Adenovirus reagent kit AltoStar®

solutionfor PCRdiagnostic

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Adenovirus 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 quantification of human adenovirus (HAdV) specific DNA CE-IVD marked in vitro diagnostic test Analytical sensitivity reported in copies/ml Limit of detection (LoD) LoD plasma - 141 copies/ml LoD whole blood - 382 copies/ml Intended use The AltoStar® Adenovirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human adenovirus (HAdV) specific DNA in human plasma and whole blood. It is intended to be used as an aid for diagnosis of HAdV infection and for the monitoring of the HAdV load in individuals with HAdV infection.