Abstract
Introduction: 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 theMethods: 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 healthy 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 significantly 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.
Highlights
Whey-acidic protein human epididymis protein 4 (HE4) is a new promising biomarker for epithelial ovarian cancer
In its mature glycosylated form the protein has a molecular weight of approximately 20-25 kD and consists of a single peptide chain containing two whey acidic four-disulfide core (WFDC) domains [2]
The resulting chemiluminiescent reaction is measured as relative light units (RLUs)
Summary
Whey-acidic protein human epididymis protein 4 (HE4) is a new promising biomarker for epithelial ovarian cancer. Epithelial ovarian cancer (EOC) is the fourth most common cause of cancer mortality in women and the leading cause of death from gynecological malignancies. The majority of women have advancedstage disease at initial diagnosis and a 5-year survival of 10-30 %. The median survival after recurrence is only 2 years despite the advances in chemotherapy. The human epididymis protein 4 (HE4, known as WFDC2) belongs to the family of whey acidic four-disulfide core (WFDC) proteins with suspected trypsin inhibitor properties. The corresponding gene codes for a 13 kD protein. In its mature glycosylated form the protein has a molecular weight of approximately 20-25 kD and consists of a single peptide chain containing two WFDC domains [2]
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