Comparative Performance of Aptima BV/CV-TV and Vaginal Real Time Assays for the Molecular Diagnosis of Bacterial Vaginosis and Vaginitis.

Background/Objectives: Direct comparisons between commercial molecular platforms for vaginitis diagnosis are scarce. We compared the Aptima BV and CV/TV assays (Hologic) with the Vaginal Real Time kit (Vircell) for bacterial vaginosis (BV), Candida spp. and Trichomonas vaginalis, and explored the association between BV and sexually transmitted infection (STI) co-detection. Methods: In this prospective single-centre study, 350 vaginal swabs submitted for molecular STI screening were tested on both platforms. Discordances were arbitrated with the Allplex™ Vaginitis Screening assay (Seegene) within a composite reference standard (CRS). Agreement was assessed with Cohen's κ and positive/negative percentage agreement (PPA/NPA); performance was calculated against the CRS. Results: Agreement was substantial for BV (κ = 0.676; PPA 94.8%, NPA 79.1%) and almost perfect for Candida spp. (κ = 0.885) and T. vaginalis (κ = 0.920), in line with previous molecular-versus-Nugent comparisons. Vircell classified more samples as BV-positive than Aptima (45.4% vs. 33.1%; p < 0.001); the Aptima BV positivity rate closely matched the 34% reported by Vipond et al. Against the CRS, Aptima showed higher specificity (98.7%) and Vircell higher sensitivity (98.3%). Agreement fell to 75.9% in women aged ≥45 years. BV positivity was associated with STI co-detection, strongest for Chlamydia trachomatis (OR 8.97, 95% CI 3.26-24.71). Conclusions: The two platforms performed equivalently for candidiasis and trichomoniasis but diverged for BV, particularly in older women, reflecting their different classification algorithms rather than analytical quality.