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Xpert® Xpress GBS

Rapid intrapartum Group B Streptococcus (GBS) testing with results as early as 30 minutes with EAT  

Xpert<sup>®</sup>&nbsp;Xpress GBS

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 gestation2,3
  • Some women with unknown GBS status presenting at Labor & Delivery units4,5
  • 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
     

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.

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

/Site Images/Tests/GBS-impact_1.jpg

/Site Images/Tests/GBS-impact_1.jpg

 

 

References:
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.
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

Ordering Info


Xpert® Xpress GBS

Number of Tests: 10

Catalog #: XPRSGBS-CE-10

Xpert® Xpress GBS

Number of Tests: 50

Catalog #: 900-0370
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