The FDA has published data outlining the limits of 58 different molecular coronavirus tests—illustrating the ability of each authorized diagnostic to detect smaller and smaller amounts of the virus that causes COVID-19.

The data can be used to compare which manufacturer’s test is more sensitive than another’s, with each being evaluated under the same conditions using a single set of controlled reference samples distributed by the agency earlier this year.

The FDA listed each diagnostic’s limit of detection, a statistic describing the lowest amount of virus particles present within a sample that could still provide a correct test result, measured in the number of individual units of RNA detectable by nucleic acid amplification, per milliliter.

A test’s limit of detection differs from what is known as its analytical sensitivity—or the diagnostic’s ability to spot truly positive samples—which is in turn used to determine its overall rate of false-negative results.

Source: www.fiercebiotech.com