Limits of detection for FDA-authorized COVID-19 diagnostics
BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.
As more tests that diagnose active infection with SARS-CoV-2 come online, their limits of detection offer a window into their sensitivity and potential to produce false negative results.
More than 20 diagnostic tests have received Emergency Use Authorization (EUA) by FDA for COVID-19 testing in the last two months. The limits of detection (LoD) for the virus range from 40 copies/mL to 100,000 copies/mL; four tests use the measure copies per reaction, and range from three copies to 200 copies per reaction. ...