Rapid tests for detecting group B streptococcus colonization in pregnant women: A systematic review and meta-analysis of diagnostic accuracy.

backgroundMaternal colonization with group B Streptococcus is common and the leading cause of neonatal sepsis. Rapid tests can be an alternative for screening; however, their diagnostic accuracy is variable when used with non-enriched samples.

objectivesTo determine the diagnostic accuracy of rapid tests based on nucleic acid amplification techniques (NAAT) without prior enrichment for detecting group B Streptococcus colonization in pregnant women. SEARCH STRATEGY: Systematic searches of databases (Medline, Embase, CENTRAL, LILACS) from inception until February 2025, ongoing studies and gray literature. SELECTION CRITERIA: We included diagnostic accuracy studies in which participants were recruited prospectively, consecutively, or randomly; measurement and data collection had to be prospective. We excluded case-control studies. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate. We assessed the quality of the included studies using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. For the meta-analysis, we used the bivariate model by estimating a summary sensitivity and specificity. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to diagnostic test accuracy to compile the summary of findings tables. MAIN

resultsA total of 52 studies (24 653 participants) met the inclusion criteria; the median sample size was 299, and the median colonization prevalence was 21.4%. For qPCR-based rapid tests, the sensitivity was 90% (95% CI: 88%-92%), and the specificity was 96% (95% CI: 95%-97%). For the LAMP-based test, the sensitivity was 92% (95% CI: 84%-97%), and the specificity was 96% (95% CI: 94%-98%). When exploring study entry status, sample source, and test processing in the delivery room as sources of heterogeneity, we found no statistically significant differences between the subgroups analyzed (P = 0.19, P = 0.43, and P = 0.44). We found no evidence of publication bias when analyzing the asymmetry in the funnel plot.

conclusionsRapid qPCR-based tests may have acceptable sensitivity (low-certainty evidence), and they probably have acceptable specificity (moderate-certainty evidence). For the LAMP-based tests, the evidence is very uncertain regarding the acceptability of sensitivity (very low-certainty evidence), but specificity is probably acceptable (moderate-certainty evidence) for detecting GBS colonization in pregnant women. Applicability is limited in intrapartum settings due to sample processing and in low- and middle-income settings. PROSPERO REGISTRATION: CRD42024536503.