This test kit is used for rapid in vitro qualitative detection of SARS-CoV-2 antigens in human anterior nasal swab from individuals suspected of COVID-19 within the first 7 days of symptom onset. This test kit is for self-testing by lay person in a non-laboratory setting.
CONTACT USSensitivity(true positive rate): 90.16% (95% CI, 83.59% ~94.28%)
Specificity(true negative rate): 99.78% (95% CI, 98.75% ~99.96%)
Accuracy(true positive and negative rate): 97.73% (95% CI, 96.15% ~98.67%)
CE1434 by notified body PCBC
Sample type: Anterior nasal swab
