IVD Medical Antibody 25pcs Swab Covid 19 Rapid Test Kit Card For Clinic

Highly Accurate Fast Covid-19 Test Kit/SARS-CoV-2 Antigen Assay Kit by Latex Immunochromatography Method

25 Tests Rapid Covid-19 Test Kit/SARS-CoV-2 Antigen Assay Kit

Intended use

This product can be used as a supplementary test indicator for suspected cases with negative nucleic acid test of SARS-Cov-2 or used in conjunction with nucleic acid testing in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by SARS-Cov-2 infection. This product can also be used for the auxiliary diagnosis of influenza A virus and influenza B virus infection.

Test principle

Latex Immunochromatography method is used to detect SARS-Cov-2, influenza A or influenza B virus antigens. After treatment when SARS-Cov-2, influenza A or B virus antigens in the sample are added to the detection hole, the antigen and latex labeled antibody (monoclonal antibody against SARS-Cov-2, influenza A or B antigen) form an immune complex. The complex moves with the liquid to the nitrocellulose membrane, and the detection area of the nitrocellulose membrane is coated with another one. When monoclonal antibody is against SARS-Cov-2, influenza A or B antigen, the immune complex is captured by the antibody on nitrocellulose membrane, forming a red reaction line: the result is positive. When the sample does not contain SARS-Cov-2 antigen, influenza A or B antigens or are lower than the minimum detection limit of this kit, no red reaction line appears in the detection area: the result is negative. At the same time, whether the result is positive or negative, as the internal control standard of reagents, a red reaction line will be formed in the quality control area (line C), which is used to judge whether the chromatographic process is normal or not.

Result interpretation

POSITIVE: Two red lines appear. One red line appears in the control region(C), and one red
line in the test region(T). The shade of color may vary,but it should be considered positive whenever there is even a faint line.
NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T).
The negative result indicates that there are no Novel coroinavirus particles in the sample or the number of viral particles is below the detectable range.
INVALID: No red line appears in the control region(C). The test is invalid even if there is a line on test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.