Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary, University of London, Charterhouse Square, London EC1M 6BQ, UK.
Cytopathology Department, Royal Free Hospital, London NW3, UK.
Eur J Cancer. 2013 Jun;49(9):2179-86. doi: 10.1016/j.ejca.2013.01.018. Epub 2013 Feb 26.
To compare triage strategies using different human papillomavirus (HPV) consensus and genotyping tests and a p16(INK4a) test.
1228 women referred with a borderline or single mildly dyskaryotic smear. Samples were taken at colposcopy using PreservCyt. Tests included Hybrid Capture 2, Abbott RealTime PCR, BD HPV, Cobas 4800, PreTect HPV-Proofer, APTIMA and p16(INK4a). Results were based on the worst histology within 9 months.
97/1228 (7.9%) women had CIN3+ (203/1228 (17%) CIN2+). HPV testing alone using Hybrid Capture 2, Abbott RealTime PCR, BD HPV, Cobas 4800 or APTIMA had a sensitivity for CIN3+ ranging from 99.0% to 100.0% and specificity for <CIN2 from 23.3% to 34.7%. p16(INK4a) had a sensitivity of 86.8% and specificity of 50.7%. PreTect HPV-Proofer had a sensitivity of 85.1% and specificity of 73.2%. Testing for HPV type 16 only had sensitivities ranging from 66.0% to 75.5% and specificities from 81.3% to 87.6%. Dual testing with HPV type 16 combined with p16(INK4a) gave a high sensitivity for CIN3+ (78.7% to 98.0%) and specificity for <CIN2 of 58.6% to 81.5%.
Triage with sensitive HPV testing assays can substantially reduce the number of unnecessary referrals in women with low grade cytology with virtually no loss of sensitivity. Even greater gains can be made if p16 and type 16 are used, but some cases of CIN2 will be missed. In both cases short term surveillance will be needed.
比较使用不同的人乳头瘤病毒（HPV）共识和基因分型检测以及 p16（INK4a）检测的分诊策略。
1228 名因边界性或单一轻度细胞学不典型而转诊的女性。在阴道镜检查时使用 PreservCyt 采集样本。检测包括杂交捕获 2 型、雅培实时 PCR、BD HPV、Cobas 4800、PreTect HPV-Proofer、APTIMA 和 p16（INK4a）。结果基于 9 个月内的最差组织学结果。
97/1228 名（7.9%）女性患有 CIN3+（203/1228 名（17%）患有 CIN2+）。单独使用杂交捕获 2 型、雅培实时 PCR、BD HPV、Cobas 4800 或 APTIMA 进行 HPV 检测，其 CIN3+的敏感性为 99.0%至 100.0%，<CIN2 的特异性为 23.3%至 34.7%。p16（INK4a）的敏感性为 86.8%，特异性为 50.7%。PreTect HPV-Proofer 的敏感性为 85.1%，特异性为 73.2%。仅检测 HPV 型 16 的敏感性范围为 66.0%至 75.5%，特异性范围为 81.3%至 87.6%。HPV 型 16 与 p16（INK4a）双重检测对 CIN3+具有较高的敏感性（78.7%至 98.0%），<CIN2 的特异性为 58.6%至 81.5%。
使用敏感的 HPV 检测方法进行分诊可以大大减少低级别细胞学女性中不必要的转诊数量，而几乎不会降低敏感性。如果使用 p16 和 16 型 HPV，则可以获得更大的收益，但会错过一些 CIN2 病例。在这两种情况下，都需要进行短期监测。
