A new type of coronavirus colloidal gold antigen detection method

Abstract

The application discloses a novel coronavirus colloidal gold antigen detection method which can be supervised, and comprises the following steps: S1, preparing a novel coronavirus colloidal gold antigen test paper card with an interference band, and storing band position information; S2, a user tests a novel coronavirus antigen and uploads personal information and test paper card test result information; and S3, feeding back an antigen detection result according to the band position information and the test paper card test result information, and storing the personal information and the antigen detection result. The application has the beneficial effect that the user cannot directly read the antigen detection result by preparing the novel coronavirus colloidal gold antigen test paper card with the interference band, and must upload the personal information and the test result, obtain the antigen detection result by searching a record module and comparing the band position information, and store the personal information and the antigen detection result to realize supervision on the antigen detection result, thereby avoiding the defect that the antigen detection result cannot be supervised in the prior art.

Description

Technical Field

[0001] This invention relates to the field of biomedical detection, specifically to a regulated method for detecting colloidal gold antigen of the novel coronavirus. Background Technology

[0002] Coronavirus Disease 2019 (COVID-19) is a respiratory infectious disease characterized by respiratory viral infection, which can cause fever, sore throat, and ground-glass opacities in the lungs. Severe cases can lead to acute respiratory distress syndrome and organ failure. The latest variant of the COVID-19 virus, Omicron, which circulated in early 2022, is highly contagious and has spread widely globally. Given my country's large population and high aging rate, it is essential to strengthen prevention and control efforts against the spread of the COVID-19 virus. Virus detection technology is a crucial component of epidemic prevention and control.

[0003] Colloidal gold assay is a novel immunolabeling technique that uses colloidal gold as a tracer marker for antigen-antibody interactions. It offers advantages such as ease of use, rapid detection, and self-testing capabilities, and is currently widely used in antigen detection for COVID-19 infected individuals. This method plays a crucial supplementary role in COVID-19 prevention and control, mitigating the risks of cross-infection caused by insufficient nucleic acid testing capacity, long testing times, and centralized nucleic acid sampling.

[0004] When users use the COVID-19 colloidal gold assay to detect antigen expression, they can interpret the test results themselves based on the band display. Result interpretation and reporting can only be completed under the user's own discretion or with designated supervision. Due to the lack of necessary technical oversight measures and reporting mechanisms, some special populations may experience misreporting, underreporting, or deliberate concealment, leading to the spread of the epidemic and hindering the local disease control centers' epidemic prevention and control efforts. Summary of the Invention

[0005] Design objective: In order to technically control the proactive reporting of COVID-19 antigen detection results using colloidal gold assay, this invention provides a supervised method for detecting novel coronavirus colloidal gold antigen.

[0006] To achieve the above-mentioned design objectives, this invention provides a supervised method for detecting colloidal gold antigen of the novel coronavirus, characterized by comprising: Step S1: Create a novel coronavirus colloidal gold antigen test strip card with interfering bands and store the band position information; Step S2: The user tests for the novel coronavirus antigen and uploads their personal information and test results from the test strip. Step S3: Feed back the antigen detection result based on the strip position information and the test result information of the test strip card, and store the personal information and the antigen detection result.

[0007] Furthermore, the method for preparing the novel coronavirus colloidal gold antigen test strip card with interfering bands and storing the band position information in step S1 includes: Step S11: Randomly place several interfering bands near the control band and the test band of the test strip in the test strip card; Step S12: Set a unique code and scale on the outer shell of the test strip card; Step S13: The quality control strip and the detection strip maintain their relative positions and are randomly moved a certain distance along the sample chromatography direction; Step S14: The position information of the control strip, the test strip, and the interference strip corresponding to the scale and the unique code are stored in the recording module.

[0008] The interfering band is colorless before the test strip is used, and after use, the appearance and color of the interfering band are consistent with the detection band or the quality control band.

[0009] Furthermore, the personal information mentioned in step S2 includes the user's name, ID number, address, and test date.

[0010] Furthermore, the test result information of the test strip card in step S2 includes the strip position information of the displayed strip corresponding to the scale and the unique coding information.

