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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

  • Ellen H. A. van den MunckhofEmail author
  • Rosalie L. van Sitter
  • Kim E. Boers
  • Ronald F. Lamont
  • René te Witt
  • Saskia le Cessie
  • Cornelis W. Knetsch
  • Leen-Jan van Doorn
  • Wim G. V. Quint
  • Anco Molijn
  • Maurine A. Leverstein-van Hall
Original Article
  • 116 Downloads

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.

Keywords

Amsel criteria Bacterial vaginosis Culture Diagnostics Nugent score Microbiota analysis Quantitative real-time PCR 

Notes

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.

Compliance with ethical standards

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.

Informed consent

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

Supplementary material

10096_2019_3538_MOESM1_ESM.docx (15 kb)
Supplementary Table S1 Population characteristics (DOCX 15 kb)
10096_2019_3538_MOESM2_ESM.xlsx (36 kb)
Supplementary Table S2 Microbiota analysis data per sample (XLSX 36 kb)
10096_2019_3538_MOESM3_ESM.docx (17 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)
10096_2019_3538_MOESM4_ESM.docx (18 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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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Ellen H. A. van den Munckhof
    • 1
    Email author
  • Rosalie L. van Sitter
    • 2
  • Kim E. Boers
    • 2
  • Ronald F. Lamont
    • 3
    • 4
  • René te Witt
    • 5
  • Saskia le Cessie
    • 6
    • 7
  • Cornelis W. Knetsch
    • 1
  • Leen-Jan van Doorn
    • 1
  • Wim G. V. Quint
    • 1
  • Anco Molijn
    • 1
  • Maurine A. Leverstein-van Hall
    • 5
    • 8
    • 9
  1. 1.DDL Diagnostic LaboratoryRijswijkThe Netherlands
  2. 2.Department of GynaecologyHaaglanden Medical CentreThe HagueThe Netherlands
  3. 3.Division of Surgery, University College LondonNorthwick Park Institute for Medical Research CampusLondonUK
  4. 4.Department of Gynaecology and Obstetrics, Odense University Hospital, Research Unit of Gynaecology and Obstetrics, Institute of Clinical ResearchUniversity of Southern DenmarkOdenseDenmark
  5. 5.NMDL-LCPLRijswijkThe Netherlands
  6. 6.Department of Biomedical Data SciencesLeiden University Medical CentreLeidenThe Netherlands
  7. 7.Department of Clinical EpidemiologyLeiden University Medical CentreLeidenThe Netherlands
  8. 8.Department of Medical MicrobiologyHaaglanden Medical CentreThe HagueThe Netherlands
  9. 9.Department of Medical MicrobiologyAlrijne HospitalLeidenThe Netherlands

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