Objectives: Human epididymis protein 4 (HE4) is a tumor marker in diagnosing ovarian cancer. Together with cancer antigen 125 (CA125) and the risk of ovarian malignancy algorithm (ROMA) score, it can improve sensitivity and specificity. There are no reports about the serum HE4 reference intervals (RIs) with electrochemiluminescence immunoassay (ECLIA). The RI of ROMA hasn't been established yet. In this study, we establish the RIs for serum HE4, CA125 and ROMA in healthy Chinese female with ECLIA.
Methods: Serum HE4 and CA125 concentrations in healthy female (age ranged from 21 to 81 years) were simultaneously measured with ECLIA on Roche Cobas E601 system. The RIs were determined following CLSI C28-A3 guidelines using a nonparametric method.
Results: The upper limits of the 95% percentile intervals were 82.62 pmol/L for HE4, 30.91 U/mL for CA125 and 19.27 for ROMA. The reference limits for HE4, CA125 and ROMA were 65.87 pmol/L, 32.23 U/mL, 13.14 for premenopausal women, and 90.76 pmol/L, 27.52 U/mL, 25.46 for postmenopausal women respectively.
Conclusion: We established the RIs for serum HE4, CA125 and ROMA with ECLIA in healthy Chinese female. It provided a reference for clinical and laboratory studies.
Keywords: CA125; CLIA; CMIA; ECL; ECLIA; EIA; Electrochemiluminescence immunoassay; HE4; LN; RIs; ROMA; Reference intervals; cancer antigen 125; chemiluminescent immunoassay; chemiluminescent microparticle immunoassay; electrochemiluminescence; electrochemiluminescence immunoassay; enzyme immunoassay; human epididymis protein 4; natural logarithm; reference intervals; risk of ovarian malignancy algorithm.
© 2013.