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Ai sensi delle Linee Guida del Ministero della Salute del 28/03/2013 in materia di pubblicità sanitaria relativa a dispositivi medici, dispositivi medico-diagnostici in vitro e presidi medico-chirurgici, si informa che le informazioni contenute in questo sito e alle quali si accede sono destinate esclusivamente agli operatori professionali.

Simplexa VZV Direct

Only targeted FDA cleared in vitro qualitative PCR assay for the direct detection of VZV from CSF samples

Accurate and rapid targeted diagnosis of VZV in CSF Samples with seamless compatibility with Simplexa HSV 1 & 2 Direct for effective diagnosis of viral meningitis/encephalitis.

Tecnologia Simplexa® per il rilevamento del virus Varicella Zoster - Diasorin

Disease state

Varicella-zoster virus (VZV) infections cause primary (chickenpox) or secondary infection (shingles). 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 is a highly contagious pathogen associated with chickenpox, shingles, and a multitude of secondary infections, including encephalitis

The value of Simplexa VZV Direct

The only targeted FDA cleared PCR assay for diagnosing VZV CNS infections

Fast molecular workflow for CSF samples

CLIA moderate complexity assay provides results in approximately one hour - no DNA extraction is required.

Operational efficiencies with minimum CSF sample input

Uncompromised performance from 50μL of CSF sample ideal for pediatric and adult testing.

Delivering diagnostic confidence

100% Positive Percent Agreement (clinical sensitivity)
99% Negative Percent Agreement (clinical specificity) in prospective studies

How Simplexa
VZV Direct works

Simplexa VZV 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 in cerebrospinal fluid (CSF) from patients with signs and symptoms of meningitis, encephalitis, or both.

01

Sample-to-answer workflow with timely results

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

Intuitive 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 direct compatible with the Simplexa VZV Swab Direct and HSV 1 & 2 Direct assays in the same run. View PCR curves and QC Charts, interface with LIS and even access software during the run.

Indications for Simplexa VZV 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 CNS infection

Diagnostic lab

Hospital,  Commercial, Reference and Public Health laboratories

Simplexa VZV Direct 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

Scan

  • 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

Load

In each Disc wedge:

  • Load 50 µl of sample
  • Load 50 µl of reaction mix
  • Close the foil and remove the tab
03

Run

  • Load the disc onto the LIAISON® MDX and start the run. The results and a final report are automatically generated by the software.
  • Close the foil and remove the tab Disc may be re-used up to 8 times (until all Wedges are utilized)

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.

LIAISON® MDX - Strumento di Diagnostica Molecolare - Diasorin

LIAISON® MDX

One instrument.
Multiple discs.
Ultimate Flexibility.

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Simplexa VZV Direct ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa VZV Direct Kit

24

IVD

MOL3650

Simplexa VZV Positive Control Pack

10

IVD

MOL3660

Resources

Diasorin document repository

Dialog

Luminex document repository

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Research publications

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More details about Simplexa VZV Direct

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