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Stanford Health Care Receives Emergency Use Authorization for SARS-CoV-2 Test

NEW YORK – The US Food and Drug Administration on Wednesday provided Emergency Use Authorization to Stanford Health Care Clinical Virology Laboratory's SARS-CoV-2 assay.

The Stanford SARS-CoV-2 assay is a real-time RT-PCR test for detecting SARS-CoV-2 in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swabs and bronchoalveolar lavage fluid. It runs on the Qiagen Rotor-Gene Q thermocycler, and RNA can be extracted using the Qiagen EZ1 XL or QIAsymphony SP/AS extraction platforms. 

The test received EUA under expanded guidance from the FDA allowing molecular-based laboratory-developed tests to be performed by the CLIA-certified high-complexity lab that developed the test.