Simplexa HSV 1/2 & VZV Universal Direct Kitct Kit

Background

Herpes simplex viruses (HSV) and varicella-zoster virus (VZV) are members of the herpesviridae family of DNA viruses. A herpes simplex virus infection can cause cutaneous or mucosal lesions that are usually self-limited, 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, with a recent increase in genital lesions. HSV-2 infection is one of the most common sexually transmitted diseases causing vesicular genital lesions. Worldwide, approximately 90% of people are infected with HSV, 60-80% of whom have HSV-1 and 16-25% have HSV-2.

Varicella-zoster virus infection causes two clinically distinct forms of disease. The primary varicella disease, following initial infection of an individual, is commonly known as chickenpox, and is characterized by vesicular lesions in different stages of development on the face, trunk, and extremities. Secondary infection from the reactivation of endogenous latent VZV infection can result in Herpes zoster (also known as “shingles”). VZV reactivation may occur in multiple dermatomes resulting in a more widespread distribution. This condition is known as disseminated herpes zoster and is usually observed in immunocompromised individuals.

HSV-1, HSV-2 and VZV are human herpes viruses that can cause genital vesicular lesions. Although a majority of genital lesions are caused by HSV-1 and/or HSV-2, up to 2.9% of genital lesions are associated with VZV. For many individuals, VZV at the genital site is associated with childhood chickenpox, 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.

Why to choose it

A comprehensive HSV 1/2 & VZV molecular test for cutaneous and mucocutaneous swab specimens. The assay is for high throughput analysis (up to 96 triplex reactions per run) and has a streamlined workflow for results in about an hour without the need for DNA extraction.

Benefits

Reliability

The Simplexa HSV 1/2 & VZV Universal Direct assay demonstrated greater than 98% positive percent agreement and greater than or equal to 99.0% negative percent agreement compared to another CE marked NAAT during clinical studies with over 380 retrospective samples.

SWAB PERFORMANCE-SIMPLEXA HSV 1/2 & VZV UNIVERSAL DIRECT

RETROSPECTIVE SAMPLES 

a Confirmation of HSV-1 was determined in one (1) discordant upon discrepant analysis evaluation by PCR/bi-directional sequencing.

b The presence of HSV-1 was unable to be determined in one (1) discordant upon discrepant analysis evaluation by PCR/bi-directional sequencing.
c Confirmation of HSV-2 was determined for all three (3) discordants upon discrepant analysis evaluation by PCR/bi-directional sequencing.
d Confirmation of VZV was determined for all three (3) discordants upon discrepant analysis evaluation by PCR/bi-directional sequencing.
e The discordant was negative for VZV upon discrepant analysis evaluation by PCR/Bi-directional sequencing.

Rapid Results

The Simplexa HSV 1/2 & VZV Universal Direct assay allows for up to 96 triplex reactions per run with results in about an hour. The positive control is included with the kit.

For use on

LIAISON MDX

Ordering Info

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Simplexa HSV 1/2 & VZV Universal Direct Kit Brochure