NEW YORK — The US Food and Drug Administration on Tuesday reissued an Emergency Use Authorization for the US Centers for Disease Control and Prevention's PCR-based SARS-CoV-2 test to allow its use with pooled samples.
The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel first received FDA EUA in February for the detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens. A month later the EUA was reissued to, among other things, permit the test's use with additional primers, probes, and nucleic acid extraction methods. The test's authorized labeling has also been updated since the original authorization.
Under the latest reissuance, the CDC's test may now also be used with pooled samples containing up to four of the individual upper respiratory swab specimens, according to the FDA. Its use remains limited to labs CLIA-certified to perform high-complexity tests.