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

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.

Online resources:

• 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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If you have any questions, please contact LOCS@cdc.gov.

This Lab Advisory was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.