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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of Clinical and Analytical Performance of the Abbott RealTime High Risk HPV Test to the Performance of Hybrid Capture 2 in Population-Based Cervical Cancer Screening
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Comparison of Clinical and Analytical Performance of the Abbott RealTime High Risk HPV Test to the Performance of Hybrid Capture 2 in Population-Based Cervical Cancer Screening

机译：在基于人群的宫颈癌筛查中，雅培实时高风险HPV检测与Hybrid Capture 2的临床和分析性能比较

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The clinical performance of the Abbott RealTime High Risk HPV (human papillomavirus) test (RealTime) and that of the Hybrid Capture 2 HPV DNA test (hc2) were prospectively compared in the population-based cervical cancer screening setting. In women >30 years old (n = 3,129), the clinical sensitivity of RealTime for detection of cervical intraepithelial neoplasia of grade 2 (CIN2) or worse (38 cases) and its clinical specificity for lesions of less than CIN2 (3,091 controls) were 100% and 93.3%, respectively, and those of hc2 were 97.4% and 91.8%, respectively. A noninferiority score test showed that the clinical specificity (P < 0.0001) and clinical sensitivity (P = 0.011) of RealTime were noninferior to those of hc2 at the recommended thresholds of 98% and 90%. In the total study population (women 20 to 64 years old; n = 4,432; 57 cases, 4,375 controls), the clinical sensitivity and specificity of RealTime were 98.2% and 89.5%, and those of hc2 were 94.7% and 87.7%, respectively. The analytical sensitivity and analytical specificity of RealTime in detecting targeted HPV types evaluated with the largest sample collection to date (4,479 samples) were 94.8% and 99.8%, and those of hc2 were 93.4% and 97.8%, respectively. Excellent analytical agreement between the two assays was obtained (kappa value, 0.84), while the analytical accuracy of RealTime was significantly higher than that of hc2. RealTime demonstrated high intralaboratory reproducibility and interlaboratory agreement with 500 samples retested 61 to 226 days after initial testing in two different laboratories. RealTime can be considered to be a reliable and robust HPV assay clinically comparable to hc2 for the detection of CIN2+ lesions in a population-based cervical cancer screening setting.
机译：在基于人群的宫颈癌筛查背景中，前瞻性地比较了雅培实时高风险HPV（人类乳头瘤病毒）测试（RealTime）和Hybrid Capture 2 HPV DNA测试（hc2）的临床表现。在30岁以上的女性中（ n = 3,129），RealTime检测2级（CIN2）或更严重的宫颈上皮内瘤变（38例）的临床敏感性及其对病变的临床特异性较小CIN2（3,091名对照）分别为100％和93.3％，而hc2分别为97.4％和91.8％。非劣效性评分测试显示，RealTime的临床特异性（ P <0.0001）和临床敏感性（ P = 0.011）在建议的阈值98下均不劣于hc2 ％和90％。在全部研究人群中（20至64岁的女性; n = 4,432; 57例，4,375名对照），RealTime的临床敏感性和特异性分别为98.2％和89.5％，而hc2的临床敏感性和特异性为分别为94.7％和87.7％。迄今为止，RealTime在检测到的最大样本量（4,479个样本）中评估的目标HPV类型的分析灵敏度和分析特异性分别为94.8％和99.8％，而hc2分别为93.4％和97.8％。两次测定之间获得了极好的分析一致性（kappa值为0.84），而RealTime的分析精度明显高于hc2。 RealTime展示了较高的实验室内部可重复性和实验室间一致性，在两个不同实验室中进行初始测试后的61至226天对500个样品进行了重新测试。在以人群为基础的宫颈癌筛查环境中，RealTime可被视为与hc2在临床上可比的可靠且强大的HPV检测方法，可用于检测CIN2 +病变。

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