Sponsor: DiaSorin Molecular
DiaSorin Molecular recently received FDA clearance extending the sample type claims of its Simplexa HSV 1 & 2 Direct assay, expanding the type of samples that can be tested to include genital swabs and all cutaneous and mucocutaneous swab samples. With these additional sample types, the assay now has comprehensive sample type coverage for HSV. The Simplexa HSV 1 & 2 Direct kit real-time PCR assay is intended for the in vitro qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) and swab samples. The test does not require a DNA extraction step and processes up to eight samples per run in about one hour. Rapid detection of HSV infection through molecular testing can be critical to decision-making for life-saving therapeutics. The coverage of multiple sample types in a moderate complexity assay enables laboratories to easily manage various HSV testing needs with one test.