An antigen test kit and data collection system suitable for self-service testing

Abstract

The present invention discloses an antigen test kit and a data acquisition system suitable for self-service detection. The chromatographic detection card of the antigen test kit is arranged inside the test kit cartridge; the top surface of the upper cover of the test kit cartridge is provided with a serial number window, a result observation window and a sample addition port in sequence; the sample pad and the water absorbent pad are arranged at both ends of the reaction pad, and the sample pad, the water absorbent pad and the reaction pad are fixedly arranged between the upper cover of the test kit cartridge and the bottom cover of the test kit cartridge. The serial number of the antigen test kit, the text information of the detection barcode and the corresponding detection results are stored in the background database of the antigen test data acquisition system. The detection results of the present invention are displayed in the form of encrypted patterns. The pattern itself or the decrypted text cannot be used to judge the detection results. The detection results can only be obtained by matching with the serial number in the data acquisition system. The detection is accurate and fast, the device is simple, and it is easy to promote, and the accurate and fast centralized collection of the detection results can be realized.

Description

Technical Field

[0001] The present invention relates to an antigen testing kit, and in particular to an antigen testing kit suitable for self-service testing and a data acquisition system. Background Art

[0002] Coronavirus disease (Covid-19) is a severe respiratory illness caused by the SARS-CoV-2 virus.

[0003] The COVID-19 antigen test kit enables individuals to collect oropharyngeal swabs and nasopharyngeal swabs at home, perform tests and obtain results through simple operations. The entire antigen test process only takes 10-20 minutes and is completed entirely by individuals, making up for the many shortcomings of nucleic acid testing. However, the detection and result interpretation of existing antigen test kits are all completed by individuals, and it is impossible to achieve accurate and rapid centralized collection of whether the test is completed, when the test is conducted, and whether it is correctly interpreted. How to combine the advantages of simple, rapid, and distributed detection of the COVID-19 antigen test kit with the needs of large-scale centralized and rapid collection and ultimately obtain accurate test results is the key problem to be solved by the present invention. Summary of the invention

[0004] The present invention provides an antigen test kit and data collection system suitable for self-service testing. The essence of the system is to encrypt the antigen test results to eliminate incorrect test processes and incorrect test results, and use the unique serial number of the kit to achieve correct acquisition and centralized collection of test results, which well meets the requirements in actual scenarios.

[0005] The technical solution adopted by the present invention is:

[0006] 1. An antigen detection kit:

[0007] The antigen test kit comprises a test kit cartridge and a chromatographic test card, wherein the chromatographic test card is arranged inside the test kit cartridge; the test kit cartridge comprises a test kit cartridge upper cover and a test kit cartridge bottom cover, wherein a serial number window, a result observation window and a sample addition port are sequentially provided on the top surface of the test kit cartridge upper cover along the card length direction of the chromatographic test card, and the chromatographic test card is in the shape of a strip card.

[0008] The chromatography test card comprises a sample pad, a water absorbent pad and a reaction pad, which are arranged at both ends of the reaction pad and are fixedly arranged between an upper cover of a test kit housing and a bottom cover of the test kit housing.

[0009] The reaction pad comprises a test result area and a serial number area. The top surfaces of the sample pad, the test result area and the serial number area are respectively opposite to the sample adding port, the result observation window and the serial number window; the serial number area is provided with a serial number printed by oily ink.

[0010] After the pre-prepared sample solution is added to the sample pad through the sample adding port, it is sequentially chromatographed through the test result area and the serial number area on the reaction pad, and an encrypted pattern of the test result is displayed in the test result area.

[0011] The absorbent pad can absorb the excess sample solution overflowing from the reaction pad. During the test, add the sample liquid to the test buffer and stir it thoroughly. After it stands still, add it to the sample injection port. After waiting for a certain period of time, the test result will be displayed in the test result area in the form of an encrypted pattern.

[0012] The encrypted patterns are uniquely corresponding to the serial number of the serial number area on the reaction pad. The encrypted pattern itself or the text decrypted from the encrypted pattern cannot be directly used to determine the test result, and the test result can only be obtained by matching it with the corresponding serial number in the antigen test data collection system.

[0013] The encryption pattern is a one-dimensional barcode or a two-dimensional code, or other encryption patterns.

