Hasanbegovic Lejla, Alicelebic Selma, Sljivo Nedeljka
Biochemical-Immunological-Haematological "Medical Laboratory" Ilidza, Sarajevo, Bosnia and Herzegovina.
Institute of Histology and Embryology, School of Medicine, Sarajevo, Bosnia and Herzegovina.
Acta Inform Med. 2015 Apr;23(2):86-9. doi: 10.5455/aim.2015.23.86-89. Epub 2015 Apr 14.
the most widely used tumor marker in ovarian cancer, often considered the 'gold standard' is CA125 but reliable clinical evidence demonstrates that human epididymis protein (HE4), used alone or in combination with CA125, substantially improves the accuracy of screening and/or disease monitoring.
to evaluate the reliability of the determination a tumor marker HE4 in comparison with CA125 on the Elecsys analyzer 2010 in epithelial ovarian cancer, benign ovarian cyst and healthy controls.
we prospectively determined CA125 and HE4 serum levels in the Biochemical-Immunological-Haematological "Medical Laboratory" Ilidza, Sarajevo, B&H between June 1(st) and December 31(st) 2011. Electro-chemiluminescence immunoassay (ECLIA) methods for quantitative determination in vitro were performed on the Roche/Hitachi Elecsys 2010 Immunoassay Analyzer. Standard methods of descriptive statistics were performed for the data analysis.
univariate statistical analyze of tumor marker control serum revealed a high reliability for both CA125 and HE4 determination (p>0.05). Levey-Jennings charts of quality control data show that the target and the obtained values of both markers control sera do not differ significantly in relation to the ideal value. In a total number of 60 patients compared values of tumor markers show a high correlation (r=0.85). This study confirmed higher sensitivity and specificity of HE4 tumor marker compared with CA125. ROC-AUC values show that the diagnostic performance of HE4 was significantly higher compared with CA125.
We concluded that HE4 was better than CA125 as a single tumor marker.
卵巢癌中最广泛使用的肿瘤标志物，通常被视为“金标准”的是CA125，但可靠的临床证据表明，单独使用或与CA125联合使用的人附睾蛋白（HE4）可显著提高筛查和/或疾病监测的准确性。
在Elecsys 2010分析仪上，评估肿瘤标志物HE4与CA125相比，在卵巢上皮癌、卵巢良性囊肿和健康对照中的检测可靠性。
2011年6月1日至12月31日期间，我们在波斯尼亚和黑塞哥维那萨拉热窝伊里扎的生化-免疫-血液学“医学实验室”前瞻性地测定了CA125和HE4的血清水平。采用罗氏/日立Elecsys 2010免疫分析仪上的电化学发光免疫分析（ECLIA）方法进行体外定量测定。数据分析采用描述性统计的标准方法。
肿瘤标志物对照血清的单变量统计分析显示，CA125和HE4测定均具有较高的可靠性（p>0.05）。质量控制数据的Levey-Jennings图显示，两种标志物对照血清的值与理想值相比，目标值和实测值差异均无统计学意义。在总共60例患者中，肿瘤标志物的比较值显示出高度相关性（r=0.85）。本研究证实，与CA125相比，HE4肿瘤标志物具有更高的敏感性和特异性。ROC-AUC值显示，HE4的诊断性能显著高于CA125。
我们得出结论，作为单一肿瘤标志物，HE4优于CA125。
