Mobidiag's first CE-IVD marked viral product line is targeted at the identification of human herpesviruses due to their high clinical relevance. The identification is based on the PCR amplification of conserved gene regions, particularly DNA polymerase genes. In a single PCR reaction it is possible to amplify 7 herpesviruses:
- HSV-1 (Herpes simplex virus 1)
- HSV-2 (Herpes simplex virus 2)
- VZV (Varicella-zoster virus)
- EBV (Epstein-Barr virus)
- HHV-6 (Human herpesvirus 6)
- HHV-7 (Human herpesvirus 7)
- CMV (Cytomegalovirus)*
Microarray-based detection enables the extremely high performance of the test:
- Sensitivity 90%
- Specificity 98%
*Cytomegalovirus is not CE-IVD marked