Evaluation of the Hologic Aptima® Vaginitis and Seegene Allplex™ assays for microbiological diagnosis of bacterial vaginosis and Candida vaginitis in women in France, relative to Nugent score and culture.

Introduction. Molecular assays such as the Hologic Aptima® Vaginitis Panel and Seegene Allplex™ Vaginitis assay offer improved sensitivity and multiplex detection for the diagnosis of vaginitis compared with the non-molecular standard of care.Gap Statement. Evidence comparing the relative performance of Aptima versus Seegene is limited, as is knowledge of Aptima's compatibility with non-proprietary swabs.Aim. This prospective study assessed the diagnostic performance of the Aptima BV (bacterial vaginosis) and Aptima CV/TV assays (Candida vaginitis/Trichomonas vaginitis) alongside the Seegene Allplex assay in symptomatic women (≥18 years) presenting for vaginitis testing in primary care in France.Methodology. Two vaginal swabs were taken per patient: one Aptima Multitest Swab and one non-proprietary Σ-TRANSWAB liquid Amies collection swab. Aptima swab data were used solely to confirm performance of the Aptima assays under current test conditions, while all primary assay comparisons were performed using Σ-TRANSWAB samples. These comparisons were performed for each assay relative to Nugent score (for BV) or culture (for CV), as well as Aptima relative to Seegene.Results. In total, 500 women underwent vaginitis testing between July and August 2024. When using non-proprietary Σ-TRANSWAB collection methods, sensitivity and specificity values for the Aptima BV assay were 96.7 and 89.7% relative to Nugent score, and 89.9 and 90.6% for Seegene Allplex relative to Nugent score. Among 'intermediate BV' samples (n=66), agreement between Seegene Allplex and Nugent score was 1.5%. Sensitivity and specificity values for the detection of CV were 88.6 and 90.8% for the Aptima CV/TV assay, and 90.2 and 93.7% for Seegene Allplex. Assay detection of TV could not be validated due to an insufficient number of TV-positive samples (n=1). These findings were consistent with Aptima's performance when using proprietary collection methods.Conclusion. Overall, the Aptima Vaginitis Panel demonstrated comparably high diagnostic performance to Seegene Allplex for the detection of BV and CV when using a non-proprietary sample collection method. TV prevalence was too low in this cohort to permit meaningful assay evaluation for this pathogen.