Boehmer Gerd, Wang Lisa, Iftner Angelika, Holz Barbara, Haedicke Juliane, von Wasielewski Reinhard, Martus Peter, Iftner Thomas
German Clinic Bad Münder, Bad Münder, Germany.
Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Tübingen, Germany.
BMC Infect Dis. 2014 Dec 9;14:674. doi: 10.1186/s12879-014-0674-1.
High-risk human papillomavirus (HR HPV) testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical pre-cancer and cancer.
We report a purely observational study evaluating HR HPV prevalences in residual liquid-based cytology (LBC) samples using both the Cervista™ HPV HR Test and the Digene Hybrid Capture 2 High-Risk HPV DNA Test (HC2) in a sample of 1,741 women aged ≥30 years of a German routine screening population of 13,372 women. Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.
The overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8). Relative sensitivities for the detection of histologically confirmed severe cervical intraepithelial dysplasia (CIN3+) were similar for both HPV-tests, which was confirmed by the ratio analysis. However, discrepancy analysis between the Cervista HPV HR test and HC2 revealed a high false positive rate of the Cervista HPV HR test in the cytology normal category.
Performance of the Cervista HPV test in cervical specimens with abnormal cytology is comparable to HC2 as both tests were highly sensitive and specific for the detection of high grade cervical disease. We also demonstrate evidence that modification of the cut-off values drastically reduces the false positive rate in the cytology normal category without affecting the detection of CIN3+, which ultimately improved specificity of the Cervista HPV HR assay.
高危型人乳头瘤病毒（HR HPV）检测已被证明是宫颈癌筛查中用于检测宫颈上皮内瘤变和癌症的一项重要工具。
我们报告了一项纯观察性研究，在13372名德国常规筛查女性样本中，选取1741名年龄≥30岁的女性，使用Cervista™ HPV HR检测法和Digene杂交捕获2高危型HPV DNA检测法（HC2），评估残留液基细胞学（LBC）样本中的HR HPV流行率。计算检测特征，并通过计算灵敏度或特异性比值应用一种测量检测性能的新方法。
两种检测方法检测HR HPV的总体一致性良好（κ = 0.8）。两种HPV检测方法检测组织学确诊的重度宫颈上皮内瘤变（CIN3+）的相对灵敏度相似，这一点通过比值分析得到证实。然而，Cervista HPV HR检测法与HC2之间的差异分析显示，Cervista HPV HR检测法在细胞学正常类别中的假阳性率较高。
Cervista HPV检测法在细胞学异常的宫颈样本中的性能与HC2相当，因为两种检测方法在检测高级别宫颈疾病时都具有高度敏感性和特异性。我们还证明，修改临界值可大幅降低细胞学正常类别中的假阳性率，而不影响CIN3+的检测，这最终提高了Cervista HPV HR检测法的特异性。