[0014] When the encryption pattern is a one-dimensional barcode, an initial barcode is provided on the test result area of ​​the reaction pad, and the initial barcode is composed of a plurality of colorless test lines T, a colorless marking line M and a colorless quality control line C arranged in an arrangement. The plurality of colorless test lines T, the colorless marking line M and the colorless quality control line C are arranged with a plurality of blank bands B arranged therebetween, and the arrangement of the initial barcode uniquely corresponds to the serial number of the serial number area of ​​the reaction pad where it is located.

[0015] The two ends of the initial barcode are the starting area and the ending area respectively, the middle part of the initial barcode is the coding area, the starting area is close to the sequence number area, and the ending area is close to the sample pad.

[0016] Only a number of colorless quality control lines C and a number of blank bands B are set in the starting area, only a number of colorless marking lines M and a number of blank bands B are set in the ending area, and only a number of colorless detection lines T, colorless marking lines M and a number of blank bands B are set in the coding area.

[0017] The coding area is evenly divided into a number of coding block areas. Each coding block area is provided with at most one detection line T, and the detection line T must be located between two marking lines M and not separated by blank bands B.

[0018] The labeling line M is fixed with a complementary nucleic acid aptamer, the detection line T is fixed with an antigen IgG, and the quality control line C is fixed with mouse anti-rabbit IgG.

[0019] When the sample solution is chromatographed to the test result area, the initial barcode changes color to form a test barcode. The text information represented by the test barcode is the test result, including positive results, negative results and invalid results, that is, the test result corresponding to the unique serial number on the antigen test kit.

[0020] When the sample solution is chromatographed to each marking line M of the initial barcode, the complementary nucleic acid aptamer on the marking line M contacts the sample solution, causing each marking line M to change color.

[0021] When the sample solution is chromatographed to each quality control line C of the initial barcode, the mouse anti-rabbit IgG of the quality control line C contacts the sample solution, causing each quality control line C to change color. If no color change occurs, the antigen test kit is damaged or the liquid added to the sample pad is not a sample solution, that is, the test result displayed by the test barcode is an invalid result.

[0022] When the sample solution is chromatographed to each detection line T of the initial barcode, if the antigen IgG on each detection line T contacts the sample solution so that each detection line T does not change color, the detection result displayed by the detection barcode is a negative result; if one or several of the detection lines T or all the detection lines T change color, the detection result displayed by the detection barcode is a positive result.

[0023] From the appearance, the test line T, marking line M and quality control line C before and after the test are exactly the same and cannot be distinguished by the naked eye.

[0024] The sample solution comprises a sample liquid and a detection buffer solution. The sample liquid is added to the detection buffer solution and then mixed evenly to form a sample solution.

[0025] The detection buffer comprises a colloidal gold-antigen IgG complex and a colloidal gold-nucleic acid aptamer complex.

[0026] The sample pad is arranged at one end of the reaction pad near the test result area, and the absorbent pad is arranged at the other end of the reaction pad near the serial number area. The sample pad and the absorbent pad are fixed between the upper cover of the test kit cartridge and the bottom cover of the test kit cartridge by a chromatography test card fixing column arranged on the bottom cover of the test kit cartridge.

[0027] 2. An antigen test data acquisition system for an antigen test kit:

[0028] The data acquisition system includes a data acquisition module and a barcode scanning device for converting the detection barcode into text information. The barcode scanning device can be a special barcode reader or a mobile phone software. The data acquisition module includes a front-end for data collection, such as a website, WeChat account, etc., and a back-end database for result matching and recording. The back-end database stores the serial numbers of all antigen test kits, the text information corresponding to each detection barcode corresponding to each serial number, and the test result corresponding to each text information, that is, each serial number corresponds to an actual test result.

[0029] For one of the antigen test kits to be collected, the user of the antigen test kit to be collected converts the detection barcode of the antigen test kit to be collected into text information through a barcode scanning device, and then the user inputs the serial number and text information of the antigen test kit to be collected into the front end of the data acquisition system; the back-end database of the data acquisition system first matches the serial number received by the front end with the serial number in the back-end database. If the serial number of the antigen test kit to be collected matches one of the serial numbers in the back-end database, the detection continues. If the serial number of the antigen test kit to be collected does not match any of the serial numbers in the back-end database, the front end of the data acquisition system outputs a re-input prompt, and the user re-enters the serial number of the antigen test kit to be collected. After the re-entered serial number of the antigen test kit to be collected matches one of the serial numbers in the back-end database, the preliminary matching is completed and the detection continues.

