Immunochromatography detection reagent card

Abstract

The utility model belongs to the field of rapid diagnosis and detection, and particularly relates to an immunochromatography detection reagent card which comprises two parts, namely a reagent card body and a reagent cap, has few parts and is convenient to carry; when the reagent card is specifically used, the cover body on the sample putting opening is opened, a sample (such as a sampling swab) is put into the reagent bin through the sample putting opening, the cover body is covered, the sample and a reagent in the reagent bin are uniformly mixed, then the insertion part of the reagent card body is inserted into the channel on the cap body, and force is applied, so that the insertion part punctures the sealing film and extends into the reagent bin; the sample pad of the test strip absorbs sample liquid through the liquid inlet for detection, and the whole process is simple and rapid to operate; compared with dropper dropping and sampling, the immunochromatography detection reagent card can automatically load samples by being inserted, so that the risk of cross interference in the detection process is avoided.

Description

Technical Field

[0001] This application relates to the field of rapid diagnostic testing technology, and in particular to an immunochromatographic assay reagent card. Background Technology

[0002] Immunochromatographic assay (ICA) is an analytical method developed in the late 20th century that combines immunoassay and chromatographic techniques. This method is characterized by its specificity, simplicity, and speed, and is widely used in important fields such as clinical diagnosis, environmental monitoring, and food safety. The principle of immunochromatography is as follows: specific antibodies / antigens are first immobilized in strips on a nitrocellulose membrane. Then, labeled antibodies / antigens are adsorbed onto a conjugate pad. When the sample is added to the sample pad at one end of the test strip, the absorbent paper causes the sample to move forward along the membrane. When it reaches the area in the conjugate pad where antibodies / antigens are adsorbed, the corresponding antigen / antibody in the sample specifically binds to the antibody / antigen in the conjugate pad. It continues to precipitate forward and is captured by the antibodies / antigens immobilized on the nitrocellulose membrane, accumulating on the detection band, thus forming a labeled antigen / antibody reaction complex. Currently, immunogold or immunoenzyme staining is often used as the antigen / antibody marker to achieve visually observable colorimetric results, thereby realizing specific immunodiagnosis.

[0003] Existing immunochromatographic assay kits for respiratory diseases typically consist of a test kit, sample diluent, dropper, and disposable sampling swabs, making them complex and cumbersome to operate. Sample addition is primarily done by dropping, which can lead to problems such as the dropper failing to dispense the sample or clogging the membrane when the sample is too viscous or contains many impurities. Furthermore, the dropping method increases the risk of cross-interference during the testing process. Utility Model Content

[0004] This application provides an immunochromatographic assay kit to address the problems of existing immunochromatographic assay kits having many components, cumbersome operation, and increased cross-interference during the addition process.

[0005] To achieve the above objectives, this application provides an immunochromatographic assay kit, comprising:

[0006] The reagent card body includes a housing with an observation window and a test strip disposed within the housing. The housing has an insertion part, and the front end of the insertion part has a liquid inlet. The sample pad of the test strip is located within the liquid inlet.

[0007] A reagent cap includes a cap body and a cover. The cap body has a reagent chamber for filling liquid reagents inside. The cap body has a channel for inserting an insertion part into the reagent chamber. One end of the channel near the reagent chamber is sealed by a sealing film that can be punctured by the insertion part. The cap body also has a sample dispensing port that communicates with the reagent chamber. The cover blocks the sample dispensing port.

[0008] Optionally, the inlet is covered with a filter screen.

[0009] Optionally, the insertion part is provided with a sharp part for piercing the sealing membrane.

[0010] Optionally, the immunochromatographic assay reagent card further includes a limiting member, wherein the front end of the insertion part is inserted into the channel and spaced apart from the sealing membrane, and the limiting member is detachably disposed at the rear end of the insertion part. After the limiting member is removed, the insertion part can puncture the sealing membrane and extend into the reagent chamber under the action of external force.

[0011] Optionally, the limiting member has two spaced-apart elastic clamping portions, and the rear end of the insertion portion is clamped between the two elastic clamping portions.

