FDA Clearance for Solana® Strep Complete Assay
Quidel's new Solana® Strep Complete Assay is now FDA cleared for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients. Specimens identified as negative by the Solana assay do not require additional testing by culture.
The Solana Strep Complete Assay accurately differentiates pyogenic Group A from pyogenic Group C or G. Non-group A strains, especially Group C&G, are found in a significant number of Group A negative symptomatic patients (≥20%) and treatment appears to shorten the symptomatic period of the disease.
The Solana Strep Complete Assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results, an industry first for Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus). The assay requires no upfront extraction of DNA and generates an accurate result in approximately 25 minutes.
The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 25-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.
"We are very pleased to receive FDA clearance for a definitive, comprehensive diagnostic for Streptococcal infections, and along with our recently-cleared Solana Influenza A+B Assay, comes just in time for the upcoming respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "With the Solana system, we've given moderately complex labs what they want: a platform that provides definitive test results quickly, and in a scalable connected format with a low total cost of ownership. We believe that Solana's utility and value will continue to increase with the launch of each additional assay."
Solana® Strep Complete is Quidel's fourth molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana® Influenza A+B received 510(k) clearance in September, Solana® Trichomonas assay received 510(k) clearance in August, and Solana® Group A Strep assay was cleared in June 2015.
Tags: Group A Streptococcus, Streptococcus pyogenes, Group B Streptococcus
Date Published: November 1, 2016
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