[0030] After the preliminary matching is completed, the back-end database queries the text information of all the detection barcodes corresponding to the serial number, and matches it with the text information of the antigen test kit to be collected. If the text information of the antigen test kit to be collected matches one of the text information in the back-end database, continue; if the text information of the antigen test kit to be collected is different from any text information in the back-end database, the front-end output of the data acquisition system will prompt the user to re-enter the preliminary matching process until the text information of the antigen test kit to be collected matches one of the text information in the back-end database. The front-end outputs and records the test result corresponding to the text information, and feeds back the test result to the user to complete the test.

[0031] When the test result output module outputs a retest prompt or an invalid result prompt, the sample liquid in the sample solution used by the antigen test kit to be collected needs to be recollected and a new sample solution is obtained, and the new antigen test kit is used for testing and collection.

[0032] The antigen test data collection system can provide real-time query functions for testing progress and results.

[0033] The beneficial effects of the present invention are:

[0034] 1. The results are presented through encrypted patterns, and the unique serial number corresponding to each antigen test kit is used to obtain the test results corresponding to each serial number to ensure the accuracy of the test results.

[0035] 2. Centralized management of test results is achieved by tracking the unique serial number of each antigen test kit.

[0036] 2. Distributed self-service testing methods greatly shorten the time required for mandatory screening and reduce the manpower and material costs of testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 For antigen test kit;

[0038] Figure 2 This is a schematic diagram of the explosion of the antigen test kit;

[0039] Figure 3 It is a schematic diagram of the structure of the chromatography detection card;

[0040] Figure 4 This is a schematic diagram of an example of the coding composition of the test result area in the chromatography test card;

[0041] Figure 5 It is a schematic diagram of the test result area in the chromatography test card and its various test barcode results;

[0042] Figure 5 (a) is a schematic diagram showing an example of the initial barcode arrangement in the test result area of ​​the chromatographic test card;

[0043] Figure 5 (b) is a schematic diagram showing an example of the test result area of ​​the chromatography test card before the test;

[0044] Figure 5 (c) is a schematic diagram of an example of a test barcode when the test result of the chromatographic test card is a negative result;

[0045] Figure 5 (d) is a schematic diagram of an example of a first test barcode when the test result of the chromatography test card is a positive result;

[0046] Figure 5 (e) is a schematic diagram of an example of a second test barcode when the test result of the chromatography test card is a positive result;

[0047] Figure 5 (f) is a schematic diagram of an example of a third test barcode when the test result of the chromatography test card is a positive result;

[0048] Figure 5(g) is a schematic diagram showing an example in which the test result of the chromatography test card is an invalid result;

[0049] Figure 6 A workflow of using the antigen detection kit of the present invention;

[0050] In the figure: 1. upper cover of the test kit cartridge, 2. chromatography test card, 3. bottom cover of the test kit cartridge, 4. fixing column of the chromatography test card, 5. serial number window, 6. result observation window, 7. sample injection port, 8. sample pad, 9. test result area, 10. serial number area, 11. water absorbent pad, 12. reaction pad. DETAILED DESCRIPTION

[0051] The present invention will be further described in detail below with reference to the accompanying drawings with reference to a specific embodiment of detecting novel coronavirus antigens.

[0052] The specific embodiments are as follows:

[0053] like Figure 1 and Figure 2 As shown, the antigen test kit comprises a test kit cartridge and a chromatographic test card 2, wherein the chromatographic test card 2 is arranged inside the test kit cartridge; the test kit cartridge comprises a test kit cartridge upper cover 1 and a test kit cartridge bottom cover 3, wherein a serial number window 5, a result observation window 6 and a sample addition port 7 are sequentially provided on the top surface of the test kit cartridge upper cover 1 along the card length direction of the chromatographic test card 2, and the chromatographic test card 2 is in the shape of a strip card.

[0054] The chromatography test card 2 includes a sample pad 8, a water absorbent pad 11 and a reaction pad 12, which are arranged at both ends of the reaction pad 12 and are fixedly arranged between the upper cover 1 of the test kit card housing and the bottom cover 3 of the test kit card housing.

[0055] The sample pad 8 is arranged at one end of the reaction pad 12 near the test result area 9, and the absorbent pad 11 is arranged at the other end of the reaction pad 12 near the serial number area 10. The sample pad 8, the reaction pad 12 and the absorbent pad 11 are fixedly arranged between the upper cover 1 of the test kit cartridge and the bottom cover 3 of the test kit cartridge by the chromatography test card fixing column 4 arranged on the bottom cover 3 of the test kit cartridge.

