March 13 LOCS (CDC) Email

Audience: Clinical Laboratory Professionals
Subject: FDA FAQs on Diagnostic Testing for SARS-CoV-2
Level: Laboratory Advisory

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.