Evaluation of the Affirm Ambient Temperature Transport System for the detection and identification of Trichomonas vaginalis, Gardnerella vaginalis, and Candida species from vaginal fluid specimens

The objective of this study was to measure the performance of the Affirm Am bient Temperature Transport System (ATTS) over time and to estimate the len gth of time the system can preserve a vaginal specimen containing the three common organisms causing vaginitis: Trichomonas vaginalis, Candida species , and Gardnerella vaginalis (one of the causative agents of bacterial vagin osis). Women with symptoms of vaginitis presenting to one of three clinical centers were evaluated over a 4- to 8-week period. Four simultaneously obt ained swabs were collected and tested by the Affirm VPIII assay at time zer o with and without a preservative reagent, at 24 h with reagent, and at eit her 48 or 72 h with reagent. For each of the three organisms, Trichomonas, Gardnerella, and Candida, positivity at each time point was evaluated and c ompared to that at reference time zero with and without the ATTS. A total o f 940 specimens were obtained from the three clinical sites. Eight hundred three were positive for one or more of the three organisms. Gardnerella had the highest overall positive rate (62%), followed by Candida with 18% and Trichomonas at 9%. The percent sensitivity versus control for Trichomonas r anged from 100% at time zero with and without reagent to 91% by 72 h. Gardn erella and Candida sensitivity remained at 100% for each time period. The A ffirm VPIII ATTS system performed within 10% of the control swab (no transp ort reagent) at all four time points (0, 24, 48, and 72 h) for Trichomonas, Gardnerella, and Candida.