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SD Biosensor Coronavirus PCR Test Receives FDA Emergency Use Authorization

NEW YORK – SD Biosensor has received Emergency Use Authorization from the US Food and Drug Administration for its molecular coronavirus test, called Standard M nCoV Real-Time Detection kit.

According to an FDA document dated April 23, the test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, as well as sputum of individuals suspected of having COVID-19 by their healthcare provider. It involves nucleic acid extraction, reverse transcription, and PCR amplification on an authorized RT-PCR instrument.

The test may be performed by laboratories that are CLIA-certified for high-complexity testing.