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FDA Grants EUAs for Boston Medical Center, Beijing Wantai Biological Pharmacy Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for SARS-CoV-2 tests developed by Boston Medical Center (BMC) and Beijing Wantai Biological Pharmacy.

The BMC-CReM COVID-19 Test is designed to detect two regions in the SARS-CoV-2 N gene in nasopharyngeal, oropharyngeal, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens.

The test comes in one-step and two-step versions. For the one-step test, both cDNA synthesis and PCR amplification are completed on Thermo Fisher Scientific's Applied Biosystems QuantStudio 6 Flex Real-Time PCR System. The two-step test uses the Eppendorf Mastercycler Nexus X2 for cDNA synthesis and runs on the Applied Biosystems QuantStudio 6 Flex Real-Time PCR System.

The test may only be performed by BMC, according to the FDA.

The Wantai SARS-CoV-2 Ab Rapid Test is a lateral flow assay designed to detect total antibodies, including immunoglobulin G and M antibodies, against the virus in human serum, plasma, and venous whole blood. Results are available within 15 minutes, according to the Beijing-based company.

The FDA said that Beijing Wantai's assay may be performed by any lab CLIA-certified to perform moderate- or high-complexity tests.