Quidel Corporation has received 510(k) clearance for the sale of its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex viruses 1 and 2.
The AmpliVue HSV 1+2 Assay is easy-to-use, handheld and disposable. The assay requires no upfront extraction of DNA and generates an accurate result in approximately one hour. Like other previously FDA-cleared AmpliVue assays, the AmpliVue HSV 1+2 Assay does not require investment in expensive thermocycling equipment. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.
The AmpliVue product line now enables laboratories of all sizes to perform highly sensitive and specific molecular tests for four pathogens -- two viruses and two bacterial species -- without incurring the significant expense that is usually required to adopt and maintain molecular testing methods on-site. The AmpliVue HSV 1+2 is Quidel's third assay to launch in its hand-held, disposable format. The AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012. The AmpliVue GBS Assay for the molecular detection of Group B Streptococcus infections received FDA clearance in December of 2013. All three assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.