[0011] Furthermore, the method for feeding back the antigen detection result based on the band position information and the test result information of the test strip in step S3 includes: Step S31: Retrieve the recording module using the unique coding information in the test result information of the test strip card to obtain the corresponding strip position information; Step S32: By comparing the strip position information and the strip position information of the displayed strip corresponding to the scale in the test result information of the test strip card, determine whether the displayed strip is a detection strip, a quality control strip, or an interference strip; Step S33: Obtain the validity results of the test based on the appearance of the quality control bands; Step S34: Obtain the antigen detection results based on the appearance of the detection bands; Step S35: Feed back the judgment results of S33 and S34 to the user, and store the personal information and the antigen test results in the recording module.

[0012] The present invention has the following advantages: 1. Existing test strips have detection bands and control bands, allowing users to easily read the test results by observing one or two colored bands. This invention, by placing several interfering bands of the same color and appearance near the detection and control bands on existing test strips, enables the test strip to display multiple colored bands. These bands are indistinguishable as detection, control, or interfering bands, preventing users from directly reading the antigen test results. 2. This invention maintains the relative positions of the control strip and the detection strip, while randomly moving them a certain distance along the sample chromatography direction. This ensures that the starting position of the detection strip is not fixed, preventing users from comparing test strips with known results to obtain antigen detection results. Maintaining the relative positions of the control strip and the detection strip avoids reducing the sample chromatography travel distance between the two strips, thus preventing any impact on the accuracy of the detection results. 3. This invention stores the strip position information of the control strip, detection strip, and interference strip at corresponding scale graduations in a recording module, corresponding to unique codes. This allows the strip position information to be retrieved based on the unique code on the test strip outer shell. Because this strip position information is stored in the recording module, it is inaccessible to the user, ensuring that the antigen detection results cannot be interpreted by the user. 4. This invention requires users to test for the novel coronavirus antigen and upload their personal information and test results from the test strip. Based on the band position information and the test results from the test strip, the system queries, compares, and judges to obtain and return the antigen test results. It stores personal information and antigen test results, thus restricting users to uploading test results in order to obtain antigen test results. The uploaded information also includes the user's name, ID number, address, and test date. This information can be reported to or retrieved by the local CDC, which helps in disease tracing and epidemic prevention. Attached Figure Description

[0013] Figure 1 A schematic diagram of a regulated method for detecting colloidal gold antigen of the novel coronavirus. Figure 2 This is a schematic diagram of step S1 of a regulated method for detecting colloidal gold antigen of the novel coronavirus. Figure 3 This is a schematic diagram of a novel coronavirus colloidal gold antigen test strip card with interfering bands. Figure 4 This is a schematic diagram of step S3 in a regulated method for detecting colloidal gold antigen of the novel coronavirus. Figure 5 This is a schematic diagram of a novel coronavirus colloidal gold antigen test strip card with interfering bands, showing different results before and after use. Detailed Implementation

[0014] Example

[0015] The following is in conjunction with the appendix Figure 1-5 The present invention will be further described with reference to specific embodiments, but these are not intended to limit the invention.

[0016] This invention includes: A regulated method for detecting the colloidal gold antigen of the novel coronavirus, such as Figure 1 As shown, including Step S1: Create a novel coronavirus colloidal gold antigen test strip card with interfering bands and store the band position information; Step S2: The user tests for the novel coronavirus antigen and uploads their personal information and test results from the test strip. Step S3: Based on the strip position information and the test result information of the test strip, the antigen test result is fed back, and personal information and antigen test result are stored.

[0017] In a preferred embodiment, such as Figure 2 As shown, the method for creating a novel coronavirus colloidal gold antigen test strip with interfering bands and storing the band position information in step S1 includes: Step S11: Randomly place several interfering bands near the control band and the test band of the test strip in the test strip card; Step S12: Set a unique code and scale on the outer shell of the test strip card; Step S13: Keeping the relative positions of the quality control strip and the detection strip unchanged, move them randomly a certain distance along the sample chromatography direction; Step S14: The strip position information and unique code of the corresponding scale of the quality control strip, the test strip, and the interference strip are stored in the recording module.

[0018] Interfering bands are colorless before use. After use, the appearance and color of the interfering bands are consistent with the test or control bands. Interfering bands are either control bands or pigment bands.

