1(st) Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
3(th) Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Hippokratio General Hospital, Thessaloniki, Greece.
Gynecol Oncol. 2021 Sep;162(3):560-568. doi: 10.1016/j.ygyno.2021.06.020. Epub 2021 Jun 29.
To identify the optimal strategy for the triage of women who test high-risk (hr) HPV positive on self-collected cervicovaginal samples.
This is a diagnostic accuracy sub-analysis of the GRECOSELF study, which reported on HPV-DNA testing with self-sampling in Greece. More than 13,000 women, 25-60 years old, who resided in rural areas of Greece, provided a self-collected cervicovaginal sample. Samples were tested for HPV-DNA and HPV16/18 genotyping with the cobas® HPV test (Roche® Molecular Systems, Pleasanton, CA, USA). HrHPV positive women were referred for colposcopy. Prior to colposcopy a physician-collected sample was obtained for cytology. After colposcopy/biopsy, women were classified as having cervical disease or not, and treated accordingly.
Out of 1070 hrHPV positive women, 773 were subjected to colposcopy. Seventeen triage strategies, combining HPV16/18 genotyping and cytology, were investigated. The strategy referring to colposcopy women positive for HPV16 regardless of the cytology report, and women positive for other hrHPVs, in case of a subsequent atypical squamous cells of undetermined significance or worse (ASCUS+) cytology report, presented optimal trade-off; sensitivity 96.36% [(95%CI: (91.41-100.0)], positive predictive value (PPV) 27.46% [95%CI: (21.16-33.76)], and number of colposcopies required to detect one case of Cervical Intraepithelial Neoplasia grade-2 or worse (CIN2+) 3.64.
The optimal strategy for the triage to colposcopy of hrHPV positive women, detected with the cobas® HPV test on self-collected cervicovaginal samples, is referring all HPV16 positive women directly to colposcopy, and women positive for HPV18 or other hrHPVs only after an ASCUS or worse cytology report.
确定对自我采集宫颈阴道样本中 HPV 高危（hr）阳性的女性进行分诊的最佳策略。
这是 GRECOSELF 研究的诊断准确性子分析，该研究报告了在希腊进行 HPV-DNA 自我采样检测的情况。13000 多名年龄在 25-60 岁之间的女性居住在希腊农村地区，提供了自我采集的宫颈阴道样本。样本用 cobas® HPV 检测（罗氏分子系统公司，普莱森顿，加利福尼亚州，美国）进行 HPV-DNA 和 HPV16/18 基因分型检测。hrHPV 阳性的女性被转诊行阴道镜检查。阴道镜检查前，医生采集样本进行细胞学检查。阴道镜检查/活检后，根据宫颈疾病的有无对女性进行分类，并进行相应的治疗。
在 1070 名 hrHPV 阳性的女性中，773 名女性接受了阴道镜检查。研究了 17 种分诊策略，这些策略结合了 HPV16/18 基因分型和细胞学检查。将 HPV16 阳性且无论细胞学报告如何的女性转诊行阴道镜检查，以及 HPV16 以外的其他 hrHPV 阳性女性，在随后的非典型鳞状细胞不明确意义或更差（ASCUS+）细胞学报告的情况下转诊行阴道镜检查的策略，具有最佳的权衡效果；敏感性为 96.36%（[95%CI：（91.41-100.0]），阳性预测值（PPV）为 27.46%（[95%CI：（21.16-33.76]），以及检测一例宫颈上皮内瘤变 2 级或更高级别（CIN2+）所需的阴道镜检查次数为 3.64。
对于用 cobas® HPV 检测在自我采集的宫颈阴道样本中检测到的 hrHPV 阳性女性进行阴道镜检查的最佳分诊策略是直接将所有 HPV16 阳性女性转诊行阴道镜检查，仅将 HPV18 或其他 hrHPV 阳性女性转诊行阴道镜检查，前提是细胞学检查为 ASCUS 或更差。
