Smartphone-based COVID-19 test garners U.S. FDA emergency use authorization
Diagnostics company Luminostics (Milpitas, CA) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and will scale up production activities for its Clip COVID rapid antigen test to meet testing demand in the fight against COVID-19. The test is a lateral flow immunoluminescent assay that uses glow-in-the-dark nanochemistry along with a smartphone’s optics, an inexpensive adapter, and artificial intelligence (AI) to detect SARS-CoV-2 viral antigens from nasal swabs in around 30 minutes.
The Clip COVID rapid antigen test is said to offer 100% specificity (negative percent agreement) and 96.9% sensitivity (positive percent agreement) compared to FDA-authorized, laboratory-based high-sensitivity real-time polymerase chain reaction (RT-PCR) in an independently run multisite prospective clinical study. Test results are objectively displayed on the smartphone’s screen, eliminating the sorts of errors that plague result interpretation of visual lateral flow tests. This objectivity, along with its minimal hands-on time, enables high-throughput processing of over 30 tests per operator per hour from sample collection to result. Automated result integration to electronic health record and laboratory information management systems, as well as automated result reporting to federal, state, and local public health authorities can easily be enabled by the Clip COVID mobile app to minimize the administrative burden of organizations that run rapid COVID tests.
Luminostics continues to increase its production capacity and expects to be manufacturing over 2 million tests per month by April 2021 and more than 4 million tests per month by the summer. Another immediate goal for the company is to expand Clip COVID’s EUA labeling to include non-prescription, non-laboratory use, according to Bala Raja, Ph.D., Luminostics co-founder and CEO.
Source: Luminostics press release via GlobeNewswire – February 15, 2021