The first and only FDA-cleared molecular Trichomonas vaginalis test for both women and men
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.
The Xpert® GBS LB test delivers 99.0% sensitivity and 92.4% specificity. Part of 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:
- Moderately complex testing with < 1 min hands-on time
- Reduces lab’s work for antenatal screening
- Random access ensures any test on the menu can be run anytime, without the need to batch
- 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.
A molecular in vitro diagnostic, Xpert GBS LB is designed for use in the clinical lab. It allows users to simply perform ONE easy step and the GeneXpert System does the rest.
Impact on Patient Pathway
Xpert® GBS LB
Number of Tests: 10Catalog #: GXGBSLB-10