[0056] like Figure 2 and Figure 3 As shown, the reaction pad 12 includes a test result area 9 and a serial number area 10. The top surfaces of the sample pad 8, the test result area 9 and the serial number area 10 are respectively opposite to the sample injection port 7, the result observation window 6 and the serial number window 5. The serial number area 10 is provided with a serial number printed by oily ink, which can be directly viewed through the serial number window 5.

[0057] After the pre-prepared sample solution is added to the sample pad 8 through the sample adding port 7 , it is sequentially chromatographed through the test result area 9 and the serial number area 10 on the reaction pad 12 , and an encrypted pattern of the test result is displayed in the test result area 9 , which can be directly viewed through the result observation window 6 .

[0058] The absorbent pad 11 can absorb the excess sample solution overflowing from the reaction pad 12. During the test, the sample liquid is added to the test buffer and stirred thoroughly, and then added to the sample addition port 7 after standing. After a certain period of time, the test result will be displayed in the test result area 9.

[0059] The encrypted patterns all uniquely correspond to the serial number of the serial number area 10 on the reaction pad 12. The test results of the antigen test kit are presented in the form of encrypted patterns. The encrypted pattern itself or the text decrypted from the encrypted pattern cannot be directly used to determine the test results. The test results can only be obtained by matching it with the corresponding serial number in the antigen test data acquisition system. The encrypted pattern is a one-dimensional barcode or a two-dimensional code, or other encrypted patterns.

[0060] like Figure 4 , Figure 5 As shown in (a), when the encrypted pattern is a one-dimensional barcode, an initial barcode is set on the test result area (9) of the reaction pad (12), and the initial barcode is composed of a plurality of colorless test lines T, a colorless marking line M and a colorless quality control line C. The plurality of colorless test lines T, colorless marking lines M and colorless quality control lines C are arranged with a plurality of blank bands B arranged therebetween, and the arrangement of the initial barcode is uniquely corresponding to the serial number of the serial number area 10 of the reaction pad 12. Before the test, the initial barcode is blank. Figure 5 as shown in (b).

[0061] The two ends of the initial barcode are a start region and a stop region respectively, and the middle part of the initial barcode is a coding region. The start region is close to the serial number region 10 , and the stop region is close to the sample pad 8 .

[0062] Only three colorless quality control lines C and one blank band B are set in the starting area, that is, they are arranged in CCBC along the chromatographic direction of the detection solution; only two colorless marking lines M and two blank bands B are set in the termination area, that is, they are arranged in MBBM along the chromatographic direction of the detection solution; only two colorless detection lines T, eight marking lines M and six blank bands B are set in the coding area.

[0063] The coding area is evenly divided into four coding block areas, namely, coding block 4, coding block 3, coding block 2 and coding block 1 along the chromatographic direction of the detection solution. In order to increase the reliability of reading the detection results, at most one detection line T is set in each coding block area, and the detection line T must be located between two marking lines M and not separated by a blank band B; wherein the coding blocks 4, coding blocks 3, coding blocks 2 and coding blocks 1 along the chromatographic direction of the detection solution are TMMM, BMBM, BMTM and BBMB respectively.

[0064] The sample solution includes a sample liquid and a detection buffer. The sample liquid is added to the detection buffer and mixed evenly to form a sample solution. The detection buffer includes a colloidal gold-antigen IgG complex and a colloidal gold-nucleic acid aptamer complex.

[0065] If the sample liquid contains the target antigen, the sample liquid and the detection buffer are evenly mixed and left to stand to form a colloidal gold-antigen IgG-antigen complex. If the target antigen is not contained, no reaction occurs.

[0066] Complementary nucleic acid aptamers are fixed on the marking line M, which is used to capture free colloidal gold-nucleic acid aptamer complexes in the sample solution. After capturing, the marking line M will change from colorless to red. If the marking line M does not change color, the displayed test result will also be an invalid result; antigen IgG is fixed on the detection line T, which is used to capture the colloidal gold-antigen IgG-antigen complex formed after the sample liquid containing the target antigen is evenly mixed with the detection buffer and allowed to stand. After capturing, the detection line T will change from colorless to red; mouse anti-rabbit IgG is fixed on the quality control line C, which is used to capture free colloidal gold-antigen IgG complexes in the sample solution. After capturing, the quality control line C will change from colorless to red. If the capture is unsuccessful, the quality control line C will not change color, and the displayed test result will be an invalid result.

