Reference ranges for HE4 and CA125 in a large Asian population by automated assays and diagnostic performances for ovarian cancer
Reference ranges for HE4 and CA125 in a large Asian population by automated assays and diagnostic performances for ovarian cancer
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DOI：
10.1002/ijc.26129
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发表时间：
2012-03-01
影响因子：
6.4
通讯作者：
Kim, Hyon-Suk
中科院分区：
文献类型：
--
作者：
Park, Yongjung;Kim, Yoonjung;Kim, Hyon-Suk
人附睾蛋白4（HE4）是检测卵巢癌的新生物标志物。我们评价了一种新型自动化HE4检测试剂盒的分析性能，并建立了HE4和CA125的参考范围。我们还比较了两种生物标志物对卵巢癌的诊断性能。评估了HE4测定的精密度性能和线性。还测定了来自2，182名健康妇女和72名孕妇的血清样品的HE4和CA125，并计算了两种标志物的95%、97.5%和99%参考限。此外，检测了66例卵巢癌和257例良性妇科疾病患者的血清，以验证参考范围和诊断性能。HE4测定的总精密度为
Human epididymis protein 4 (HE4) is a new biomarker for the detection of ovarian cancer. We evaluated the analytical performance of a novel automated HE4 assay and established reference ranges of HE4 and CA125. We also compared the diagnostic performance of both biomarkers for ovarian cancer. Precision performances and linearity of the HE4 assay were assessed. Serum samples from 2,182 healthy and 72 pregnant women were also assayed for HE4 and CA125, and the 95%, 97.5% and 99% reference limits for both markers were calculated. Additionally, sera from 66 ovarian cancer and 257 benign gynecologic disease patients were tested to validate reference ranges and diagnostic performances. The total precision of the HE4 assay was