New-mode chromatography reagent

Abstract

The utility model relates to the technical field of inspection and detection, in particular to a chromatography reagent with a new mode. The test strip is attached to the bottom lining and is used for separating, detecting and analyzing a sample; the sealing film covers the surfaces of the bottom lining and the test strip and is used for isolating the test strip from the external environment. According to the utility model, a sealed space is created for the bottom lining through the sealing film, so that the internal test strip and the external environment can be isolated to a certain extent, the situation that a reaction area is polluted by sample splashing and a reagent is scrapped during non-standard operation is prevented, and the performance of the reagent is optimized. Sealing can be carried out again after detection, pollution is reduced, and safety is higher. Compared with a conventional chromatography reagent, a detection card, a drying agent and other related components are omitted, the cost of the reagent is saved, and the reagent production process is simplified.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of inspection and detection, especially a new mode's chromatography reagent. BACKGROUND

[0002] The immune chromatography technology is a simple and rapid diagnostic method, and is also an important tool for point of care testing (POCT), and has been widely applied in the fields of clinical diagnosis, food safety, drug detection and environmental pollution, because of simple operation, rapid detection, good stability and convenient carrying.

[0003] The immune chromatography reagent is mainly composed of a bottom plate, a sample pad, a combination pad, an NC film and an absorption pad, and is also provided with a plastic shell, an aluminum foil bag, a drying agent and other accessories and packaging. Active proteins are coated on the NC film as a reaction area, and the active protein labeled tracer is located in the combination pad, the sample pad is used as a sample adding area, the absorption pad is used for draining chromatography and absorbing waste liquid, and the bottom plate is used for supporting the components; other accessories and packaging mainly play the roles of sealing, drying and protection. During the reaction, the sample moves forward along the film, and when the sample moves to the area where the active protein is fixed, the reactant in the sample specifically binds with the protein, and the tracer is labeled in the area, so that specific immune diagnosis is realized.

[0004] At present, most of the immune chromatography reagents sold on the market are exposed, and when the sample is splashed, the reaction area may be contaminated, which affects the detection result. At the same time, the whole reagent is in contact with air, and the chromatography process and the detection result are greatly affected by the detection environment. After the aluminum foil bag is torn open, the reagent is easily affected by moisture, and needs to be used within a short time, and the exposed immune chromatography reagent after use has the risk of polluting the environment and spreading diseases. SUMMARY

[0005] This part aims to summarize some aspects of the embodiments of the utility model and briefly introduce some preferred embodiments. Some simplifications or omissions may be made in this part and the abstract of the specification and the utility model name to avoid obscuring the purpose of this part, the abstract of the specification and the utility model name, and such simplifications or omissions cannot be used to limit the scope of the utility model.

[0006] In view of the above-mentioned problems that after the aluminum foil bag is torn open, the reagent is easily affected by moisture, needs to be used within a short time, and has the risk of polluting the environment and spreading diseases after use, the utility model is proposed.

[0007] Therefore, the utility model aims to provide a new mode of chromatography reagent, which can reduce the potential risk of immune chromatography reagent after use, and has better performance compared with conventional chromatography reagent.

[0008] To solve the above technical problems, the utility model provides the following technical scheme: A new mode's chromatography reagent, including,

[0009] The bottom lining;

[0010] The test paper strip is placed on the bottom lining and is used for sample separation, detection and analysis.

[0011] The sealing film covers the surface of the bottom lining and the test paper strip and is used for isolating the test paper strip from the external environment.

[0012] In the utility model, the covering mode of the sealing film and the paper strip, the sealing film and the bottom lining includes adhesive paste, hot covering, electrostatic adsorption and bonding.

[0013] As a preferred scheme of the utility model's new mode's chromatography reagent, wherein: the test paper strip includes NC film, binding pad, absorption pad and bottom plate, the NC film is pasted along the bottom plate extension direction, the binding pad and the absorption pad are respectively overlapped on the opposite ends of the NC film and are used for detecting the measured object, and the NC film, binding pad and absorption pad are pasted on the bottom plate.

