Herpes simplex virus reagent kit AltoStar®

solutionfor PCRdiagnostic

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® alpha Herpesvirus PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components. Key features Detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA CE-IVD marked in vitro diagnostic test Analytical sensitivity reported in copies/ml The AltoStar® alpha Herpesvirus PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user. Intended use The AltoStar® alpha Herpesvirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA in human cutaneous and mucocutaneous swab specimens. It is intended to be used as an aid for diagnosis of HSV-1, HSV-2 and VZV infection.