heated by heater 92. In step S24, the first solution 6 is heated to maintain its temperature at the aforementioned suitable temperature for the biological sample. In step S24, the first solution 6 is heated to, for example, a temperature of 36.8°C to 37.2°C. In step S24, the first solution 6 is heated while rotor 5 rotates. Step S24 continues until the biological sample determination method is completed.

[0131] Next, in step S25, the second solution 8 is thawed. In step S25, with the second container 7 of the second assay kit 3 attached to the nozzle 93, the second assay kit 3 is left for 1 to 2 minutes. That is, in step S25, the second solution 8 is thawed naturally. Because there is a temporary storage space S3 between the second solution 8 and the opening 7a, even if a portion of the thawed second solution 8 moves toward the opening 7a, that portion of the second solution 8 is still contained within the temporary storage space S3. During the thawing of the second solution 8, the air in space S4 expands due to the temperature rise. When the air in space S4 expands, the thawed second solution 8 moves toward the opening 7a, and the volume of the temporary storage space S3 decreases. However, the temporary storage space S3 still exists between the moved second solution 8 and the opening 7a. Even after the thawing of the second solution 8 is complete, the thawed second solution 8 can still reach the opening 7a. That is, even when the second solution 8 has finished thawing, there may be no space between the second solution 8 and the opening 7a. Step S25 may also be performed simultaneously with at least one of steps S22 to S24.

[0132] Next, in step S26, the thawed second solution 8 is discharged from opening 7a and added to the first receiving space S1 via opening 4a. In step S26, the contents of the second receiving space S2 from a predetermined position relative to the second solution 8 opposite to opening 7a to opening 7a are discharged from opening 7a. The predetermined position is the position between the surface 8b of the second solution 8 and opening 7b. That is, the predetermined position is away from the surface 8b of the second solution 8. In step S26, contents having a volume larger than the combined volume of the thawed second solution 8 and the temporary receiving space S3 are discharged from opening 7a. In step S26, air is ejected from nozzle 93. The volume of the ejected air is greater than the combined volume of the thawed second solution 8 and the temporary receiving space S3. Thus, the second solution 8 and the contents located on the side of the second solution 8 closer to opening 7a are reliably discharged from opening 7a. Alternatively, in step S26, the second solution 8 can be added to the first storage space S1 while maintaining the temperature of the second solution 8 at a suitable temperature (optimal temperature) for the stimulant.

[0133] Next, in step S27, the light transmitted through the light transmission region 4b generated in the first storage space S1 and transmitted through the first container 4 is measured. In step S27, the first storage space S1 is continuously irradiated with excitation light, and the light generated in the first storage space S1 is continuously detected. The irradiation of the excitation light and the detection of the light begin before step S26. That is, the irradiation of the excitation light and the detection of the light begin before the second solution 8 is added to the first container 4.

[0134] When the first storage space S1, which is used to react the fluorescent indicator of the first solution 6 with HOCl produced by the biological sample, is irradiated with excitation light of wavelength 480 nm, fluorescence of wavelength 515 nm is generated in the first storage space S1. In step S27, the fluorescence of wavelength 515 nm is detected. Thus, myeloperoxidase activity is determined.

[0135] The above describes one embodiment of the present invention, but the present invention is not limited to the above embodiment.

[0136] In the above implementation methods, such as Figure 1 The illustration shows a case where a first assay kit 2, a second assay kit 3, and a desiccant 10 are housed within the internal space V of the sealed bag 100. However, the number of each of the first assay kit 2, the second assay kit 3, and the desiccant 10 housed within the internal space V of the sealed bag 100 is not limited to one. For example, Figure 15 The assay unit 1A shown includes multiple first assay kits 2 and multiple second assay kits 3, which are stored in the internal space V of the sealed bag 100. The number of first assay kits 2 and multiple second assay kits 3 in the internal space V of the sealed bag 100 is the same as the number of second assay kits 3.

