12/08/2020: Lab Advisory: FDA Authorizes Pooling for the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel
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 websiteexternal icon for more information.
- Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic, Screening, and Surveillance Testing
- Guidance for SARS-CoV-2 Point-of-Care Testing
- Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
- Information for Laboratories about COVID-19
- Frequently Asked Questions about COVID-19 for Laboratories
- CDC’s Laboratory Outreach Communication System (LOCS)
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For questions, please contact us at LOCS@cdc.gov.
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)