Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany
Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany
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DOI：
10.1128/jcm.01013-15
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发表时间：
2015-08-01
影响因子：
9.4
通讯作者：
Sasieni, Peter
中科院分区：
文献类型：
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作者：
Iftner, Thomas;Becker, Sven;Sasieni, Peter
检测高危型人乳头瘤病毒(HPV)感染细胞中的E6/E7基因可提高HPV检测对宫颈癌前病变诊断的特异性。在这里，我们对接受常规宫颈筛查的妇女进行了基于RNA的Aptima HPV(AHPV)检测(HOLOGIC)和基于DNA的杂交捕获2(HC2)HPV检测(QIGEN)与液基细胞学(LBC)的比较。共有10,040名年龄在30岁至60岁之间的女性被邀请参加这项研究，其中9,451人被纳入分析。样本通过LBC、AHPV检测和HC2检测进行集中检测，任何检测呈阳性的妇女都会被转介到阴道镜检查。对所有HR-HPV阳性标本进行基因分型。在组织学回顾的基础上计算测试特性。结果，我们确定了90名宫颈上皮内瘤变2级+(CIN2+)的女性，包括43名CIN3+的女性。AHPV和HC2检测CIN2+(P=0.180)或CIN3+(P=0.0625)的敏感性差异无统计学意义。在AHPV试验漏诊的3例CIN3病例中，2例无病变锥体，1例非HR HPV67感染。特异度(
Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2+ (CIN2+), including 43 women with CIN3+. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2+ (P = 0.180) or CIN3+ (P = 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (