Harmonizing limits of detection for FDA-authorized COVID-19 diagnostics

Comparing the limits of detection for COVID-19 molecular diagnostic tests offers a window into their relative sensitivity and potential to produce false negative results. New data published by FDA, based on a reference panel of patient samples, shakes up the standing of tests authorized early in the pandemic, whose initial metrics weren’t standardized and didn’t come from patient samples.

The new data, which compare the tests using the same samples and report results in the same units, highlight the benefits of harmonized protocols for decision-making, particularly in a pandemic (see “Having Touched the Third Rail of Data Sharing in the Pandemic, Drug Developers Should Hold on Tight”).  ...