[0137] As with assay unit 1A, when multiple first assay kits 2 and multiple second assay kits 3 are housed within the internal space V of the sealed bag 100, the production and transportation costs of assay unit 1A can be reduced by centrally housing multiple containers within the internal space of the sealed bag during mass production of frozen containers. Assay unit 1A may also include multiple desiccant 10s. The number of multiple first assay kits 2 in assay unit 1A may also differ from the number of multiple second assay kits 3.

[0138] like Figure 16 The measurement unit 1B shown can also accommodate a third measurement kit 2A in addition to the first measurement kit 2, the second measurement kit 3, and the desiccant 10 within the internal space V of the sealed bag 100. For example... Figure 17As shown, the third assay kit 2A has a third container 4A, a third solution 6A, a first sealing component 31A, and a second sealing component 32A. In the assay unit 1B, the first solution 6, contained in the first container 4 of the first assay kit 2, contains at least one of physiological saline and buffer solution, but does not contain a fluorescent indicator. The fluorescent indicator is contained in the third solution 6A, which is contained in the third container 4A of the third assay kit 2A. Therefore, within the internal space V of the sealed bag 100 of the assay unit 1B, the first solution 6, containing at least one of physiological saline and buffer solution, and the third solution 6A, containing a fluorescent indicator, are contained in different containers.

[0139] The third container 4A, which houses the third solution 6A containing the fluorescent indicator, has, for example, a second container 7 (see reference 3) similar to the second assay kit 3. Figure 6 The same structure. For example... Figure 17 As shown, the third container 4A is, for example, a cone-shaped structure with a line parallel to the Z-axis as its centerline, and is elastic. The third container 4A includes a second receiving space S2A, an opening 4Aa, and an opening 4Ab. Openings 4Aa and 4Ab are formed in the third container 4A at positions facing opposite sides. For example, opening 4Ab is formed at the first end E1A of the third container 4A in the Z-axis direction. Opening 4Aa is formed at the second end E2A of the third container 4A in the Z-axis direction. Openings 4Aa and 4Ab are respectively connected to the second receiving space S2A. The second receiving space S2A is, for example, cone-shaped. The cross-sectional area of ​​the second receiving space S2A decreases from opening 4Ab towards opening 4Aa. The diameter of opening 4Aa is smaller than the diameter of opening 4Ab. Opening 4Aa is the outlet of the third container 4A. Opening 4Aa can also function as the suction inlet of the third container 4A. The third container 4A is, for example, a straw end.

[0140] The third solution 6A is contained within the second storage space S2A. The third solution 6A fills a portion of the second storage space S2A. A temporary storage space S3A exists between the third solution 6A and the opening 4Aa, and a space S4A exists between the third solution 6A and the opening 4Ab. Specifically, the third solution 6A is located further inward than both the openings 4Aa and 4Ab.

[0141] The third solution 6A is cooled while contained within the second receiving space S2A. In this modified example, the third solution 6A is shown being cooled to a state where it is not frozen while contained within the second receiving space S2A. The third solution 6A can also be frozen while contained within the second receiving space S2A. In this case, the third solution 6A can be frozen, for example, with a temporary receiving space S3A existing between the third solution 6A and the opening 4Aa, and a space S4A existing between the third solution 6A and the opening 4Ab. In this case, the third solution 6A can be frozen entirely or partially. The temperature of the third solution 6A can, for example, be the same as the temperature of the first solution 6. The temperature of the third solution 6A can, for example, be -20°C. The temperature of the third solution 6A can also be lower than the temperature of the first solution 6. The temperature of the third solution 6A can, for example, be below -30°C, below -40°C, or below -80°C.

[0142] The first sealing member 31A has, for example, the same structure as the first sealing member 31 of the second assay kit 3. The first sealing member 31A is configured to block the opening 4Ab of the third container 4A. The first sealing member 31A completely covers the opening 4Ab of the third container 4A without gaps. The first sealing member 31A may or may not contact the first end E1A of the third container 4A. The first sealing member 31A is detachably mounted relative to the third container 4A.

