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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

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Abstract

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

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Acknowledgements

The authors are grateful to Hanna Breijer† and Leonie van den Berg of NMDL-LCPL, and Frank M.M. Smedts, Ph.D. of the Pathology Department of the Reinier de Graaf Gasthuis (RdGG, Delft, the Netherlands) for their technical assistance.

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Authors and Affiliations

  1. DDL Diagnostic Laboratory, Visseringlaan 25, 2288 ER, Rijswijk, The Netherlands

    Ellen H. A. van den Munckhof, Cornelis W. Knetsch, Leen-Jan van Doorn, Wim G. V. Quint & Anco Molijn

  2. Department of Gynaecology, Haaglanden Medical Centre, The Hague, The Netherlands

    Rosalie L. van Sitter & Kim E. Boers

  3. Division of Surgery, University College London, Northwick Park Institute for Medical Research Campus, London, UK

    Ronald F. Lamont

  4. Department of Gynaecology and Obstetrics, Odense University Hospital, Research Unit of Gynaecology and Obstetrics, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark

    Ronald F. Lamont

  5. NMDL-LCPL, Rijswijk, The Netherlands

    René te Witt & Maurine A. Leverstein-van Hall

  6. Department of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, The Netherlands

    Saskia le Cessie

  7. Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, The Netherlands

    Saskia le Cessie

  8. Department of Medical Microbiology, Haaglanden Medical Centre, The Hague, The Netherlands

    Maurine A. Leverstein-van Hall

  9. Department of Medical Microbiology, Alrijne Hospital, Leiden, The Netherlands

    Maurine A. Leverstein-van Hall

Authors
  1. Ellen H. A. van den Munckhof
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  2. Rosalie L. van Sitter
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  8. Leen-Jan van Doorn
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  9. Wim G. V. Quint
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Corresponding author

Correspondence to Ellen H. A. van den Munckhof.

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Conflict of interest

LD and WQ are shareholders of DDL Diagnostic Laboratory. The other authors declare that they have no competing interests.

Ethical approval

All procedures performed were in accordance with the ethical standards of the local ethics board (METC Zuidwest Holland, The Hague, The Netherlands) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Electronic supplementary material

Supplementary Table S1

Population characteristics (DOCX 15 kb)

Supplementary Table S2

Microbiota analysis data per sample (XLSX 36 kb)

Supplementary Table S3

Individually comparison of Amsel criteria, Nugent score, culture, the AmpliSens assay and the BD MAX assay with microbiota analysis using data obtained during a) visit 1, b) visit 2 or c) both visits (DOCX 17 kb)

Supplementary Table S4

Test characteristics of Amsel criteria, Nugent score, culture, the AmpliSens assay and the BD MAX assay using microbiota analysis as reference test (DOCX 18 kb)

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van den Munckhof, E.H.A., van Sitter, R.L., Boers, K.E. et al. 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. Eur J Clin Microbiol Infect Dis 38, 959–966 (2019). https://doi.org/10.1007/s10096-019-03538-7

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