The evaluation of the AllplexTM 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 TM BV molecular assay with the reference test, Nugent score microscopy, for vaginal swab speci-mens 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 AllplexTM, respectively. The AllplexTM BV assay dis-played 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%) (k = 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.(c) 2023 Elsevier Inc. All rights reserved.