Comparison of Specific Ovarian Tumor Markers by Elecsys Analyzer 2010

Background: 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. Aim: 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. Methods: we prospectively determined CA125 and HE4 serum levels in the Biochemical-Immunological-Haematological “Medical Laboratory” Ilidza, Sarajevo, B&H between June 1st and December 31st 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. Results: 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. Conclusion: We concluded that HE4 was better than CA125 as a single tumor marker.