NEW YORK — The US Food and Drug Administration last week reissued an Emergency Use Authorization for a SARS-CoV-2 assay developed by BioMérieux subsidiary BioFire Defense to allow the test's use with pooled samples.
The BioFire COVID-19 test was first authorized in March for the detection of SARS-CoV-2 nucleic acid nasopharyngeal swabs in transport media, with results available within 45 minutes. Under the reissued EUA, the PCR-based test can now also be used with pooled samples containing up to eight nasopharyngeal swabs collected individually in transport media.
The testing of nonpooled samples can be done by any lab CLIA-certified to perform moderate- or high-complexity tests. The testing of pooled samples, however, is limited to Department of Defense labs that meet the requirements to perform high-complexity tests, according to the FDA.