INTENDED USE
Severe acute respiratory syndrome coronavirus 2 (SARS SARS-CoVCoV-2) is an enveloped non non-segmented positivepositive-sense RNA virus. It is the cause of coronavirus disea se (COVID COVID-19), which is contagious in humans. SARS-CoVCoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The antigen is detectable in oral fluid samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, which do not rule out SARS SARS-CoVCoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, in cluding infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID COVID-19, and confirmed with a molecular.
HIGHLIGHT
- Rapid detection of Sars-COV-2 nucleocapsid antigen in less than 15 minutes
- Non-invasive covid-19 testing with saliva speciman
- no instrumentation required
- Cost-effective Solutions for large scale testing
PERFORMANCE
- SENSITIVITY: 96.26%
- SPECIFICITY: 99.67%
- CLINICAL STUDY POPULATION: 772 individuals, including 160 PCR-positives and 612 PCR-negatives