Multi Pack IVD Nasal Saliva Antigen Rapid Test Kit 8mins Reaction

Multi-pack Nasal Covid-19 Self-Test Kit for Family Use/SARS-CoV-2 Antigen Assay Kit by Latex Immunochromatography Method

Summary

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.

Test Result:

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.

In conjuction with IgG/IgM antibody test

Qualitative assessment on six dimensions

• Accuracy: the inaccuracy of antigen test due to manual sampling is addressed by antibody test, resulting in combined accuracy of close to 100%.
• Easy of Use: flexibility in determining either or both tests to apply given operators’availability.
• Speed: antibody test takes 8 min and both tests can be done in 15 min simultaneously.
• Early Detection: the deficiency of testing during incubation period of antibody test is supplemented by antigen test.
• Cost Effectiveness: The price of nucleic acid (PCR) detection weighs more than antibody and antigen tests combined, given PCR test is labor-intensive in operation and demanding with lab environment.
• Non-Laboratory Settings: both antibody and antigen test are read by the same model fluorescent immunoanalyzer instrument, which is portable and easy to operate. No lab for analyzing or low temperature for preservation is required.