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Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method

机译:与标准临床收集的采样方法相比,宫颈人乳头瘤病毒检测与两个家庭自集方法相比

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Background The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory. Methods The 2 self-collection methods were a tampon-based method and a swab-based method using a commercial device, an Eve Medical HerSwab. All HPV samples were processed by a clinical laboratory using the Food and Drugs Administration approved Roche Cobase HPV method, which specifically identifies HPV 16, HPV 18, and a set of 12 other high-risk subtypes. Patients were recruited from 2 cancer screening clinics 2015 to 2017. All patients signed an informed consent. Screening outcomes, such as prevalence, percent agreement with standard, sensitivity, and specificity, were calculated for each self-collection method. Measures of similarity between self and standard collection outcomes, Cohen's kappa, percent concordance, McNemar equivalence, and others were tested statistically. Results One hundred seventy-four patients were randomized. The prevalence of 1 or more positive HPV high-risk subtypes from the standard clinical specimens was 13.5%. All clinical specimens were sufficient for valid HPV detection. For the tampon method, 15 (27%) of the specimens were insufficient quality. Only 1 (2%) swab specimen was insufficient. Only the swab self-collection method was found to be statistically noninferior to the clinical method. The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests. Conclusions The swab home collection samples were equivalent to the clinical samples, but the tampon method had an unacceptably high rate of specimens insufficient for HPV detection.
机译:背景技术本研究的目的是将2种自集方法的结果进行比较,以检测宫颈人乳头瘤病毒(HPV)DNA与标准临床方法的结果。标准方法样品被临床医生收集在常规骨盆检查中。自我样本被送到家里并邮寄给临床实验室。方法采用2个自收集方法是一种基于卫生棉条的方法和使用商业设备的基于SWAB的方法,Eve Medical Herswab。所有HPV样品都是通过使用食物和药物授权的植物和药物授权的罗氏COBase HPV方法处理所有HPV样品,该方法特异性地识别HPV 16,HPV 18和一组其他高风险亚型。患者是从2015年至2017年的2次癌症筛查诊所招募。所有患者签署了知情同意。为每个自集方法计算筛选结果,例如患病率,与标准,敏感性和特异性的达重百分比。自我和标准收集成果之间的相似性,科恩的κ,Concordance,McNemar等价和其他人的相似性进行了统计测试。结果一百七十四名患者随机。标准临床标本的1或更多阳性HPV高风险亚型的患病率为13.5%。所有临床标本都足以进行有效的HPV检测。对于卫生棉条方法,标本的15个(27%)不足。只有1(2%)的棉签样本不足。只发现拭子自集方法才能统计上不合理到临床方法。卫生棉条方法具有不可接受的质量标本的高速率,并且还失效了等效测试。结论SWAB家庭收集样品相当于临床样品,但卫生棉条方法具有不可接受的高速率对HPV检测不足。

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