Multiple-viruses IVDs

Intended purpose

Using the realtime amplification PCR technique after extraction of viral DNA, the HSV1&2 VZV R-GENE® kit is designed to: • Detect and/or quantify and differentiate the HSV1 and HSV2 viral genomes in whole blood, blood plasma,cerebrospinal fluid and bronchoalveolar lavage. • Detect and differentiate the HSV1 and HSV2 viral genomes in throat swabs, anogenital swabs and mucocutaneousswabs. • Detect and/or quantify the VZV viral genome in whole blood, blood plasma and cerebrospinal fluid. • Detect the VZV viral genome in mucocutaneous swabs. Combined with other biological investigation methods (medical imaging, biochemical and immunological analysis, etc.), the results obtained with the HSV1&2 VZV R-GENE® kit are an aid to the diagnosis and monitoring of HSV1, HSV2 and VZV virus in patients showing pathological condition suggesting an herpesviridae infection. This kit is intended for in vitro diagnostic use only, in clinical laboratories by laboratory health professionals. This kit cannot be used for screening donors.