It has become common these days to hear “We live in unprecedented times.” The medical device industry and FDA have…
IVD tests have two components of accuracy – sensitivity and specificity. Just as specificity is important for serology tests (https://asell.com/regulatory-considerations-for-sars-cov-2-serology-test-developers/),…
Given the considerable recent focus on serology assays for the detection of IgG and IgM antibodies to SARS-CoV-2, we wanted…