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ARIES® NOROVIRUS ASSAY

ARIES® Norovirus Assay

The ARIES® Norovirus Assay rapidly detects and differentiates norovirus GI and norovirus GII in raw stool samples

ARIES® Norovirus Assay Overview

 

 

Noroviruses are single-stranded RNA viruses in the genus Norovirus, family Caliciviridae.1 Norovirus is also known as “winter-vomiting disease” or “stomach-flu” due to its spread in human population, especially during the winter months. Primarily spread through the fecal-oral route, norovirus is highly contagious and 10-100 viral particles may be sufficient to infect an individual.2

 

The ARIES® Norovirus Assay is a fully-automated solution that easily integrates into the clinical laboratory. The on-demand testing capability of the ARIES® platform enables rapid detection of infected patients so appropriate clinical actions can be taken and infection control procedures can be implemented. The assay is CE marked for IVD use.

 

ARIES® Norovirus Assay Offers:

 

  • Ease of Use: A simple, fully closed sample to answer system that can be easily operated with minimal risk of contamination
  • High Performance: Report results with a high degree of confidence
  • Fully Integrated: Automate all aspects of testing, from sample preparation through analysis, to enable easy implementation on weekends and night shifts
  • Flexible: Ability to run both IVD and laboratory developed assays on the same system simultaneously, when using a Universal Assay Protocol
  • Scalable: On-demand testing of up to 12 samples per run for rapid, actionable results

 

Performance

 

Performance of the ARIES® Norovirus Assay was established by testing raw (fresh or frozen) stool samples retrospectively collected from six geographically diverse sites in the United States and Europe.

 

Summary of Norovirus GI Results After Discordant Analysis (N=200)
ARIES® Norovirus Assay NAAT Reference Method and Bidirectional Sequencing
Norovirus GI Positive Norovirus GI Negative Total
Norovirus GI Positive 14 1 15
Norovirus GI Negative 0 185 185
Total 14 186 200
  95% CI  
PPA 100% 78.5% – 100%
NPA 99.5% 97.0% – 99.9%

 

 

Summary of Norovirus GII Results After Discordant Analysis (N=200)
ARIES® Norovirus Assay NAAT Reference Method and Bidirectional Sequencing
Norovirus GII Positive Norovirus GII Negative Total
Norovirus GII Positive 84 1 85
Norovirus GII Negative 0 115 115
Total 84 116 200
  95% CI  
PPA 100% 95.6% – 100%
NPA 99.1% 95.3% – 99.8%

 

Please see the Package Insert for more detailed information.

Workflow

 

The operator loads specimen in the sample chamber and puts the cassette in the magazine. Once the magazine is placed in the ARIES® System, the run begins automatically.

ARIES® Norovirus Assay - Workflow Step 1

Step 1

Add ARIES® Stool Resuspension Buffer to the ARIES® Cassette

ARIES® Norovirus Assay - Workflow Step 2

Step 2

Load the sample into the cassette

ARIES® Norovirus Assay - Workflow Step 3

Step 3

Insert up to six cassettes into the magazine

ARIES® Norovirus Assay - Workflow Step 4

Step 4

Insert the magazines into the instrument

ARIES® Norovirus Assay Workflow - Step 5

Step 5

Review & release results

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® Norovirus Assay Kit

Includes ARIES® Norovirus Assay and ARIES® Norovirus Assay Loops

24 tests CE Marked 50-10042
ARIES® Norovirus Assay Protocol File
(one time order only)
  CE Marked CN-0338-01
ARIES® Stool Resuspension Buffer   General Purpose Reagent (GPR) 30-00103
Note: The ARIES® Stool Resuspension Buffer must be ordered separately
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
  1. Zheng, Du-Ping; Ando, Tamie; Fankhauser, Rebecca L.; Beard, R. Suzanne; Glass, Roger I.; Monroe, Stephan S. 2006. Norovirus Classification and Proposed Strain Nomenclature. Public Health Resources. Paper 89.
  2. ECDC website. Factsheet. http://ecdc.europa.eu/en/healthtopics/norovirus_infection/factsheet-health-professionals/Pages/factsheet_health_professionals.aspx. Accessed online April 2017.

 

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® Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the identification and differentiation of norovirus genogroup I (GI) and genogroup II (GII) RNA from raw or unpreserved unformed stool specimens collected from individuals with symptoms of acute gastroenteritis. The ARIES® Norovirus Assay is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The assay also aids in the detection and identification of norovirus infections in the context of outbreaks.

The ARIES® Norovirus Assay is indicated for use with ARIES® Systems.

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

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