NEW YORK — The US Food and Drug Administration on Wednesday issued separate Emergency Use Authorizations for molecular SARS-CoV-2 tests developed by Cue Health, Tide Laboratories, and TBG Biotechnology.
Cue Health's Cue COVID-19 Test is designed to detect the SARS-CoV-2 N gene in nasal swabs and is authorized for use by either CLIA-certified laboratories or at the point of care. Samples are collected using the Cue Sample Wand, which is then inserted into a test cartridge. DNA/RNA amplification and immunoassay chemistry occur within the test cartridge automatically when it is coupled to the company's portable monitoring system, and results are provided within 25 minutes through a mobile device app.
San Diego-based Cue, which received $13 million in funding from US Department of Health and Human Services Biomedical Advanced Research and Development Authority to develop the assay, said it intends to seek FDA authorizations for use of its test in additional settings such as schools, workplaces, and homes.Â
Tide's DTPM COVID-19 RT-PCR Test is designed to detect the SARS-CoV-2 N gene in nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, and mid-turbinate swab specimens. It runs on Thermo Fisher Scientific's QuantStudio 5 instrument with software version 1.5.1 and may be performed by Tide or CLIA-certified labs designated by the Fort Payne, Alabama-based company.
TBG's ExProbe SARS-CoV-2 Testing Kit is designed to detect the virus' RdRP, N, and E genes in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as in nasopharyngeal aspirate/wash and nasal aspirate specimens and bronchoalveolar lavage. It runs on Thermo Fisher's Applied Biosystems 7500 Real-Time PCR system with software version 2.3 and may be performed by any CLIA-certified lab, according to the Melbourne, Australia-based company.