C-158. Validation of the Gen-Probe APTIMA® TV ASR for Trichomonas vaginalis Specimens Collected in PreservCyt® Liquid Cytology Media and M4RT Transport Media

J. Harrison1, M. Garrasi1, W. LeBar1,2, K. Moore2, R. Welch2;
1Hosp. Consolidated Lab., Southfield, MI, 2Providence Hosp., Southfield, MI.

Background: Traditional cytology identifies approximately 60-70% of culture proven Trichomonas vaginalis cases, but is not as sensitive as identification on wet mount. Culture, while more sensitive than wet mount, may be challenging and delay diagnosis by days. We evaluated the performance of the Gen-Probe APTIMA® TV ASR (ATV) for detection of TV in specimens collected in PreservCyt® Liquid Cytology Media (PC) and M4RT Transport Media (M4). Methods: PreservCyt®- Samples were chosen based on the presence (n=121) or absence (n=79) of TV on cytology smears. A 1ml aliquot of PC was added to an APTIMA Transport Tube and tested on the APTIMA DTS system using the ATV ASR. Discordant samples were retested with ATV, an alternate target TV TMA (alt-TV TMA) RUO assay developed at Gen-Probe and re-evaluation of cytology smears. M4- 304 patients who had specimens submitted for T. vaginalis culture/wet prep and M4 samples submitted for C. trachomatis/N. gonorrhoeae APTIMA Combo 2 were included in the study. A 1 ml aliquot of M4 was added to an APTIMA Transport Tube and tested as above. Results: PreservCyt® -All specimens demonstrating TV on the Pap smear were positive with the ATV ASR resulting in a sensitivity of 100% (121/121). Of the 79 samples negative by cytology, 72 were negative in the ATV ASR, resulting in an initial specificity of 91.1% (72/79). Upon repeat testing five of the discordant samples were negative in the ATV, the altTV TMA and the re-screened Pap. The remaining two specimens repeated positive in the ATV ASR and the alternate ATV assay. Following discordant analysis, sensitivity and specificity of ATV for specimens collected in PC were recalculated as 100%and 93.5% respectively. M4- All specimens from which TV was isolated were positive in the ATV assay (26/26). Of 278 specimens negative by culture, 260 tested negative in the ATV ASR. The 18 discordant specimens repeated positive in the ATV ASR as well as the alternate ATV assay. Following discordant analysis the sensitivity and specificity of ATV for specimens collected in M4 were recalculated as 100% and 100% respectively. Conclusions: These data demonstrate that PreservCyt® and M4 transport media are acceptable test media for the performance of the ATV ASR.