Xpert® Xpress GBS

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Xpert® Xpress GBS

Qualitative real-time PCR test providing accurate intrapartum detection of Group B Streptococcus in Labor/delivery

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10 Tests

XPRSGBS-CE-10

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Collection devices

Collection Device (Pack of 50)

900-0370

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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
Challenges remain, including:

Risk of change of GBS colonization status following screening at 35–37 weeks of gestation^2,3
Some women with unknown GBS status presenting at Labor and Delivery unit^4,5
Risk-based IAP exposes 65–85% of GBS-negative women to antibiotics⁶

1 Wicker E, et al. Group B streptococci: declining incidence in infants in Germany. Pediatr Infect Dis J. 2019 May;38(5):516–9.
2 Helmig R, et al. Diagnostic accuracy of polymerase chain reaction for intrapartum detection of Group B Streptococcus colonization. Acta Obstet Gynecol Scand. 2017
Sep;96(9):1070-1074.
3 Melin P. Neonatal group B streptococcal disease: from pathogenesis to preventive strategies. Clin Microbiol Infect. 2011 Sep;17(9):1294-303.
4 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
5 ASM, March 2020, Guidelines for the Detection and Identification of Group B Streptococcus - Revised Guidelines from CDC, 2020
6 Saari A, et al. Antibiotic exposure in infancy and risk of being overweight in the first 24 months of life. Pediatrics. 2015 Apr;135(4):617–626.

The Solution

The Xpert Xpress GBS test is a qualitative in vitrodiagnostic test intended for the detection of DNA from Group B Streptococcus (GBS). The test is performed usinga dual vaginal/rectal swab specimen collected from pregnant females during antepartum or intrapartum.
The Xpert Xpress GBS test is intended to aid in the diagnosis of GBS colonization to identify candidates for antibiotic prophylaxis.

The Impact

Identify GBS colonization status at the right time, at the time of labor (intrapartum).⁴
Identifying more women with GBS at the time of delivery and providing them with timely Intrapartum AntibioticProphylaxis (IAP) may result in a reduction of early-onset GBS disease in neonates.⁷
Fast and easy-to-interpret results enable adequate IAP delivered to mothers with unknown status, which may resultin less impact on the newborn intestinal flora.^8,9

4 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
7 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) 49 (3):
417-423.
8 Björklund V, 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
9 Zimmermann P, et al. Effect of intrapartum antibiotics on the intestinal microbiota of infants: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):201–8

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