Abstract / Summary
Group B Streptococcus (GBS) contributes majorly to neonatal morbidity and mortality. Although antenatal culture screening and risk-based intrapartum antibiotic prophylaxis (IAP) reduce neonatal early-onset GBS (EOGBS) compared to no screening, limitations hinder further reduction of EOGBS incidence. Point-of-care polymerase chain reaction (PCR) tests can address these limitations and offer an alternative to detect intrapartum GBS colonization in near-patient settings. Despite European clinical consensus recommending PCR-based intrapartum screening, adoption remains limited, partly due to lack of health economic evidence. This systematic literature review (SLR) evaluated the clinical effectiveness and economic impact of GBS tests for intrapartum screening, and the health-related quality of life (HRQoL) associated with EOGBS.
Systematic searches were conducted on 19 March 2025 in Embase®, MEDLINE®, EBM Reviews, and EconLit® via OVID SP®, without geographic restriction. Eligible studies included pregnant women undergoing intrapartum GBS screening compared with intrapartum culture as the reference standard. Two reviewers independently screened studies using pre-defined eligibility criteria; a third resolved discrepancies. Study quality was appraised using Quality Assessment of Diagnostic Accuracy studies tool for clinical studies and Drummond and Jefferson checklist for economic studies. Sixty-six studies were included: 38 clinical, 17 economic, and 11 HRQoL/utility.
Clinical evidence demonstrated that intrapartum PCR tests provide high diagnostic accuracy and operational reliability by delivering results in <60 min (significantly faster than antenatal cultures). Four assays (Xpert® GBS, Revogene® DBS GS, GenomEra®, and IDI-Strep B™) met the European clinical expert consensus criteria for reliable and effective intrapartum GBS screening (≥90% sensitivity and ≥95% specificity) in at least one study; only Xpert® GBS met these criteria in more than one study. Economic evidence indicated potential cost-neutrality or savings with intrapartum PCR, compared with antepartum culture. Higher PCR test costs were offset by cost-savings from reduced EOGBS cases and associated resource utilization (e.g. hospitalization/neonatal intensive care, treatment, long-term sequelae), in some studies resulting in dominant ICERs in cost-effectiveness analyses. HRQoL studies reported considerable risk of physical impairment due to long-term sequelae among neonates surviving EOGBS.
Point-of-care intrapartum PCR-based screening methods offer potential to improve prevention strategies for neonatal infection and reduce the clinical, economic, and HRQoL burden of GBS disease. Limited primary HRQoL evidence highlights the need for further research.