[0143] The second sealing member 32A has, for example, the same structure as the second sealing member 32 of the second assay kit 3. The second sealing member 32A is configured to block the opening 4Aa of the third container 4A, which is located on the side opposite to the opening 4Ab. The second sealing member 32A may or may not contact the second end E2A of the third container 4A. A space may also be formed between the second sealing member 32A and the second end E2A of the third container 4A. The second sealing member 32A may also completely cover the opening 4Aa of the third container 4A without gaps. The second sealing member 32A is detachably mounted relative to the third container 4A.

[0144] By blocking the openings 4Aa and 4Ab of the third container 4A respectively through the first sealing component 31A and the second sealing component 32A, the second storage space S2A of the third container 4A is sealed. Figure 16When the third assay kit 2A is stored in the internal space V of the sealed bag 100, for example, the third assay kit 2A is stored in the second storage space S2A after the third solution 6A has cooled, and the openings 4Ab and 4Aa are blocked by the first sealing member 31A and the second sealing member 32A. Depending on the temperature of the third solution 6A, the first sealing member 31A may sometimes detach from the opening 4Ab of the third container 4A. Therefore, the assay unit 1B may not have the first sealing member 31A blocking the opening 4Ab of the third container 4A. That is, the opening 4Ab of the third container 4A may be open without being blocked by the first sealing member 31A when the third container 4A is stored in the internal space V of the sealed bag 100.

[0145] As with the measurement unit 1B, in the internal space V of the sealed bag 100, when a first solution 6 containing at least one of physiological saline and buffer solution and a third solution 6A containing a fluorescent indicator are stored in different containers, the quality of the solutions stored in each container is less likely to deteriorate compared to the case where at least one of physiological saline and buffer solution and the fluorescent indicator are stored in one container. Therefore, the quality of each solution can be maintained more reliably.

[0146] like Figure 18 As shown, in manufacturing the measuring unit 1B, in addition to the steps S11 to S19 described above, steps S11A to S14A are also performed. Furthermore, in Figure 18 In step S12, a first solution 6 is prepared, containing at least one of physiological saline and buffer solution but without a fluorescent indicator. The order of steps S11A to S14A is not limited to [specific steps not specified in the original text]. Figure 18 The example shown can be modified arbitrarily. Steps S11A to S14A can be performed simultaneously with steps S11 to S14, for example. At least one of steps S11A to S14A can be performed simultaneously with at least one of steps S11 to S14, or it can be performed before or after steps S11 to S14.

[0147] In step S11A, a third container 4A is prepared. Next, in step S12A, a third solution 6A is prepared. The third solution 6A contains at least a fluorescent indicator. Next, in step S13A, the pre-prepared third solution 6A is introduced into the second receiving space S2A of the third container 4A. Next, in step S14A, the third solution 6A is cooled to a non-freezing state while contained in the second receiving space S2A. The third solution 6A can also be cooled, for example, to approximately -20°C while contained in the second receiving space S2A. Thus, a third assay kit 2A is manufactured after the third solution 6A has been cooled. In step S14A, the third solution 6A can also be frozen while contained in the second receiving space S2A. Furthermore, when the fluorescent indicator is left at room temperature for an extended period, the quality of the fluorescent indicator may be affected. Therefore, it is preferable to manage the third solution 6A in an environment similar to the manufacturing environment of the second assay kit 3. That is, steps S11A, S12A, and S13A are preferably performed in a state of cooling to a certain extent, i.e., at a low temperature. For example, steps S11A, S12A, and S13A can also be performed in a manner similar to the manufacturing process of the second assay kit 3. Figure 9 The cold storage box B1 or B2 shown is implemented. However, the temperature management of the third solution 6A does not need to be as strict as that of the second solution 8, which is particularly concerned about degradation due to hydrolysis. It can be implemented within the temperature range that maintains the quality of the fluorescent indicator (e.g., below 4°C).