[0014] In the utility model, the NC film, binding pad and absorption pad are pasted on the bottom plate, and then the test paper strip is integrally covered on the bottom lining through the sealing film, the NC film part of the test paper strip can be integrally wrapped, on the one hand, the risk of polluting the environment can be reduced, and on the other hand, compared with directly pasting the NC film, binding pad and absorption pad on the bottom plate, the performance of the test paper strip detection result is better.

[0015] As a preferred scheme of the utility model's new mode's chromatography reagent, wherein: the sealing film has a tear line, when the sealing film is torn along the tear line, the binding pad is exposed.

[0016] In the utility model, when the sealing film is torn along the tear line, the remaining sealing film covers the NC film and absorption pad of the test paper strip, the influence of the external environment on the chromatography reaction can be reduced, and the performance of the chromatography test result is improved, and compared with the technical scheme that the sealing film covers the binding pad, not covering the binding pad can avoid the chromatography flow abnormality caused by sample film overflow, and further avoid the invalid detection result.

[0017] As a preferred scheme of the utility model's new mode's chromatography reagent, wherein: the film is provided with a detection band and a control band, and further preferably, the detection band is arranged close to the binding pad, and the control band is arranged close to the absorption pad.

[0018] As a preferred scheme of the utility model's new mode's chromatography reagent, wherein: the test paper strip further includes a sample pad, and the sample pad is overlapped on the surface of the binding pad away from the absorption pad.

[0019] As a preferred scheme of the chromatography reagent of the new mode of the utility model, wherein: the closed film is transparent above the NC film.

[0020] As a preferred scheme of the chromatography reagent of the new mode of the utility model, wherein: the closed film does not destroy the three-dimensional structure of the NC film.

[0021] As a preferred scheme of the chromatography reagent of the new mode of the utility model, wherein: the tear opening line is close to the combination pad.

[0022] As a preferred scheme of the chromatography reagent of the new mode of the utility model, wherein: the closed film is integral structure, covers the surface of the bottom lining and the test strip, and exposes the combination pad.

[0023] In the utility model, the NC film and the absorption pad of the test strip are covered by the closed film, which can reduce the influence of external environment on the chromatography reaction and improve the specificity of the chromatography test result; at the same time, compared with the technical scheme that the closed film covers the combination pad, not covering the combination pad can avoid the chromatography flow abnormality caused by sample film overflow, and further cause the invalidity of the detection result.

[0024] As a preferred scheme of the chromatography reagent of the new mode of the utility model, wherein: the bottom lining has a containing groove, and the test strip is installed in the containing groove along the extension direction of the bottom lining.

[0025] The chromatography reagent of the new mode of the utility model has the beneficial effects that: a sealed space is created for the bottom lining by the closed film, which can play a certain isolation role on the internal test strip and external environment, prevent sample splashing and pollution of the reaction area caused by non-standard operation, cause the reagent to be scrapped, optimize the performance of the reagent, and better specificity. After detection, it can be sealed again, reduce pollution, and be safer. Compared with the conventional chromatography reagent, the detection card and the desiccant and other related components are saved, the cost of the reagent is saved, and the process of reagent production is simplified. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the technical scheme of the embodiment of the utility model, the drawings needed in the embodiment description will be briefly introduced as follows, obviously, the drawings in the following description are only some embodiments of the utility model, and for those skilled in the art, other drawings can be obtained without creative labor under the premise of the drawings. Among them:

[0027] Figure 1 It is the whole schematic view of the chromatography reagent of the new mode in example 1;

[0028] Figure 2 It is the whole schematic view of the chromatography reagent of the new mode in example 1;Figure 1 Schematic diagram of closed film tearing structure;

[0029] Figure 3 Overall schematic diagram of a new mode of chromatographic reagent in Example 2;

[0030] Figure 4 For Figure 3 Schematic diagram of side view structure;

[0031] Figure 5 Schematic diagram of side view structure with accommodation groove for a new mode of chromatographic reagent.

