REF:

C2102 (Cassette)

INTENDED USE：

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the novel coronavirus (SARS-CoV-2) nucleocapsid protein from Nasal swab (NS) and Oropharyngeal swab (OPS) from patients who are suspected of COVID-19 by a healthcare provider. Performance of the test is limited to professional use.

SARS-CoV-2 Antigen Rapid 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. Its clinical manifestations contain fever, fatigue, and dry cough. A few patients have nasal congestion, runny nose, and sore throat and diarrhea and other symptoms. In severe cases, dyspnea and/or hypoxemia usually occurs after one week. Some critical patients show distress syndrome, septic shock, metabolic acidosis that is difficult to correct, and rapidly develop coagulopathy.