Edblad-Svensson Ann, Silfverdal Lena, Collberg Pia, Tunón Katarina
Department of Clinical Science, Obstetrics and Gynecology, Unit of Obstetrics and Gynecology-Östersund, Umeå University, Östersund,
Department of Clinical Science, Obstetrics and Gynecology, Umeå University, Umeå, Sweden.
Acta Cytol. 2018;62(5-6):411-417. doi: 10.1159/000490487. Epub 2018 Jul 13.
To determine whether high-risk types of human papilloma virus (hrHPV) DNA testing is reliable for selection patients in need of further investigation with colposcopy in women with increased risk of high-grade cervical lesions as a result of false negative cytology. The secondary objective was to compare the sensitivity of hrHPV testing on self-collected versus physician-collected samples for the detection of histological high-grade cervical intraepithelial neoplasia (CIN2+).
Sixty-three patients identified with a missed abnormality following the re-evaluation of benign cervical cytology were included. A patient-collected and a physician-collected sample for HPV, colposcopy and cervical specimen collection for histology and cytology were performed.
The sensitivity of hrHPV testing of physician-collected samples for CIN2+ was 100% (95% CI 82.7-100), and the negative predictive value (NPV) was 100% (95% CI 93.3-100). The sensitivity of the self-sampling device to identify CIN2+ was 84.6% (95% CI 59.1-96.7), and the NPV was 94.4% (95% CI 83.4-98.8). The differences in the sensitivity and NPV between the 2 methods were non-significant. The agreement between the 2 methods regarding the HPV results was good, with a kappa value of 0.74 (95% CI 0.57-0.91).
The current findings indicate that physician-collected samples for hrHPV DNA testing may be used as triage for the colposcopy of women with false negative cytology.
确定高危型人乳头瘤病毒（hrHPV）DNA检测对于因细胞学检查假阴性而有高级别宫颈病变风险增加的女性中选择需要进一步行阴道镜检查的患者是否可靠。次要目的是比较hrHPV检测在自我采集样本与医生采集样本中检测组织学高级别宫颈上皮内瘤变（CIN2+）的敏感性。
纳入63例经重新评估宫颈细胞学检查结果为良性但存在漏诊异常的患者。分别采集患者自我采集和医生采集的样本进行HPV检测、阴道镜检查以及用于组织学和细胞学检查的宫颈标本采集。
医生采集样本检测CIN2+时hrHPV检测的敏感性为100%（95%CI 82.7-100），阴性预测值（NPV）为100%（95%CI 93.3-100）。自我采样装置检测CIN2+的敏感性为84.6%（95%CI 59.1-96.7），NPV为94.4%（95%CI 83.4-98.8）。两种方法在敏感性和NPV上的差异无统计学意义。两种方法在HPV检测结果方面的一致性良好，kappa值为0.74（95%CI 0.57-0.91）。
目前的研究结果表明，医生采集的样本用于hrHPV DNA检测可作为细胞学检查假阴性女性阴道镜检查的分流手段。
