Simplexa® VZV Swab Direct Kit

The First and Only FDA Cleared Stand Alone Molecular Assay for VZV

KIT for Infectious Diseases

Overview

Background

Varicella-zoster virus infection causes two clinically distinct forms of disease, depending on whether an individual is experiencing a primary (chickenpox) or secondary infection (shingles)1. Varicella-zoster virus is highly contagious, spread by exposure to an individual shedding virus from either a varicella or herpes zoster infection. The virus can be spread from person to person by direct contact, inhalation of aerosols from vesicular fluid of skin lesions of acute varicella or zoster and possibly through infected respiratory secretions that also may be aerosolized2.

Common complications of VZV infection are bacterial infections of the skin and soft tissue in children and pneumonia in adults. Severe complications include encephalitis, pneumonia (either direct viral pneumonia or secondary bacterial pneumonia), bronchitis (either viral bronchitis or secondary bacterial bronchitis), visceral dissemination (VZV infection of internal organs) and postherpetic neuralgia in immunocompromised individuals. Varicella-zoster virus can also complicate pregnancy; newborns of infected mothers have a small risk of developing congenital varicella syndrome or neonatal varicella2.

The clinical presentation of zoster can often be confused with the dermal distribution produced by HSV, and thus it is important to detect VZV rapidly for proper patient treatment and management. The diagnosis of these two diseases is usually made clinically. PCR can be used to provide rapid and sensitive detection of VZV DNA in properly collected specimens.

1. 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.
2. Centers for Disease Control and Prevention. (2016). Chicken Pox (Varicella). Retrieved from https://www.cdc.gov/chickenpox/hcp/clinical-overview.html. 

 

Why to choose it

A CLIA moderate complexity assay for the direct detection of the VZV DNA Polymerase gene from only 50 µl of cutaneous and mucocutaneous swab specimens. The assay provides broad sample coverage and improves efficiency with a true sample-to-answer workflow without DNA extraction.

Benefits

Reliability

Reliable performance that you can count on

greater than 97% clinical agreement

The Simplexa® VZV Swab Direct assay demonstrated high performance with excellent clinical agreement against a three part composite reference method.

Simplexa® VZV Swab Direct Clinical Agreement Study
Sample TypeSample Type Positive % Agreement Negative % Agreement
Sample TypeProspective

(cutaneous & mucocutaneous)

Positive % Agreement97.8% (87/89)
95% CI: 92.2% to 99.4%
Negative % Agreement99.2% (360/363)
95% CI: 97.6% to 99.7%
Sample TypeRetrospective

(cutaneous & mucocutaneous)

Positive % Agreement98.4% (61/62)
95% CI: 91.4% to 99.7%
Negative % Agreement99.2% (117/118)
95% CI: 95.4% to 99.9%
Sample TypeContrived

(mucocutaneous only)

Positive % Agreement100.00% (60/60)
95% CI: 94.0% to 100.0%
Negative % Agreement100.0% (60/60)
95% CI: 94.0% to 100.0%
Broad Coverage

Broad Coverage for Your Testing Needs

Our Simplexa® VZV Swab Direct assay utilizes only 50 µl of cutaneous or mucocutaneous swab specimen. Broad coverage includes samples collected from lesion locations including:

  • anorectal
  • genital
  • nasal
  • ocular
  • oral
  • urethra
  • skin

Ordering info

Product Code Reactions
Product

Simplexa® VZV Swab Direct Kit

Code MOL3655 Reactions 24
Product

Simplexa® VZV Positive Control Pack

Code MOL3660 Reactions 10

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