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FDA Reissues EUA for Stanford Health Care Coronavirus Test to Include Self-Collected Nasal Swabs

NEW YORK — The US Food and Drug Administration last week reissued an Emergency Use Authorization for Stanford Health Care Clinical Virology Laboratory's SARS-CoV-2 assay to allow its use with self-collected nasal swab samples.

The RT-PCR-based test was first authorized earlier this year for the detection of SARS-CoV-2 nucleic acid in nasopharyngeal, oropharyngeal, nasal, and midturbinate nasal swabs, as well as bronchoalveolar lavage fluid, collected by a healthcare provider. According to the FDA, the test may now also be used with nasal swab specimens collected at home or in a healthcare setting using the recently authorized Vera COVID-19 Test Unsupervised Collection Kit. 

Stanford University said it developed the collection kit in collaboration with the Chan Zuckerberg Biohub. The kit is being used as part of the Community Alliance to Test Coronavirus at Home (CATCH) study, which aims to investigate the demographics of COVID-19 infection and whether at-home sample collection could boost access to accurate testing.