ArticleEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2026
A Rapid Molecular Detection Method for Streptococcus agalactiae Based on Bacteriophage Lysin Lysis and Real-Time PCR.
Article in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeStreptococcus agalactiae (Group B Streptococcus, GBS) is a leading cause of neonatal infections. This study aimed to establish a rapid GBS detection method using a bacteriophage lysin-based lysis approach.
methodsSpecific primers and probes were designed for GBS cylA gene and human ACTB gene. A rapid nucleic acid extraction and purification method was established for GBS, achieving complete lysis and extraction within 5 min through the use of a bacteriophage lysin. A point-of-care assay was developed using real-time fluorescence quantitative PCR. In Phase I, 331 vaginal swab samples were tested by POCT and conventional culture; in Phase II, 180 separate samples were tested by POCT, culture, and antigen testing.
resultsThe assay completed nucleic acid extraction within 5 min and PCR amplification within 30 min, resulting in a total turnaround time of 35 min. Culture required 18-48 h. The assay had a detection limit of 2,000 copies/mL and no cross-reactivity. In the Phase I cohort, the assay achieved 100% sensitivity and 94.24% specificity. Following 16 S rDNA sequencing confirmation of discordant samples, the adjusted specificity increased to 97.76%. In the Phase II cohort, the assay showed higher sensitivity than the antigen test (100% vs. 58.06%).
conclusionsWe developed a rapid GBS molecular assay centered on bacteriophage lysin lysis. The assay showed high diagnostic performance in the study cohorts and has potential for intrapartum or near-patient screening, although real-world workflow feasibility requires further validation. CLINICAL TRIAL NUMBER: Not applicable.
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