Yamazaki Hiroyuki, Wada Tsuneyuki, Asano Hiroshi, Fujita Hiromasa, Okamoto Kazuhira, Watari Hidemichi
Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine and Faculty of Medicine, Kita 15, Nishi 7, Kita-Ku, Sapporo 060-8638, Japan.
Hokkaido Cancer Society, 1-15, Kita 26, Higashi 14, Higashi-Ku, Sapporo 065-0026, Japan.
Diagnostics (Basel). 2021 Oct 14;11(10):1895. doi: 10.3390/diagnostics11101895.
Most uterine cervical cancers are caused by the persistent infection of the high-risk human papillomavirus (hrHPV). Thus, the hrHPV-DNA test, which examines specimens from the cervix, is the standard screening method as well as cytology in western countries. Urine sampling for the hrHPV-DNA test would be easier and help improving screening rates. This study prospectively investigated the concordance between urine and cervical hrHPV tests for patients with atypical squamous cells of undetermined significance (ASC-US) in cervical cytology. We recruited 338 women with the cytologic diagnosis of ASC-US and performed hrHPV-DNA tests to both samples from the uterine cervix and first void urine, using the Cobas 4800 system. In all hrHPV genotypes, the simple concordance rate was 90.8% (307/338) and the Kappa statistic value was 0.765, which shows substantial concordance. The positive concordance rate was 70.5% (74/105), which was the rate excluding women who had negative results in both tests. When limited to types 16 and 18, the simple concordance rate was 98.8% (334/338), and the Kappa statistical value was calculated to be 0.840, which showed almost perfect concordance. The positive concordance rate resulted in 81.8% (18/22). We conclude that the urine hrHPV-DNA test could substitute the cervical test in women with ASC-US.
大多数子宫颈癌是由高危型人乳头瘤病毒（hrHPV）持续感染引起的。因此，在西方国家，检测宫颈标本的hrHPV-DNA检测以及细胞学检查是标准的筛查方法。用于hrHPV-DNA检测的尿液采样会更容易，并有助于提高筛查率。本研究前瞻性地调查了宫颈细胞学检查中意义不明确的非典型鳞状细胞（ASC-US）患者尿液和宫颈hrHPV检测之间的一致性。我们招募了338名细胞学诊断为ASC-US的女性，并使用Cobas 4800系统对子宫颈样本和首次晨尿进行hrHPV-DNA检测。在所有hrHPV基因型中，简单一致性率为90.8%（307/338），Kappa统计值为0.765，显示出高度一致性。阳性一致性率为70.5%（74/105），这是排除两项检测结果均为阴性的女性后的比率。当仅限于16型和18型时，简单一致性率为98.8%（334/338），计算出的Kappa统计值为0.840，显示出几乎完美的一致性。阳性一致性率为81.8%（18/22）。我们得出结论，尿液hrHPV-DNA检测可以替代ASC-US女性的宫颈检测。
