ARIES® HSV 1&2 Assay

Cerebrospinal Fluid (CSF)

The ARIES® HSV 1&2 Assay is a rapid molecular method for the detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and 2) in cutaneous or mucocutaneous lesion specimens and cerebrospinal fluid (CSF) using a sample to answer platform.*

 

In addition to oral and genital infection, HSV 1&2 can cause infections of the central nervous system. Meningitis is an inflammation of the tissue that covers the brain and spinal cord. Viral meningitis is the most common type of meningitis. Infants younger than 1 month old and people with weakened immune systems are more likely to have severe illness.1 Due to the nature of the infection, obtaining results from cerebrospinal fluid (CSF) in a timely fashion is critical.2

 

Clinical Performance—CSF

 

The following table represents post-discordant analysis, where contrived positive and natural specimens tested by both the ARIES® System and the alternate NAT reference method were positive.

 

ARIES® HSV 1&2 Assay Reference Method
HSV 1 95% CI
PPA 100% 89.6%–100%
NPA 100% 97.6%–100%
HSV 2  
PPA 100% 90.8%–100%
NPA 99.3% 96.1%–99.9%

 

 

Please see package insert for more detailed information.

The ARIES® HSV 1&2 Assay Workflow

 

The four-step work flow reduces the amount of hands-on time required to perform molecular testing. ARIES® cassettes are pre-loaded with all of the sample processing reagents needed. Simply add the sample to the side cassette, load the cassettes into the magazine, load the magazine into the instrument, and a run will start automatically.

 

ARIES® Four-Step Workflow

  1. 2015 sexually transmitted diseases treatment guidelines: Genital HSV infections. CDC (Internet). Cited 2017 July. Available from: https://www.cdc.gov/std/tg2015/herpes.htm.
  2. ARIES® HSV 1&2 Assay (CE Marked for IVD Use) Package Insert.

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

* Intended Use (CE Marked)

The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 and 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients or in CSF from patients suspected of HSV infections of the central nervous system (CNS). The test is indicated for use with symptomatic individuals to aid in the diagnosis of HSV infections.

Negative CSF results do not preclude HSV 1 and HSV 2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The assay is not intended to be used for prenatal screening.

The ARIES® HSV 1&2 Assay (EU) is indicated for use on the ARIES® Systems.

ARIES® Systems are class 1(I) laser products.

Validation of the LIS compatibility must be performed by the end user.