通过等温解旋酶依赖性扩增检测法检测阴道拭子快速诊断阴道毛滴虫
Rapid Diagnosis of Trichomonas vaginalis by Testing Vaginal Swabs in an Isothermal Helicase-Dependent AmpliVue Assay.
作者信息
Gaydos Charlotte A, Hobbs Marcia, Marrazzo Jeanne, Schwebke Jane, Coleman Jenell S, Masek Billie, Dize Laura, Jang Dan, Li Jenny, Chernesky Max
机构信息
From the *Division of Infectious Diseases, The Johns Hopkins University, Baltimore, MD; †Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC; ‡Division of Infectious Diseases, University of Washington, Seattle, WA; §Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL; and ¶Division of Infectious Diseases, St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
出版信息
Sex Transm Dis. 2016 Jun;43(6):369-73. doi: 10.1097/OLQ.0000000000000447.
BACKGROUND
The AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes.
OBJECTIVE
The objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay.
METHODS
Four clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC.
RESULTS
A total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%.
CONCLUSIONS
The rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.
背景
AmpliVue滴虫检测法（奎德尔公司）是一种新的经美国食品药品监督管理局批准的快速检测方法，用于定性检测女性阴道标本中的阴道毛滴虫（TV）DNA。该检测法基于BioHelix公司的解旋酶依赖性扩增等温技术，并结合一次性侧向流动检测装置，总周转时间约为45分钟。
目的
本研究的目的是将这种新检测法的性能与湿片检查和培养法以及另一种经美国食品药品监督管理局批准的核酸扩增检测法进行比较。
方法
从性传播疾病、计划生育和妇产科诊所就诊的女性中采集了4份临床医生收集的阴道拭子，并通过AmpliVue滴虫检测法和对照检测进行检测：盐水显微镜检查、TV培养（InPouch）和Aptima TV检测。将AmpliVue滴虫检测法的结果与由培养和/或湿片显微镜检查结果确定的复合阳性对照（CPC）进行比较。湿片检查或培养参考检测结果中至少有一项为阳性才能确定CPC。
结果
共有992名患者，其中342名有症状患者和650名无症状患者纳入研究。将所有女性的AmpliVue检测结果与作为CPC的盐水显微镜检查和培养结果进行比较，灵敏度为100%。所有女性的特异性为98.2%。与Aptima TV相比，总体一致性百分比为97.8%。与Aptima相比，AmpliVue的灵敏度为90.7%，而特异性为98.9%。
结论
快速的AmpliVue滴虫检测法的性能与显微镜检查和培养法相当，并且在检测TV方面与另一种核酸扩增检测法具有相当的灵敏度和特异性。本研究提供了新的诊断选择的证据，并表明扩增检测法在检测有症状和无症状女性的TV方面表现非常出色。
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