Emergency Use Authorization (EUA) Updates

Emergency Use Authorization (EUA) Updates

FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection Authorization is also second to allow testing of pooled samples On July 24, 2020, FDA reissued (PDF) the LabCorp COVID-19 RT-PCR Test EUA to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing. The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand use of the test to anyone, after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population. Additionally, the reissuance includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation. Sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more samples to be evaluated quicker.

Testing supply substitution strategies FDA updated the Testing Supply Substitution Strategies slide show. This presentation includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a molecular test. Download the 1.5MB PowerPoint slide show file and click Slide Show > From Beginning. (July 23, 2020) Diagnostic test EUAs To date, FDA has currently authorized 193 tests under EUAs, which include 158 molecular tests, 33 antibody tests, and 2 antigen tests. Also see: Coronavirus Testing Basics

Related links: FAQs on Testing for SARS-CoV-2 (frequently updated) Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices