Manchester Clinical Virology, Central Manchester University Hospitals NHS Foundation Trust, Manchester M13 9WL, United Kingdom.
J Clin Microbiol. 2010 Feb;48(2):554-8. doi: 10.1128/JCM.00896-09. Epub 2009 Dec 9.
We present data on the use of the Hybrid Capture 2 (HC2) test for the detection of high-risk human papillomavirus (HR HPV) with different thresholds for positivity within a primary screening setting and as a method of triage for low-grade cytology. In the ARTISTIC population-based trial, 18,386 women were screened by cytology and for HPV. Cervical intraepithelial neoplasia lesions of grade two and higher (CIN2+ lesions) were identified for 453 women within 30 months of an abnormal baseline sample. When a relative light unit/cutoff (RLU/Co) ratio of > or = 1 was used as the threshold for considering an HC2 result positive, 15.6% of results were positive, and the proportion of CIN2+ lesions in this group was 14.7%. The relative sensitivity for CIN2+ lesion detection was 93.4%. When an RLU/Co ratio of > or = 2 was used as the threshold, there was a 2.5% reduction in positivity, with an increase in the proportion of CIN2+ lesions detected. The relative sensitivity decreased slightly, to 90.3%. Among women with low-grade cytology, HPV prevalences were 43.7% and 40.3% at RLU/Co ratios of > or = 1 and > or = 2, respectively. The proportions of CIN2+ lesions detected were 17.3% and 18.0%, with relative sensitivities of 87.7% at an RLU/Co ratio of > or = 1 and 84.2% at an RLU/Co ratio of > or = 2. At an RLU/Co ratio of > or = 1, 68.3% of HC2-positive results were confirmed by the Roche line blot assay, compared to 77.2% of those at an RLU/Co ratio of > or = 2. Fewer HC2-positive results were confirmed for 35- to 64-year-olds (50.3% at an RLU/Co ratio of > or = 1 and 63.2% at an RLU/Co ratio of > 2) than for 20- to 34-year-olds (78.7% at an RLU/Co ratio of > or = 1 and 83.7% at an RLU/Co ratio of > 2). If the HC2 test is used for routine screening as an initial test or as a method of triage for low-grade cytology, we would suggest increasing the threshold for positivity from the RLU/Co ratio of > or = 1, recommended by the manufacturer, to an RLU/Co ratio of > or = 2, since this study has shown that a beneficial balance between relative sensitivity and the proportion of CIN2+ lesions detected is achieved at this threshold.
我们提供了在初级筛查环境中使用杂交捕获 2 （HC2）检测高危型人乳头瘤病毒（HR HPV）的数据，并针对不同的阳性截断值进行了分析，同时也评估了其在低级别细胞学检查中的分流作用。在基于人群的 ARTISTIC 试验中，18386 名女性通过细胞学和 HPV 检测进行筛查。在 30 个月的基线异常样本后，发现 453 名女性患有二级及以上的宫颈上皮内瘤变（CIN2+病变）。当相对光单位/临界值（RLU/Co）比值大于或等于 1 被用作 HC2 阳性结果的截断值时，有 15.6%的结果为阳性，该组中 CIN2+病变的比例为 14.7%。CIN2+病变检测的相对灵敏度为 93.4%。当 RLU/Co 比值大于或等于 2 时，阳性率降低 2.5%，但 CIN2+病变的检出率增加。相对灵敏度略有下降，为 90.3%。在低级别细胞学检查的女性中，当 RLU/Co 比值大于或等于 1 和大于或等于 2 时，HPV 的流行率分别为 43.7%和 40.3%。检测到的 CIN2+病变的比例分别为 17.3%和 18.0%，相对灵敏度分别为 RLU/Co 比值大于或等于 1 时为 87.7%和 RLU/Co 比值大于或等于 2 时为 84.2%。在 RLU/Co 比值大于或等于 1 时，罗氏线印迹检测确认了 68.3%的 HC2 阳性结果，而在 RLU/Co 比值大于或等于 2 时，这一比例为 77.2%。对于 35 岁至 64 岁的女性（RLU/Co 比值大于或等于 1 时为 50.3%，大于或等于 2 时为 63.2%），HC2 阳性结果的确认率低于 20 岁至 34 岁的女性（RLU/Co 比值大于或等于 1 时为 78.7%，大于或等于 2 时为 83.7%）。如果 HC2 检测被用作常规筛查的初始检测或低级别细胞学检查的分流方法，我们建议将阳性截断值从制造商推荐的 RLU/Co 比值大于或等于 1 提高到大于或等于 2，因为本研究表明，在此截断值下，可以在相对灵敏度和检测到的 CIN2+病变比例之间实现有益的平衡。
