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FDA Grants Emergency Use Authorizations for Sansure Biotech, UTHSC Coronavirus Tests

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Hunan, China-based Sansure Biotech and the University of Tennessee Health Science Center (UTHSC).

Sansure's Novel Coronavirus Nucleic Acid Diagnostic Kit is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate swabs, nasal washes, and nasal aspirates. It runs on authorized RT-PCR instruments and can be used by any lab CLIA certified to perform high-complexity tests.

UTHSC's UTHSC/UCH SARS-CoV-2 RT-PCR assay is designed to detect SARS-CoV-2 nucleic acid in nasal swabs. It is performed using Promega's Maxwell RSC nucleic acid purification platform, Tecan's Genesis Liquid Handler, and Agilent Technologies AriaMx RT-PCR system and software. The test may only be used by UTMG Pathology, a private practice lab affiliated with UTHSC.