[0032] In the figure:

[0033] 100-bottom lining; 101-accommodation groove;

[0034] 200-test strip; 201-sample pad; 202-bonding pad; 203-NC film; 203a-detection band; 203b-control band; 204-absorbent pad; 205-bottom plate;

[0035] 300-closed film; 301-tear line. DETAILED DESCRIPTION

[0036] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0037] In the following description, many specific details are set forth in order to provide a thorough understanding of the present application, but the present application can also be implemented in other ways different from the description, and those skilled in the art can make similar generalizations without departing from the spirit of the present application, therefore the present application is not limited to the specific embodiments disclosed below.

[0038] Secondly, the "one embodiment" or "embodiment" referred to herein means that the specific features, structures or characteristics can be included in at least one implementation of the present application. In this specification, "in one embodiment" does not mean the same embodiment, nor is it an independent or alternative embodiment that excludes other embodiments.

[0039] Example 1, refer to Figure 1 and Figure 2 and Figure 5 The present application provides a new mode of chromatographic reagent, which comprises a bottom lining 100, a test strip 200 and a closed film 300.

[0040] The bottom liner 100 is usually made of plastic or other materials with certain rigidity and chemical corrosion resistance, such as polypropylene (PP), polystyrene (PS) or other components, or can be replaced by components with drying function to enhance the ability to keep reagents dry.

[0041] The test strip 200 includes an NC membrane 203, a conjugate pad 202, an absorbent pad 204, and a base plate 205. The NC membrane 203 is nitrocellulose membrane, which has good protein binding capacity and fluid conductivity. The NC membrane 203 is attached along the extension direction of the base plate 205 to ensure full contact with the sample liquid, which is used for detecting the analyte. The conjugate pad 202 is made of glass fiber or other porous carrier materials, which can effectively carry markers such as labeled colloidal gold particles, fluorescent particles, etc., to ensure the strength of the detection signal and guide the flow to the NC membrane 203. The absorbent pad 204 is made of filter paper or other water-absorbing materials, which has high liquid absorption capacity and speed, and can quickly absorb excess sample liquid to prevent sample liquid from overflowing and ensure smooth detection process.

[0042] The sealing film 300 is covered on the surface of the bottom liner 100 and exposes the conjugate pad 204, which facilitates sample addition. The material of the sealing film 300 can be other materials in addition to plastic film, such as polyester (PET), polyethylene (PE), polyamide (PA), polyvinyl chloride (PVC), polypropylene (PP), or other high molecular materials, or a mixture of two or more of the above materials, which can prevent external pollutants from entering and maintain the stability and integrity of the reagents, and is used to isolate the NC membrane 203 of the test strip 200 from the external environment. The covering method of the sealing film 300 and the bottom liner 100 includes adhesive bonding, thermal covering, electrostatic adsorption, and bonding, etc. As an option, the sealing film 300 has a tear line 301, which can be an opening way in the form of tearable glue, etc. When the sealing film 300 is torn along the tear line 301, the conjugate pad 204 of the test strip 200 is exposed, and the detection result is better than that of the conventional naked test strip 200.

[0043] The new mode of chromatographic reagent in this embodiment can reduce the influence of the external environment on the chromatographic reaction and improve the specificity of the chromatographic test result when the sealing film is torn along the tear line and the remaining sealing film covers the NC membrane and the absorbent pad of the test strip. Compared with the technical solution of covering the conjugate pad with the sealing film, not covering the conjugate pad can avoid the occurrence of chromatographic flow abnormalities caused by sample film overflow, which in turn leads to invalid detection results, etc.

[0044] This embodiment presents a new type of chromatography reagent, creating a sealed space for the backing 100 through a sealing membrane 300. This provides a certain degree of isolation between the internal test strip 200 and the external environment, preventing the risk of sample splashing and contamination of the reaction area caused by improper operation, which could render the reagent useless, and optimizing reagent performance. Furthermore, the reagent can be resealed after testing, reducing contamination and providing greater safety. Compared to conventional chromatography reagents, this eliminates the need for test cards, desiccant, and other related components, saving reagent costs and simplifying the reagent production process.

