Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions
Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions
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DOI：
10.1016/j.jcv.2017.12.008
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发表时间：
2018-02-01
影响因子：
8.8
通讯作者：
Nygard, Mari
中科院分区：
文献类型：
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作者：
Leinonen, Maarit K.;Schee, Kristina;Nygard, Mari
背景资料：Objectives：To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions.Study design：310 patients collected two cervicovaginal samples using a brush（Evalyn（R）Brush）and a swab（FLOQSwabs（TM）），and filled a questionnaire at home.然后，诊所的医生将宫颈标本放入PreservCyt（R）缓冲液中进行hrHPV检测和细胞学检查。所有标本均使用Anyplex（TM）II HPV 28、Cobas（R）4800 HPV Test和Xpert（R）HPV进行检测。结果：性能比较包括45例宫颈癌和187例癌前病变患者。与医生样本相比，Evalyn（R）Brush的hrHPV检测显示出对CIN 3+的非劣效性灵敏度（Anyplex（TM）0.99; Cobas（R）0.96; Xpert（R）HPV 0.97的相对灵敏度），而FLOQSwabs（TM）的hrHPV检测显示出劣效性灵敏度（Anyplex T 0.91; Cobas（R）0.92; Xpert（R）HPV 0.93的相对灵敏度）。对于浸润性癌观察到类似的结果，尽管FLOQSwabs（TM）在统计学上不劣于医生样本。通过Evalyn（R）Brush或FLOQSwabs（TM）进行的自我采集对于CIN 3+比LSIL或较差的细胞学检查更敏感。当标本在28天后进行hrHPV检测预处理时，观察到FLOQSwabs（TM）对CIN 3+的敏感性显著降低。这两种设备都被广泛接受，但患者认为Evalyn（R）刷比FLOQSwabs（TM）更容易和更舒适。结论：自我采集与目前检测宫颈癌和CIN 3+的筛查实践相当，但设备和标本处理效果存在。仅应使用经验证的程序，包括采集装置、hrHPV检测和标本制备。
Background: Comparative data on different self-collection methods is limited.Objectives: To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions.Study design: Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn (R) Brush) and a swab (FLOQSwabs (TM)), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt (R) buffer for hrHPV testing and cytology. All specimens were tested using Anyplex (TM) II HPV28, Cobas (R) 4800 HPV Test and Xpert (R) HPV.Results: Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn (R) Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex (TM) 0.99; Cobas (R) 0.96; Xpert (R) HPV 0.97) while hrHPV testing of FLOQSwabs (TM) showed inferior sensitivity (relative sensitivity of Anyplex T 0.91; Cobas (R) 0.92; Xpert (R) HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs (TM) was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn (R) Brush or FLOQSwabs (TM) was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs (TM) when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn (R) Brush easier and more comfortable than FLOQSwabs (TM).Conclusions: Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used.