NEW YORK – MAWD Laboratories' PCR-based COVID-19 test has received Emergency Use Authorization from the US Food and Drug Administration, according to a notice from the agency posted last week.
The MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR test qualitatively detects SARS-CoV-2 nucleic acid from nasopharyngeal swab specimens collected from people suspected of COVID-19 by their healthcare provider. Testing is limited to MAWD Laboratories and to qualified clinical laboratory personnel, the FDA noted in its authorization letter.
The test runs on an Applied Biosystems QuantStudio 7 Flex Real-Time PCR system.