DiaSorin Molecular, Cypress, Calif, has received the CE mark for its new Simplexa HSV 1/2 and VZV Universal Direct assay. The molecular diagnostic enables the direct detection and differentiation of herpes simplex virus (HSV)-1, HSV-2, and varicella-zoster virus (VZV) DNA from cutaneous and mucocutaneous swab specimens. The assay was designed for use on the company’s Liaison MDx instrument, and generates comprehensive and actionable insights for patients with lesions.
An HSV infection can cause cutaneous or mucosal lesions that are usually self-limiting, but severe disease can occur in immunocompromised patients, pregnant woman, and infants. HSV-1 is typically characterized by oral lesions, infectious keratitis, and eczema herpeticum. In addition, HSV-1 is the cause of a growing incidence of genital lesions.
VZV causes two clinically distinct forms of disease. Chickenpox is typically a mild disease, but can cause complications and is characterized by lesions on the face, trunk, and extremities. After initial infection, VZV becomes latent in sensory nerve ganglia. Reactivation occurs with increased age or immunosuppression and causes herpes zoster (shingles), a painful condition associated with complications including postherpetic neuralgia and central nervous system infections.
HSV-1, HSV-2, and VZV are human herpes viruses that can cause genital vesicular lesions. For many individuals, VZV genital infection is associated with a childhood primary infection rather than sexual transmission. Inclusion of VZV along with HSV-1 and HSV-2 testing may enable clinicians to provide improved therapeutic decisions and advice.
“Our HSV and VZV assay delivers answers for these related herpes viruses in a single reaction in about an hour, features an easy workflow with minimal hands-on time, and does not require upfront extraction,” says Michelle Tabb, PhD, chief scientific officer at DiaSorin Molecular. “We are excited to continue offering products that meet the needs of clinicians all over the globe.”
For further information, visit DiaSorin Molecular.
Featured image: Liasion MDx instrument with universal disc from DiaSorin Molecular.