[0019] Specifically, such as Figure 3As shown, the novel coronavirus colloidal gold antigen test strip with interference bands includes a test strip and a casing. All test strips with interference bands have a detection band 201, a control band 202, and an interference band 203. The casing has a unique code 101 and graduations from 1 to 15. The chromatographic direction of the sample on the test strip is from bottom to top, as shown in the diagram.The unique code of test strip A1 is 22050201. The detection strip 201 corresponds to the scale position 3, the quality control strip 202 corresponds to the scale position 13, and the interference strip 203 corresponds to the scale positions 6 and 14. To further illustrate the present invention, one interference strip can be added to test strip A1, corresponding to the scale position 4, to form test strip A2 with a new strip arrangement, with a unique code of 22050202. To further illustrate the present invention, one interference strip can also be moved from test strip A1 to the scale position 15, to form test strip A3 with a new strip arrangement, with a unique code of 22050203. To further illustrate the invention, another interfering band can be moved from test strip A1 to the corresponding scale position 5, forming test strip A4 with a new band arrangement, uniquely coded as 22050204. To further illustrate the invention, the relative positions of the control band and the detection band can be maintained on test strip A1, and the bands can be moved forward along the sample chromatography direction to form test strip A10 with a new band arrangement, uniquely coded as 22050205. In test strip A10, the detection band 201 corresponds to scale position 4, the control band 202 corresponds to scale position 14, and the interfering band 203 corresponds to scale positions 7 and 15. To further illustrate the invention, based on test strip A2, the relative positions of the control strip and the detection strip can be maintained, and the strips can be moved forward along the sample chromatography direction to form test strip A20 with a new strip arrangement. The unique code is 22050206. In test strip A20, the detection strip 201 corresponds to graduation position 4, the control strip 202 corresponds to graduation position 14, and the interference strip 203 corresponds to graduation positions 5, 7, and 15. To further illustrate the invention, based on test strip A3, the relative positions of the control strip and the detection strip can be maintained, and the strips can be moved backward along the sample chromatography direction to form test strip A20 with a new strip arrangement. 31, with a unique code of 22050207, the detection strip 201 of test strip A31 corresponds to the scale position 2, the quality control strip 202 corresponds to the scale position 12, and the interference strip 203 corresponds to the scale positions 5 and 14. To further illustrate the invention, test strip A41 can also be created by keeping the relative positions of the quality control strip and the detection strip unchanged, and moving them backward along the sample chromatography direction to form a test strip A41 with a new strip arrangement. The unique code of this version is 22050208, and the detection strip 201 of test strip A41 corresponds to the scale position 2, the quality control strip 202 corresponds to the scale position 12, and the interference strip 203 corresponds to the scale positions 4 and 13. This embodiment lists eight strip arrangement combinations, but is not limited to these.In practical applications, this invention can generate a vast number of strip arrangements through addition, reduction, and overall movement. These arrangements prevent users from directly interpreting strip position information based on the number or position of strips, or by comparing multiple sets of strip information through repeated testing. Correspondingly, the strip position information of the control strips, detection strips, and interference strips, corresponding to their respective scales and unique codes, is stored together in the recording module. This allows the strip position information to be retrieved based on the unique code, and the antigen detection results can be interpreted by further analyzing the strip position information.

[0020] In a preferred embodiment, the personal information in step S2 includes the user's name, ID number, address, and test date.

[0021] Specifically, the user's name, ID number, address, and test date provide complete traceability information—that is, who underwent antigen testing, when, and where—facilitating oversight. This design ensures that users must retrieve the record module to obtain their antigen test results; by simply technically restricting the retrieval to include personal information, oversight of both users and antigen test results can be achieved.

[0022] In a preferred embodiment, the test result information of the test strip card in step S2 includes the strip position information corresponding to the scale of the displayed strip and unique coding information.

[0023] In a preferred embodiment, the method for feeding back the antigen detection result based on the band position information and the test strip result information in step S3 includes: Step S31: Use the unique coding information in the test result information of the test strip card to retrieve the record module and obtain the corresponding strip position information; Step S32: By comparing the strip position information with the strip position information of the corresponding scale of the displayed strip in the test result information of the test strip, determine whether the displayed strip is a test strip, a quality control strip, or an interference strip; Step S33: Obtain the validity results of the test based on the appearance of the quality control bands; Step S34: Obtain the antigen detection results based on the appearance of the detection bands; Step S35: Feed back the judgment results of S33 and S34 to the user, and store personal information and antigen test results in the recording module.

