Immunoreaction detection test strip

Abstract

The utility model relates to the technical field of immune testing, in particular to an immune reaction detection test strip which comprises a bottom plate, chromatography test paper laid on the bottom plate and an external connection shell, the chromatography test paper is provided with a first end and a second end, the first end is connected with a water absorption pad, the water absorption pad is provided with a third end and a fourth end, the second end is connected with a marker pad loaded with markers, and the external connection shell is connected with the bottom plate. The marker pad is provided with a fifth end and a sixth end, the fifth end is lapped on the second end, the sixth end is connected with a sample pad, the sample pad is provided with a seventh end and an eighth end, and the seventh end is lapped on the sixth end; and the projections of the fifth end and the seventh end on the plane of the bottom plate are not overlapped. The immunoreaction chromatography test strip has good flatness and flow uniformity, the internal liquid flows smoothly, and the yield of the test strip can be improved.

Description

Technical Field

[0001] This application relates to the technical field of immunoassay, and particularly to an immunoassay test strip for detecting immune reactions. Background Art

[0002] Immunochromatography is a method used for proteins, nucleic acids, viral antigens, etc. It utilizes capillary action to induce a sample to be tested to pass through a chromatographic test strip, and enables the sample to be tested to bind to a chromogenic agent or other markers at the front end of the test strip and bind to a capture agent at the rear end of the test strip, and then be enriched on the T line (test line) to form a chromogenic region, while the chromogenic agent that has not bound to the antigen is enriched on the C line (quality control line) to determine whether the test strip is effective. It has the advantages of being convenient and easy to measure, stable, and intuitive, with a relatively low cost and wide application.

[0003] Generally, the test strip used for immunoassay in addition to the chromatographic test strip loaded with the C line and the T line, also includes a water absorption pad provided at the end of the chromatographic test strip, a marker pad provided at the front end of the chromatographic test strip, and a sample pad provided at the front end of the marker pad. The sample pad is used for injecting the sample, and it needs to have a relatively large volume. After the sample pad fully absorbs the sample, through capillary action, the liquid sequentially passes through the marker pad and the chromatographic test strip, and finally is absorbed by the water absorption pad.

[0004] In the prior art, the sample pad, the marker pad, and the chromatographic test strip are stacked so that the liquid penetrates through the sample pad, the marker pad, and the chromatographic test strip. In actual products, an outer shell is also used to fix and cover the above structure to achieve an immunoassay test strip that is convenient for operation, storage, and transportation. However, in the above solution, the stacking of multiple test strips will cause a relatively large thickness at a local position of the test strip, and the large thickness stacking will cause an increase in the overall volume of the test strip, which has an adverse effect on the smoothness of liquid flow. Summary of the Utility Model

[0005] In order to improve the uniformity and flatness of liquid flow in the test strip, this application provides an immunoassay test strip for detecting immune reactions.

[0006] First, an immunoassay test strip in this application includes a bottom plate, a chromatographic test strip laid on the bottom plate, and an outer shell. The chromatographic test strip has a first end and a second end. The first end is connected to a water absorption pad, the water absorption pad has a third end and a fourth end. The second end is connected to a marker pad loaded with colloidal gold. The marker pad has a fifth end and a sixth end. The fifth end is laid on the second end, and the sixth end is connected to a sample pad. The sample pad has a seventh end and an eighth end. The seventh end is laid on the sixth end; the projections of the fifth end and the seventh end on the plane where the bottom plate is located do not overlap.

[0007] In the above solution, the water-absorbing pad, chromatographic test strip, marker pad, and sample pad can be jointly pressed tightly against the bottom plate through the external housing. The bottom plate can be made of PP material or other water-impermeable materials. In the above solution, through the overlap of the seventh end and the sixth end, and the overlap of the fifth end and the second end, a larger contact area is formed between the sample pad, the marker pad, and the chromatographic test strip, enabling the liquid to flow from the sample pad to the marker pad and from the marker pad to the chromatographic test strip.

[0008] In the above solution, the fifth end is not directly and continuously laid on the seventh end and covering the sixth end, but is laid on the sixth end, and the fifth end and the seventh end are separated on the bottom surface. On the one hand, the smoothness of liquid flow is improved, making the liquid flow between the sample pad and the marker pad smoother after the external housing is buckled. On the other hand, the overall thickness of the test strip is more uniform, and when installed in the external housing, the sample pad and the marker pad are not easily damaged, thereby improving the yield rate of test strip preparation.

