REF:

C2112 (Saliva Stick)

INTENDED USE:

SARS-CoV-2 Antigen Saliva Test is an immunoassay that uses the double-antibody sandwich method to detect the SARS-CoV-2 nucleocapsid protein from saliva specimen from patients who are suspected of SARS-CoV-2 infection by a healthcare provider. Performance of the test is limited to professional use. 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:

Novel coronavirus pneumonia (Coronavirus disease 19, COVID-19) is an infectious disease caused by SARS- CoV-2 infection. On February 11, 2020, the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2. Since the massive COVID-19 pandemic, the application of antigen testing for large-scale screening has become popular. Currently, the most commonly used method is to use Nasopharyngeal Swab (NPS) and Oropharyngeal Swab (OPS) for nucleic acid detection. There are many reports that use of saliva samples for detection has the same level of detection as NPS. Furthermore, collecting saliva samples can effectively reduce risk of virus transmission to healthcare provider and causes less individuals discomfort compared with NPS/OPS specimen.

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.