19 July 2018 - - San Diego, California-based diagnostic testing solutions provider Quidel Corp. (NASDAQ: QDEL) has received 510(k) clearance from the US FDA to market its Solana Bordetella Complete Assay, the company said.
The molecular diagnostic assay is to be used with the Solana molecular diagnostic instrument for the qualitative detection and differentiation of Bordetella pertussis (Whooping Cough) and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis.
The Solana Bordetella Complete Assay leverages the Helicase-Dependent Amplification technology that is resident in Quidel's AmpliVue molecular product line to generate a fast and accurate test result on the Solana molecular diagnostic instrument.
The assay targets the IS481 and IS1001 sequence of the Bordetella pertussis and Bordetella pertussis genomes, respectively.
Quidel develops diagnostic solutions that aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease, and fecal occult blood.