Membrane-pad integrated chromatography test strip

Abstract

The utility model provides a membrane and pad integrated chromatography test strip, relates to the technical field of immunodetection, and solves the technical problems that the existing chromatography test strip is complicated in manufacturing process, serious in manufacturing environment pollution and inconsistent in batch performance. The kit comprises a bottom plate, an NC membrane and an absorption pad, the NC membrane and the absorption pad are arranged on the bottom plate, a binding area for embedding an antibody marker, a detection line T and a quality control line C are arranged on the NC membrane, and a sample adding area for adding a sample is further arranged in front of the binding area of the NC membrane. The device is relatively simple in structure, safe and controllable, reduces use of harmful materials such as glass fibers, and reduces errors caused by operability of workers and injuries to the workers; the ordered NC membrane is more beneficial to control of in-plate difference between plates compared with a disordered combination pad material, and CV can be better controlled; compared with the prior art, the method that the marker is embedded on the NC membrane has the advantages that the release time can be greatly shortened, the detection time of the product can be shortened, and the operation time error-tolerant rate of terminal operators can be greatly increased.

Description

Technical Field

[0001] The utility model relates to the technical field of immunoassay, and particularly to an integrated membrane pad chromatographic test strip. Background Technique

[0002] In chromatography, the structure of a traditional chromatographic test strip consists of a sample pad, a conjugate pad, a nitrocellulose membrane (NC membrane), an absorbent pad, and a PVC bottom plate. During the sample test reaction process, a liquid sample is added to the sample pad, and chromatography starts through capillary action in the sample pad and sequentially passes through the conjugate pad, the NC membrane, and reaches the absorbent pad. In this structure, the chromatographic form of the liquid determines the uniformity and stability of the detection reaction, while the structures of the sample pad and the conjugate pad determine the chromatographic form of the liquid.

[0003] Existing chromatographic test strips, such as Figure 1 the traditional chromatographic test strip shown and a double-sample-pad colloidal gold immunochromatographic test strip proposed in the patent with the publication number CN115308406A, include five parts: a sample pad, a bottom plate, a nitrocellulose membrane, a gold-labeled pad, and an absorbent pad. The present invention also discloses the structure of a double-layer sample pad test strip. Its structure except for the double-layer sample pad is the same as that of the existing conventional chromatographic test strip, and its manufacturing process is relatively complex, increasing the operation difficulty of the staff and also increasing the consumable cost.

[0004] The structures of the sample pad and the conjugate pad are usually made of materials such as glass fiber, polyester film, and non-woven fabric. Relatively speaking, the structures of these materials are in a disordered state. This disordered state is not only reflected between batches of materials, but also within batches and even within a single pad. This disorder leads to inconsistent release speeds and release degrees of the labeling substances in the chromatographic test strips of the same batch, resulting in relatively poor within-batch precision and difficult-to-control between-batch precision.

[0005] When the materials of the sample pad and the conjugate pad are made of glass fiber, a large amount of glass fiber dust will be generated during the production process. These dusts are harmful to the human body (for example: ① Skin lesions: The skin barrier is damaged, resulting in symptoms such as contact dermatitis, blisters, and skin necrosis; ② Respiratory system: Inhaled into the lungs and unable to be discharged or inhaled by itself for a long time, pneumoconiosis in occupational diseases may occur; ③ Eye diseases: Conjunctivitis, keratitis, etc. Symptoms such as conjunctival congestion, increased eye secretions, and tearing may also occur), which will cause serious pollution to both the operator and the environment.

[0006] Under the existing process, the conjugate pad usually carries markers (markers include but are not limited to microspheres, colloidal gold, quantum dots, fluorescein, etc.). Usually, the markers are treated on the conjugate pad by spraying or uniform coating; thus, the uniformity of the conjugate pad determines the distribution of the markers. As described above, the disordered state of the conjugate pad will lead to uncontrolled distribution.