[0067] When the sample solution is chromatographed to the test result area 9, the initial barcode changes color to form a test barcode. The text information represented by the test barcode is the test result, including positive result, negative result and invalid result, that is, the test result corresponding to the unique serial number on the antigen test kit.

[0068] like Figure 5 As shown in (c)-(g), when the sample solution is chromatographed to each marking line M of the initial barcode, the complementary nucleic acid aptamer on the marking line M reacts with the sample solution, causing each marking line M to change color.

[0069] When the sample solution is chromatographed to each quality control line C of the initial barcode, the mouse anti-rabbit IgG of the quality control line C reacts with the sample solution, causing each quality control line C to change color. If no color change occurs, the antigen detection kit is damaged or the liquid added to the sample pad (8) is not a sample solution, that is, the test result displayed by the test barcode is an invalid result. Figure 5 As shown in (g), the end area constitutes a termination symbol, the start area constitutes a start symbol, and the detection result when the start symbol is displayed as an invalid start symbol is an invalid result.

[0070] When the sample solution is chromatographed to each test line T of the initial barcode, if the antigen IgG on each test line T reacts with the sample solution so that each test line T does not change color, the test result displayed by the test barcode is a negative result, such as Figure 5 As shown in (c); if one or several or all of the test lines T change color, the test result displayed by the test barcode is a positive result, such as Figure 5 As shown in (d)-(f).

[0071] From the appearance, the test line T, the marking line M and the quality control line C before and after the test cannot be distinguished by the naked eye.

[0072] The preparation method of the chromatographic detection card 2 of the antigen detection kit of this embodiment is as follows:

[0073] A 0.45 μm nitrocellulose membrane is used as the raw material of the chromatographic test card 2, with an initial size of 7×8.5 cm. The test line T, the marking line M, and the quality control line C are drawn by a colloidal gold streaking instrument according to preset graphics. The solution used to draw the test line T is 0.5 mg / mL rabbit anti-new coronavirus N protein IgG, the solution used to draw the quality control line C is 0.4 mg / mL mouse anti-rabbit IgG, and the solution used to draw the marking line M is 0.2 mM Biotin-single-stranded DNA complex.

[0074] Each test line T, marking line M and quality control line C has a width of 1 mm, and each test line T, marking line M, quality control line C and blank band B are closely laid. After the film is drawn, the test card is placed in a drying oven for 40 minutes. Then, an inkjet printer is used to print the serial number in the serial number area 10 using oil-based ink. After printing, the nitrocellulose membrane is cut into 60×10 mm long sheets and cut according to the Figure 1 and Figure 2 The antigen test kit is installed in the manner described in the previous section.

[0075] The preparation method of the detection buffer of this embodiment is as follows:

[0076] 0.1wt.% 25nm amino-modified colloidal gold was mixed with 2mg / mL anti-novel coronavirus N protein IgG solution at a ratio of 40:1. After the mixture was stirred for 20 minutes, 0.5mL of 10% bovine serum albumin BSA solution was added per mL of solution, stirred for 30 minutes, and then centrifuged at 18000 times gravity acceleration for 40 minutes. The supernatant in the centrifuged solution was replaced with 20mM Tris-HCl buffer, and the concentration of 25nm amino-modified colloidal gold was adjusted to 0.2wt.%, obtaining a first solution.

[0077] 0.1wt.% 25nm amino-modified colloidal gold was mixed with 0.2mM Biotin-complementary single-stranded DNA complex at a ratio of 20:1. After the mixture was stirred for 20 minutes, 0.5mL of 10% bovine serum albumin BSA solution was added per mL of solution, stirred for 30 minutes, and then centrifuged at 18000 times gravity for 40 minutes. The supernatant in the solution after centrifugation was replaced with 20mM Tris-HCl buffer, and the concentration of 25nm amino-modified colloidal gold was adjusted to 0.2wt.%, to obtain a second solution.

[0078] The first solution and the second solution were uniformly mixed at a ratio of 1:1, and ultrasonically stirred until fully dispersed to prepare a detection buffer solution.

[0079] The data acquisition system of the present invention includes a data acquisition module and a barcode scanning device for converting a detection barcode into text information. The barcode scanning device can be a specially made barcode reader or mobile phone software. The data acquisition module includes a front end for data collection, such as a website, WeChat account, etc., and a back-end database for result matching and recording. The back-end database stores the serial numbers of all antigen test kits, the text information corresponding to each detection barcode corresponding to each serial number, and the test result corresponding to each text information, that is, each serial number corresponds to an actual test result.

