Comparison of Amsel criteria, Nugent score, culture and two CE-IVD marked quantitative real-time PCRs with microbiota analysis for the diagnosis of bacterial vaginosis.

摘要: Bacterial vaginosis (BV) is a common gynaecological condition. Diagnosis of BV typically based on Amsel criteria, Nugent score and/or bacterial culture. In this study, these conventional methods and two CE-IVD marked quantitative real-time (q)PCR assays were compared with microbiota analysis for the diagnosis BV. Eighty women evaluated during sequential hospital visits by score, culture, AmpliSens® Florocenosis/Bacterial vaginosis-FRT PCR kit (InterLabService, Moscow, Russia), BD MAX™ Vaginal Panel (BD Diagnostics, MD, USA). Microbiota amplicon sequencing 16S ribosomal RNA gene was used as reference test. The profile 36/115 (31%) included cases associated Based analysis, sensitivity detecting 38.9% 61.15% 63.9% MAX assay, 80.6% AmpliSens while specificity all ≥ 92.4%. profiles discrepant results between diagnostic variable. All five missed positive relatively high abundance genus Alloscardovia, Bifidobacterium, or Dialister, which categorised unspecified dysbiosis assay. Compared to assay most in agreement indicating that currently, may be best method available diagnose routine clinical setting.