[0012] Optionally, one of the outer wall of the front end of the insertion part and the inner wall of the channel is provided with an elastic protrusion, and the other is provided with a slot adapted to the elastic protrusion. The front end of the insertion part is inserted into the channel and the elastic protrusion and the slot are engaged with each other. The front end of the insertion part is spaced apart from the sealing film.

[0013] Optionally, the insertion part is cylindrical, the outer side wall of the insertion part is provided with external threads, the inner side wall of the channel is provided with internal threads adapted to the external threads, the front end of the insertion part is threadedly connected to the channel and spaced apart from the sealing film.

[0014] Optionally, the length of the insertion portion is greater than the length of the channel.

[0015] Optionally, the cover and the sample dispensing port are connected by a thread or an interference fit.

[0016] Optionally, the housing includes an upper cover and a lower base that interlock, with a gap between the upper cover and the lower base for accommodating the test strip, and the observation window is disposed on the upper cover.

[0017] The beneficial effects of the immunochromatographic assay reagent card provided in this application are as follows: Compared with the prior art, the immunochromatographic assay reagent card of this application includes two parts: the reagent card body and the reagent cap. It has fewer parts and is easy to carry. The shell of the reagent card body has an insertion part, and the front end of the insertion part is provided with a liquid inlet. The sample pad of the test strip is located inside the liquid inlet. The inside of the reagent cap has a reagent chamber for filling liquid reagents (such as lysis buffer or diluent). The cap body is provided with a channel for the insertion part to be inserted into the reagent chamber. The end of the channel near the reagent chamber is sealed by a sealing film. The cap body is also provided with a sample dispensing port that communicates with the reagent chamber. The cap body seals the sample dispensing port. In practical use, open the cover on the sample dispensing port, put the sample (such as a sampling swab) into the reagent chamber through the sample dispensing port, close the cover, mix the sample with the reagent in the reagent chamber, then insert the insertion part of the reagent card body into the channel on the cap and apply force so that the insertion part punctures the sealing film and extends into the reagent chamber. The sample pad of the test strip draws the sample liquid through the liquid inlet for detection. The whole process is simple and quick. Compared with the dropper for sample addition, this immunochromatographic test reagent card automatically adds samples by insertion, avoiding the risk of cross-interference during the detection process. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] in:

[0020] Figure 1 This is a schematic diagram of the assembly of an immunochromatographic assay reagent card according to an embodiment of this application;

[0021] Figure 2 yes Figure 1 An exploded view of the immunochromatographic assay kit shown;

[0022] Figure 3 yes Figure 1 The diagram shows a cross-sectional view of the immunochromatographic assay reagent card.

[0023] Figure 4 This is a schematic diagram of the assembly of an immunochromatographic assay reagent card shown in another embodiment of this application;

[0024] Figure 5 yes Figure 4 The diagram shows a cross-sectional view of the immunochromatographic assay reagent card.

[0025] Figure 6This is a schematic diagram of the assembly of an immunochromatographic assay reagent card, as shown in another embodiment of this application;

[0026] Figure 7 yes Figure 6 The diagram shows a cross-sectional view of the immunochromatographic assay reagent card.

[0027] Explanation of key component symbols:

[0028] 100. Reagent card body;

[0029] 110. Shell; 1101. Observation window; 1102. Insertion part; 11021. Liquid inlet; 111. Top cover; 112. Bottom;

[0030] 120. Test strips;

[0031] 200. Reagent cap;

[0032] 210. Cap body; 2101. Reagent compartment; 2102. Passageway; 2103. Sample delivery port;

[0033] 220. Cover;

[0034] 300. Sealing film;

[0035] 400. Limiting component; 410. Elastic clamping part;

[0036] 500. Filter screen;

[0037] 600. Sharp point;

[0038] 700, elastic protrusion;

[0039] 800, Card Slot. Detailed Implementation

[0040] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings. Preferred embodiments of this application are shown in the drawings. However, this application can be implemented in many other different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of this application.

[0041] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0042] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0044] It should also be noted that in the embodiments of this application, the same reference numerals are used to represent the same component or part. For the same part in the embodiments of this application, the reference numerals may only be used to mark one part or component as an example. It should be understood that the reference numerals are also applicable to other identical parts or components.