[0080] For one of the antigen test kits to be collected, the user of the antigen test kit to be collected converts the detection barcode of the antigen test kit to be collected into text information through a barcode scanning device, and then the user inputs the serial number and text information of the antigen test kit to be collected into the front end of the data acquisition system; the back-end database of the data acquisition system first matches the serial number received by the front end with the serial number in the back-end database. If the serial number of the antigen test kit to be collected matches one of the serial numbers in the back-end database, the detection continues. If the serial number of the antigen test kit to be collected does not match any of the serial numbers in the back-end database, the front end of the data acquisition system outputs a re-input prompt, and the user re-enters the serial number of the antigen test kit to be collected. After the re-entered serial number of the antigen test kit to be collected matches one of the serial numbers in the back-end database, the preliminary matching is completed and the detection continues.

[0081] After the preliminary matching is completed, the back-end database queries the text information of all the detection barcodes corresponding to the serial number, and matches it with the text information of the antigen test kit to be collected. If the text information of the antigen test kit to be collected matches one of the text information in the back-end database, continue; if the text information of the antigen test kit to be collected is different from any text information in the back-end database, the front-end output of the data acquisition system will prompt the user to re-enter the preliminary matching process until the text information of the antigen test kit to be collected matches one of the text information in the back-end database. The front-end outputs and records the test result corresponding to the text information, and feeds back the test result to the user to complete the test.

[0082] In a specific implementation, the barcode scanning device can scan and detect the barcode and interpret it through the encoding method shown in Table 1 to obtain text information:

[0083] Table 1 Barcode encoding method

[0084]

[0085]

[0086] Each coding block is formed by a group of four coding units, which are used to represent a character or control symbol, 1 represents non-white, and 0 represents white. The 1 in the start symbol is the quality control line C, and the 1 in the end symbol is the mark line M.

[0087] The coding blocks in the coding area can be divided into constant coding blocks and variable coding blocks according to their composition. The constant coding blocks are coding blocks whose coding information does not change with the change of the detection results, as shown in Table 2:

[0088] Table 2 Enumeration of constant coding block composition

[0089] BMBB BMBM BBMM BMMB BMMM MBMB MMBB MMBM MMMB MMMM

[0090] A variable coding block is a coding block whose coding information changes as the detection result changes, as shown in Table 3:

[0091] Table 3 Variable coding block enumeration and result interpretation

[0092] Code block composition Interpretation of negative results Interpretation of positive results TMBB 0100(0) 1100(6) TMBM 0101(1) 1101(7) TMMB 0110(3) 1110(8) TMMM 0111(4) 1111(9) MTMB 1010(5) 1110(8) BMTM 0101(1) 0111(4) MMTM 1101(7) 1111(9) BMMT 0110(3) 0111(4) MMMT 1110(8) 1111(9)

[0093] like Figure 5 As shown in (c), the interpretation result is 0558, indicating a negative result; Figure 5 As shown in (d), the interpretation result is 0858, indicating a positive result; Figure 5 As shown in (e), the interpretation result is 0559, indicating a positive result; Figure 5 As shown in (f), the interpretation result is 0859, indicating a positive result; Figure 5 As shown in (g), the starting character is invalid and the detection result is an invalid result.

[0094] The backend database stores a number of serial numbers corresponding to the antigen test kit and a number of detection barcodes corresponding to each serial number, specifically a number of interpretation results corresponding to the serial numbers and the number of detection barcodes corresponding to each serial number.

[0095] In the specific implementation, the tester collects the sample on his own, mixes it with the detection buffer and lets it stand for 1 minute to make a sample solution. If the sample liquid contains the new coronavirus N protein, the colloidal gold-anti-new coronavirus N protein IgG complex in the buffer will combine with it to form a colloidal gold-anti-new coronavirus N protein IgG-new coronavirus N protein complex. Add 4 drops of sample solution to the sample port and wait for the chromatography process. After the chromatography is completed, the encrypted pattern is identified by the barcode scanning device. The tester cannot identify the test results with the naked eye. The encrypted pattern presented by the test kit must be converted into text information through a mobile phone camera or a barcode reader and entered into the data acquisition module together with the serial number to obtain the results.

