Quidel Receives FDA EUA for Moderately Complex Solana SARS Molecular Test for COVID-19 Diagnosis

Quidel Corporation (San Diego, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its Solana SARS-CoV-2 Assay, an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay.

The assay is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens in viral transport media from patients suspected of COVID-19 by their healthcare provider. Testing is limited to CLIA-certified laboratories to perform high and moderate complexity tests.

The Solana SARS CoV-2 offers a number of advantages over competing laboratory-based molecular diagnostic test protocols for COVID-19, including a simple workflow with no sample extraction; a medium volume throughput design that is ideal for batch testing and improved laboratory efficiency; and a fast, 25-minute run time for up to 11 samples. The assay consists of two main steps, mainly specimen preparation, and amplification and detection of target sequences specific to SARS-CoV-2 using Quidel’s proprietary isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes.

The Solana instrument objectively measures and interprets a fluorescent signal, reports the test results to the user on its display screen, and can print out the results via an integrated printer. Solana is a bench top instrument that combines Quidel’s proprietary helicase-dependent amplification (HDA) with fluorescence detection to deliver molecular results faster than ever before. Isothermal amplification eliminates thermal cycling, operating at one temperature in one tube to reduce the time to result to as little as 25 minutes. Solana’s simplified workflow also avoids the need for specialized molecular operator training, making it easily adoptable in CLIA certified settings. In addition to the Solana SARS CoV-2 assay, Quidel’s Solana instrument can run a suite of diagnostic assays and panels including Bordetella, C. Difficile, GAS, GBS, HSV 1+2/VSV, Influenza A+B, Respiratory Viral Panel, RSV + hMPV, Strep, and Trichomonas.

“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,” said Douglas Bryant, president and CEO of Quidel Corporation. “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.”