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ARIES® BORDETELLA ASSAY

ARIES® Bordetella Assay

The ARIES® Bordetella Assay rapidly detects Bordetella pertussis and Bordetella parapertussis from nasopharyngeal swab (NPS) specimens using a sample to answer platform

ARIES® Bordetella Assay Overview

 

 

Pertussis is also known as whooping cough. The infection is known to cause life-threatening complications among infants and small children, leading to an estimated 195,000 deaths annually around the world.1

 

For cases of suspected pertussis, a contagious bacterial disease that can be difficult to distinguish from other upper respiratory infections, the ARIES® Bordetella Assay detects Bordetella pertussis and Bordetella parapertussis DNA from nasopharyngeal swab specimens. The real-time PCR assay runs on ARIES® Systems to provide specific diagnostic results in less than two hours. The assay is CE Marked and FDA cleared for IVD use.

 

ARIES® Bordetella Assay Offers:

 

  • Specificity—Aids in diagnosis and surveillance reporting by identifying patients with Bordetella pertussis infection.
  • Flexibility for Efficient Testing—Run 1 to 12 tests per batch, appropriate for both STAT testing and low to medium sample batching.
  • Full Integration—All aspects of testing are automated, from sample preparation through analysis.
  • Fast Time to Results—Answers in less than 2 hours with minimal hands-on time.
  • Error-Reducing Safeguards—Internal barcode scanning matches samples to cassettes, and may help reduce data input errors

 

Performance

 

The performance of the moderate complexity ARIES® Bordetella Assay was assessed at five geographically diverse clinical sites in the United States.

 

ARIES® Bordetella Assay Performance for B. pertussis
Specimen Description PPA 95% CI NPA 95% CI
Prospective 30/32* 93.8% 79.2% – 99.2% 1009/1020 98.9% 98.1% – 99.5%
Pre-selected 37/37 100% 90.5% – 100% 77/77 100% 95.3% – 100%
Total 67/69 97.1% 89.9% – 99.6% 1086/1097 99.0% 98.2% – 99.5%
* Two (2) prospective specimens generated false negative results by ARIES® Bordetella Assay when compared to the composite comparator method (02-179 and 06-267).

 

 

ARIES® Bordetella Assay Performance for B. parapertussis
Specimen Description PPA 95% CI NPA 95% CI
Prospective 2/2 100% 15.8% – 100% 1048/1050 99.8% 99.3% – 100%
Pre-selected 20/20 100% 83.2% – 100% 93/94* 98.9% 94.2% – 100%
Contrived 50/50 100% 92.9% – 100% 50/50 100% 92.9% – 100%
Total 72/72 100% 95.0% – 100% 1191/1194 99.7% 99.3% – 99.9%
*One (1) pre-selected specimen generated a false positive result by ARIES® Bordetella Assay when compared to the composite comparator method (01-122).

 

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 Bordetella Workflow: Step 1

Step 1

Load the sample into the cassette

ARIES Bordetella Workflow: Step 2

Step 2

Insert up to six cassettes into the magazine

ARIES Bordetella Workflow: Step 3

Step 3

Insert the magazines into the instrument

ARIES Workflow - Step 4

Step 4

Review & release results

Ordering Information

 

Luminex Online Order Management
Email: orders@luminexcorp.com
Phone: 1-512-336-3550
Toll Free: 1-866-401-5450
Fax: +31 (0)73 800 1998
Product Name Kit Size Registration Status Part Number
ARIES® Bordetella Assay 24 tests CE Marked 50-10037
ARIES® Bordetella Assay Protocol File Kit
(one time order only)
  CE Marked CN-0388-01
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
  1. https://www.cdc.gov/pertussis/fast-facts.html

 

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

Intended Use

The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

The ARIES® Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the ARIES® Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information.

The ARIES® Bordetella Assay is indicated for use with the ARIES® Systems.

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

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