03/13/2020: Lab Advisory: FDA FAQs on Diagnostic Testing for SARS-CoV-2

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

FDA FAQs on Diagnostic Testing for SARS-CoV-2

On March 10, 2020, the Food and Drug Administration (FDA) posted answers to frequently asked questions (FAQs) on Diagnostic Testing for SARS-CoV-2. This LOCS message is to raise awareness about these FDA FAQs among clinical laboratories that could potentially be asked to perform testing.

Topics covered include information on

  • Confirmatory testing for presumptive positive results
  • Additional thermal cyclers for the CDC Emergency Use Authorization (EUA) assay
  • Additional extraction platforms and reagents for the CDC EUA assay
  • Acceptable alternatives to the assay positive control material
  • Acceptable alternatives to the assay extraction control material

Clinical laboratories should contact their state health departments for guidance if they have a suspected coronavirus disease 2019 (COVID-19) case specimen. Clinical laboratories should NOT attempt viral isolation from specimens collected from COVID-19 persons under investigation (PUIs). For interim guidelines for collecting, handling, and testing clinical specimens from PUIs for COVID-19, please see the CDC Coronavirus Disease 2019 (COVID-19) website.

Online Resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)