REF:

C2103 (Cassette)

INTENDED USE:

SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the SARS-CoV-2 nucleocapsid protein from saliva specimen from patients who are suspected of COVID-19 by a healthcare provider. Performance of the test is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests. SARS-CoV-2 Antigen Saliva Test Kit provides preliminary test results, with negative results don’t preclude SARS-CoV-2 infection. The test kit cannot be used as the sole basis for treatment or other management decision.

For in vitro diagnostic use only.

SUMMARY:

SARS-CoV-2 Virus is a positive single-strand RNA virus, which could mutate rapidly, there have been a large number of gene sequencing reports on mutant viruses. Using Spike protein for detection has potential risk to be unable to identify mutant viruses. SARS-CoV-2 Antigen Saliva Test Kit takes the nucleocapsid protein of the SARS-CoV-2 virus as the antigen marker throughout, which will technically guarantee its specificity and keep off influence by the mutation of the virus.