[0045] Each structure is described in detail below with reference to the accompanying drawings.

[0046] Example 1, with reference to Figure 1 The test strip 200 includes an NC membrane 203, a conjugation pad 202, an absorption pad 204, and a bottom plate 205. The NC membrane 203 is attached along the extension direction of the bottom plate 205. The conjugation pad 202 and the absorption pad 204 are respectively overlapped at opposite ends of the NC membrane 203 for detecting the analyte. The NC membrane 203, the conjugation pad 202, and the absorption pad 204 are attached to the bottom plate 205. Furthermore, the tear line 301 is set close to the conjugation pad 202.

[0047] By setting up the above structure, the NC membrane 203, the conjugation pad 202 and the absorption pad 204 are adhered to the base plate 205, and then the test strip 200 is entirely covered on the base 100 through the sealing film 300. The NC membrane 203 part of the test strip 200 can be wrapped as a whole, which can reduce the risk of environmental pollution on the one hand; on the other hand, compared with directly adhering the NC membrane 203, the conjugation pad 202 and the absorption pad 204 to the base plate 205, the specificity of the test results of the test strip 200 is better.

[0048] Reference Figure 2 and Figure 3 NC membrane 203 is provided with a detection band 203a and a control band 203b. Furthermore, detection band 203a is positioned adjacent to conjugate pad 202. When the analyte in the sample binds to the marker and migrates to detection band 203a, a color or fluorescent signal is displayed, indicating the presence of the analyte. Control band 203b, positioned adjacent to absorbent pad 204, indicates whether the test was successful. Control band 203b provides a control signal to ensure the proper functioning of the test process.

[0049] Furthermore, in order to evenly transfer the sample liquid to the conjugate pad 202, the test strip 200 also includes a sample pad 201, which is overlapped on the surface of the conjugate pad 202 away from the absorption pad 204. The sample pad 201 is made of materials such as glass fiber or cellulose and has good sample absorption and conduction capabilities.

[0050] The sample pad 201 can be pretreated as needed. For example, pretreatment containing buffer, surfactant, protein, reagent for capturing inclusions in the sample of the measured substance, preservative, antibacterial agent, antioxidant, hygroscopic agent, etc. can be performed. In addition, the shape of the sample pad 201 is not particularly limited, for example, as the size of the sample pad 201, considering the binding of the liquid to be tested and the diagnosis time, the length of the liquid flow is preferably about 10-25 mm, and the width perpendicular to the flow of the liquid is not a problem as long as it is greater than the width of the binding pad 202.

[0051] It should be noted that the lap joint of the present embodiment refers to ensuring close contact with each other by appropriate pressing or bonding.

[0052] In order to ensure that the three-dimensional structure of the binding pad 202 and the NC membrane 203 is not affected during the detection process, ensure the flow and reaction effect of the sample liquid on the NC membrane 203, and be able to be directly read, the sealing film 300 is transparent above the NC membrane 203. The sealing film 300 does not destroy the three-dimensional structure of the NC membrane 203 and the binding pad 202.

[0053] Referring to Figure 5 As an option, the backing 100 has a receiving groove 101, and the test strip 200 is installed in the receiving groove 101 along the extension direction of the backing 100.

[0054] By covering between the receiving groove 101 and the sealing film 300, a sealed space is created for the backing 100, which can further isolate the internal test strip 200 from the external environment.

[0055] Embodiment 2, referring to Figure 3 Figure 4 Basically the same as Embodiment 1, on the basis of Embodiment 1, the sealing film 300 is a whole structure, covering the surface of the backing 100 and the test strip 200, and exposing the binding pad 202, forming a closed interval, the closed interval can be from the upper side of the binding pad 202 to any area between the absorbent pad 204, and the preferred sealing film 300 does not destroy the three-dimensional structure of the NC membrane 203.