[0007] During the chromatography process of liquid samples, there are transfers between different materials in the combination pad, sample pad, and NC membrane. This transfer is achieved by overlapping the materials on top of each other. The operator overlaps and joins the three materials on the PVC bottom plate to form a large chromatography test strip board. The overlapping position is usually only 1-2 mm. When the large chromatography test strip board is cut into strips through a process, this overlapping and joining method will cause a certain defective rate, resulting in a decline in the performance within the test strip batch. Summary of the Invention

[0008] The purpose of the present utility model is to provide an integrated membrane-pad chromatography test strip to solve the technical problems of complex manufacturing process, serious environmental pollution during manufacturing, and inconsistent performance within the batch of existing chromatography test strips.

[0009] The embodiments of the present utility model are achieved through the following technical solutions:

[0010] An integrated membrane-pad chromatography test strip includes a bottom plate, an NC membrane and an absorption pad provided on the bottom plate. The NC membrane is provided with a binding area for embedding antibody markers and a reaction area (62) for detection. The NC membrane (6) is also provided with a sample addition area (61) for adding samples in front of the binding area (8).

[0011] Preferably, the binding area includes an embedding area for embedding antibody markers.

[0012] Preferably, the antibody markers in the binding area are embedded in the embedding area in a liquid form and fixed in the embedding area through drying.

[0013] Preferably, the reaction area includes a test line T and a quality control line C. The test line T and the quality control line C are not limited to 1 strip and may include multiple recognizable strips.

[0014] Preferably, a sample pad is further provided on the sample addition area, and the sample pad is connected to both the bottom plate and the NC membrane.

[0015] Preferably, the bottom plate, the sample pad, the NC membrane and the absorption pad are adhesively connected.

[0016] Adopting this technical solution, when adding a sample from the sample addition area, the sample flows from the sample addition area to the NC membrane through chromatography. When flowing through the binding area on the NC membrane, it reacts with the antibody-markers embedded on the marker line, and a complex with a marker is formed by combination. Then it chromatographs to the reaction area and passes through the T line and the C line in sequence. When the analyte in the sample has a certain concentration, usually this concentration has a correlation with the marker signal, and the concentration of the analyte is obtained through this correlation;

[0017] In this technology, the raw material sample pads, NC membranes, and absorption pads to be pasted have relatively simple structures, are safe and controllable, and reduce errors caused by the operation of staff; the materials of the sample pads include, but are not limited to, materials produced by the same or similar processes such as glass fiber, polyester film, nylon film, cellulose acetate film, non-woven fabric, etc.;

[0018] In this technology, the marker is embedded not on the conjugate pad but on the nitrocellulose membrane (NC membrane). The ordered NC membrane is more conducive to controlling the differences between plates and within plates than the disordered conjugate pad material, and can better control the CV; the materials of the conjugate pads include, but are not limited to, materials produced by the same or similar processes such as glass fiber, polyester film, nylon film, cellulose acetate film, non-woven fabric, etc.;

[0019] In this technology, embedding the marker on the NC membrane will significantly shorten the release time compared with the previous process, which is beneficial to shortening the detection time of the product;

[0020] In this technology, after the marker is released, the change value of the signal value is small within a long time, which can greatly increase the operation time error tolerance rate of the terminal operator; the long time is defined as 3 - 25 minutes;

[0021] In this technology, the marker is directly embedded on the NC membrane in a liquid state, and it is possible to distinguish whether the marker line is evenly coated without the aid of external tools, which is convenient for reducing the working hours and error tolerance costs of the subsequent processes;

[0022] In this technology, within the sample application area of the NC membrane, the liquid sample starts chromatography through capillary action and successively chromatographs through the marker line and the reaction area of the NC membrane to reach the absorption pad. In this structure, the chromatography process of the liquid always occurs within the uniform NC membrane structure, thus ensuring the uniformity and stability of the liquid sample chromatography process;

[0023] In this technology, the sample application area on the NC membrane will be sprayed with the sample pad liquid to achieve the purpose of pre-treating the sample; at the same time, due to the pore structure of the NC membrane, it can filter the formed components (including microparticles, cells, etc.) in the sample. Due to the combination of the thickness of the NC membrane and the cassette, it can also temporarily store the liquid at this position;

[0024] In this technology, the marker line on the binding area plays the role of the original conjugate pad. After the marker is drawn at this position and dried, it can achieve the function of storing the marker. The NC membrane is used to filter the sample; this solution reduces the use of harmful materials such as glass fiber.