[0009] Preferably, the distance between the side of the seventh end close to the fifth end and the fifth end is 0.5 - 5 mm.

[0010] In the above solution, the distance between the seventh end and the fifth end will form a recessed area, which is not conducive to the spatial structure reliability of the product after the test strip is completed. Therefore, this distance needs to be controlled within a small range. At the same time, they cannot be too close to leave a margin for a small amount of displacement and deformation of the sample pad and the marker pad during the encapsulation process, so as to avoid overlap or detachment between the sample pad, the marker pad, and the chromatographic test strip during actual encapsulation, transportation, and use.

[0011] Preferably, the external housing is provided with a first pressing member for pressing the fifth end tightly against the second end and a second pressing member for pressing the seventh end tightly against the sixth end. The contact area between the first pressing member and the fifth end is less than 10% of the area of the fifth end, and the contact area between the second pressing member and the seventh end is less than 10% of the area of the seventh end.

[0012] By pressing the fifth end and the seventh end through the pressing members and using a smaller area to press them tightly, it can not only ensure the flatness of the surface and make the pressing members not easily hinder the liquid flow.

[0013] In the above solution, the area ranges of the first pressing member and the second pressing member on the marker pad and the sample pad are further controlled, reducing the influence of the first pressing member and the second pressing member on the liquid flow and the damage to the membrane integrity.

[0014] Preferably, there is a gap between the first pressing member and the second pressing member.

[0015] In the above solution, the first pressing member and the second pressing member are arranged in a non-integrated manner, which can reduce the obstruction to the liquid flow and make the overall structure more stable.

[0016] Preferably, the third end is placed on the first end, and the external housing is provided with a third pressing member for pressing the absorbent pad against the bottom plate or the chromatographic test strip.

[0017] In this solution, the area of the absorbent pad that can produce the siphon effect is increased, thereby improving the overall stability and reducing liquid leakage.

[0018] Preferably, the ratio of the length of the third end to the thickness of the chromatographic test strip is 50 - 300:1.

[0019] Within the above ratio range, a good siphon effect can be achieved. For a thicker chromatographic test strip, the third end requires a greater length to provide better siphon suction, making the liquid flow in the test strip more uniform.

[0020] Preferably, the projected area of the third pressing member on the absorbent pad is smaller than the projected area of the first pressing member on the marker pad and the projected area of the second pressing member on the sample pad.

[0021] In the above solution, a smaller pressing area is adopted for the third pressing member, reducing the deformation of the third pressing member, increasing the accommodation capacity of the third pressing member, reducing the possibility of liquid overflow, and at the same time improving the attraction effect of the third pressing member on the liquid.

[0022] Preferably, the ratio of the length of the fifth end to the thickness of the marker pad is 30 - 200:1, and the ratio of the length of the seventh end to the thickness of the sample pad is 30 - 200:1.

[0023] In the above solution, the thicker the marker pad, the greater the length of the fifth end that can be supported. Similarly, the thicker the sample pad, the greater the length of the seventh end that can be supported. Within the above range, the marker pad and the sample pad are not easily damaged by the pressing members during folding and placement, and at the same time, the influence of their own folding areas is small, and it is not easy to cause damage to the flow channel structure due to film breakage in the contact area.

[0024] Preferably, there is a blood filtration membrane between the fifth end and the second end, and the blood filtration membrane at least completely covers all the contact areas between the fifth end and the second end.

[0025] In the above solution, the blood filtration membrane can filter cell debris and other structures in the blood, reducing the influence of sample self - contamination on the test results.

[0026] Preferably, the ratio of the thickness of the blood filtration membrane to the thickness of the NC is 0.1 - 1:1.

[0027] The blood filtering membrane is usually relatively thin to reduce its influence on liquid flow. However, during the laying process, the blood filtering membrane will be folded on the surface of the chromatographic test strip. Therefore, the greater the thickness of the chromatographic test strip, the greater the thickness of the blood filtering membrane required to maintain its good filtering performance.

[0028] In summary, in the present application, an immunoassay test strip is provided, which has a stacked sample pad and a marker pad, and does not form a three-layer composite structure with the chromatographic test strip, so that the internal structure of the external housing has a uniform thickness, good liquid flow uniformity, and is not easily damaged during production, storage, and use. Description of the Drawings

[0029] Figure 1 It is a schematic cross-sectional structure diagram of the immunoassay test strip in Example 1 (the dropping hole and the window are not shown);

[0030] Figure 2 It is a schematic cross-sectional structure diagram of the immunoassay test strip in Example 2 (the dropping hole and the window are not shown).

