Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T-vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications
Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T-vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications
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DOI：
10.1128/jcm.02367-10
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发表时间：
2011-03-01
影响因子：
9.4
通讯作者：
Chapin, Kimberle C.
中科院分区：
文献类型：
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作者：
Andrea, Sarah B.;Chapin, Kimberle C.
阴道毛滴虫是一种被低估的性传播感染(STI)，与许多临床后遗症有关。滴虫病的真实患病率和临床影响尚不清楚，因为目前的检测方法与分子扩增方法相比灵敏度较低。用于检测阴道毛滴虫的BD确证VPIII杂交试验和基因探针阿蒂玛阴道毛滴虫(ATV)转录介导扩增(TMA)试验的比较数据有限。在这项研究中，对766名患者的标本进行了评估。标本是从有阴道不适和/或有STI病史的患者连续提取的。纳入研究取决于卫生保健提供者在同一办公室访问期间要求和收集用于确认的阴道拭子和用于Aptima Combo 2的样本。使用特定的收集拭子和为测试提供的运输工具进行确认。对残留的Aptima Combo2标本进行ATV检测。对初次TMA和/或确认试验阳性的所有标本进行第二次ATV TMA试验，使用交替的阴道毛滴虫引物和探针组。通过至少2次检测，将感染患者状态定义为阴道毛滴虫试验阳性。总体而言，5.1%的受试者阴道毛滴虫呈阳性。阴道毛滴虫在36岁至45岁(11.9%)、51岁至60岁(7.7%)和16岁至25岁(4.2%)的女性中最为常见。在统计学上，ATV检测比肯定性检测更敏感(100%比63.4%，P<；0.0001)，多识别36.6%的阳性患者。
Trichomonas vaginalis is an underestimated sexually transmitted infection (STI) associated with numerous clinical sequelae. The true prevalence and clinical impact of trichomoniasis are unknown, as current methods of detection exhibit poor sensitivity compared to molecular amplification methods. Limited data exist comparing the BD Affirm VPIII hybridization assay to the Gen-Probe Aptima T. vaginalis (ATV) transcription-mediated amplification (TMA) assay for detection of T. vaginalis. In this study, specimens from 766 patients were evaluated. Specimens were retrieved consecutively from patients with vaginal complaints and/or with histories suggestive of STI. Study inclusion was dependent upon the request for and collection of both a vaginal swab for Affirm and a specimen for Aptima Combo 2 by the health care provider during the same office visit. Affirm was performed using the specific collection swab and the transport provided for the test. The ATV assay was performed on remnant Aptima Combo 2 specimens. A second ATV TMA assay, utilizing an alternate T. vaginalis primer and probe set, was performed on all specimens positive by the initial TMA and/or the Affirm assay. Infected-patient status was defined as positive T. vaginalis test results by at least 2 assays. Overall, 5.1% of subjects were positive for T. vaginalis. T. vaginalis was most prevalent in women who were 36 to 45 (11.9%), 51 to 60 (7.7%), and 16 to 25 (4.2%) years of age. The ATV assay was statistically more sensitive than the Affirm assay (100% versus 63.4%, P < 0.0001), identifying 36.6% more positive patients.