[0045] An embodiment of this application provides an immunochromatographic assay reagent card, such as... Figures 1-7 As shown, the immunochromatographic assay kit includes a kit body 100 and a kit cap 200. The kit body 100 includes a housing 110 with an observation window 1101 and a test strip 120 disposed within the housing 110. The result display area of ​​the test strip 120 corresponds to the observation window 1101. The housing 110 has an insertion part 1102, and the front end of the insertion part 1102 is provided with a liquid inlet 11021. The sample pad of the test strip 120 is located within the liquid inlet 11021. The reagent cap 200 includes a cap body 210 and a cover 220. The cap body 210 has a reagent chamber 2101 for filling liquid reagents (such as lysis buffer or diluent). The cap body 210 is provided with a channel 2102 for inserting the insertion part 1102 into the reagent chamber 2101. It can be understood that the length of the insertion part 1102 is greater than the length of the channel 2102. The end of the channel 2102 near the reagent chamber 2101 is sealed by a sealing film 300. The sealing film 300 can be punctured by the insertion part 1102. The cap body 210 is also provided with a sample inlet 2103 communicating with the reagent chamber 2101. The cover 220 seals the sample inlet 2103.

[0046] When using this immunochromatographic assay test kit, open the cover 220 on the sample inlet 2103 of the cap 210, put the sample (such as a sampling swab) into the reagent chamber 2101 through the sample inlet 2103, close the cover 220, mix the sample with the reagent in the reagent chamber 2101, then insert the insertion part 1102 of the test kit body 100 into the channel 2102 on the cap 210 and apply force so that the insertion part 1102 punctures the sealing film 300 and extends into the reagent chamber 2101. The sample pad of the test strip 120 draws the sample liquid through the liquid inlet 11021 for detection. The detection result can be observed through the observation window 1101 on the shell 110 of the test kit body 100.

[0047] In this embodiment, the immunochromatographic assay reagent card comprises two parts: a reagent card body 100 and a reagent cap 200. With fewer components, it is easy to carry. The entire testing process is simple and rapid. Compared to dropper-based sample addition, this immunochromatographic assay reagent card automatically adds samples via insertion, preventing spillage and contamination, and avoiding the risk of cross-interference during testing. It also avoids leakage from the sample addition orrium, spillage onto the membrane, or excessive / insufficient sample addition during dropper-based addition. Furthermore, it reduces the likelihood of the dropper failing to dispense the sample or the reagent strip clogging the membrane when the sample is viscous or contains many impurities.

[0048] The immunochromatographic assay kit in this embodiment can be applied to various testing purposes, such as pregnancy testing and infectious disease diagnosis, and is compatible with different sample types, such as urine and blood. Simultaneously, it can reduce the risk of cross-infection and improve the safety of the test.

[0049] In one implementation, the housing 110 includes an upper cover 111 and a lower base 112 that interlock, with a gap formed between the upper cover 111 and the lower base 112 for accommodating a test strip 120. The test strip 120 is held between the upper cover 111 and the lower base 112, and an observation window 1101 is disposed on the upper cover 111. Figure 1 , Figure 4 and Figure 6 As shown, the cross-sectional dimension of the insertion part 1102 is smaller than the cross-sectional dimension of other parts of the housing 110, and the insertion part 1102 can be formed by reducing the size of one end of the housing 110. It should be noted that the connection method between the cover 220 and the sample delivery port 2103 includes, but is not limited to, threaded connection and interference fit.

[0050] In one embodiment, such as Figure 3 , Figure 5 and Figure 7As shown, a filter screen 500 covers the liquid inlet 11021 at the front end of the insertion part 1102. By setting the filter screen 500, the sample liquid entering the liquid inlet 11021 can be filtered to prevent the liquid inlet 11021 from becoming blocked.

[0051] In one embodiment, such as Figure 3 , Figure 5 and Figure 7 As shown, the insertion part 1102 is provided with a sharp part 600 for piercing the sealing membrane 300. By providing the sharp part 600 (such as a spike), during use, only a small amount of external force needs to be applied to the insertion part 1102 to pierce the sealing membrane 300, which is more labor-saving.

