EUA CE ISO13485 SARS-CoV-2 Antigen Rapid Test Card For Self Testing

EUA, CE, ISO13485 SARS-CoV-2 Antigen Rapid Test Card For Self-Testing

Product Description :

Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasopharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card can not be used as the basis to diagnose or exclude SARS-CoV-2 infection.

Rapid SARS-CoV-2 Antigen Test Card detects the SARS-CoV-2 nucleocapsid protein (N protein). Theoretically, genetic SARS-CoV-2 variants with non-nucleocapsid protein mutations do not affect the product performance.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.