FDA approves sample pooling with CDC’s SARS-CoV-2 RT-PCR test

Dec. 8, 2020

The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to allow pooling of samples for testing with the Centers for Disease Control and Prevention’s (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.

The EUA authorizes labs using the CDC’s test to pool samples containing up to four of the individual upper respiratory swab specimens that were collected using individual vials containing transport media from people suspected of being infected with SARS-CoV-2 by their healthcare provider.

The FDA granted the EUA for the CDC’s test initially on February 4, 2020, for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the requirements to perform high complexity tests, the FDA said. 

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