PMID- 32193689 OWN - NLM STAT- MEDLINE DCOM- 20210316 LR - 20210719 IS - 1435-4373 (Electronic) IS - 0934-9723 (Linking) VI - 39 IP - 8 DP - 2020 Aug TI - Assessing a diagnosis tool for bacterial vaginosis. PG - 1481-1485 LID - 10.1007/s10096-020-03862-3 [doi] AB - 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(R) 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. FAU - Singh, Ravesh AU - Singh R AD - Department of Microbiology, National Health Laboratory Services, KwaZulu-Natal Academic Complex, Inkosi Albert Luthuli Central Hospital, Durban, South Africa. singhra@ukzn.ac.za. AD - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa. singhra@ukzn.ac.za. AD - Department of Microbiology, University of KwaZulu-Natal (UKZN), 238 King George 5th Ave, Durban, South Africa. singhra@ukzn.ac.za. FAU - Ramsuran, Veron AU - Ramsuran V AD - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa. AD - Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa. AD - KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), School of Laboratory Medicine and Medical Sciences, College of Health Sciences, UKZN, Durban, South Africa. FAU - Mitchev, Nireshni AU - Mitchev N AD - Department of Microbiology, National Health Laboratory Services, KwaZulu-Natal Academic Complex, Inkosi Albert Luthuli Central Hospital, Durban, South Africa. AD - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa. FAU - Niehaus, Abraham Johannes AU - Niehaus AJ AD - Department of Microbiology, National Health Laboratory Services, KwaZulu-Natal Academic Complex, Inkosi Albert Luthuli Central Hospital, Durban, South Africa. AD - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa. FAU - Han, Khine Swe Swe AU - Han KSS AD - Department of Microbiology, National Health Laboratory Services, KwaZulu-Natal Academic Complex, Inkosi Albert Luthuli Central Hospital, Durban, South Africa. AD - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa. FAU - Osman, Farzana AU - Osman F AD - Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa. FAU - Ngcapu, Sinaye AU - Ngcapu S AD - Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa. FAU - Karim, Salim Abdool AU - Karim SA AD - Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa. AD - Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA. FAU - Rompalo, Anne AU - Rompalo A AD - Johns Hopkins University, Baltimore, USA. FAU - Garrett, Nigel AU - Garrett N AD - Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa. AD - School of Nursing and Public Health, Discipline of Public Health Medicine, University of KwaZulu-Natal, Durban, South Africa. FAU - Mlisana, Koleka AU - Mlisana K AD - Department of Microbiology, National Health Laboratory Services, KwaZulu-Natal Academic Complex, Inkosi Albert Luthuli Central Hospital, Durban, South Africa. AD - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal (UKZN), Durban, South Africa. AD - Centre for the AIDS Programme of Research in South Africa (CAPRISA), UKZN, Durban, South Africa. LA - eng GR - FLR\R1\190204/UK royal society/ PT - Evaluation Study PT - Journal Article DEP - 20200320 PL - Germany TA - Eur J Clin Microbiol Infect Dis JT - European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology JID - 8804297 RN - 0 (DNA, Bacterial) RN - Atopobium vaginae RN - Lactobacillus iners RN - Lactobacillus jensenii RN - Prevotella bivia SB - IM MH - Actinobacteria/isolation & purification MH - Adult MH - Area Under Curve MH - DNA, Bacterial/analysis MH - Female MH - Gardnerella vaginalis/isolation & purification MH - Humans MH - Lactobacillus/isolation & purification MH - Predictive Value of Tests MH - Prevotella/isolation & purification MH - Real-Time Polymerase Chain Reaction MH - Specimen Handling MH - Vaginosis, Bacterial/*diagnosis/microbiology MH - Young Adult OTO - NOTNLM OT - Bacterial vaginosis OT - Diagnosis OT - Real-time PCR EDAT- 2020/03/21 06:00 MHDA- 2021/03/17 06:00 CRDT- 2020/03/21 06:00 PHST- 2020/01/21 00:00 [received] PHST- 2020/03/05 00:00 [accepted] PHST- 2020/03/21 06:00 [pubmed] PHST- 2021/03/17 06:00 [medline] PHST- 2020/03/21 06:00 [entrez] AID - 10.1007/s10096-020-03862-3 [pii] AID - 10.1007/s10096-020-03862-3 [doi] PST - ppublish SO - Eur J Clin Microbiol Infect Dis. 2020 Aug;39(8):1481-1485. doi: 10.1007/s10096-020-03862-3. Epub 2020 Mar 20.