Fast and Accurate Diagnosis of Chlamydia and Gonorrhea
- 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 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
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
Number of Tests: 10Catalog #: GXGBS-100N-10
Number of Swabs: 50Catalog #: SWAB/A-50
Intrapartum GBS screening and antibiotic prophylaxis
Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference; J Matern Fetal Neonatal Med. 2015 May;28(7):
Cost and effectiveness of intrapartum group B streptococcus polymerase
El Helali et al . Cost and Effectiveness of Intrapartum Group B Streptococcus Polymerase Chain Reaction Screening for Term Deliveries. Obstet Gynecol. 2012 Apr;119(4):822-9.
Diagnostic accuracy of a rapid real-time polymerase
El Helali et al. Diagnostic Accuracy of a Rapid Real-Time Polymerase Chain Reaction Assay for Universal Intrapartum Group B Streptococcus Screening. Clin Infect Dis. 2009 Aug 1;49(3):417-23.
Replacing risk-based early-onset-disease prevention
Björklund et al, Replacing risk-based early-onset-disease prevention with intrapartum group B streptococcus PCR testing. J Matern Fetal Neonatal Med. 2017 Feb;30(3):368-373