Clinical usefulness in intrapartum GBS screening would consist of a simple bedside kit that enables labor and delivery staff to perform a test, have a turnaround time of 30 minutes, and a sensitivity and specificity of ≥90%."
- Prevention of Perinatal Group B Streptococcal Disease. MMWR 2010 Nov 19; 59 (10)
In the U.S., 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.
Cepheid's Xpert® GBS test is the only in vitro diagnostic test to fully meet CDC criteria for rapid intrapartum GBS testing. With results in just over 35 minutes for positive and 52 minutes for negative, Xpert GBS delivers 91.9% sensitivity and 95.6% specificity.
Not just a solution, a complete solution - Cepheid’s GeneXpert System, with Xpert® GBS LB and Xpert GBS is the only solution able to fully meet CDC criteria for both antenatal and intrapartum testing.
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 minute 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
Xpert GBS is the first and only molecular test designed to be run in the clinical lab and near-patient by non-laboratory professionals such as labor and delivery nurses — 24 hours a day, 365 days a year.
Impact on Patient Pathway
- Cepheid - The Molecular Diagnostics Leader
- Catalog #: GXGBS-10
Number of Tests: 10
- How can I place an order?
Submit your request using our Request Information form, or call 1.888.838.3222, select option 1.