Evaluation of tumor marker HE4 assay on the Elecsys 2010 analyzer

Jozo Ćorić, Lejla Hasanbegović, Aleksandar Bodulović, Jasminka Mujić
2014 Journal of Health Sciences  
Whey-acidic protein human epididymis protein 4 (HE4) is a new promising biomarker for epithelial ovarian cancer. The measured HE4 values may depend on the testing procedure used. The aim of this study was to evaluate the Methods: We evaluated a HE4 method on Elecsys 2010 analyzer. The method for quantitative determination of HE4 is direct, competitive chemiluminescent immunoassay. For quality control we use Elecsys PreciControl HE4 1 and 2. HE4 was measure on sera obtained from 56 women ( 20
more » ... lthy and 36 with epithelial ovarian cancer). Results: The Roche HE4 assays showed a good linearity (r=0.99) and precision (intrassayed total CV<5%). The median HE4 serum concentrations was signifi cantly higher among EOC patients than healthy females (p<0,05). Elevated levels HE4 were found in 78 % patients with epithelial ovarian cancer. Conclusions: The presented results of the analytical evaluation methods for the determination of HE4 on the Elecsys 2010 analyzer showed an acceptable accuracy and precision.
doi:10.17532/jhsci.2014.148 fatcat:6uzanbivijhnppgbknfqsvmqbe