a Division of Laboratory Medicine , European Institute of Oncology , Milan , Italy.
b Preventive Gynecology Unit , European Institute of Oncology , Milan , Italy.
Infect Dis (Lond). 2018 Jul;50(7):554-559. doi: 10.1080/23744235.2018.1441538. Epub 2018 Feb 20.
High-risk (HR) Human Papilloma Virus (HPV) Tests for HPV detection differ in sensitivity and specificity. In this study, we evaluated the sensitivity and specificity of the HC2 HR HPV Test and the Cobas 4800 HPV Test in consecutive cervical samples collected from a referral population with a high prevalence of disease, using CIN2+ histology as clinical outcome.
Ten thousand two-hundred and thirteen consecutive cervical samples were assayed for HR-HPV in the Laboratory Medicine Division of IEO: 5140 from January 2012 to June 2013 with HC2 and 5073 from July 2013 to December 2014 with the Cobas HPV Test. These two assays differ in terms of target genes and testing methods.
The test positivity rates for HC2 and Cobas 4800 were 29.5% (1515/5135, 95% CI 28.3-30.8%) and 23.9% (1212/5069, 95% CI 22.7-25.1%), respectively. The detection rates of CIN2+ in the two time periods were 2.8% (145/5140, 95% CI 2.4-3.3%) and 1.6% (79/5073, 95% CI 1.2-1.9%), respectively. The sensitivity for CIN2+ for HC2 and Cobas 4800 was 95.2% (138/145, 95% CI 91.7-98.7%) and 93.7% (74/79, 95% CI 88.3-99.0%), respectively. The specificity for CIN2+ for HC2 and Cobas 4800 was 72.4% (3613/4990, 95% CI 71.2-73.6%) and 77.2% (3852/4990, 95% CI 76.0-78.4%), respectively. There were 23 cases of cancer in each of the two time periods. HC2 detected 100% (23/23). Cobas 4800 detected 82.6% (19/23).
The detection rate of CIN2+ was higher in the first period than in the second period. There was no significant difference in sensitivity of HC2 and Cobas 4800 in women with CIN2+. The specificity of CIN2+ using Cobas 4800 in the second period was higher than HC2 in the first period, probably due to the lower prevalence of CIN2+ in the second period.
用于 HPV 检测的高危型（HR）人乳头瘤病毒（HPV）检测在灵敏度和特异性方面存在差异。本研究采用 CIN2+组织学作为临床终点，评估了在高危 HPV 阳性率较高的转诊人群中连续采集的宫颈样本中，HC2 检测和 Cobas 4800 HPV 检测的灵敏度和特异性。
在 IEO 检验科，用 HC2 检测了 2012 年 1 月至 2013 年 6 月期间采集的 5140 例连续宫颈样本，用 Cobas HPV 检测了 2013 年 7 月至 2014 年 12 月期间采集的 5073 例连续宫颈样本。这两种检测方法在靶基因和检测方法上有所不同。
HC2 和 Cobas 4800 的检测阳性率分别为 29.5%（1515/5135，95%CI 28.3-30.8%）和 23.9%（1212/5069，95%CI 22.7-25.1%）。两个时期 CIN2+的检出率分别为 2.8%（145/5140，95%CI 2.4-3.3%）和 1.6%（79/5073，95%CI 1.2-1.9%）。HC2 和 Cobas 4800 检测 CIN2+的灵敏度分别为 95.2%（138/145，95%CI 91.7-98.7%）和 93.7%（74/79，95%CI 88.3-99.0%）。HC2 和 Cobas 4800 检测 CIN2+的特异性分别为 72.4%（3613/4990，95%CI 71.2-73.6%）和 77.2%（3852/4990，95%CI 76.0-78.4%）。两个时期各有 23 例癌症病例。HC2 检测出 100%（23/23），Cobas 4800 检测出 82.6%（19/23）。
第一阶段 CIN2+的检出率高于第二阶段。在 CIN2+女性中，HC2 和 Cobas 4800 的灵敏度无显著差异。第二阶段使用 Cobas 4800 检测 CIN2+的特异性高于第一阶段使用 HC2，可能是因为第二阶段 CIN2+的患病率较低。