[0148] Next, steps S15 to S19 are performed. In step S19, as follows: Figure 16As shown, the first assay kit 2, the second assay kit 3, and the third assay kit 2A are housed together with the desiccant 10 in the internal space V of the sealed bag 100. In the sealed internal space V, the first solution 6 housed in the first container 4, the second solution 8 housed in the second container 7, and the third solution 6A housed in the third container 4A are, for example, in a frozen state. In this state, the openings 7b and 7a of the second container 7 are blocked by the first sealing member 31 and the second sealing member 32, respectively, and the openings 4ab and 4Aa of the third container 4A are blocked by the first sealing member 31A and the second sealing member 32A, respectively. Through the above manufacturing method, the assay unit 1B achieving the aforementioned effects can be manufactured. Inside the sealed bag 100, the first assay kit 2, the second assay kit 3, and the third assay kit 2A can also be housed in separate, mutually separated spaces. That is, inside the sealed bag 100, a space housing the first container 4 and a space housing the second container 7 and the third container 4A can also be separated from each other. For example, the sealing bag 100 may be pre-separated using a sealing machine or the like, or the second assay kit 3 and the third assay kit 2A may be housed in a sealing bag smaller than the sealing bag 100. In this case, the desiccant 10 may also be housed inside the sealing bag 100 in the same space as the second assay kit 3 and the third assay kit 2A. Alternatively, the desiccant 10 may not be placed inside the sealing bag 100.

[0149] In the above embodiments and modifications, a human body was shown as the test subject, but the test subject could also be, for example, an animal. An example of a biological sample being the blood of a test subject was shown. The biological sample could also be, for example, the body fluids of a test subject. The biological sample could also be, for example, the saliva, perfusion fluid, tears, sweat, or urine of a test subject. As a characteristic of the biological sample, the activity of neutrophils was shown as an example, but the characteristic of the biological sample could also be the activity of tissue cells such as monocytes, eosinophils, basophils, B cells, T cells, NK cells, or vascular endothelial cells.

[0150] In the above embodiments and variations, examples are shown where the first solution 6 and the third solution 6A contain fluorescent indicators, but the first solution 6 and the third solution 6A may also contain chemiluminescent indicators. The chemiluminescent indicator reacts with the component (superoxide) produced by the biological sample. The chemiluminescent indicator is, for example, MCLA (2-Methyl-6-(4-methoxyphenyl)-3,7-dihydroimidazo[1,2-a]pyrazin-3-one, 2-methyl-6-(4-methoxyphenyl)-3,7-dihydroimidazo[1,2-a]pyrazin-3-one). Commercially available products may also be used as chemiluminescent indicators. In the first storage space S1 where the reaction between the superoxide produced by the biological sample and the chemiluminescent indicator in the first solution 6 takes place, chemiluminescence with a maximum emission wavelength of 465 nm is generated. In step S27, the chemiluminescence with a maximum emission wavelength of 465 nm can also be detected. Thus, the superoxide generation activity is determined.

[0151] In the above embodiments and variations, examples are shown where the second container 7 and the third container 4A are pipette ends. However, the second container 7 and the third container 4A can also be, for example, capillary nozzles, droppers, full-capacity pipettes, Komagome Pipette pipettes, graduated pipettes, hematocrit capillaries, or syringes.

[0152] In the above embodiments and variations, an example is shown where the volume of the temporary storage space S3 is greater than or equal to the volume of the second solution 8, but the volume of the temporary storage space S3 may also be less than the volume of the second solution 8.

[0153] In the above-described embodiments and modifications, an example is shown where the second solution 8 is introduced into the second storage space S2 using a suction nozzle inserted into the opening 7b of the second container 7. However, the second solution 8 can also be introduced into the second storage space S2 by the suction force of the second container 7 itself. Specifically, first, the opening 7b of the second container 7 is blocked. Then, for example, pressure is applied to the second container 7 from the outside by an operator's hand. As a result, air in the second storage space S2 is discharged through the opening 7a. Next, the second container 7 is positioned so that the opening 7a of the second container 7 is in contact with the second solution 8. Then, the pressure applied by the operator's hand is released. As a result, the second solution 8 is drawn into the second storage space S2 through the opening 7a.