[0056] As one of the application scenarios of the new mode of chromatographic reagent:

[0057] Application Example 1: Verification of the anti-pollution performance of the novel coronavirus (2019-nCoV-Ag) antigen detection reagent kit (colloidal gold method).

[0058] ​After the positive sample is detected by using the conventional test strip, the sealed membrane strip (semi-closed), the tear-off sealed membrane strip (fully closed), and the detection card, the above strips are respectively placed in a sealed environment and stand for 15 min, and then are inverted 5 times to simulate the state after being discarded in daily use. Each group of strips is sampled at three fixed points in a closed environment, and the nucleic acid detection of the new coronavirus N gene is performed to confirm the safety according to the level of nucleic acid contamination. The detection results are shown in Table 1.

[0059] Table 1: Detection CT value results of different mode strips

[0060]

[0061]

[0062] (Note: The lower the CT value, the more serious the pollution.)

[0063] According to the above results, compared with the naked conventional test strip and the detection card, the sealed membrane strip and the tear-off sealed membrane strip using the closed film 300 to close (semi-closed) the reaction area of the test strip can effectively reduce the number of viruses in the environment, thereby reducing the risk of pollution environment. And the tear-off sealed membrane strip is better, and the detection result of the pathogen in the sealed environment is negative.

[0064] Application Example Two: Performance verification of the closed position of the novel coronavirus (2019-nCoV-Ag) antigen detection reagent kit (colloidal gold method).

[0065] The semi-closed sealed membrane strip is used, the NC membrane 203 of the test strip 200 is coated with murine 2019-nCoV recombinant N antigen monoclonal antibody and goat anti-mouse polyclonal antibody, and the conjugated pad 202 is attached with colloidal gold labeled murine 2019-nCoV recombinant N antigen monoclonal antibody. After the test strip 200 is assembled, the closed film 300 is located at different positions of the test strip 200, and the positive and negative coincidence rates of the detection results are compared with the conventional test strip and the detection card. The specific results are shown in Table 2.

[0066] Table 2: Comparison of results of different closed positions of the strip mode

[0067]

[0068] According to the above results, the negative sample coincidence rate of the sealed membrane strip is better than that of the conventional test strip and the detection card. If the sealing film 300 is located from the right end of the sample pad 201 to the right end of the absorption pad 204, the result will be invalid, and the coincidence rate of the reagent negative sample can be improved in other positions. It is speculated that the possible reason why the sealing film 300 is located from the right end of the sample pad 201 to the right end of the absorption pad 204 will cause the result to be invalid is that when the sealing film 300 is located at the right end of the sample pad 201, the chromatographic flow is abnormal during sample addition, and the sample to be tested cannot be normally coated and labeled, resulting in invalid results.

[0069] Application Example Three: Verification of Anti-pollution Performance of Influenza A Virus Antigen Detection Kit (Colloidal Gold Method).

[0070] After detecting the positive samples using the conventional test strip, the sealed membrane strip (semi-sealed), the tear strip type sealed membrane strip (fully sealed), and the detection card, the above strips were respectively placed in a sealed environment and left for 15 min, and then inverted 5 times to simulate the state after being discarded in daily use. Three sampling points were fixed in the sealed environment for each group of strips, and the influenza A virus M gene was detected by nucleic acid detection. The safety was confirmed by the level of nucleic acid pollution, and the detection results are shown in Table 3.

[0071] Table 3 Comparison of detection CT value results of different mode strips

[0072] Strip format Conventional test strip Sealed test strip Sealed test strip with tear-off tab Test card 1 17.30 29.23 Negative 25.09 2 23.16 26.21 Negative 24.94 3 18.39 29.62 Negative 24.31 Mean 19.61 28.35 Negative 24.78

[0073] (Note: The lower the CT value, the more serious the pollution.)

