Impact Story
2m Read
September 10, 2024
COMMUNITY AND GLOBAL HEALTH
Whitepaper
3m Read
October 17, 2025
COMMUNITY AND GLOBAL HEALTH
The Need
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
- Centers for Disease Control and American College of Obstetricians and Gynecologists practice guidelines recommend universal antepartum screening along with intrapartum where indicated based on risk
- 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. Prevention of Perinatal Group B Streptococcal Disease: Revised Guidelines from CDC, 2010. Nov 19, 2010 / 59(RR10);1-32.
2 ACOG Committee Opinion No. 485: Prevention of early-onset group B streptococcal disease in newborns. Obstet Gynecol. 2011 Apr;117(4):1019-27.
3 Alfa MJ, et al. Real-time PCR assay provides reliable assessment of intrapartum carriage of group B Streptococcus. J Clin Microbiol. 2010 Sep;48(9):3095-9.
4 Paolucci M, et al. How can the microbiologist help in diagnosing neonatal sepsis? Int J Pediatr. 2012;2012:120139
US-IVD. For In Vitro Diagnostic Use.
2 ACOG Committee Opinion No. 485: Prevention of early-onset group B streptococcal disease in newborns. Obstet Gynecol. 2011 Apr;117(4):1019-27.
3 Alfa MJ, et al. Real-time PCR assay provides reliable assessment of intrapartum carriage of group B Streptococcus. J Clin Microbiol. 2010 Sep;48(9):3095-9.
4 Paolucci M, et al. How can the microbiologist help in diagnosing neonatal sepsis? Int J Pediatr. 2012;2012:120139
US-IVD. For In Vitro Diagnostic Use.
The Solution
Cepheids GeneXpert® System*, with Xpert® GBS LB XC is a solution designed to support CDC‑recommended antenatal screening strategies, with results in approximately 42 minutes.
On-demand molecular testing — an ideal solution:
- Provides an automated molecular testing workflow for antenatal screening
- Random access ensures any test on the menu can be run anytime, without the need to batch run
On-demand molecular testing — an ideal solution:
- System designed with Early Assay Termination (EAT) with positive samples reported STAT
- Moderately complex testing with minimal hands-on time
- Provides an automated molecular testing workflow for antenatal screening
- Random access ensures any test on the menu can be run anytime, without the need to batch run
The Impact
The Xpert GBS LB XC test, performed on Cepheid's GeneXpert systems, delivers an elegant, simple and streamlined solution.
A molecular in vitro diagnostic, Xpert GBS LB XC is designed for use in the clinical lab. It allows users to perform three simple steps and the GeneXpert does the rest.![]()
A molecular in vitro diagnostic, Xpert GBS LB XC is designed for use in the clinical lab. It allows users to perform three simple steps and the GeneXpert does the rest.
- An automated molecular test with minimal hands‑on steps
- Delivers results in as early as 27 minutes with early assay termination.
- Fast accurate NAAT results
- Moderate complexity