Xpert® Xpress GBS

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Xpert® Xpress GBS

Dual target for S. agalactiae (DNA) Serotypes I-X and non-beta hemolytic in 30–42 minutes

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10 Tests

XPRSGBS-CE-10

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Collection devices

Collection Device

900-0370

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The Need

Group B Streptococcus (GBS) remains a leading cause of early-onset neonatal sepsis. Rates of maternal colonisation 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 & Delivery units^4,5
Risk-based IAP exposes 65–85% of GBS-negative women to antibiotics⁶
69% sensitivity of antenatal culture for GBS detection when compared to intrapartum culture⁷

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.
7 Young BC, et al. Evaluation of a rapid, real-time intrapartum group B streptococcus assay. Am J Obstet Gynecol. 2011 Oct;205(4):372.e1-6.

The Solution

Cepheid's Xpert^® Xpress GBS test is the only in vitro diagnostic test to fully meet the GBS European consensus criteria for rapid intrapartum GBS testing.⁴ The Xpert Xpress GBS test delivers rapid results with 93.5% sensitivity* and 95.5% specificity.^*

On-demand molecular testing — an ideal solution:

Dual targets in highly conserved regions for an extended GBS strain coverage
Test designed with Early Assay Termination (EAT) to provide positive results in approximately 30 mins
Easy-to-use testing with 1 min hands-on time
Intrapartum rectal/vaginal swabs can be tested by trained lab, or labor and delivery staff
Sample Adequacy Control integration to ensure correct sample incorporation into the cartridge
Random access enables any test in the menu to be run at any time, without the need to batch

^*Sensitivity and specificity results for intrapartum vaginal/rectal.
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

The Impact

The Xpert Xpress GBS test can easily be run in near-patient settings by trained non-laboratory personnel. Now clinicians are able to identify GBS colonisation status when it matters most.

Identify GBS colonisation status at the time of labor
Fast and easy to interpret results, enables timely appropriate treatment preventing early onset of GBS disease in newborns
Reduce unnecessary use of intrapartum antibiotic prophylaxis (IAP)
– Reduce overall hospital cost⁸
– Reduce length of stay⁹
– Streamline patient management
– Less impact on newborn intestinal flora¹⁰

Impact on Patient Pathway

8 Picchiassi E, et al. Intrapartum test for detection of Group B Streptococcus colonization during labor. J Matern Fetal Neonatal Med. 2018 Dec;31(24):3293-330.
9 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
10 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