NEW YORK — The US Food and Drug Administration on Friday granted separate Emergency Use Authorizations (EUAs) for SARS-CoV-2 tests developed by Access Genetics and Megna Health.
Access Genetics' OraRisk COVID-19 RT-PCR test is designed to detect the RdRp gene of the virus in nasopharyngeal swab and nasal swab specimens using Co-Diagnostics' Logix Smart Coronavirus COVID-19 Test, which received EUA in April. It runs on Roche Molecular Systems' LightCycler 480 II RT-PCR instrument.
The test is only authorized for use by Eden Prairie, Minnesota-based Access Genetics, according to the FDA.
Megna's Rapid COVID-19 IgM/IgG Combo Test Kit is a lateral flow assay designed to detect immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma.
According to the Exton, Pennsylvania-based specialty medical device maker, the test has demonstrated sensitivity of 100 percent and specificity of 95 percent for both of its targets and provides results within 15 minutes.
The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.