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Abstract：
Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen\'s kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99-1.03) and 1.02 (95% CI: 1.0-1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance >98% and kappas >0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.
摘要：
目的：宫颈癌筛查中使用的人乳头瘤病毒（HPV）检测应根据国际标准进行临床验证。OncoPredictHPV®筛选（SCR）是针对13个高风险（hr）HPV的E6/E7基因的部分基因分型多重实时PCR测定。OncoPredictHPV®SCR（指数测定）分别鉴定HPV-16和HPV-18，总共有11个其他hrHPV，包括样品充分性的质量控制，DNA提取效率和PCR抑制。
方法：1,300份VALGENT-2研究样本（来自参加苏格兰宫颈癌筛查计划的20-60岁女性）用指数测定法和GP5+/6+PCR酶免疫测定（标准比较测定法）进行了测试。与比较指标相比，检测2级或更差（CIN2）的宫颈上皮内瘤变的准确性不低。通过总体一致性和Cohen'skappa评估指标的实验室内和实验室间可重复性，使用亚群体(n=526)。
结果：该指数对CIN2+的相对灵敏度和特异度与比较为1.01(95CI:0.99-1.03)和1.02(95CI:1.0-1.04)，分别。非劣效性p值均≤0.05，但≥30岁患者的CIN3+除外。表现出优异的实验室内和实验室间可重复性,一致性>98%,kappas>0.95。
结论：OncoPredictHPV®SCR符合宫颈癌筛查中hrHPVDNA检测的三个国际验证标准。本文受版权保护。保留所有权利。
方法：1,300份VALGENT-2研究样本（来自参加苏格兰宫颈癌筛查计划的20-60岁女性）用指数测定法和GP5+/6+PCR酶免疫测定（标准比较测定法）进行了测试。与比较指标相比，检测2级或更差（CIN2）的宫颈上皮内瘤变的准确性不低。通过总体一致性和Cohen'skappa评估指标的实验室内和实验室间可重复性，使用亚群体(n=526)。
结果：该指数对CIN2+的相对灵敏度和特异度与比较为1.01(95CI:0.99-1.03)和1.02(95CI:1.0-1.04)，分别。非劣效性p值均≤0.05，但≥30岁患者的CIN3+除外。表现出优异的实验室内和实验室间可重复性,一致性>98%,kappas>0.95。
结论：OncoPredictHPV®SCR符合宫颈癌筛查中hrHPVDNA检测的三个国际验证标准。本文受版权保护。保留所有权利。
