Simplexa HSV 1/2 & VZV Universal Direct Kit

A Comprehensive HSV 1/2 & VZV Molecular Test for Cutaneous and Mucocutaneous Swab Specimens

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KIT for Infectious Diseases

Overview

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.1,2 HSV-1 is typically characterized by oral lesions, infectious keratitis, and eczema herpeticum, with a recent increase in genital lesions.3 HSV-2 infection is one of the most common sexually transmitted diseases causing vesicular genital lesions.4 Worldwide, approximately 90% of people are infected with HSV, 60-80% of whom have HSV-1 and 16-25% have HSV-2.5,6

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.7 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.8

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 VZV9. 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.

1. Corey Lawrence, (2004) Herpes Simplex virus, In: Madell G.L., Bennett, J.E. and Dolin R., eds., Principles and Practice of Infectious Diseases, 6th edition, Philadelphia, PA Elsevier, Churchill and Livingstone: pp 1762-80.
2. Adelson, Martin E., et al. (2005) Simultaneous detection of herpes simplex virus types 1 and 2 by real-time PCR and Pyrosequencing. J. Clin. Virol. 33:25-34.
3. Shipley, M. M., Renner, D. W., Ott, M., Bloom, D. C., Koelle, D. M., Johnston, C., & Szpara, M. L. (2018). Genome-Wide Surveillance of Genital Herpes Simplex Virus Type 1 From Multiple Anatomic Sites Over Time. The Journal of infectious diseases, 218(4), 595-605.
4. LeGoff, J., Péré, H., & Bélec, L. (2014). Diagnosis of genital herpes simplex virus infection in the clinical laboratory. Virology journal, 11, 83. doi:10.1186/1743-422X-11-83.
5. Selma Emre and Ayse Akkus (September 6th 2017). Genital Herpes, Fundamentals of Sexually Transmitted Infections, Server Serdaroglu and Zekayi Kutlubay, IntechOpen, DOI: 10.5772/intechopen.70105.
6. Wald A, Corey L. Persistence in the population: epidemiology, transmission. In: Arvin A, Campadelli-Fiume G, Mocarski E, et al., editors. Human Herpesviruses: Biology, Therapy, and Immunoprophylaxis. Cambridge: Cambridge University Press; 2007. Chapter 36.
7. Albrecht MA. (2017, May 31). Diagnosis of varicella-zoster virus infection. UpToDate. Retrieved on 06/27/2018 from https://www.uptodate.com/contents/diagnosis-of-varicella-zoster-virus-infection.
8. Lewis DJ, Schlichte MJ, Dao H Jr. Atypical disseminated herpes zoster: management guidelines in immunocompromised patients. Cutis. 2017; 100(5): 321; 324-330.
9. Birch, C. J., Druce, J. D., Catton, M. C, MacGregor L., & Read, T. Detection of varicella zoster virus in general specimens using multiplex polymerase chain reaction. Sex Transm Infect. 2003; 79: 298-300.

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

Reliable performance that you can count on

Greater Than 98% clinical agreement

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 UniversalDirect
Retrospective Samples
Type Agreement with Positives Agreement with Negatives
TypeHSV-1 Agreement with Positives100.0% (108/108)
95% CI: 96.6% to 100.0%
Agreement with Negatives99.3% (276/278)ab
95% CI: 97.4% to 99.8%
TypeHSV-2 Agreement with Positives100.0% (98/98)
95% CI: 96.2% to 100.0%
Agreement with Negatives99.0% (285/288)c
95% CI: 97.0% to 99.6%
TypeVZV Agreement with Positives98.4% (60/61)d
95% CI: 91.3% to 99.7%
Agreement with Negatives99.1% (322/325)e
95% CI: 97.3% to 99.7%

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

Rapid results and high-throughput

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.


Ordering info

Product Code Reactions
Product

Simplexa HSV 1/2 & VZV Universal Direct Kit

Code MOL2185 Reactions 100
Product

Simplexa HSV 1/2 & VZV Universal Direct Kit

Code MOL2175 Reactions 1000

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assay protocols and more.

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