NEW YORK — The US Food and Drug Administration on Monday reissued an Emergency Use Authorization for Applied BioCode's SARS-CoV-2 Assay to allow the test to be used with pooled samples.
The PCR-based test, which runs on Applied Biocode's MDx-3000 instrument, was first authorized in June for the detection of two conserved regions in the SARS-CoV-2 N gene in upper respiratory specimens and bronchoalveolar lavage. Under the reissued EUA, the test may also be used with pooled samples containing up to five individual upper respiratory specimens collected by a healthcare provider using individual vials containing transport media.
With pooled sampling, Santa Fe Springs, California-based Applied BioCode said that its MDx-3000 instrument can run 2,820 samples a day.
Use of the assay is limited to labs CLIA-certified to perform high-complexity tests, according to the FDA.