[0052] Understandably, the length of the insertion part 1102 should be greater than the length of the channel 2102. Preferably, the length of the insertion part 1102 is 1.5 to 2 times the length of the channel 2102. This configuration ensures that when the insertion part 1102 is inserted into the reagent chamber 2101 via the channel 2102, the liquid inlet 11021 at the front end of the insertion part 1102 is completely submerged in the sample solution within the reagent chamber 2101, guaranteeing that the sample pad of the test strip 120 can absorb the sample solution for detection.

[0053] In one embodiment, such as Figures 1-3 As shown, the immunochromatographic assay reagent card also includes a limiting member 400. The insertion part 1102 is divided into a front end and a rear end in its length direction. The front end of the insertion part 1102 is inserted into the channel 2102 and spaced apart from the sealing film 300. The limiting member 400 is detachably disposed at the rear end of the insertion part 1102. After the limiting member 400 is removed, the insertion part 1102 can puncture the sealing film 300 and extend into the reagent chamber 2101 under the action of external force.

[0054] With the above settings, the immunochromatographic assay kit will remain in the following state when not in use: Figure 1 and Figure 3 As shown, the front end of the insertion part 1102 is inserted into the channel 2102 on the cap body 210. The cap body 210 protects the front end of the insertion part 1102. The limiting member 400 prevents leakage caused by the external force puncturing the sealing film 300 during transportation and before use. In actual use, open the cover 220 on the sample dispensing port 2103 on the cap body 210, put the sample (such as a sampling swab) into the reagent chamber 2101 through the sample dispensing port 2103, close the cover 220, mix the sample with the reagent in the reagent chamber 2101, then remove the limiting member 400, press down the reagent card body 100 so that the insertion part 1102 moves downward in the channel 2102 and punctures the sealing film 300 before extending into the reagent chamber 2101. The sample pad of the test strip 120 can then draw the sample liquid through the liquid inlet 11021 for testing.

[0055] In one specific embodiment, such as Figure 1 and Figure 2 As shown, the limiting member 400 has two spaced-apart elastic clamping portions 410, and the rear end of the insertion portion 1102 is clamped between the two elastic clamping portions 410. By setting the limiting member 400 in this way, when it is necessary to remove the limiting member 400, it is only necessary to apply a lateral force to the limiting member 400 to pull the two elastic clamping portions 410 off the insertion portion 1102.

[0056] In another embodiment, such as Figures 4-5 As shown, one of the outer wall of the front end of the insertion part 1102 and the inner wall of the channel 2102 is provided with an elastic protrusion 700, and the other is provided with a slot 800 adapted to the elastic protrusion 700. The front end of the insertion part 1102 is inserted into the channel 2102 and the elastic protrusion 700 and the slot 800 are engaged with each other. The front end of the insertion part 1102 is spaced apart from the sealing film 300.

[0057] With the above settings, the immunochromatographic assay kit will remain in the following state when not in use: Figure 4 and Figure 5 As shown, the front end of the insertion part 1102 is inserted into the channel 2102 on the cap body 210. The cap body 210 protects the front end of the insertion part 1102. The elastic protrusion 700 cooperates with the card slot 800 to prevent leakage caused by the external force puncturing the sealing film 300 during transportation and before use. In practical use, open the cover 220 on the sample inlet 2103 of the cap 210, put the sample (such as a sampling swab) into the reagent chamber 2101 through the sample inlet 2103, close the cover 220, mix the sample with the reagent in the reagent chamber 2101, and then press down hard on the reagent card body 100. The elastic protrusion 700 can move out of the card slot 800 under the action of external force. As you continue to press down, the insertion part 1102 moves downward in the channel 2102 and punctures the sealing film 300 and extends into the reagent chamber 2101. The sample pad of the test strip 120 can then draw the sample liquid through the liquid inlet 11021 for detection.

[0058] In yet another embodiment, such as Figures 6-7 As shown, the insertion part 1102 is cylindrical, the outer side wall of the insertion part 1102 is provided with external threads, the inner side wall of the channel 2102 is provided with internal threads adapted to the external threads, the front end of the insertion part 1102 is threadedly connected to the channel 2102, and is spaced apart from the sealing film 300.

