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.
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||Reference|
|95% Confidence Interval|
* 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.
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.
|Luminex Online Order Management|
|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
|ARIES® GBS Assay Protocol File Kit
(one time order only)
|ARIES® Two Module System
|ARIES® M1 System
For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at email@example.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.