[0074] According to the above results, compared with the naked conventional test strip and the detection card, the sealed membrane strip and the tear strip type sealed membrane strip using the sealing film 300 to seal (semi-sealed) the reaction area of the test strip can effectively reduce the number of viruses in the environment, thereby reducing the risk of pollution in the environment. And the tear strip type sealed membrane strip is better, and the detection result of the pathogen in the sealed environment is negative.

[0075] Application Example Four: Verification of Performance of Sealing Position of Influenza A Virus Antigen Detection Kit (Colloidal Gold Method).

[0076] A semi-sealed sealed membrane strip was used, the NC membrane 203 of the test strip 200 was coated with FluA antibody (mouse monoclonal antibody) and goat anti-mouse antibody (polyclonal antibody), and the combination pad 202 was attached with colloidal gold labeled FluA antibody (mouse monoclonal antibody). After assembling the test strip 200, the sealing film 300 was located at different positions of the test strip 200, and the positive and negative coincidence rates of the detection results were compared with those of the conventional test strip and the detection card. The specific results are shown in Table 4.

[0077] Table 4 Comparison of results of different sealing positions of the test strip

[0078]

[0079]

[0080] According to the above results, the negative sample coincidence rate of the sealed membrane paper strip is better than that of the conventional test paper strip and the detection card. If the sealing film 300 is from the right end of the sample pad 201 to the right end of the absorption pad 204, the result will be invalid, and other positions can improve the coincidence rate of the reagent negative sample. It is speculated that the possible reason why the sealing film 300 is set from the right end of the sample pad 201 to the right end of the absorption pad 204 will cause the result to be invalid is that when the sealing film 300 is set at the right end of the sample pad 201, the chromatographic flow is abnormal during sampling, and the sample to be tested cannot be normally combined with the coating or label, resulting in invalid results.

[0081] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present application and are not limiting. Although the present application has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solutions of the present application can be modified or replaced without departing from the spirit and scope of the technical solutions of the present application, and they should be included in the scope of the claims of the present application.

Claims

1. A new type of chromatography reagent, characterized in that: include, Bottom lining (100); A test strip (200) is placed on the substrate (100) and is used for separation, detection and analysis of samples; The sealing film (300) is covered on the substrate (100) and the surface of the test strip (200) and is used to isolate the test strip (200) from the external environment.

2. The novel chromatography reagent according to claim 1, wherein: The test strip (200) comprises an NC membrane (203), a conjugated pad (202), an absorption pad (204) and a base plate (205); the NC membrane (203) is attached along the extension direction of the base plate (205); the conjugated pad (202) and the absorption pad (204) are respectively overlapped at opposite ends of the NC membrane (203) for detecting an analyte; the NC membrane (203), the conjugated pad (202) and the absorption pad (204) are attached to the base plate (205).

3. The novel chromatography reagent according to claim 2, characterized in that: The closing film (300) has a tear line (301), and when the closing film (300) is torn along the tear line (301), the binding pad (202) is exposed.

4. The novel chromatography reagent according to claim 2, wherein: The NC film (203) is provided with a detection band (203a) and a control band (203b).

5. The novel chromatography reagent according to claim 2, characterized in that: The test strip (200) further includes a sample pad (201), and the sample pad (201) is overlapped on the surface of the conjugate pad (202) away from the absorption pad (204).

6. The novel chromatography reagent according to claim 2, characterized in that: The sealing film (300) is located above the NC film (203) and is transparent.

7. The novel chromatography reagent according to claim 2, characterized in that: The sealing film (300) does not destroy the three-dimensional structure of the NC film (203).

8. The novel chromatography reagent according to claim 3, characterized in that: The tear line (301) is arranged close to the bonding pad (202).

9. The novel chromatography reagent according to claim 2, characterized in that: The sealing membrane (300) is an integral structure, covering the surface of the base (100) and the test strip (200), and exposing the conjugation pad (202).

10. The new type of chromatography reagent according to any one of claims 1 to 9, characterized in that: The base liner (100) has a receiving groove (101), and the test strip (200) is installed in the receiving groove (101) along the extension direction of the base liner (100).

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