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ARIES® HSV 1&2 ASSAY

ARIES HSV 1&2 Assay (IVD)

 
ARIES® HSV 1&2 Assay

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 genital lesions 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 50 million people in the United States and cause more than one million new infections every year.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

 

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 (CDC 2015). Due to the nature of the infection, obtaining results from cerebrospinal fluid (CSF) in a timely fashion is critical.5

 

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
Sensitivity 91.1%
(51/56)
80.4%–97.0%
Specificity 94.2%
(274/291)
90.8%–96.6%
HSV 2  
Sensitivity 95.0%
(96/101)
88.8%–98.4%
Specificity 88.8%
(308/347)
85.0%–91.9%

 

 

Summary of HSV 1 and 2 Results for Mucocutaneous Lesions
ARIES® HSV 1&2 Assay Reference Method
HSV 1 95% CI
Sensitivity 97.0%
(262/270)
94.2%–98.7%
Specificity 95.4%
(878/920)
93.9%–96.7%
HSV 2  
Sensitivity 98.5%
(250/263)
96.2%–99.6%
Specificity 93.2%
(1109/1190)
91.6%–94.6%

 

 

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

Ordering Information
Luminex Online Order Management
Email: [email protected]
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)
  CE Marked CN-0371-01
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
ARIES® HSV 1&2 Assay Resources
Sales Sheet
ARIES® HSV 1&2 Assay (CE Marked)
ARIES®—Welcome to the New Way to Work (IVD)
ARIES® M1—Welcome to the New Way to Work (IVD)
Posters
Comparison of Luminex® ARIES® HSV 1&2 Assay and Viral Culture for Laboratory Detection of Neonatal HSV Infection from Mucosal Swab Specimens
Workflow Study of Multi-Platforms vs Single Platform Testing of Routine Clinical Molecular Assays
Validation of ARIES® HSV 1 and 2 Using Formalin-Fixed Paraffin-Embedded Tissue
Comparison of ARIES® HSV 1&2 Assay, Simplexa™ HSV 1 & 2 Direct and a Real-Time PCR Lab Developed Test for the Detection of HSV from Lesions
Comparison of Two Multiplex Molecular Assays for the Detection of Herpes Simplex 1 and 2 and Varicella Zoster Virus
Comparative Evaluation of Three Automated Platforms for the Detection of Herpes Simplex Virus in Clinical Specimens
Comparison of Three Assays for HSV 1 and HSV 2 Detection: A Look at Focus Diagnostics 3M Integrated Cycler, Luminex ARIES® System, and Roche Lightcyler® 2.0
Evaluation of ARIES® HSV 1&2 and Simplexa™ HSV 1&2 Direct Assays for the Detection and Differentiation of Herpes Simplex Virus from Cerebrospinal Fluid and Swab Specimens
Diagnosis of Disseminated HSV Infection Using Plasma Samples on the ARIES Sample-to-Answer HSV 1&2 PCR Assay
Performance Comparison and Workflow Evaluation of Simplexa™ HSV 1&2 Direct and ARIES® HSV 1&2 Assay for the Detection of HSV 1 & 2 in Genital and Non-genital Specimens
Detection of Herpes Simplex Virus by Three Nucleic Acid Amplification Methods and the ELVIS ID System
Brochures & White Papers
ARIES® M1 Brochure – Welcome to the New Way to Work
ARIES® Lean Lab White Paper: Delivering More with Less
  1. http://www.cdc.gov/std/tg2015/herpes.htm
  2. 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).
  3. 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.
  4. Slomka, M.J. 2000. Current diagnostic techniques in genital herpes; their role in controlling the epidemic. Clin. Lab. 46:591-607.
  5. 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. The assay is not intended to be used for prenatal screening.

The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System.

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

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