Immediate GBS results you can trust,
at the right time — as early as 30 minutes*
Xpert® Test
Xpress GBSCepheid Bold
15/19
* For Positive Results.
CE-IVD. In
CE-IVD. Vitro Diagnostic
In Vitro Diagnostic Medical
Medical Device.
Device. Not
Not available
available in
in all
all countries.
countries.
“
The benefits of this solution are extreme.
Everything becomes easier for everyone.
It is a team effort based on trust between
laboratories, midwives, and gynecologists,
all of whom must be convinced that this
POC solution is useful and provides an
effective response to their organisation.”
Prof. Luton,
Head of the Obstetrician Gynecologist Department
Bichat- Claude Bernard Hospital (APHP)
The Need The Solution
Group B Streptococcus (GBS) remains a leading cause of early Cepheid’s Xpert® Xpress GBS test is the only in vitro
onset neonatal sepsis. Rates of maternal colonisation have not diagnostic test to fully meet the GBS European consensus
changed, but universal antenatal screening at 35–37 weeks criteria for rapid intrapartum GBS testing.4 The Xpert
along with the use of intrapartum antibiotic prophylaxis (IAP) Xpress GBS test delivers rapid results with 93.5%
has resulted in a decrease of early onset disease.1 sensitivity* and 95.5% specificity.*
Challenges remain, including: On-demand molecular testing — an ideal solution:
• Risk of change of GBS colonisation status following • Dual targets in highly conserved regions for an extended
screening at 35–37 weeks of gestation2,3 GBS strain coverage
• Some women with unknown GBS status presenting at • Test designed with Early Assay Termination (EAT) to
Labor & Delivery unit4,5 provide positive results in approximately 30 mins
• Risk-based IAP exposes 65–85% of GBS-negative women • Easy-to-use testing with 1 min hands on time
to antibiotics6 • Intrapartum rectal/vaginal swabs can be tested by trained
• 69% sensitivity of antenatal culture for GBS detection lab, or labor and delivery staff
when compared to intrapartum culture7 • Sample Adequacy Control integration to ensure correct
sample incorporation into the cartridge
• Random access, enables any test in the menu to be
run at anytime, without the need to batch
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 • Reduce unnecessary use of intrapartum antibiotic
• Fast and easy to interpret results, enables timely prophylaxis (IAP)
appropriate treatment preventing early onset of GBS – Reduce overall hospital cost8
disease in newborns – Reduce length of stay 9
– Streamline patient management
– Less impact on newborn intestinal flora10
* Sensitivity and specificity results for intrapartum vaginal/rectal.
Coverage, plus
Accuracy, plus
Peace of mind
That’s the PCRplus advantage.
From Cepheid.
Impact on Patient Pathway
Challenge
Increased Threat to Newborns Due to Inaccurate Antepartum or Risk-Based GBS Screening
High Risk of GBS Status Change
Antepartum
Following Screening at 35–37
Negative
Weeks Pregnancy1
Incorrect Administration of IAP^ May
Antepartum
Result in EOD2^ and May Impact the
Positive
Correct Assembly of Neonatal Flora3
GBS Status Some Pregnant Women with Unknown
Pregnant Healthcare Unknown GBS Status During Labour4
Woman Professional
Poor outcomes for newborn baby
Solution
Fast & Accurate Intrapartum PCR Testing for GBS as early as 30 minutes*
Correct Identification of GBS Status
During Delivery
Evidence-Based IAP^ & Patient
Management5
Pregnant Healthcare Fast PCR Across Lab Reduced Infection Risks & Overall
Woman Professional & Decentralised
Hospital Costs2,6
Settings, 24/7
INFOGRAPHIC REFERENCES
* For positive GBS results with Early Assay Termination (EAT). 42 minutes for negative GBS results.
^ IAP: Intrapartum Antibiotic Prophylaxis, EOD: Early Onset Disease, AMR: Antimicrobial Resistance.
1 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.
2 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
3 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
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 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.
6 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.
CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.
Clinical Performance
Xpert Xpress GBS test results and estimated performance by specimen collection type.
Specimen Sensitivity Specificity
Collection Type (95% CI) (95% CI)
Intrapartum
93.5% (85.7– 97.2) 95.5% (93.9– 96.7)
vaginal/rectal
Antepartum
88.1% (81.1– 92.8) 95.6% (93.5– 97.0)
vaginal/rectal
Workflow: 2 Easy Steps
1 2
Insert the swab into the chamber S Insert cartridge and start test
Catalog Information
Xpert® Xpress GBS 10 tests XPRSGBS-CE-10
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
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