[0031] In the figure, 1. External housing; 2. Bottom plate; 3. Chromatographic test strip; 31. First end; 32. Second end; 4. Absorbent pad; 41. Third end; 42. Fourth end; 5. Marker pad; 51. Fifth end; 52. Sixth end; 6. Sample pad; 61. Seventh end; 62. Eighth end; 71. First pressing member; 72. Second pressing member; 73. Third pressing member; 8. Blood filtering membrane. Detailed Embodiments

[0032] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0033] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0034] In the description of the present utility model, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", and "coupling" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0035] Embodiment 1. An immune reaction detection test strip, as Figure 1 shown, which has an external housing 1. There is a cavity inside the external housing 1, and a bottom plate 2 is arranged inside the cavity. The bottom plate 2 is a rectangular structure made of rigid PP or PTFE material and is laid at the bottom of the internal space of the external housing 1. A chromatographic test strip 3 is laid on the bottom plate 2. A water absorption pad 4 is arranged at one end of the chromatographic test strip 3, and a marker pad 5 and a sample pad 6 are arranged on the other side. In this embodiment, the water absorption pad 4 is made of cotton fiber material, the chromatographic test strip 3 is an NC membrane, the marker pad 5 and the sample pad 6 are made of glass fiber material, and colloidal gold is loaded on the marker pad 5 as a color developer. During the installation process, the external housing 1 generally has two upper and lower parts, and it can be installed by a snap structure, welding, adhesive bonding or other means. The bottom plate 2 can be fixed inside the external housing 1 by bonding or snap connection. In addition, the surface of the external housing 1 has a liquid dropping hole and a viewing window (not shown in the figure).

[0036] Specifically, referring to Figure 1 , the length of the marker pad 5 is 95 mm and the thickness is 130 μm. It has a first end 31 connected to the water absorption pad 4 and a second end 32 close to the marker pad 5. The thickness of the water absorption pad 4 is 165 μm and the total length is 30 mm. It has a third end 41 stacked on the first end 31 and a fourth end 42 away from the chromatographic test strip 3. The projected length of the third end 41 on the plane where the bottom plate 2 is located is 15 mm. The second end 32 of the chromatographic test strip 3 is connected to the marker pad 5. The thickness of the marker pad 5 is 110 μm and the overall length is 42 mm. The marker pad 5 has a fifth end 51 and a sixth end 52. The fifth end 51 is laid on the third end 41, and the sixth end 52 is arranged on the bottom plate 2. The overall thickness of the sample pad 6 is 105 μm and the length is 38 mm. It has a seventh end 61 and an eighth end 62. The seventh end 61 is laid on the sixth end 52, and the eighth end 62 is arranged on the bottom plate 2. Specifically, the projected length of the fifth end 51 on the plane where the bottom plate 2 is located is 15 mm, the projected length of the seventh end 61 on the plane where the bottom plate 2 is located is 15 mm, and the distance between the projections of the fifth end 51 and the seventh end 61 on the plane where the bottom plate 2 is located is 3 mm. The marker pad 5, the sample pad 6, the detection test strip and the water absorption pad 4 all adopt the same width as the bottom plate 2, and the width is.

[0037] Reference Figure 1 , there is a pressing member inside the external housing 1. The pressing member is located on the upper surface inside the external housing 1 and is used to press each structure against the bottom plate 2. The pressing member includes a first pressing member 71 for pressing the fifth end 51 against the second end 32 and a second pressing member 72 for pressing the seventh end 61 against the sixth end 52. The contact area between the first pressing member 71 and the fifth end 51 is 3 mm 2 , and the contact area between the second pressing member 72 and the seventh end 61 is 3 mm 2 . It should be noted that when measuring the contact area here, only the area of the release area projected on the plane where the bottom plate 2 is located is considered, and the increase in the contact area caused by the deformation of the sample pad 6 and the marker pad 5 caused by the first pressing member 71 and the second pressing member 72 is not considered. The pressing member also includes a third pressing member 73 for pressing the absorbent pad 4 against the bottom plate 2 and the chromatographic test strip 3. The projected area of the third pressing member 73 on the absorbent pad 4 is smaller than the projected area of the first pressing member 71 on the marker pad 5 and the projected area of the second pressing member 72 on the sample pad 6. (In this solution, the projected area of the third pressing member 73 on the absorbent pad 4 is 2 mm 2 , and its shape is cylindrical) to improve the water absorption effect of the absorbent pad 4. The shape and area of the pressing member can be adjusted. Generally, it is necessary to control that the projection of the first pressing member 71 on the bottom plate 2 is less than 10% of the projection area of the fifth end 51 on the bottom plate 2, and the projection of the second pressing member 72 on the bottom plate 2 is less than 10% of the projection area of the seventh end 61 on the bottom plate 2.

