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.