Background: Human epididymis protein 4 (HE4) is known to be overexpressed in ovarian cancer, and therefore, it can be considered an important biomarker of epithelial ovarian cancer. HE4 shows higher specificity than cancer antigen 125 (CA-125); this characteristic can be used to discriminate between benign and malignant pelvic masses. The Risk of Ovarian Malignancy Algorithm (ROMA) value based on the results obtained for CA-125 and HE4 is used for risk assessment for ovarian cancer. The aim of this study is to evaluate the performance of ARCHITECT HE4 assay (Abbott Laboratories, US) and ROMA value. Methods: Precision, linearity, limit of blank (LoB), and limit of detection (LoD) values were evaluated on the basis of the guidelines supplied by the Clinical and Laboratory Standards Institute. All assay procedures were performed on an Architect i2000 analyzer (Abbott Laboratories, US) using the ARCHITECT HE4 assay reagent. ARCHITECT HE4 quality control materials, calibrator B, calibrator F, multi assay diluent, and patient serum samples were used for the assay. ROMA values (%) were calculated for patients and healthy controls based on their menopausal state. Results: A total CV of 3% was noted for precision analysis. Linearity was confirmed in the analytic measurement range (AMR). LoB and LoD values were below the lower limit of AMR. The ROMA values for patients with ovarian cancer were higher than those for healthy controls. Conclusions: The ARCHITECT HE4 assay showed suitable analytical performance characteristics with respect to precision, linearity, LoB, and LoD. This assay, along with ROMA values, is expected to be widely used for rapid risk assessment and differential diagnosis of patients with pelvic mass. (J Lab Med Qual Assur 2014;36:149-156)

Keywords: HE4, Ovarian neoplasms, Risk

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