NEW YORK — Lawmakers on Thursday called on the US Food and Drug Administration to provide information about the accuracy of the various SARS-CoV-2 diagnostics being used in response to the ongoing pandemic.
In a letter to FDA Commissioner Stephen Hahn, representatives Lloyd Doggett (D-Texas) and Rosa DeLauro (D-Connecticut) specifically requested details about sensitivity and specificity data the FDA has received from test makers, how the FDA is handling these data, and information on which labs are meeting regulatory guidelines.