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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 real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients.*

 

Key features of this assay include:

 

  • Integrated sample processing control ensures the assay run is successful from extraction through amplification.
  • 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.
  • Reduced turnaround time with simultaneous STAT and batch testing on a single ARIES® System.

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

 

The ARIES® HSV 1&2 Assay Offers:

 

  • High Sensitivity: Diagnose more patients, reduce time to treatment.
  • High Accuracy: Confidence in results gives patients and clinicians peace of mind, and helps ensure correct treatment.
  • Fast Time to Results: Answers in as little as two hours will allow physicians to counsel patients and treat sooner to decrease disease transmission.
  • Fully Integrated: Automate all aspects of testing, from sample preparation through analysis, to reduce human error.

 

Assay Performance

The performance of the ARIES® HSV 1&2 Assay was assessed at three (3) geographically diverse clinical sites in the United States.

 

The reference/comparative method used to evaluate the clinical performance of ARIES® HSV 1&2 Assay was ELVIS® HSV-ID and D3 Typing Test System.

 

 

Summary of HSV 1 Results for Cutaneous Lesions (N=347)

 

ARIES® HSV 1&2 AssayReference Method
 PositiveNegativeTOTAL
Positive5117A68
Negative5B274279
TOTAL56291347
  95% Cl 
Sensitivity91.1%
(51/56)
80.4%-97.0% 
Specificity94.2%
(274/291)
90.8%-96.6% 

A. Thirteen (13) HSV 1 ARIES® positive specimens that were negative by the reference method were positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. The remaining four (4) false positive specimens were negative for both HSV 1 and HSV 2 by bi-directional sequencing.

 

B. All five (5) HSV 1 ARIES® negative specimens that were positive by the reference method were negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. One of these specimens was positive for HSV 2 by both ARIES® and sequencing.

 

 

Summary of HSV 1 Results for Mucocutaneous Lesions (N=1190)

 

ARIES® HSV 1&2 AssayReference Method
 PositiveNegativeTOTAL
Positive26242A304
Negative8B878886
TOTAL2709201190
  95% Cl 
Sensitivity97.0%
(262/270)
94.2%-98.7% 
Specificity95.4%
(878/920)
93.9%-96.7% 

A. Nineteen (19) HSV 1 ARIES® positive specimens that were negative by the reference method were positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. Twenty (20) false positive specimens were negative for both HSV-1 and HSV-2 by bi-directional sequencing. The remaining three (3) specimens were unavailable (QNS) for sequence analysis.

 

B. Seven (7) HSV 1 ARIES® negative specimens that were positive by the reference method were negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. One of these specimens was positive for HSV 2 by both ARIES® and sequencing. One (1) false negative specimen was confirmed as positive for HSV-1 by bi-directional sequencing.

 

 

Summary of HSV 2 Results for Cutaneous Lesions (N=448)

 

ARIES® HSV 1&2 AssayReference Method
 PositiveNegativeTOTAL
Positive9639A135
Negative5B308313
TOTAL101347448
  95% Cl 
Sensitivity95.0%
(96/101)
88.8%-98.4% 
Specificity88.8%
(308/347)
85.0%-91.9% 

A. Thirty five (35) HSV 2 ARIES® positive specimens that were negative by the reference method were positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. The remaining four (4) false positive specimens were negative for both HSV-1 and HSV-2 by bi-directional sequencing.

 

B. All five (5) HSV 2 ARIES® negative specimens that were positive by the reference method were negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. Two of these specimens were positive for HSV 1 by both ARIES® and sequencing.

 

 

Summary of HSV 2 Results for Mucocutaneous Lesions (N=1453)

 

ARIES® HSV 1&2 AssayReference Method
 PositiveNegativeTOTAL
Positive25981A340
Negative4B11091113
TOTAL26311901453
  95% Cl 
Sensitivity98.5%
(250/263)
96.2%-99.6% 
Specificity93.2%
(1109/1190)
91.6%-94.6% 

A. Fifty eight (58) HSV 2 ARIES® positive specimens that were negative by the reference method were positive by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay.Twenty-one (21) false positive specimens were negative for both HSV-1 and HSV-2 by bi-directional sequencing. The remaining two (2) specimens were unavailable (QNS) for sequence analysis.

 

B. All four (4) HSV 2 ARIES® negative specimens that were positive by the reference method were negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® HSV 1&2 Assay. Three (3) of these specimens were positive for HSV 1 by both ARIES® and sequencing.

 

 

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:1-512-336-3550
Toll Free:1-866-401-5450
Fax:1-512-219-0544
Fax (Europe, Middle East, India, Asia):+31 (0)73 800 1998
Product NameKit SizeRegistration StatusPart Number
ARIES® HSV 1&2 Assay24 testsUS-IVD
CA-IVD
CE Marked
50-10017
ARIES® HSV 1&2 Assay Protocol File Kit
(one time order only)
 US-IVD
CA-IVD
CE Marked
CN-0337-01
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 unitUS-IVD
CA-IVD
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 unitUS-IVD
CA-IVD
CE Marked
ARIES-M6V1-IVD
SYNCT™ Software US-IVD
CA-IVD
CE Marked
CN-SW47
ARIES® HSV 1&2 Assay Resources
Sales Sheet
Posters
MultiCenter Evaluation of the ARIES® HSV 1&2 Assay for Direct Detection of Herpes Simplex Virus Types 1 and 2 from Unprocessed Cutaneous and Mucosal Specimens
Brochures & White Papers
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.

 

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 (US-IVD)

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 differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System.

WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.

The ARIES® System is a class 1(I) laser product.

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