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Simplexa® VZV Swab Direct Kit

The first and only FDA Cleared stand-alone molecular assay for VZV

Direct detection of varicella-zoster virus DNA in cutaneous and mucocutaneous lesion swab specimens.

Disease state

Varicella-zoster virus (VZV) infections cause primary (chickenpox) or secondary infection (shingles)1. VZV is highly contagious, spread by exposure to individuals shedding the virus by person-to-person contact, vesicular fluid aerosol inhalation from skin lesions, and aerosolized respiratory secretions.

Complications of VZV infection include bacterial skin infections, adult pneumonia, and in children, soft tissue infections. Severe complications include:

  • Encephalitis.
  • VZV infection of internal organs.
  • Postherpetic neuralgia in immunocompromised individuals.
  • VZV can complicate pregnancy; newborns of infected mothers may develop congenital varicella syndrome or neonatal varicella.

VZV is a leading cause of adult encephalitis, second only to HSV. Approximately 90 percent of the population will be infected by age 15 and are at risk for developing encephalitis caused by VZV.

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)

The value of Simplexa® VZV Swab Direct Kit

Fast and accurate detection of VZV with the seamless flexibility for differential diagnosis with HSV 1&2

Proven VZV testing efficiencies

One test for a wide range of mucocutaneous and cutaneous lesions of VZV with only 50µl of unextracted sample input and uncompromised performance in 60 minutes.

Delivers diagnostic confidence and testing flexibility

Greater than 97% clinical sensitivity and 99% specificity.
The ability to run separately or alongside the Simplexa® HSV 1 & 2 Direct and the Simplexa® VZV Direct (CSF) on the same disc at the same time.

How the Simplexa® VZV Swab Kit works

Simplexa® VZV Swab Direct is an in-vitro qualitative real-time PCR assay with a simple workflow, enabling unextracted primary sample and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON® MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab —qualitative detection of varicella-zoster virus (VZV) DNA from patients with signs and symptoms of VZV infection.

01

Sample-to-answer

Scan 1-8 primary unextracted samples per run, ready-to-use single-use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON® MDX Instrument and press run for results in 60 minutes.

02

Intiutive LIAISON® MDX Studio Software

Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays - Simplexa® VZV Direct is compatible with the Simplexa® VZV Swab and HSV 1&2 Direct assays in the same run: view PCR curves and QC Charts, interface with LIS and even during run access software.

03

Most comprehensive sample types covered

Cutaneous and mucocutaneous lesion swabs can be collected from locations including anorectal, genital, nasal, ocular, oral, urethra, skin, and others.

Indications for Simplexa® VZV Swab Direct use

Assay and system

A real-time PCR assay run on LIAISON® MDX to detect VZV

Patient types

Human patients with signs and symptoms of VZV infection

Diagnostic lab

Hospital, commercial, reference and public health laboratories

Simplexa® VZV Direct Swab workflow

Scan, load and go

Ready to use

  • No prep & No waste
  • Single use reagents (24 reactions)
  • No mixing, pouring or rehydrating

Simple & easy workflow

  • No extraction needed, direct sample input
  • Liquid sensor to ensure adequate sample volume metered: No precise pipetting required
  • CLIA Moderate Complexity
01

Scanning

  • Scan the assay definition QR code (upon first use only)
  • Scan the lot-specific QR code on a vial or card
  • Scan the disc barcode
  • Scan the sample barcode
02

Loading

In each Disc Wedge:

  • Load 50 µl of sample
  • Load 50 µl of reaction mix (= 1 vial content)
  • Close the foil and remove the tab
  • Disc may be re-used up to 8 times (until all Wedges are utilized)
  • Close the foil and remove the tab
03

Load and run

Load the disc onto the LIAISON® MDX and start the  run. The results and a final report are automatically generated by the software.

To be used on the LIAISON® MDX Instrument

The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.

Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.

Molecular Diagnostic Tool LIAISON® Mdx - Diasorin

LIAISON® MDX

One instrument.
Multiple discs.
Ultimate Flexibility.

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Simplexa® VZV Swab Direct ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa® VZV Swab Direct Kit

24

IVD

MOL3655

Simplexa® VZV Positive Control Pack

10

-

MOL3660

Resources

Diasorin document repository

Dialog

Luminex document repository

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Research publications

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More details about Simplexa® VZV Swab Direct Kit

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