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ARIES® GBS ASSAY

ARIES® GBS Assay (IVD)

The ARIES® GBS Assay rapidly detects Group B Streptococcus (GBS) from LIM broth enriched specimens using a sample to answer platform

ARIES® GBS Assay Overview

 

The ARIES® GBS Assay detects Streptococcus agalactiae, also known as Group B Streptococcus or GBS, from Lim broth enriched vaginal-rectal specimen swabs obtained from pregnant women using ARIES® Systems.

 

Infection with GBS is one of the most important infectious causes of neonatal morbidity and mortality, causing meningitis, pneumonia and septicemia in newborns and their mothers. About 12-27% of pregnant women harbor GBS in their rectum or vagina.1 Most women colonized with GBS do not have symptoms; however, GBS can be transmitted to the newborn during delivery. In the U.S., GBS is the leading cause of meningitis and sepsis in a newborn’s first week of life.

 

ARIES® GBS Assay Offers:

 

  • High Sensitivity—Aid in the diagnosis of more patients, using PCR to improve patient outcomes.
  • 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.
  • Ease of Use—A simple to use, sample to answer assay for antepartum detection of GBS colonization, that is accessible to all sizes of laboratories.
  • Full Integration—Automate all aspects of testing, from sample preparation through analysis.
  • Reduce User Error—Internal barcode scanning matches samples to cassettes, enabling Position Independent Results no matter where each cassette is placed. Additionally, reduce data input errors with electronic ordering through bidirectional laboratory information system (LIS) connectivity.

 

Performance

 

The performance of the ARIES® GBS Assay was evaluated using excess leftover de-identified Lim broth cultures from women in their 35th-37th week of pregnancy, whose standard of care screening called for the collection of vaginal-rectal swab specimens for GBS testing, ordered by a physician. The vaginal-rectal swab specimens were enriched by being placed into Lim broth for 18 to 24 hours at 35°C to 37°C. After enrichment, an aliquot of the Lim broth was used for standard of care testing, and the leftover Lim broth was used for reference culture testing and for ARIES® GBS Assay testing. The reference culture testing was performed in accordance with published CDC guidelines.

 

ARIES® GBS Assay Performance (N=687)

 

ARIES® GBS Assay Reference  
  Positive Negative TOTAL
Positive 124 48* 172
Negative 5 510 515
TOTAL 129 558 687
    95% Confidence Interval
Sensitivity 96.1% 91.3%-98.3%
Specificity 91.4% 88.8%-93.5%

* Forty-five (45) ARIES® GBS 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® GBS Assay.

† Two (2) ARIES® GBS 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® GBS Assay.

‡ One (1) specimen (01027) generated an invalid result by the ARIES® GBS Assay after allowable re-run. This specimen was negative by the reference method and was excluded from the device performance calculations.

 

Please see Package Insert for more detailed information.

Workflow

 

The operator simply adds specimen to the sample chamber, puts the cassette in the magazine, loads the magazine into the ARIES® System, and the run will start automatically.

 

ARIES® GBS Assay Workflow

Ordering Information

 

Luminex Online Order Management
Email: orders@luminexcorp.com
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 Name Kit Size Registration Status Part Number
ARIES® GBS Assay 24 tests US-IVD
CA-IVD
CE-IVD
50-10021
ARIES® GBS Assay Protocol File Kit
(one time order only)
  US-IVD
CA-IVD
CE-IVD
CN-0336-01
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 US-IVD
CA-IVD
CE-IVD
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 US-IVD
CA-IVD
CE-IVD
ARIES-M6V1-IVD
SYNCT™ Software   US-IVD
CA-IVD
CE-IVD
CN-SW47
  1. WHO 2006 – State of the art of vaccine research and development: Initiative for Vaccine Research. World Health Organization. http://apps.who.int/iris/bitstream/10665/69348/1/WHO_IVB_06.01_eng.pdf.

 

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 (US-IVD)

The ARIES® GBS Assay, performed on ARIES® Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES® GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal swab specimens obtained from pregnant women. The ARIES® GBS Assay is intended for use as a method for detection of GBS colonization in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection.

The ARIES® GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

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

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