The evaluation of the Allplex™ BV molecular assay for the diagnosis of bacterial vaginosis in symptomatic South African females

Bacterial vaginosis (BV) is a dysbiosis of vaginal microbiota characterized by a shift from Lactobacillus species predomination to a heterogeneous mixture of anaerobes. We compared the performance characteristics of the Allplex ™ BV molecular assay with the reference test, Nugent score microscopy, f...

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Published in:Diagnostic microbiology and infectious disease 2023-06, Vol.106 (2), p.115924-115924, Article 115924
Main Authors: Mabugana, Matamela C., Dias, Bianca Da Costa, Muller, Etienne E., Kufa, Tendesayi, Gumede, Lindy, Mahlangu, Mahlape P., Maseko, Dumisile V., Kularatne, Ranmini S.
Format: Article
Language:English
Subjects:
Bacterial vaginosis
Female
Humans
Lactobacillus
Molecular diagnosis
NAAT
Nugent scoring
South Africa
Vagina - microbiology
Vaginosis, Bacterial - diagnosis
Vaginosis, Bacterial - microbiology
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Summary:Bacterial vaginosis (BV) is a dysbiosis of vaginal microbiota characterized by a shift from Lactobacillus species predomination to a heterogeneous mixture of anaerobes. We compared the performance characteristics of the Allplex ™ BV molecular assay with the reference test, Nugent score microscopy, for vaginal swab specimens from symptomatic South African women. A total of 213 patients were enrolled, of whom 99 (46.5%) and 132 (62.0%) were diagnosed with BV by Nugent and Allplex™, respectively. The Allplex™ BV assay displayed a sensitivity of 94.9% (95% CI, 88.7%−97.8%) and a specificity of 66.7% (95% CI, 57.6%−74.6%), with an agreement of 79.8% (95% CI, 73.9%−84.7%) (κ = 0.60). Assay design may be enhanced for improved specificity by accounting for differences in healthy and BV-associated vaginal microbiomes among women of different ethnicities.
ISSN:0732-8893
1879-0070
DOI:10.1016/j.diagmicrobio.2023.115924