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Assessing a diagnosis tool for bacterial vaginosis

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

Diagnosis of bacterial vaginosis (BV) in resource-poor settings relies on semiquantitative microscopy algorithm such as the Nugent score (NS). We evaluated a quantitative real-time PCR (qPCR) assay to detect and quantify individual BV-associated bacterial communities. Vaginal swabs from 247 South African women attending an STI clinic were evaluated for BV using NS. We used qPCR to analyze DNA from vaginal swabs for eight BV-associated bacteria, Gardnerella vaginalis (GV), Prevotella bivia (PB), BV-associated bacteria 2 (BVAB2), Megasphaera-1 (M-1), Atopobium vaginae (AV), Lactobacillus crispatus (LC), Lactobacillus jensenii (LJ), and Lactobacillus iners (LI). Sensitivities and specificities were generated for each qPCR assay. Using a ROC analysis, cutoffs were calculated for each bacterial species. A logistic regression model was used to determine the strongest predictors of BV status. Nugent scores indicated 35.6% of patients harbor BV-associated flora (NS 7-10). AV, GV, GAMB (GV + AV + M-1 + BVAB2), and LC + LJ showed the highest AUC, sensitivities, and specificities (listed respectively): AV (0.96; 96%; 93%), GV (0.88; 78%; 79%), GAMB (0.9; 87%; 82%), and LC + LJ (0.84; 82%; 72%) (all p < 0.05). Increased GAMB copies (effect = 0.15, p = 0.01) and decreased LC + LJ copies (effect = − 0.26, p < 0.0001) demonstrated the strongest association with higher BV scoring. Scoring of BV did not differ across our qPCR assay when compared to the commercial BD MAX® and the gold standard Nugent scores. We developed an accurate assay, which has the potential to be used as a BV diagnosis tool that is cost-effective and has the potential to be utilized in a resource limited setting.

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Funding

Funding for this study was available from the Centre of Excellence, CAPRISA, and DST-NRF. This study was funded by a USA-South Africa Program for Collaborative Biomedical Research grant through the South African Medical Research Council and the National Institute of Health (AI116759). VR is funded as a FLAIR Research Fellow (the Future Leaders – African Independent Research [FLAIR] fellowship program is a partnership between the African Academy of Sciences [AAS] and the Royal Society that is funded by the UK Government as part of the Global Challenge Research Fund [GCRF]) and supported by the South African Medical Research Council (SAMRC) with funds from the Department of Science and Technology (DST), and VR is also supported in part through the sub-Saharan African Network for TB/HIV Research Excellence (SANTHE), a DELTAS Africa Initiative [grant no. DEL-15-006] by the AAS.

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Authors and Affiliations

  1. Department of Microbiology, National Health Laboratory Services, KwaZulu-Natal Academic Complex, Inkosi Albert Luthuli Central Hospital, Durban, South Africa

    Ravesh Singh, Nireshni Mitchev, Abraham Johannes Niehaus, Khine Swe Swe Han & Koleka Mlisana

  2. School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa

    Ravesh Singh, Veron Ramsuran, Nireshni Mitchev, Abraham Johannes Niehaus, Khine Swe Swe Han & Koleka Mlisana

  3. Department of Microbiology, University of KwaZulu-Natal (UKZN), 238 King George 5th Ave, Durban, South Africa

    Ravesh Singh

  4. Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa

    Veron Ramsuran, Farzana Osman, Sinaye Ngcapu, Salim Abdool Karim, Nigel Garrett & Koleka Mlisana

  5. KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), School of Laboratory Medicine and Medical Sciences, College of Health Sciences, UKZN, Durban, South Africa

    Veron Ramsuran

  6. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA

    Salim Abdool Karim

  7. Johns Hopkins University, Baltimore, USA

    Anne Rompalo

  8. School of Nursing and Public Health, Discipline of Public Health Medicine, University of KwaZulu-Natal, Durban, South Africa

    Nigel Garrett

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  1. Ravesh Singh
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  2. Veron Ramsuran
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  3. Nireshni Mitchev
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  4. Abraham Johannes Niehaus
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  5. Khine Swe Swe Han
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  6. Farzana Osman
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  7. Sinaye Ngcapu
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  8. Salim Abdool Karim
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  9. Anne Rompalo
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  10. Nigel Garrett
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  11. Koleka Mlisana
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Correspondence to Ravesh Singh.

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The authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the UKZN Biomedical Research Ethics Committee (BFC410/15).

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All participants used in this study received information on this study and provide informed consent

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Singh, R., Ramsuran, V., Mitchev, N. et al. Assessing a diagnosis tool for bacterial vaginosis. Eur J Clin Microbiol Infect Dis 39, 1481–1485 (2020). https://doi.org/10.1007/s10096-020-03862-3

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  • DOI: https://doi.org/10.1007/s10096-020-03862-3

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