HPV Research Group, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Institute, Edinburgh, UK.
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, UK.
J Clin Pathol. 2014 Jun;67(6):458-63. doi: 10.1136/jclinpath-2013-202014. Epub 2014 Jan 16.
Human papillomavirus (HPV) testing is more sensitive than cytology for detection of residual/recurrent cervical disease after lesion treatment. Several HPV test comparison studies have been performed within triage and screening populations, but data on their comparative performance in a test of cure context is lacking. This study aims to address this gap.
We compared the technical and clinical performance of Abbott RealTime High risk (HR)-HPV, Genprobe Aptima PV, Hologic Cervista HPV-HR, Qiagen Hybrid Capture 2 and Roche cobas HPV in the Early Implementation phase of a 'test of cure' service within the Scottish Cervical Screening Programme.
Valid results with all five HPV Tests from 1020 first samples taken ∼6 months post-treatment showed HPV positivity ranging from 17.84% to 26.96%. There was perfect agreement in 74%, and greatest variation between assays was observed in cytologically negative samples. Clinical performance was judged on cumulative incidence of cervical intraepithelial neoplasia 2+ (CIN2+) during follow-up (mean: 13.2 months). There were 23 cases of CIN2+ of which 14 were CIN3+. All assays, including cytology, were 100% sensitive for detection of CIN3+. Of the nine cases of residual CIN2, three assays detected all, one assay missed one and one assay missed two cases. Specificity ranged from 75% to 84% according to assay.
All assays were sensitive for detection of CIN2+ at 6 months post-treatment. The range of positivity equated to a 50% increase between assays with the lowest and highest positivity rates. The relevance of HPV positivity in the absence of cytological abnormalities requires longer follow-up to determine whether additional tools for risk stratification are required.
人乳头瘤病毒（HPV）检测比细胞学检查更敏感，可用于检测病变治疗后残留/复发的宫颈疾病。已经在分流和筛查人群中进行了几项 HPV 检测比较研究，但缺乏关于其在治疗检测背景下比较性能的数据。本研究旨在解决这一差距。
我们比较了 Abbott RealTime High risk（HR）-HPV、Genprobe Aptima PV、Hologic Cervista HPV-HR、Qiagen Hybrid Capture 2 和 Roche cobas HPV 在苏格兰宫颈筛查计划的“治疗检测”服务早期实施阶段的技术和临床性能。
1020 例首次治疗后约 6 个月的样本中，所有 5 种 HPV 检测均获得有效结果，HPV 阳性率为 17.84%至 26.96%。74%的检测结果完全一致，检测结果差异最大的是细胞学阴性样本。临床性能根据随访期间（平均 13.2 个月）宫颈上皮内瘤变 2+（CIN2+）的累积发病率进行判断。有 23 例 CIN2+，其中 14 例为 CIN3+。所有检测方法，包括细胞学检查，对 CIN3+的检测均为 100%敏感。在 9 例残留 CIN2 中，3 种检测方法均能检测到所有病例，1 种检测方法漏诊 1 例，1 种检测方法漏诊 2 例。根据检测方法的不同，特异性为 75%至 84%。
所有检测方法在治疗后 6 个月时对 CIN2+的检测均具有敏感性。阳性率的范围相当于检测方法中最低和最高阳性率之间的 50%差异。在细胞学异常缺失的情况下 HPV 阳性的相关性需要更长时间的随访来确定是否需要额外的风险分层工具。
