NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a version of the Broad Institute's PCR-based SARS-CoV-2 test that can be used with self-collected nasal swab specimens.
The CRSP SARS-CoV-2 Real-time Reverse Transcriptase-PCR Diagnostic Assay (Version 3) is designed to detect the SARS-CoV-2 N gene in anterior nasal swabs collected either by a healthcare provider or self-collected using the Broad's CRSP Self-Swab kit, the Color COVID-19 Self-Swab Collection Kit, or the Binx Health At-home Nasal Swab COVID-19 Sample Collection Kit.
The test runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 7 Flex Real-Time PCR System and may only be performed by the Broad's Clinical Research Sequencing Platform, according to the FDA.
Last summer, the FDA granted an EUA for a version of the Broad's assay that uses upper respiratory and bronchoalveolar lavage specimens collected by healthcare providers. A second version of the test received FDA EUA in December for use with dry nasal swabs collected by healthcare providers.