[0059] With the above settings, the immunochromatographic assay kit will remain in the following state when not in use: Figure 6 and Figure 7As shown, the front end of the insertion part 1102 is located inside the channel 2102 on the cap 210. The cap 210 protects the front end of the insertion part 1102. The insertion part 1102 is threadedly connected to the channel 2102, which can prevent leakage caused by the sealing film 300 being punctured by external force during transportation and before use. In actual use, open the cover 220 on the sample dispensing port 2103 on the cap 210, put the sample (such as a sampling swab) into the reagent chamber 2101 through the sample dispensing port 2103, close the cover 220, mix the sample with the reagent in the reagent chamber 2101, and then rotate the reagent card body 100. The insertion part 1102 moves downward in the channel 2102 and punctures the sealing film 300 before extending into the reagent chamber 2101. The sample pad of the test strip 120 can then draw the sample liquid through the liquid inlet 11021 for testing.

[0060] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0061] The above embodiments are merely illustrative of several implementation methods of this application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. An immunochromatographic assay reagent card, characterized in that, include: The reagent card body (100) includes a housing (110) with an observation window (1101) and a test strip (120) disposed within the housing (110). The housing (110) has an insertion part (1102), and the front end of the insertion part (1102) is provided with a liquid inlet (11021). The sample pad of the test strip (120) is located within the liquid inlet (11021). A reagent cap (200) includes a cap body (210) and a cover (220). The cap body (210) has a reagent chamber (2101) for filling liquid reagents inside. The cap body (210) is provided with a channel (2102) for inserting the insertion part (1102) into the reagent chamber (2101). One end of the channel (2102) near the reagent chamber (2101) is sealed by a sealing film (300). The sealing film (300) can be punctured by the insertion part (1102). The cap body (210) is also provided with a sample dispensing port (2103) communicating with the reagent chamber (2101). The cover (220) seals the sample dispensing port (2103).

2. The immunochromatographic assay kit according to claim 1, characterized in that, The inlet (11021) is covered with a filter screen (500).

3. The immunochromatographic assay kit according to claim 1, characterized in that, The insertion part (1102) is provided with a sharp part (600) for piercing the sealing membrane (300).

4. The immunochromatographic assay kit according to claim 1, characterized in that, The immunochromatographic assay reagent card also includes a limiting member (400). The front end of the insertion part (1102) is inserted into the channel (2102) and spaced apart from the sealing membrane (300). The limiting member (400) is detachably disposed at the rear end of the insertion part (1102). After the limiting member (400) is removed, the insertion part (1102) can puncture the sealing membrane (300) and extend into the reagent chamber (2101) under the action of external force.

5. The immunochromatographic assay kit according to claim 4, characterized in that, The limiting member (400) has two spaced elastic clamping portions (410), and the rear end of the insertion portion (1102) is clamped between the two elastic clamping portions (410).

6. The immunochromatographic assay kit according to claim 1, characterized in that, One of the outer wall of the front end of the insertion part (1102) and the inner wall of the channel (2102) is provided with an elastic protrusion (700), and the other is provided with a slot (800) adapted to the elastic protrusion (700). The front end of the insertion part (1102) is inserted into the channel (2102) and the elastic protrusion (700) and the slot (800) are engaged with each other. The front end of the insertion part (1102) is spaced apart from the sealing film (300).

7. The immunochromatographic assay reagent card according to claim 1, characterized in that, The insertion part (1102) is cylindrical, and the outer side wall of the insertion part (1102) is provided with an external thread. The inner side wall of the channel (2102) is provided with an internal thread that matches the external thread. The front end of the insertion part (1102) is threadedly connected to the channel (2102) and is spaced apart from the sealing membrane (300).

8. The immunochromatographic assay kit according to claim 1, characterized in that, The length of the insertion part (1102) is greater than the length of the channel (2102).

9. The immunochromatographic assay reagent card according to claim 1, characterized in that, The cover (220) and the sample dispensing port (2103) are connected by a thread or interference fit.

10. The immunochromatographic assay kit according to claim 1, characterized in that, The housing (110) includes an upper cover (111) and a lower bottom (112) that are interlocked, with a gap between the upper cover (111) and the lower bottom (112) for accommodating the test strip (120), and the observation window (1101) is disposed on the upper cover (111).

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