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Simplexa HSV 1 & 2 Direct

In vitro qualitative PCR assay for the direct detection of HSV 1 & 2

HSV molecular test for CSF, cutaneous and mucocutaneous swab samples.

Simplexa Congenital CMV Direct Kit

Disease state

HSV 1 & 2 cause a variety of diseases with multiple presentations, ranging from mucocutaneous and cutaneous lesions to fulminate encephalitis that can have devastating results. An estimated 3.7 billion people under age 50 (67%) have HSV-1 infection globally, while an estimated 491 million people aged 15–49 (13%) worldwide have HSV-2 infection.

HSV-1 is the common cause of most cold sores and also encephalitis. HSV-2 commonly causes genital herpes and viral meningitis. Encephalitis can occur at any age with devastating results if untreated, with up to 70% mortality, and only a minority of survivors will achieve full recovery.

The CDC estimates that 776,000 people in the United States get new herpes infections annually. Nationwide, 16% of persons aged 14-49 have HSV 2 infection. Recognition of genital herpes is important to prevent transmission and provide counseling.


HSV is one of the most common causes of sexually transmitted disease

The value of Simplexa HSV 1 & 2 Direct

A complete solution for fast and effective diagnosis of HSV 1 & HSV 2

Proven HSV testing efficiencies

One test for wide range of mucocutaneous/cutaneous lesions and CSF with only 50 µl of sample input to increase access and usability of high quality patient results.

Operational excellence in HSV testing

Whether primary HSV infection or life-threatening viral meningitis or encephalitis, this solution empowers your lab to consolidate HSV testing.

Confident clinical performance

100% agreement with CSF from HSV positive patients and over 96% agreement with prospective cutaneous/mucocutaneous swab samples.

How the Simplexa HSV 1 & 2 Direct works

Simplexa HSV 1 & 2 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.



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.


Intuitive LIAISON® MDX Studio Software

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


Most comprehensive sample coverage

Cerebrospinal fluid and cutaneous and mucocutaneous lesion swabs from anorectal, genital, nasal, ocular, oral, urethra, and skin.

Indications for Simplexa® HSV 1 & 2 Direct use

Assay and system

A real-time PCR assay run on LIAISON® MDX to detect and differentiate HSV 1 & 2

Patient types

Signs and symptoms of HSV 1 & 2 infection or suspected of HSV CNS infection

Diagnostic lab

Hospital,  Commercial, Reference and Public Health laboratories

Simplexa® HSV 1 & 2 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


  • 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


In each Disc wedge:

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


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

Molecular Diagnostic Tool LIAISON® MDX - Diasorin


One instrument.
Multiple discs.
Ultimate Flexibility.

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Simplexa HSV 1 & 2 ordering info

Part Name
Kit Size
Registration Status
Part Number

Simplexa HSV 1 & 2 Direct Kit




Simplexa HSV 1 & 2 Positive Control Pack





Diasorin document repository


Luminex document repository

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Research publications

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More details about Simplexa® HSV 1 & 2 Direct

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