03/13/2020: Lab Advisory: FDA FAQs on Diagnostic Testing for SARS-CoV-2
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:
- FDA FAQs on Diagnostic Testing for SARS-CoV-2
- CDC 2019 Novel Coronavirus Laboratory Biosafety
- CDC Information for Laboratories: 2019-nCoV
- CDC 2019 Novel Coronavirus
- International Air Transport Association (IATA) Dangerous Goods Regulation
- IATA Packing Instructions
- Register for CDC Health Alert Network (HAN) notifications, including updates about the 2019 Novel Coronavirus. Enter your email address, search for HAN, and sign-up
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)