CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
February 2017—Quidel has received 510(k) clearance from the Food and Drug Administration to market its Solana Strep Complete Assay 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 assay requires no upfront extraction of DNA and generates an accurate result in approximately 25 minutes.
Quidel, 858-552-1100