CDC LOCS Lab 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.

This Lab Advisory was originally deployed by CDC's Laboratory Outreach Communication System (LOCS). Check out the CDC LOCS website and Coronavirus Disease 2019 (COVID-19) Information for Laboratories website for the latest information.