[0154] The first solution 6 and the third solution 6A may also contain, for example, taurine / TNB (see J. Clin. Invest., Vol. 70, pp. 598-607, 1982), 8-amino-5-chloro-7-phenylpyridino[3,4-d]pyridazine-1,4-(2H,3H)dione (see L-012: AnalBiochem., Vol. 271(1), pp. 53-58, 1999) as indicators of the reaction with hypochlorous acid (or its halogen equivalent) produced by myeloperoxidase.

[0155] The first solution 6 and the third solution 6A may also contain, for example, 2-methyl-6-phenyl-3,7-dihydroimidazo[1,2-a]pyrazin-3-one (CLA), 2-methyl-6-p-methoxyphenylethynylimidazopyrazinone (MPEC), indocyanine imidazopyrazine compound (NIR-CLA), 2-[2,4,5,7-tetrafluoro-6-(2-nitro-4,5-dimethoxyphenylsulfonyloxy)-3-oxo-3H-oxanthracene-9-yl]benzoic acid (BES-So) as indicators of reaction with superoxide.

[0156] The second solution 8 may also contain, for example, conditioned yeast polysaccharide (OZ) as a stimulant. The water content of the DMSO, which is the organic solvent contained in the second solution 8, may be pre-removed using an organic solvent purification apparatus or a DMSO dehydration apparatus. Ultra-dehydrated DMSO may also be used as the DMSO.

[0157] In the above embodiments and modifications, an example is shown where a first solution 6, pre-prepared outside the first storage space S1, is introduced into the first storage space S1. However, the first solution 6 can also be prepared inside the first storage space S1. For example, multiple reagents can be introduced into the first storage space S1 separately. Each of the multiple reagents can also be introduced into the first storage space S1 sequentially or simultaneously. Similarly, the third solution 6A can be pre-prepared outside the second storage space S2A and then introduced into the second storage space S2A, or it can be prepared inside the second storage space S2A.

[0158] Here, when the combined amount of buffer solution required to prepare the first solution 6 and the amount of buffer solution required to prepare the second solution 8 is determined to be a specific predetermined amount, this predetermined amount of buffer solution can also be prepared in step S12 of preparing the first solution 6. In this case, in step S12, a first solution 6 containing the buffer solution required to prepare the first solution 6 and the buffer solution required to prepare the second solution 8 (i.e., containing the predetermined amount of buffer solution) can also be prepared. Then, in step S13, the first solution 6 containing the predetermined amount of buffer solution can also be introduced into the first container 4. In other words, the amount of buffer solution required to prepare the second solution 8 can also be introduced into the first container 4 in advance in step S13. Alternatively, the amount of buffer solution required to prepare the second solution 8 can be added to the first container 4 before the second solution 8 is added to the first container 4 in step S26. In these cases, the second solution 8 inside the second container 7 does not contain buffer solution. Alternatively, in step S12, a first solution 6 containing only the amount of buffer solution required to prepare the first solution 6 can be prepared at the same time. Furthermore, when the second solution 8 contains buffer solution and when the second solution 8 does not contain buffer solution, the amount of buffer solution contained in the first solution 6 can be appropriately adjusted.

[0159] In the above embodiments and modifications, a case was shown where the second container 7 containing the frozen second solution 8 was stored in the internal space V of the sealed bag 100. However, the second container 7 containing the frozen stimulant could also be stored in the internal space V of the sealed bag 100. Even when the frozen stimulant is stored in the internal space V of the sealed bag 100 with only the second container 7 inside, there is a concern that the stimulant may hydrolyze due to humidity. Therefore, when the second container 7 containing the frozen stimulant is stored in the sealed internal space V of the sealed bag 100, similar to the above embodiments, it is possible to prevent the stimulant from absorbing moisture from the air surrounding the second container 7, thereby suppressing the degradation of the stimulant's quality caused by hydrolysis.

