Simplexa^® HSV 1 & 2 Direct

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

The only FDA cleared HSV molecular test for CSF, cutaneous and mucocutaneous swab samples.

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.

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

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.

03

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