Molecular detection of Trichomonas vaginalis from vaginal swabs collected in Copan Transystem^TM M40 Amies media using...

We evaluated the performance of the Copan Transystem™ M40 collection swab containing Amies agar gel ('M40') on the Aptima® TV Assay for the detection of Trichomonas vaginalis ribosomal RNA (rRNA) using a novel 'Single Swab' molecular workflow. Overall agreement between Aptima TV Assay and wet mount microscopy was 99 % (152/153; 95 % confidence interval 0.9806 to 1.006), a positive agreement of 100 % and negative agreement of 99 %. Limit of detection for microscopy was 100,000-fold higher compared to molecular. T. vaginalis rRNA was stable in M40 under room-temperature and refrigerated conditions. The 'Single Swab' workflow resulted in a 57.4 % reduction in hands-on time, and a 5-fold increase in technologist productivity. Post-molecular test implementation analysis demonstrated a 2.27-fold increase in T. vaginalis positivity rate compared to the pre-implementation method. Collectively, our 'Single Swab' molecular testing approach was non-inferior to wet mount microscopy with the added benefits of a simplified and more efficient workflow.