Halfon Philippe, Trepo Elisabeth, Antoniotti Gilles, Bernot Catherine, Cart-Lamy Philippe, Khiri Hacène, Thibaud Didier, Marron Jean, Martineau Agnès, Pénaranda Guillaume, Benmoura Dominique, Blanc Bernard
Alphabio Laboratory, 23 rue de Friedland, 13006 Marseille, France.
J Clin Microbiol. 2007 Feb;45(2):313-6. doi: 10.1128/JCM.00992-06. Epub 2006 Nov 22.
The use of high-risk human papillomavirus (hrHPV) testing as an adjunct to cervical cytology in population-based screening programs is currently based on DNA hybridization and PCR assays. The aim of this study was to prospectively assess the diagnostic performance of the Hybrid Capture 2 test (HC2; Digene Corporation) in comparison with that of the recently developed PCR-based AMPLICOR HPV test (Roche Molecular Systems) for the detection of 13 hrHPV types. A reverse line blot hybridization assay (Innogenetics) was used as an internal reference standard in discordant cases. Two hundred seventy-one patients with atypical squamous cells of uncertain significance (ASCUS) in cervical samples underwent hrHPV testing. The chi-square test was performed to compare respective proportions. Totals of 160/271 (59%) and 156/271 (58%) were found to be positive for hrHPV with HC2 and AMPLICOR, respectively. Concordant results were obtained for 235 (86.7%) of the 271 samples (kappa statistic, 0.73 +/- 0.04). Considering types 26, 53, and 66 as oncogenic types, negative predictive values (NPVs) of HC2 and AMPLICOR were 92.8% and 87.8%, respectively (difference was not significant), and their respective accuracies were 94.8% and 91.9% (difference was not significant). Considering types 26, 53, and 66 as not oncogenic, the respective HC2 and AMPLICOR NPVs were 92.8% and 97.4% (difference was not significant), and accuracy was significantly higher for the AMPLICOR assay (95.9% versus 90.8% for HC2) (P<0.05). For ASCUS samples, the NPV was 92.8% for HC2 testing and might be compromised if the copy number of HPV DNA was low. The NPV was 97.4% for the AMPLICOR assay and might be compromised if HPV types 26, 53, and 66 were considered oncogenic. The accuracy of these two assays is good and is compatible with routine clinical use in the triage of ASCUS cases.
在基于人群的筛查项目中，将高危型人乳头瘤病毒（hrHPV）检测作为宫颈细胞学检查的辅助手段，目前是基于DNA杂交和聚合酶链反应（PCR）检测。本研究的目的是前瞻性评估杂交捕获2代检测法（HC2；Digene公司）与最近开发的基于PCR的AMPLICOR HPV检测法（罗氏分子系统公司）在检测13种hrHPV型别方面的诊断性能。对于结果不一致的病例，采用反向线印迹杂交检测法（Innogenetics公司）作为内部参考标准。271例宫颈样本中存在意义不明确的非典型鳞状细胞（ASCUS）的患者接受了hrHPV检测。采用卡方检验比较各自的比例。HC2和AMPLICOR检测发现hrHPV阳性的患者分别为160/271（59%）和156/271（58%）。271份样本中的235份（86.7%）获得了一致结果（kappa统计量，0.73±0.04）。将26、53和66型视为致癌型别时，HC2和AMPLICOR的阴性预测值（NPV）分别为92.8%和87.8%（差异无统计学意义），其各自的准确率分别为94.8%和91.9%（差异无统计学意义）。将26、53和66型视为非致癌型别时，HC2和AMPLICOR各自的NPV分别为92.8%和97.4%（差异无统计学意义），AMPLICOR检测法的准确率显著更高（HC2为90.8%，AMPLICOR为95.9%）（P<0.05）。对于ASCUS样本，HC2检测的NPV为92.8%，如果HPV DNA拷贝数较低，该值可能会受到影响。AMPLICOR检测法的NPV为97.4%，如果将26、53和66型视为致癌型别，该值可能会受到影响。这两种检测法的准确率良好，适用于ASCUS病例分流的常规临床应用。
