12/08/2020: Lab Advisory: FDA Authorizes Pooling for the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

On Tuesday, December 1, 2020, the U.S. Food and Drug Administration (FDA) authorized pooling for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.

The new authorized indication of use is for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled specimens containing up to four of the individual upper-respiratory swab specimens (nasopharyngeal, oropharyngeal, nasopharyngeal/oropharyngeal combined, or nasal swabs).

Visit the FDA website for more information.

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For questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

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

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

Centers for Disease Control and Prevention (CDC)