NEW YORK – Access Medical Laboratories and Drexel University College of Medicine each recently were issued Emergency Use Authorizations by the US Food and Drug Administration for COVID-19 molecular diagnostic tests to detect the SARS-CoV-2 virus.
The agency granted Access Medical an EUA on Wednesday for its Global Direct RT-PCR Test for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal and anterior nasal swab specimens. The use of the test is limited to the company's CLIA-certified laboratory in Jupiter, Florida.
Meantime, the FDA granted EUA to Drexel's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay last week for the qualitative detection of SARS-CoV-2 nucleic acid in mid-turbinate nasal swab specimens. The test can be performed only at Drexel's CLIA-certified lab in Philadelphia.
According to the FDA, for both tests, nucleic acid is extracted, isolated, and purified then reverse transcribed into cDNA for PCR amplification followed by detection with an RT-PCR instrument.