[0024] Specifically, such as Figure 5As shown, a novel coronavirus colloidal gold antigen test strip A1 with interfering bands was fabricated. During fabrication, the detection band 201 corresponds to graduation 3, the control band 202 corresponds to graduation 13, and the interfering band 203 corresponds to graduations 6 and 14. The unique code is 22050201. The stored band position values ​​and the unique code 22050201 represent the band position information. When a user receives test strip A1, its appearance is as shown in B1; the user can only see the graduations and cannot observe any bands. After the user completes the antigen test, the test strip may appear in one of three ways, as shown in C1, D1, or E1. However, regardless of which of the three situations occurs, the user cannot know the antigen test result. At this point, the user uploads their personal information and test results from the test strip. By retrieving the strip position information in the record module using the unique code 22050201, it can be seen that the detection strip 201 corresponds to the scale position 3, the quality control strip 202 corresponds to the scale position 13, and the interference strip 203 corresponds to the scale positions 6 and 14. Compare the band position information and the color development of the three bands C1, D1, or E1: C1 shows bands 6, 13, and 14, corresponding to interference band 203, control band 202, and interference band 203 respectively. Control band 202 shows color while band 201 does not, indicating a negative antigen test result. D1 shows bands 3, 6, 13, and 14, corresponding to detection band 201, interference band 203, control band 202, and interference band 203 respectively. Control band 202 shows color while band 201 shows color, indicating a positive antigen test result. E1 shows bands 3, 6, and 14, corresponding to detection band 201, interference band 203, and interference band 203 respectively. Control band 202 does not show color while band 201 shows color, indicating an invalid antigen test result. The antigen test results corresponding to the above test results are fed back to the user, and the user's personal information and antigen test results are stored in the recording module. The results can be retrieved by the local CDC or delivered directly to the local CDC in accordance with laws and regulations. This method of requiring users to submit personal information and test results in order to obtain antigen test results provides necessary regulatory technical means for epidemic prevention and control, and is helpful for epidemic prevention and control and disease tracing.

[0025] The above are merely preferred embodiments of the present invention and are not intended to limit the implementation methods and protection scope of the present invention. Those skilled in the art should recognize that any equivalent substitutions and obvious changes made based on the description and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. A regulated method for detecting colloidal gold antigen of the novel coronavirus, characterized in that, include Step S1: Prepare a novel coronavirus colloidal gold antigen test strip with interfering bands. The interfering bands are colorless before use. After use, the appearance and color of the interfering bands are consistent with the detection bands or control bands. The interfering bands are either control bands or pigment bands. Store the band position information. The method includes: Step S11: Randomly place several interfering bands near the quality control band and the detection band of the test strip in the test strip card; Step S12: Set a unique code and scale on the outer shell of the test strip card; Step S13: The quality control strip and the detection strip maintain their relative positions and are randomly moved a certain distance along the sample chromatography direction; Step S14: The position information of the quality control strip, the detection strip, and the interference strip corresponding to the scale and the unique code are stored in the recording module; Step S2: The user tests for the novel coronavirus antigen and uploads their personal information and test results from the test strip. Step S3: Based on the band position information and the test result information of the test strip, the antigen detection result is fed back, and the personal information and the antigen detection result are stored. The method includes: Step S31: Retrieve the recording module using the unique coding information in the test result information of the test strip card to obtain the corresponding strip position information; Step S32: By comparing the strip position information and the strip position information of the displayed strip corresponding to the scale in the test result information of the test strip card, determine whether the displayed strip is a detection strip, a quality control strip, or an interference strip; Step S33: Obtain the validity result of the test based on the appearance of the quality control stripes; Step S34: Obtain the antigen detection result based on the appearance of the detection bands; Step S35: Feed back the judgment results of S33 and S34 to the user, and store the personal information and the antigen test results in the recording module.

2. The detection method according to claim 1, characterized in that, The personal information mentioned in step S2 includes the user's name, ID number, address, and test date.

3. The detection method according to claim 1, characterized in that, The test result information of the test strip card in step S2 includes the strip position information of the displayed strip corresponding to the scale and the unique code information.

Images