02/18/2020: Lab Advisory: Reminder: COVID-19 Diagnostic Testing

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

Reminder: COVID-19 Diagnostic Testing

The Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the CDC 2019-Novel Coronavirus (COVID-19) Real-Time RT-PCR Diagnostic Panel which is to be used in qualified laboratories for testing patient respiratory specimens that meet CDC criteria for COVID-19 testing. This message is to remind clinical laboratories that this is currently the only EUA assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. Any laboratory that is not designated by CDC as a qualified laboratory and is implementing a COVID-19 diagnostic test other than the CDC EUA assay must contact the FDA to obtain an EUA before any COVID-19 diagnostic testing may be performed in their facilities.

The Secretary of Health and Human Services issued an emergency declaration that justifies the authorization of emergency use of in vitro diagnostics for the detection of SARS-CoV-2 and the diagnosis of COVID-19. All tests for SARS-CoV-2, including laboratory developed tests (LDTs), must be reviewed and cleared or authorized by the FDA for emergency use, or they cannot be used for diagnostic testing. The FDA requests that developers of such LDTs submit information about their tests to help FDA better understand their design, validation, and performance characteristics. For more details, please refer to FDA: Information for Laboratories Implementing IVD Tests Under EUA.

Qualified laboratories for use of the CDC-distributed 2019-nCoV Real-Time RT-PCR Diagnostic Panel, as defined by the EUA, include select U.S. state and local public health laboratories and Department of Defense laboratories. Diagnostic testing with this assay can only be done at CDC and by these qualified laboratories. The state and local public health laboratories are in the process of implementing the CDC EUA assay.

Clinical laboratories should contact their state health departments for guidance if they have a suspected COVID-19 case specimen. Clinical laboratories that need a diagnostic test for COVID-19 performed should contact their local health department, which will either provide testing or facilitate referral of the specimen to the CDC for testing.

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.

Additional 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)