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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of Clinical Performance of Abbott RealTime High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting
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Comparison of Clinical Performance of Abbott RealTime High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting

机译：筛选环境中雅培实时高风险HPV检测与Hybrid Capture 2检测的临床性能比较

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Randomized trials have produced sound evidence about the efficacy of screening with human papillomavirus (HPV) DNA tests in reducing cervical cancer incidence and mortality. We evaluated the clinical performance and reproducibility of the Abbott RealTime High Risk (HR) HPV test compared with that of the HR hybrid capture 2 (HC2) assay as assessed by a noninferiority score test. A random sample of 998 cervical specimens (914 specimens of cervical intraepithelial neoplasia less severe than grade 2 [me HR HPV test. Absolute specificity was 92.3% (95% confidence interval [CI], 90.4 to 94.0) and 92.6% (95% CI, 90.7 to 94.2) for the Abbott RealTime HR HPV test and the HR HC2, respectively. Absolute sensitivity was 96.4% (95% CI, 89.9 to 99.3) and 97.6% (95% CI, 91.7 to 99.7) for the Abbott RealTime HR HPV test and the HR HC2, respectively. The noninferiority score test revealed that the clinical sensitivity and specificity of the Abbott RealTime HR HPV test were not inferior (P = 0.004 and 0.009, respectively) to those of HR HC2. Overall agreement between the two assays was 96.5%, with a k value of 0.86 (CI 95%, 0.82 to 0.91). We evaluated the intralaboratory reproducibility by retesting 521 samples at least 4 weeks after the first test; the crude agreement between the first and second test was 98.5%, with an overall k value of 0.97 (CI 95%, 0.95 to 0.99). This test fully satisfies the requirements of a primary cervical cancer screening test. This assay differentiates between HPV16, HPV18, and non-HPV16/18 types in every specimen, but how to use this information in a screening setting still is unclear.
机译：随机试验提供了可靠的证据，证明了使用人乳头瘤病毒（HPV）DNA测试进行筛查可降低宫颈癌的发病率和死亡率。我们通过非劣性评分测试评估了雅培RealTi m e高风险（HR）HPV检测与HR Hybrid Capture 2（HC2）检测的临床性能和可重复性。在佛罗伦萨和卡塔尼亚子宫颈癌中收集了998份宫颈标本的随机样本（914份小于2级[ m e HR HPV测试进行了重新测试。雅培RealTi m e HR HPV测试和HR HC2的绝对特异性为92.3％（95％置信区间[CI]，90.4至94.0）和92.6％（95％CI，90.7至94.2） ， 分别。雅培RealTiem HR HPV测试和HR HC2的绝对灵敏度分别为96.4％（95％CI，89.9至99.3）和97.6％（95％CI，91.7至99.7）。非劣效性评分测试显示，雅培RealTi m e HR HPV检验的临床敏感性和特异性均不逊于HR（ P = 0.004和0.009） HC2。两次检测之间的总体一致性为96.5％， k 值为0.86（CI 95％，0.82至0.91）。我们通过在第一次测试后至少4周重新测试521个样品来评估实验室内的可重复性。第一次测试和第二次测试之间的粗略一致性为98.5％，总体 k 值为0.97（CI 95％，0.95至0.99）。该测试完全满足基本宫颈癌筛查测试的要求。该测定法可以区分每个样本中的HPV16，HPV18和非HPV16 / 18类型，但如何在筛查环境中使用此信息仍不清楚。

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