[0096] The barcode scanning device converts the encrypted pattern into text information, as shown in Table 1 and Table 3. The barcode scanning device will first look for the starting symbol (1011) to verify whether the result is valid and determine the direction of the barcode reading. If the starting symbol (1011) cannot be correctly identified, it proves that the inspection has failed, the barcode cannot be read further, and re-testing is required. The starting symbol also determines the width of each encoding unit in the barcode for the subsequent reading of the encoding block. When the end symbol (1001) is encountered, the reading ends and a four-digit interpretation result number is obtained.

[0097] The antigen test data collection system can provide real-time query functions for testing progress and results.

[0098] like Figure 6 As shown, an application process of the present invention under mandatory testing is described. First, the screening execution unit needs to pre-order the required number of test kits. Before receiving the test kit, the screening execution unit will first receive the serial number of the test kit to set the pre-set operation of the serial number. The pre-set operation may include real-time reminder of positive results, verification of identity information, etc. The test kit manufacturer will produce the antigen test kit according to the serial number. The initial barcode of each test kit is randomly generated according to the rules and recorded in the back-end database. After the kit manufacturer completes the production, the antigen test kit is directly sent to the screening execution unit. The screening execution unit issues the antigen test kit to the screened object, and can choose to bind the serial number with the identity information or contact information as needed to improve traceability. After receiving the test kit, the screened object performs the test according to the plan. After the test is completed, the four-digit text information is obtained through a barcode reader or mobile phone software and the information is input into the front end of the data acquisition system together with the serial number. The back end of the data acquisition system interprets the text information obtained by the user by retrieving the database storing the serial number and the test results. At this time, the data acquisition system will determine whether the test result is a positive result based on the result, and execute it according to the pre-set operation of the serial number. The screening execution unit can understand the testing progress and results in real time at any time.

[0099] Compared with several traditional nucleic acid detection methods and existing antigen detection kits, the advantage of the present invention is that it absorbs the advantages of antigen test kits to realize distributed detection, greatly improves the efficiency of detection, saves manpower and material costs of detection, and realizes centralized result management through serial numbers and encrypted results.

[0100] The above description of the embodiment for detecting the novel coronavirus antigen and the embodiment under the mandatory detection conditions are to facilitate the understanding and use of the invention by ordinary technicians and managers in the technical field. Personnel and managers familiar with the technology in the field can obviously easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention are also within the scope of protection of the present invention.

Claims

1. An antigen detection kit, characterized in that: It comprises a test kit cartridge and a chromatographic test card (2), wherein the chromatographic test card (2) is arranged inside the test kit cartridge; The test kit cartridge comprises a test kit cartridge upper cover (1) and a test kit cartridge bottom cover (3), and a serial number window (5), a result observation window (6) and a sample addition port (7) are sequentially provided on the top surface of the test kit cartridge upper cover (1) along the card length direction of the chromatographic test card (2); The chromatographic test card (2) comprises a sample pad (8), a water absorbent pad (11) and a reaction pad (12); the sample pad (8) and the water absorbent pad (11) are arranged at two ends of the reaction pad (12); the sample pad (8), the water absorbent pad (11) and the reaction pad (12) are fixedly arranged between an upper cover (1) of the test kit card housing and a bottom cover (3) of the test kit card housing; The reaction pad (12) comprises a test result area (9) and a serial number area (10), and the top surfaces of the sample pad (8), the test result area (9) and the serial number area (10) are respectively opposite to the sample addition port (7), the result observation window (6) and the serial number window (5); The serial number area (10) is provided with a serial number; After the pre-prepared sample solution is added to the sample pad (8) through the sample adding port (7), it is sequentially chromatographed on the reaction pad (12) through the test result area (9) and the serial number area (10), and an encrypted pattern of the test result is displayed in the test result area (9); The encryption pattern is a one-dimensional barcode; an initial barcode is arranged on the test result area (9) of the reaction pad (12), and the initial barcode is composed of a plurality of colorless test lines T, a colorless marking line M and a colorless quality control line C arranged in an arranged manner, wherein the plurality of colorless test lines T, the colorless marking line M and the colorless quality control line C are arranged in an arranged manner and separated by a plurality of blank bands B arranged therebetween, and the arrangement of the initial barcode uniquely corresponds to the serial number of the serial number area (10) of the reaction pad (12) in which it is located; The two ends of the initial barcode are a starting region and a termination region, respectively. The middle part of the initial barcode is a coding region. The starting region is close to the sequence number region (10), and the termination region is close to the sample pad (8). The starting area is only provided with a number of colorless quality control lines C and a number of blank bands B, the ending area is only provided with a number of colorless marking lines M and a number of blank bands B, and the coding area is only provided with a number of colorless detection lines T, a colorless marking line M and a number of blank bands B; The coding area is evenly divided into several coding block areas, each coding block area is provided with at most one detection line T, and the detection line T must be located between two marking lines M and not separated by blank bands B; The labeling line M is fixed with a complementary nucleic acid aptamer, the detection line T is fixed with an antigen IgG, and the quality control line C is fixed with mouse anti-rabbit IgG; The sample solution includes a sample liquid and a detection buffer, and the sample liquid is added to the detection buffer and mixed evenly to form a sample solution; The detection buffer comprises a colloidal gold-antigen IgG complex and a colloidal gold-nucleic acid aptamer complex.

