CE ANVISA Lateral Flow Test Kit SARS-CoV-2 SWAB Antigen IVD Kit

SARS-CoV-2 antigen IVD kit SWAB (Whitelist CE certification)

Product Description

REAGEN This kit is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs and nasopharyngeal swab samples.

Mechanism Of Reaction

REAGEN This kit adopts the detection principle of double antibody sandwich method. The binding pad of the detection card contains colloidal gold-labeled mouse N protein monoclonal antibody I; the detection line (T line) of the nitrocellulose membrane is coated with mouse N protein monoclonal antibody II, quality control line (line C) is coated with goat anti-mouse antibody.

The collected samples are processed by the sample extract and added. During the test, when the extract containing the N protein of the SARS-CoV-2 is added to the sample hole of the test card, under the action of chromatography, the sample moves to the end of the absorbent paper and first passes through the binding pad. The N protein and colloidal gold labeled mice The source N protein monoclonal antibody I specifically binds and continues to move to the absorbent paper end. When the sample moves to the T line, the N protein bound to the labeled antibody specifically binds to the N protein monoclonal antibody II coated in the T line in a double antibody sandwich mode, and stays at the T line; the remaining liquid continues to absorb water The paper end moves. When it moves to the C line, the mouse N protein antibody I labeled with colloidal gold specifically binds to the goat anti-mouse antibody in the C line. The T line shows a red band, indicating that the SARS-CoV-2 antigen is positive. No matter whether the T line is colored or not, the C line should show red. If the C line is not colored, the test is invalid and the sample needs to be tested again.

Kit Contents, Storage And Shelf Life

The REAGEN SARS-CoV-2 antigen IVD kit SWAB has the capacity for 20 determinations. The shelf life is 24 months when the kit is properly stored.

Warnings And Precautions

1. This kit is only used for in-vitro auxiliary diagnosis and must be operated in strict accordance with the instructions.

2. Please check the validity period and package integrity of the kit before use. If the package of the test card is damaged or exceeds the validity period, it cannot be used.

3. Must follow the time of determination and judgment result.

4. It is recommended to use it immediately, for one-time use only; the test card should be tested within 30 minutes after being taken out of the package to avoid prolonged exposure of the test card to the air.

5. The kit can be stored at room temperature. Beware of moisture, light, heat, heavy pressure, and freezing.

6. It is recommended that the waste or remaining samples generated during the test be soaked in a lipid solvent such as ether, 75% ethanol, chlorine-containing disinfectant, peracetic acid and chloroform for virus inactivation treatment.

7. The test results of this kit are for clinical reference only. The clinical diagnosis of the disease should be comprehensively considered in conjunction with its symptoms, signs, medical history, other laboratory tests and treatment responses.