Quidel Corp. (NSDW:QDEL) announced that it received FDA emergency use authorization (EUA) for its Solana SARS-CoV-2 assay.
San Diego-based Quidel’s Solana SARS-CoV-2 assay is an isothermal reverse transcriptase-helicase-dependent amplification (RT-HDA) assay designed for the qualitative detection of nucleic acid from the virus causing COVID-19 in nasopharyngeal and nasal swab specimens, according to a news release.
Testing with the Solana assay is limited to CLIA-certified laboratories for performing high and moderate-complexity tests, Quidel noted.
Solana’s features include a simple workflow with no sample extraction, a medium volume throughput design tailored for batch testing and efficiency and a 25-minute run time for up to 11 samples. It objectively measures and interprets a fluorescent signal, reports test results to the user on its display screen and can print out the results through an integrated printer.
The bench-top instrument includes an interactive touchscreen and barcode scanner for data entry, as well as ethernet and USB ports for data transfer, printing and compatibility with Dymo Label Writer systems.
“With so many of our nation’s laboratories overwhelmed by demand for COVID-19 tests and under pressure to produce more timely results, there is a compelling societal need for the throughput and quick runtime offered by our new Solana molecular testing technology,” Quidel president & CEO Douglas Bryant said in the news release. “Joining our Lyra and Lyra Direct assays for SARS-CoV-2, we now offer another molecular weapon in the fight against COVID-19 to quickly diagnose symptomatic patient populations. The Solana SARS-CoV-2 Assay nicely complements our Sofia and QuickVue tests that are run at the point-of-care, for pre-symptomatic, asymptomatic and symptomatic patients.
“We are pleased to bring the benefits of our proprietary RT-HDA technology to detect COVID-19 to the marketplace and further democratize access to testing across the country. Solana is a powerful diagnostic solution at a critical time.”