Fast and Accurate Diagnosis of Chlamydia and Gonorrhea
Xpert® GBS
Intrapartum or antepartum Group B Streptococcus testing in 56 minutes*
The Need
- Group B Streptococcus (GBS) remains a leading cause of early onset neonatal sepsis. Rates of maternal colonization have not changed, but universal antenatal screening at 35-37 weeks along with the use of intrapartum antibiotic prophylaxis (IAP) has resulted in a decrease of early onset disease.1,2
Challenges remain, including:
- Risk-based IAP exposes 65-85% of GBS-negative women with risk factors to antibiotics. This has been linked to emergence of resistant strains3
- Up to 50% false negatives when testing with agar alone4
(1) CDC. (2010). Prevention of Perinatal Group B Streptococcal Disease, Revised Guidelines. Morbidity and Mortality Weekly Report, Vol.59.
(2) ACOG, A.C. (2011). Prevention of Early-Onset Group B Streptococcal Disease in Newborns. Committee Opinion, 1.
(3) Alfa, M. J. (Sept. 2010). Real-Time PCR Assay provides reliable assessment of intrapartum carriage of group B streptococcus. Journal of Clinical Microbiology, 3095-3099.
(4) Paolucci, M. E. (2012). How can the microbiologist help in diagnosing neonatal sepsis? International Journal of Pediatrics, 14.
The Solution
- Cepheid's Xpert® GBS test is the only in vitro diagnostic test to fully meet the GBS European consensus criteria for rapid intrapartum GBS testing5. With results in less than an hour, Xpert GBS delivers 91.9% sensitivity and 95.6% specificity.
On-demand molecular testing — an ideal solution:
- System designed with Early Assay Termination (EAT) with positive samples reported STAT
- As soon as positive sample is confirmed, software concludes test and reports immediately.
- Moderately complex testing with 1 min hands-on time
- STAT intrapartum specimens can be performed by lab, or by labor and delivery staff
- Random access ensures any test on the menu can be run anytime, without the need to batch
(5) Di Renzo et al. Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference. J Maternal Fetal Neonatal Med. 2014:1-17. Available at: https://pubmed.ncbi.nlm.nih.gov/25162923
* With EAT (early assay termination) for positive results
The Impact
Xpert GBS is the first and only molecular test designed to be run in the clinical lab and close to the patient by non-laboratory professionals such as labor and delivery nurses — 24 hours a day, 365 days a year.
Impact on Patient Pathway
Ordering Info
Xpert® GBS
Number of Tests: 10
Catalog #: GXGBS-100N-10Xpert® GBS
Number of Swabs: 50
Catalog #: SWAB/A-50
