Department of Pathology, VU University Medical Center, de Boelelaan 1117, Amsterdam 1081 HV, Netherlands.
J Clin Microbiol. 2010 Mar;48(3):797-801. doi: 10.1128/JCM.01743-09. Epub 2009 Dec 30.
We compared the clinical performance of the PapilloCheck human papillomavirus (HPV) assay with that of the GP5+/6+-PCR method with an enzyme immunoassay readout (GP5+/6+-PCR-EIA) for the detection of high-risk HPV (hrHPV) types by the use of cervical samples originating from women in a population-based by the use of cervical screening cohort tested by combined cytology and GP5+/6+-PCR-EIA (POBASCAM trial). Specimens from a random sample of 1,437 controls (women ages 40 to 60 years with normal cytological findings and without evidence of cervical intraepithelial neoplasia grade 2 or higher [> or = CIN2] within up to 8 years of follow-up) and 192 cases (women ages 30 to 60 years in whom > or = CIN3 was detected within up to 3 years of follow-up) were subjected to analysis by the PapilloCheck method. When all 17 (probably) hrHPV types were taken into account, the PapilloCheck assay had a clinical sensitivity for the detection of > or = CIN3 of 96.4% (185/192 samples; 95% confidence interval [CI], 93.7 to 99.7) and a clinical specificity for the detection of > or = CIN2 of 96.3% (95% CI, 95.3 to 97.3). After restriction of the analysis by the PapilloCheck assay to the 14 hr HPV types targeted by GP5+/6+-PCR-EIA, the clinical sensitivity and clinical specificity values were 95.8% (95% CI, 92.8 to 98.8) and 96.7% (95% CI, 95.7 to 97.7), respectively. By comparison, these values were 96.4% (95% CI, 93.9 to 98.9) and 97.7% (95% CI, 96.9 to 98.5), respectively, for the GP5+/6+-PCR-EIA. When all 17 (probably) hrHPV types were included in the analysis, noninferiority score testing revealed that the clinical sensitivity of the PapilloCheck assay for the detection of > or = CIN3 was noninferior to that of the GP5+/6+-PCR-EIA (P < 0.0001), but the clinical specificity of the PapilloCheck assay for the detection of > or = CIN2 was inferior to that of the GP5+/6+-PCR-EIA (P = 0.08) when lower bounds of 90% for sensitivity and 98% for specificity were used. When the analysis was restricted to the 14 hrHPV types targeted by the GP5+/6+-PCR-EIA, both the clinical sensitivity and the clinical specificity of the PapilloCheck assay were noninferior to those of the GP5+/6+-PCR-EIA (noninferiority score test; P < 0.0001 and P = 0.007, respectively). Thus, when the findings obtained for the 14 hrHPV types detectable by the GP5+/6+-PCR-EIA are considered, the PapilloCheck assay is clinically compatible with the GP5+/6+-PCR-EIA.
我们比较了 PapilloCheck 人乳头瘤病毒（HPV）检测与 GP5+/6+-PCR 方法的临床性能，该方法使用酶免疫测定（GP5+/6+-PCR-EIA）检测高危型 HPV（hrHPV），使用来自基于人群的宫颈筛查队列的宫颈样本，该队列通过联合细胞学和 GP5+/6+-PCR-EIA（POBASCAM 试验）进行检测。对随机样本 1437 例对照（年龄在 40 至 60 岁之间的女性，细胞学检查正常，在 8 年的随访中无宫颈上皮内瘤变 2 级或更高（>或= CIN2）的证据）和 192 例病例（年龄在 30 至 60 岁之间的女性，在 3 年的随访中检测到>或= CIN3）的样本进行了 PapilloCheck 方法分析。当考虑所有 17 种（可能）hrHPV 类型时，PapilloCheck 检测方法对检测>或= CIN3 的临床灵敏度为 96.4%（192 例样本；95%置信区间 [CI]，93.7 至 99.7），对检测>或= CIN2 的临床特异性为 96.3%（95%CI，95.3 至 97.3）。在将 PapilloCheck 检测方法的分析限制为 GP5+/6+-PCR-EIA 靶向的 14 种 hrHPV 类型后，灵敏度和特异性值分别为 95.8%（95%CI，92.8 至 98.8）和 96.7%（95%CI，95.7 至 97.7）。相比之下，GP5+/6+-PCR-EIA 的这些值分别为 96.4%（95%CI，93.9 至 98.9）和 97.7%（95%CI，96.9 至 98.5）。当所有 17 种（可能）hrHPV 类型都包括在分析中时，非劣效性评分检验显示，PapilloCheck 检测方法对检测>或= CIN3 的临床灵敏度不劣于 GP5+/6+-PCR-EIA（P<0.0001），但 PapilloCheck 检测方法对检测>或= CIN2 的临床特异性劣于 GP5+/6+-PCR-EIA（P=0.08），当灵敏度的下限为 90%和特异性的下限为 98%时。当分析仅限于 GP5+/6+-PCR-EIA 靶向的 14 种 hrHPV 类型时，PapilloCheck 检测方法的灵敏度和特异性均不劣于 GP5+/6+-PCR-EIA（非劣效性评分检验；P<0.0001 和 P=0.007）。因此，当考虑到 GP5+/6+-PCR-EIA 可检测到的 14 种 hrHPV 类型的结果时，PapilloCheck 检测方法与 GP5+/6+-PCR-EIA 在临床上是一致的。
