GenomEra® HSV 1/2, VZV and Enterovirus Assay Kit

The GenomEra® HSV-1/2, VZV + EV Assay Kit, performed on the GenomEra CDX system, is an in vitro diagnostic (IVD) multiplex real-time reverse transcriptase polymerase chain reaction (rRT-PCR) assay intended for the qualitative detection and differentiation of viral DNA of herpes simplex viruses 1 and 2 (HSV-1 and HSV-2) and varicella-zoster virus (VZV), and viral RNA of enterovirus (EV).

The GenomEra HSV-1/2, VZV + EV Assay Kit uses cerebrospinal fluid (CSF) or lesion swab specimens (in viral transport medium) from patients with signs and symptoms of central nervous system (CNS) infection or cutaneous/mucocutaneous lesions, respectively. The use of CSF specimens is validated for HSV-1, HSV-2, VZV and EV. The use of lesion swab specimens is validated for HSV-1 and HSV-2, but not for VZV and EV.