2. An antigen detection kit according to claim 1, characterized in that: When the sample solution is chromatographed to the test result area (9), the initial barcode changes color to form a test barcode. The text information represented by the test barcode is the test result, including a positive result, a negative result and an invalid result, that is, the test result corresponding to the unique serial number on the antigen test kit; When the sample solution is chromatographed to each marking line M of the initial barcode, the complementary nucleic acid aptamer on the marking line M contacts the sample solution, causing each marking line M to change color; When the sample solution is chromatographed to each quality control line C of the initial barcode, the mouse anti-rabbit IgG of the quality control line C contacts the sample solution, causing each quality control line C to change color. If no color change occurs, the antigen detection kit is damaged or the liquid added to the sample pad (8) is not a sample solution, that is, the test result displayed by the test barcode is an invalid result; When the sample solution is chromatographed to each detection line T of the initial barcode, if the antigen IgG on each detection line T contacts the sample solution so that each detection line T does not change color, the detection result displayed by the detection barcode is a negative result; if one or several of the detection lines T or all the detection lines T change color, the detection result displayed by the detection barcode is a positive result; The encrypted pattern itself or the text decrypted from the encrypted pattern cannot be used directly to determine the test results. The test results can only be obtained by matching it with the corresponding serial number in the antigen test data collection system.

3. An antigen detection kit according to claim 1, characterized in that: The encrypted patterns all uniquely correspond to the serial number of the serial number area (10) on the reaction pad (12) where they are located.

4. An antigen detection kit according to claim 1, characterized in that: The sample pad (8) is arranged at one end of the reaction pad (12) close to the test result area (9), and the absorbent pad (11) is arranged at the other end of the reaction pad (12) close to the serial number area (10). The sample pad (8) and the absorbent pad (11) are fixedly arranged between the test kit cartridge upper cover (1) and the test kit cartridge bottom cover (3) by means of a chromatography test card fixing column (4) provided on the test kit cartridge bottom cover (3).

5. The antigen test data acquisition system of an antigen test kit according to claim 2, characterized in that: It includes a data acquisition module and a barcode scanning device for converting the detection barcode into text information. The data acquisition module includes a front end for data collection and a back-end database for result matching and recording; the back-end database stores the serial numbers of all antigen test kits, the text information corresponding to each detection barcode corresponding to each serial number, and the test results corresponding to each text information; For one of the antigen test kits to be collected, the user of the antigen test kit to be collected converts the detection barcode of the antigen test kit to be collected into text information through a barcode scanning device, and the user inputs the serial number and text information of the antigen test kit to be collected into the front end of the data acquisition system; the back-end database of the data acquisition system first matches the serial number received by the front end with the serial number in the back-end database, if the serial number of the antigen test kit to be collected matches one of the serial numbers in the back-end database, then the detection continues; if the serial number of the antigen test kit to be collected does not match any of the serial numbers in the back-end database, then the front end of the data acquisition system outputs a re-input prompt, and the user re-inputs the serial number of the antigen test kit to be collected. After the re-input serial number of the antigen test kit to be collected matches one of the serial numbers in the back-end database, the preliminary matching is completed, and the detection continues; After the preliminary matching is completed, the back-end database queries the text information of all the detection barcodes corresponding to the serial number, and matches it with the text information of the antigen test kit to be collected. If the text information of the antigen test kit to be collected matches one of the text information in the back-end database, continue; if the text information of the antigen test kit to be collected is different from any text information in the back-end database, the front-end output of the data acquisition system will prompt the user to re-enter the preliminary matching process until the text information of the antigen test kit to be collected matches one of the text information in the back-end database. The front-end outputs and records the test result corresponding to the text information, and feeds back the test result to the user to complete the test.

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