The Biomedical Advanced Research and Development Authority (BARDA) awarded a contract to Detect, Inc. last week for the development of an over-the-counter test capable of detecting SARS-CoV-2, as well as influenza A and B, within 30 minutes.
This rapid diagnostic – the Detect COVID/Flu Test – will make use of a single nasal swab for sampling, along with a reusable Detect Hub and accompanying mobile applications. Users at home would require no lab expertise or sophisticated equipment to get their results. The main goal is to create a home diagnostic tool capable of differentiating between respiratory infections with sometimes similar symptoms, allowing greater ability for personal decision-making on illness and treatment.
The molecular test will work through rapid targeting and amplification of nucleic acid sequences, using the process of isothermal amplification. It maintains accuracy at low viral loads while identifying viruses faster than traditional PCR tests.
BARDA added that the Detect test is expected to be able to identify all known SARS-CoV-2 variants of concern, including the now-dominant Omicron variant.
Detect will push forward through studies required by the U.S. Food and Drug Administration (FDA), reaching for emergency use authorization (EUA) and, potentially, 510(k) clearance to market the test kits.