Comparison of two immunoassays for the measurement of serum HE4 for ovarian cancer

• DOI: 10.1016/j.plabm.2021.e00235
• Publication Date: 2021-05-09T14:32:57Z
• Authors: Chloe E. Barr; Garth Funston; Luke T.A. Mounce; Phillip W. