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