[0025] The technical solution of the embodiment of the present utility model has at least the following advantages and beneficial effects:

[0026] 1. The structure of the present utility model is relatively simple, safe and controllable, reducing the use of harmful materials such as glass fiber, and reducing the errors caused by the operation of staff and the harm to staff.

[0027] 2. The orderly NC membrane of the present utility model is more conducive to controlling the differences between and within plates than the disordered binding pad material, and can better control the CV.

[0028] 3. Embedding the marker on the NC membrane in the present utility model will greatly shorten the release time compared with the previous process, which is beneficial to shortening the detection time of the product and can greatly increase the operation time error tolerance rate of the terminal operator.

[0029] 4. The chromatography process of the liquid in the present utility model is always carried out in a uniform NC membrane structure, thus ensuring the uniformity and stability of the liquid sample chromatography process.

[0030] 5. Due to the pore structure of the NC membrane in the present utility model, it can achieve the function of filtering the formed components (including particles, cells, etc.) in the sample. Due to the combination of the thickness of the NC membrane and the cartridge, the liquid can also be temporarily stored at this position. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the drawings required to be used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present utility model, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative efforts.

[0032] Figure 1 It is a schematic diagram of the overall structure of the chromatography test strip provided by the prior art.

[0033] Figure 2 It is a schematic side view of an integrated membrane-pad chromatography test strip provided in Embodiment 1 of the present invention.

[0034] Figure 3 It is a schematic diagram of the structure of the NC membrane of an integrated membrane-pad chromatography test strip provided in Embodiment 1 of the present invention.

[0035] Figure 4 It is a schematic side view of an integrated membrane-pad chromatography test strip provided in Embodiment 2 of the present invention.

[0036] Reference numerals: 1, bottom plate; 2, sample pad; 3, binding pad; 4, test line T; 5, quality control line C; 6, NC membrane; 61, sample application area; 62, reaction area; 7, absorption pad; 8, binding area. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present utility model clearer, the technical solutions in the embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present utility model. Obviously, the described embodiments are some, but not all, of the embodiments of the present utility model. Components of the embodiments of the present utility model described and illustrated in the accompanying drawings here can be arranged and designed in various different configurations.

[0038] Therefore, the following detailed description of the embodiments of the present utility model provided in the accompanying drawings is not intended to limit the scope of the claimed present utility model, but merely represents selected embodiments of the present utility model. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present utility model without creative efforts fall within the scope of protection of the present utility model.

[0039] It should be noted that similar reference numerals and letters indicate similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0040] In the description of the present utility model, it should be noted that if terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of this application is usually placed during use, it is only for the convenience of describing the present utility model 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 utility model.

[0041] In the description of the present utility model, it should also be noted that unless otherwise clearly specified and defined, if terms such as "set", "installed", "connected", "connected" are 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 elements. 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 situations.

[0042] Embodiment 1

[0043] A membrane-pad integrated chromatography test strip, comprising a bottom plate 1, an NC membrane 6 and an absorption pad 7 provided on the bottom plate 1. A binding area 8 for embedding antibody markers and a reaction area 62 for detection are provided on the NC membrane 6. A sample adding area 61 for adding samples is further provided on the NC membrane 6 in front of the binding area 8.

[0044] In this embodiment, the binding region 8 includes an embedding region for embedding the antibody marker.

[0045] In this embodiment, the antibody marker in the binding region 8 is embedded in the embedding region in a liquid form and fixed in the embedding region by drying.

[0046] In this embodiment, the reaction region 62 includes a test line T4 and a quality control line C5.

[0047] In this embodiment, a sample pad 2 is further provided on the sample adding region 61, and the sample pad 2 is connected to both the bottom plate 1 and the NC membrane 6.

[0048] With this technical solution, a sample is added from the sample adding region 61. The sample flows from the sample pad 2 to the NC membrane 6 through chromatography. When flowing through the binding region 8 on the NC membrane 6, it reacts with the antibody - marker embedded on the marker line, and the combined product with the marker is generated. Then it chromatographs to the reaction region 62 and passes through the T line and the C line in sequence. When the analyte in the sample has a certain concentration, usually this concentration has a correlation with the marker signal, and the concentration of the analyte is obtained through this correlation.

