Objective: The objective of this study was to calculate the positive rate and overall concordance rate of high-risk human papillomavirus (hrHPV) test and cytology using self-sampled and physician-sampled cervicovaginal tests and to compare both specimens. Methods: In collaboration with 3 private hospitals in Sapporo city, 300 women visiting these organizations were enrolled in the study by previously signing an informed consent. From these women, both types of samples (self-obtained and physician-sampled) were obtained at the same time. HrHPV test and cytology were performed on both specimens, and the positive rate and overall concordance rate were calculated to compare both specimens. Results: HrHPV-positive women were 13.7% in physician-sampled specimens and 14.7% in self-sampled specimens, with an overall concordance rate of 96.3% (95% confidence interval [CI]: 94–98%). On the other hand, the positive rate of the cases higher than or equal to atypical squamous cells of undetermined significance (ASCUS) on cytology was different between both groups, that is, 12.3% in physician-obtained and 5.3% in self-sampled specimens; the overall concordance rate was 90.7% (95% CI: 87–94%), indicating an apparent decrease in the positive rate of cytology in self-obtained specimens. Conclusion: HrHPV test and cytology were performed on parallel samples obtained by the patients with a self-sampling tool and by the physician. The positive rate of cytology was considerably different between these specimens, while almost equivalent results were obtained for hrHPV test in both specimens. It was concluded that hrHPV test may be safely and accurately performed on self-obtained cervicovaginal samples by the help of a self-sampling device in the Japanese population as a first screening tool, with equivalent results to physician-obtained specimens.
Acta Cytologica

中文翻译：

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高风险人乳头瘤病毒测试和细胞学的自采样和医师采样标本的比较研究。

目的：本研究的目的是通过自我取样和医生取样的宫颈阴道试验来计算高危型人乳头瘤病毒（hrHPV）测试和细胞学的阳性率和总体一致性率，并比较两个标本。方法：与札幌市的3家私立医院合作，通过事先签署知情同意书，访问了这些组织的300名妇女。从这些妇女中，同时获得了两种类型的样品（自行获得和医生采样）。对两个标本进行HrHPV检测和细胞学检查，并计算阳性率和总体一致性率以比较两个标本。结果：HrHPV阳性的女性在医师抽样标本中占13.7％，在自我抽样标本中占14.7％，总体一致性率为96.3％（95％置信区间[CI]：94–98％）。另一方面，两组之间在细胞学意义上高于或等于未定意义的非典型鳞状细胞（ASCUS）的阳性率在两组之间是不同的，即在医生获得的标本中为12.3％，在自采样标本中为5.3％ ; 总体一致性率为90.7％（95％CI：87–94％），表明自体标本的细胞学阳性率明显下降。结论：HrHPV测试和细胞学检查是由患者使用自采样工具和医师对平行样本进行的。这些标本之间的细胞学阳性率差异显着，而在两个标本中的hrHPV检测获得的结果几乎相等。结论是，可以通过在日本人群中使用自采样设备作为第一个筛查工具，对自获取的宫颈阴道样本进行安全，准确的hrHPV检测，其结果与医生获取的样本相当。
细胞学学报