NEW YORK – UK molecular diagnostic firms Rapid Diagnostics and GeneFirst announced this week that they have reached a deal to validate an assay for SARS-CoV-2.
The agreement covers the validation of GeneFirst's COVID-19 assay, a point-of-care test for use on Rapid Dx's Rapid Minilab RT-PCR Desktop Point of Care Platform. The system leverages technology originally invented and developed by scientists at the Defence Science and Technology Laboratory, Porton Down, to detect infectious diseases in 45 minutes or less.
The system combines PCR technology with high-resolution melt analysis, provided by a patented electrically conducting polymer thermal cycler, which accelerates amplification capability, the companies said.
The COVID-19 assay will be validated to detect samples positive for the coronavirus with an automated sample-to-result workflow, the firms said. It has been evaluated by Public Health England and based on a statistical analysis of 195 samples, it delivered measured specificity of 100 percent and true specificity of at least 98.1 percent.
The assay has been added to the list of validated COVID-19 tests by French regulators, and it is undergoing additional third-party validation by the Foundation for Innovative New Diagnostics in collaboration with the World Health Organization, the partners said.
A spokesperson declined to disclose the terms of the agreement but said it covers respiratory multiplex panels as well.