Rapid detection and differentiation of HSV 1 and HSV 2 DNA from broad sources of lesion specimens using a sample to answer platform
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.*
Key features of this assay include:
- High Sensitivity—Reduces the risk of false negatives and thus improves diagnosic accuracy.
- High Accuracy—Confidence in results gives patients and clinicians peace of mind and helps ensure correct treatment. Integrated sample processing control ensures the assay run is successful from extraction through amplification.
- Fast Time to Results—Answers in as little as 2 hours will allow physicians to quickly optimize therapeutic decisions in the management of suspected HSV infections.
- Fully Integrated—STAT testing availability ensures results when needed.
- Reduce User Error—Internal barcode scanning matches samples to cassettes, enabling Position Independent Results no matter where each cassette is placed. Reduced data input errors with electronic ordering through bidirectional LIS connectivity†.
Herpes Simplex Virus Overview
HSV 1 and HSV 2 are common human pathogens that cause incurable infections in neonates, children and adults worldwide. Combined, HSV infections affect half a billion people between the ages of 15-49 years globally.1 HSV 1 is generally associated with infections in the tongue, mouth, lips, pharynx, and eyes, whereas HSV 2 is primarily associated with genital and neonate infections.
Viral isolation, direct or indirect fluorescent antibody testing, in situ hybridization, and serology can be used to diagnose HSV infections.2 However, due to the length of culture time, sample transport difficulties, procedural complexity, and a lack of desirable sensitivity, nucleic acid amplification methods such as PCR are often preferred as the diagnostic test method.3, 4
Clinical Performance—Cutaneous and Mucocutaneous
The reference/comparative method used to evaluate the clinical performance of the ARIES® HSV 1&2 Assay was ELVIS® HSV-ID and D3 Typing Test System.
|Summary of HSV 1 and 2 Results for Cutaneous Lesions|
|ARIES® HSV 1&2 Assay||Reference Method|
|HSV 1||95% CI|
|Summary of HSV 1 and 2 Results for Mucocutaneous Lesions|
|ARIES® HSV 1&2 Assay||Reference Method|
|HSV 1||95% CI|
Click here to view the clinical performance of the ARIES® HSV 1&2 Assay with Cerebrospinal Fluid (CSF).
Please see package insert for more detailed information.
The operator prepares the sample, adds it to the cassette, puts the cassette in the magazine, loads the magazine into the ARIES® System, and the run will start automatically.
Load the sample into the cassette
Insert up to six cassettes into the magazine
Insert the magazines into the instrument
Review & release results
|Luminex Online Order Management|
|Phone:||+31 (0)73 800 1900|
|Fax:||+31 (0)73 800 1998|
|Product Name||Kit Size||Registration Status||Part Number|
|ARIES® HSV 1&2 Assay||24 tests||CE Marked||50-10031|
|ARIES® HSV 1&2 Assay Protocol File Kit
(one time order only)
|ARIES® Two Module System
Includes instrument, system operation manual, two magazines, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand
|1 unit||CE Marked||ARIES-M12V1-IVD|
|ARIES® M1 System
Includes instrument, system operation manual, one magazine, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand
|1 unit||CE Marked||ARIES-M6V1-IVD|
|SYNCT™ Software||CE Marked||CN-SW47|
- Media centre: Globally, an estimated two-thirds of the population under 50 are infected with herpes simplex virus type 1. WHO (Internet). Cited 2017 July. Available from: http://www.who.int/mediacentre/news/releases/2015/herpes/en/.
- Jerome, K.R. and R.A. Morrow. Herpes Simplex Viruses and Herpes B Virus. 1530-1544. Versalovic, J., K.C. Carroll, G. Funke, J.H. Jorgensen, M.L. Landry, D.W. Warnock (editors). Manual of Clinical Microbiology. 10th Ed. ASM Press, Washington, D.C. (2011).
- Filén F., A. Strand, A. Allard, J. Blomberg, and B. Herrmann. 2004. Duplex real-time polymerase chain reaction assay for detection and quantification of herpes simplex virus type 1 and herpes simplex virus type 2 in genital and cutaneous lesions. Sex. Transm. Dis. 31(6):331-6.
- Slomka, M.J. 2000. Current diagnostic techniques in genital herpes; their role in controlling the epidemic. Clin. Lab. 46:591-607.
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.
† These products are for Research Use Only. Not for use in diagnostic procedures. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.