ARTICLE | Product Development

Limits of detection for FDA-authorized COVID-19 diagnostics

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April 2, 2020 12:53 AM UTC
Updated on Apr 4, 2020 at 1:27 AM UTC

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. ...