Quidel Receives Emergency Use Authorization for Moderately Complex Solana® SARS Molecular Test for Covid-19 Diagnosis
December 23, 2020 at 01:30 pm EST
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Quidel Corporation announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Solana® SARS-CoV-2 Assay, an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay 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 laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, 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: (1) specimen preparation, and (2) 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. Quidel’s Solana® bench-top instrument is designed for maximum space efficiency and ease of use. The small-profile instrument features an interactive touchscreen and barcode scanner for easy data entry, Ethernet and USB ports for data transfer and printing and compatibility with Dymo Label Writer systems. Solana® also comes with access to Quidel’s proprietary Virena® data management and surveillance ecosystem, which provides aggregated, de-identified testing data to public health authorities in near real time. 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.
QuidelOrtho Corporation is engaged in vitro diagnostics, developing and manufacturing intelligent solutions. The Company sells its products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other point-of-care (POC) settings, blood banks and donor centers, as well as for individual, non-professional, over the counter (OTC) use. The Company provides diagnostic testing solutions under various brand names, including AdenoPlus, BIOVUE, FreshCells, InflammaDry, Lyra, MeterPro, MicroVue, Ortho, Ortho Clinical Diagnostics, Ortho Connect, Ortho Plus, Ortho Vision, QuickVue, Quidel, QuidelOrtho, QVue, Savanna, Sofia, Solana, Thyretain, Triage, Virena, Vitros among others. It provides support for its customers across more than 130 countries and territories.
QUIDELORTHO CORPORATION 
