Molecular detection of Trichomonas vaginalis from vaginal swabs collected in Copan Transystem

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.

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Déclaration de conflit d'intérêts

Declaration of Competing Interest MAS, JL, AP and LWG are employees of Dynacare (a subsidiary of Laboratory Corporation of America), which is a private, for-profit laboratory that offers diagnostic testing services to government and non-government clients. While the individuals noted herein will not personally benefit from this submission, the company could benefit financially if the test is commercially marketed. No other potential conflicts of interest are reported.