[0038] It should be noted that in this embodiment, the length and thickness parameters of each structure are for reference only. In actual situations, according to the specifications of the housing, the length, thickness, and area parameters of each component can be adjusted, but the adjustment process should meet the following conditions: The distance between the seventh end 61 and the fifth end 51 can be adjusted within the range of 0.5 - 5 mm, which can ensure the structural stability and at the same time reduce the uneven structure on the test strip, facilitating installation and fixation. The ratio of the length of the third end 41 to the thickness of the chromatographic test strip 3 is 50 - 300:1, thereby providing better flow channel stability. The ratio of the length of the fifth end to the thickness of the marker pad is 30 - 200:1, and the ratio of the length of the seventh end to the thickness of the sample pad is 30 - 200:1. Within this range, there is better liquid flow stability, and overall, better quality control effects can be achieved.

[0039] Example 2, reference Figure 2, on the basis of Embodiment 1, a blood filtration membrane 8 made of PES material is further added. The blood filtration membrane 8 is arranged between the fifth end 51 and the second end 32, and it completely covers all the contact areas between the fifth end 51 and the second end 32 to isolate the marker pad 5. The thickness of the blood filtration membrane 8 is 35 μm. In other solutions, the ratio of the thickness of the blood filtration membrane 8 to the thickness of the NC membrane can be controlled within the range of 0.1-1:1.

[0040] The above embodiments are only the preferred embodiments of the present invention, and the scope of protection of the present invention cannot be limited thereby. Any non-substantial changes and substitutions made by those skilled in the art on the basis of the present invention belong to the scope of protection required by the present invention.

Claims

1. An immunological reaction detection test strip, characterized in that, It includes a bottom plate, a chromatographic test strip laid on the bottom plate, and an external housing. The chromatographic test strip has a first end and a second end. A blotting pad is connected to the first end. The blotting pad has a third end and a fourth end. A marker pad carrying a load marker is connected to the second end. The marker pad has a fifth end and a sixth end. The fifth end is laid on the second end. A sample pad is connected to the sixth end. The sample pad has a seventh end and an eighth end. The seventh end is laid on the sixth end. The projections of the fifth end and the seventh end on the plane of the bottom plate do not overlap.

2. The immunological reaction detection test strip according to claim 1, characterized in that, The distance between the side of the seventh end close to the fifth end and the fifth end is 0.5 - 5 mm.

3. The immunoresponse detection test strip according to claim 1, wherein The external housing is provided with a first pressing member for pressing the fifth end tightly against the second end and a second pressing member for pressing the seventh end tightly against the sixth end. The contact area between the first pressing member and the fifth end is less than 10% of the area of the fifth end, and the contact area between the second pressing member and the seventh end is less than 10% of the area of the seventh end.

4. The immunological reaction detection test strip according to claim 3, wherein There is a gap between the first pressing member and the second pressing member.

5. An immunological reaction detection test strip according to claim 3, characterized in that, The third end is laid on the first end. The external housing is provided with a third pressing member for pressing the blotting pad tightly against the bottom plate or the chromatographic test strip.

6. An immune reaction detection test strip according to claim 5, characterized in that The ratio of the length of the third end to the thickness of the chromatographic test strip is 50 - 300:

1.

7. An immunological reaction detection test strip according to claim 6, characterized in that, The projected area of the third pressing member on the blotting pad is smaller than the projected area of the first pressing member on the marker pad and the projection of the second pressing member on the sample pad.

8. The immunoresponse detection test strip according to claim 1, wherein The ratio of the length of the fifth end to the thickness of the marker pad is 30 - 200:1, and the ratio of the length of the seventh end to the thickness of the sample pad is 30 - 200:

1.

9. An immune reaction detection test strip according to claim 1, wherein, There is also a blood filtering membrane between the fifth end and the second end. The blood filtering membrane at least completely covers all the contact areas between the fifth end and the second end.

10. An immunological reaction detection test strip according to claim 9, characterized in that, The ratio of the thickness of the blood filtering membrane to the thickness of the chromatographic test strip is 0.1 - 1:1.

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