[0049] In this technology, the marker is not embedded on the conjugate pad 3 but on the nitrocellulose membrane (NC membrane 6). The ordered NC membrane 6 is more conducive to controlling the between - plate and within - plate differences than the disordered conjugate pad 3, and can better control the CV. The materials of the conjugate pad 3 include but are not limited to materials produced by the same or similar processes such as glass fiber, polyester film, nylon film, cellulose acetate film, non - woven fabric, etc.

[0050] In this technology, embedding the marker on the NC membrane 6 will significantly shorten the release time compared with the previous process, which is beneficial to shortening the detection time of the product.

[0051] In this technology, after the marker is released, the change value of the signal value is small within a long time, which can significantly increase the operation time error tolerance rate of the terminal operator.

[0052] In this technology, the marker is directly embedded on the NC membrane 6 in a liquid form, and it is possible to distinguish whether the marker line is evenly coated without the aid of external tools, which is convenient for reducing the working hours of the subsequent processes and the error - tolerance cost.

[0053] In this technology, when a liquid sample is added within the range of the sample adding region 61 of the NC membrane 6, it starts chromatography through capillary action and chromatographs successively through the marker line and the reaction region 62 of the NC membrane 6 and reaches the absorption pad 7. In this structure, the chromatography process of the liquid always occurs in the uniform NC membrane 6 structure, thus ensuring the uniformity and stability of the chromatography process of the liquid sample.

[0054] In the present technology, the sample application area 61 on the NC membrane 6 is sprayed with the liquid of the sample pad 2, so as to achieve the purpose of pre-treating the sample; at the same time, due to the pore structure of the NC membrane 6, it can filter the formed components (including microparticles, cells, etc.) in the sample. Due to the combination of the thickness of the NC membrane 6 and the card shell, it can also temporarily store the liquid at this position;

[0055] In the present technology, the marker line on the binding area 8 plays the role of the original binding pad 3. After the marker is drawn at this position and dried, the function of storing the marker can be achieved. The filtration of the sample is achieved through the NC membrane 6.

[0056] Embodiment 2

[0057] The difference between this embodiment and Embodiment 1 is only that, in this embodiment, a sample pad 2 is further provided on the sample application area 61, and the sample pad 2 is simultaneously connected to the bottom plate 1 and the NC membrane 6.

[0058] In this embodiment, the bottom plate 1, the sample pad 2, the NC membrane 6 and the absorption pad 7 are adhesively connected.

[0059] In the present technology, the raw material sample pad 2, the NC membrane 6 and the absorption pad to be pasted have a relatively simple structure, are safe and controllable, and reduce the errors caused by the operation of the staff; this solution reduces the use of harmful materials such as glass fiber.

[0060] The above are only the preferred embodiments of the present utility model and are not used to limit the present utility model. For those skilled in the art, the present utility model can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present utility model shall be included in the protection scope of the present utility model.

Claims

1. An integrated membrane and pad chromatographic test strip, characterized in that: It includes a bottom plate (1), an NC membrane (6) and an absorption pad (7) provided on the bottom plate (1). A binding region (8) for embedding antibody markers and a reaction region (62) for detection are provided on the NC membrane (6). A sample addition region (61) for adding samples is further provided on the NC membrane (6) in front of the binding region (8).

2. The integrated membrane-pad chromatographic test strip according to claim 1, wherein: The binding region (8) includes an embedding region for embedding antibody markers.

3. The integrated membrane and pad chromatographic test strip according to claim 2, wherein: The antibody markers in the binding region (8) are embedded in the embedding region in a liquid form and fixed in the embedding region by drying.

4. A membrane-pad integrated chromatographic test strip according to any one of claims 1-3, characterized in that: The reaction region (62) includes a test line T (4) and a quality control line C (5).

5. A membrane-pad integrated chromatographic test strip according to any one of claims 1-3, characterized in that: A sample pad (2) is further provided on the sample addition region (61), and the sample pad (2) is connected to both the bottom plate (1) and the NC membrane (6).

6. The integrated membrane-pad chromatographic test strip according to claim 5, wherein: The bottom plate (1), the sample pad (2), the NC membrane (6) and the absorption pad (7) are adhesively connected.

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