[0160] In the above embodiments and variations, the second assay kit 3 is shown to have a first sealing member 31 and a second sealing member 32 that respectively block the openings 7b and 7a of the second container 7. However, the openings 7b and 7a of the second container 7 do not need to be blocked by the sealing members. That is, when the second assay kit 3 has a first sealing member 31 that blocks the opening 7b of the second container 7, the second assay kit 3 may not have a second sealing member 32 that blocks the opening 7a of the second container 7, and the opening 7a of the second container 7 may be open. Similarly, when the second assay kit 3 has a second sealing member 32 that blocks the opening 7a of the second container 7, the second assay kit 3 may not have a first sealing member 31 that blocks the opening 7b of the second container 7, and the opening 7b of the second container 7 may be open. Even in this manner, similar to the embodiments described above, it is possible to prevent moisture in the air from being absorbed by the second solution 8, and therefore, it is possible to suppress the degradation of the quality of the second solution 8 caused by hydrolysis.

[0161] Measuring device 9 (refer to) Figure 12 and Figure 13 The device may also have an adjustment mechanism for adjusting the position of the nozzle 93 in the Z-axis direction (vertical direction). In step S26, the second solution 8 may be added to the first solution 6 with the opening 7a (front end of the second container 7) of the second container 7 located between the opening 4a of the first container 4 and the surface (liquid surface) 6a of the first solution 6. The distance between the front end of the second container 7 and the surface 6a of the first solution 6 may, for example, be 1 mm. In this case, the scattering of the second solution 8 or the disturbance of the surface 6a of the first solution 6 is suppressed, resulting in a decrease in the accuracy of the determination of the properties of the biological sample. Specifically, when the second solution 8 does not contain buffer solution, the amount of the second solution 8 added tends to be very small, and therefore, it is difficult to control the dripping of the second solution 8 using the nozzle 93 and the second container 7. As a result, the ejection pressure of the air from the nozzle 93 becomes large, and sometimes the second solution 8 is sprayed from the opening 7a of the second container 7. When the second solution 8 is sprayed from the opening 7a, the second solution 8 scatters, and as a result, the amount of stimulant added to the first solution 6 may be insufficient. Furthermore, when the second solution 8 is sprayed from the opening 7a, the surface 6a of the first solution 6 becomes disordered due to air bubbles, which may result in scattered light. The inventors have successfully suppressed the decrease in the accuracy of biological sample characteristic measurements caused by the scattering of the second solution 8 or the disorder of the surface 6a of the first solution 6 by optimizing the distance between the front end of the second container 7 and the surface 6a of the first solution 6. Additionally, the distance between the front end of the second container 7 and the surface 6a of the first solution 6 can also be adjusted based on the amount of second solution 8 added or the ejection pressure of air from the nozzle 93.

[0162] In step S17 of the manufacturing method of measuring unit 1 (refer to...) Figure 8 In this process, a micropipette or similar device can be used as a pipette tip. Specifically, first, the tip of the micropipette is inserted into the opening 7b of the second container 7. Then, using the suction force of the micropipette, a predetermined amount (e.g., 0.75 μL) of the second solution 8 is drawn through the opening 7a of the second container 7 into the second receiving space S2 of the second container 7. Next, with the tip of the micropipette still inserted in the opening 7b of the second container 7, the suction force of the micropipette is increased to, for example, 3 μL. As a result, a predetermined amount of air is further drawn through the opening 7a into the second receiving space S2.

Claims

1. A measuring unit, wherein, The measuring unit is used to measure the characteristics of biological samples and has the following features: A solution comprising a stimulant that activates the function of the biological sample and an organic solvent that dissolves the stimulant; A container for holding the frozen solution; and A resealable bag that contains the container in a sealed internal space.

2. The measuring unit according to claim 1, wherein, It also includes: a sealing component that blocks at least one of a first opening formed in the container and a second opening formed in the container at a location different from the first opening.

3. The measuring unit according to claim 1, wherein, It also has: A first sealing component, the blockage of which is formed at the first opening of the container; and The second sealing component blocks the second opening in the container at a location different from the first opening.

4. The measuring unit according to any one of claims 1 to 3, wherein, It also includes a desiccant, which is stored together with the container in the internal space of the sealed bag to absorb moisture from the air.

