Gold standard performance in the EUA PDF...4 Sep 2020 13:13
In a total of 290 specimens, collected using various swab types and RNA isolation methods, the sensitivity was 100%, specificity was 99.0%, with a PPV of 99.4% and NPV of 100%. The overall diagnostic accuracy was 99.6%. The total error rate was 3.4%, all resulting from specimens collected at one site.