FDA granted separate emergency use authorizations for tests developed by QDx Pathology Services and Biocan Diagnostics that are designed to detect SARS-CoV-2, the virus that causes covid-19. The QDx SARS-CoV-2 Assay is a RT-PCR-based assay designed to detect the N gene of the virus in nasal swab specimens self-collected using the Cranford, NJ-based medical lab’s Qdetect home collection kit or other authorized home collection kits. It is performed using ChromaCode’s HDPCR SARS-CoV-2 assay, which received EUA from the FDA in June, and may be performed only in QDx’s CLIA-certified lab. Biocan’s Tell Me Fast Novel Coronavirus IgG/IgM Antibody Test is an immunochromatography-based lateral flow assay designed to detect immunoglobulin G and M antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood samples. Results are provided within 15 minutes, according to the British Columbia, Canada-based company. The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.
March 4, 2020