5. The measuring unit according to any one of claims 1 to 4, wherein, The container is housed within the interior space of the sealed bag.

6. The measuring unit according to any one of claims 1 to 4, wherein, It has multiple containers for storing the frozen solution. The sealed bag contains a plurality of the containers within its internal space.

7. The measuring unit according to any one of claims 1 to 6, wherein, It also has: A first solution comprising an indicator that reacts with components produced by the biological sample; and The first container holds the first solution. The sealed bag is stored in the internal space: The first container, which holds the first solution; and As a second container of the container, it contains a second solution as the solution.

8. The measuring unit according to any one of claims 1 to 6, wherein, It also has: The first solution contains at least one of physiological saline and buffer solution; A first container that holds the first solution; The third solution contains an indicator that reacts with components produced by the biological sample; as well as A third container holds the third solution. The sealed bag is stored in the internal space: The first container holds the first solution; As a second container of the aforementioned container, it contains a second solution as the aforementioned solution; and The third container holds the third solution.

9. The measuring unit according to claim 7 or 8, wherein, The indicator is a fluorescent indicator.

10. The measuring unit according to any one of claims 1 to 9, wherein, The organic solvent is dimethyl sulfoxide (DMSO).

11. A measuring unit, wherein, The measuring unit is used to measure the characteristics of biological samples and has the following features: Stimulants that activate the function of the biological sample; A container that holds the frozen stimulant; and A resealable bag that contains the container in a sealed internal space.

12. A method for manufacturing a measuring unit, wherein, The method describes a measuring unit for determining the properties of biological samples, and it includes: The process of preparing a solution comprising a stimulant that activates the function of the biological sample and an organic solvent that dissolves the stimulant, a container capable of holding the solution, and a sealed bag capable of holding the container. The process of freezing the solution while it is contained in the container; and The process of sealing the internal space of the sealed bag while the container is inside the sealed bag.

13. The method for manufacturing the measuring unit according to claim 12, wherein, In the process of freezing the solution, the solution is frozen while a first opening formed in the container is blocked by a first sealing member, and a second opening formed in the container at a different location than the first opening is blocked by a second sealing member.

14. The method for manufacturing the measuring unit according to claim 12 or 13, wherein, In the process of sealing the internal space of the sealed bag, the internal space is sealed while the desiccant that absorbs moisture from the air is stored together with the container in the internal space.

15. The method for manufacturing the measuring unit according to any one of claims 12 to 14, wherein, It also includes the step of: containing a first solution comprising an indicator that reacts with components produced by the biological sample in a first container. In the process of sealing the internal space of the sealed bag, the internal space is sealed while the first container containing the first solution and the second container containing the second solution are placed in the internal space.

16. The method for manufacturing the measuring unit according to claim 12, wherein, It also has: The step of placing a first solution containing at least one of physiological saline and buffer solution into a first container; and The process of storing a third solution containing an indicator that reacts with components produced by the biological sample in a third container. In the process of sealing the internal space of the sealed bag, the internal space is sealed while the first container containing the first solution, the second container containing the second solution, and the third container containing the third solution are housed in the internal space.

17. The method for manufacturing the measuring unit according to any one of claims 12 to 16, wherein, In all processes except for the preparation of the solution and the introduction of the solution into the container, the temperature around the container is maintained below the freezing point of the organic solvent.

18. The method for manufacturing the measuring unit according to any one of claims 12 to 17, wherein, In the process of freezing the solution, the solution is frozen while a desiccant that absorbs moisture from the air is placed around the container.

19. The method for manufacturing the measuring unit according to any one of claims 12 to 18, wherein, In the process of sealing the internal space of the sealed bag, the internal space of the sealed bag is sealed while the atmosphere of the internal space is replaced with a nitrogen atmosphere.

20. The method for manufacturing the measuring unit according to any one of claims 12 to 18, wherein, In the process of sealing the internal space of the sealed bag, the internal space of the sealed bag is sealed while maintaining the internal space as a vacuum.

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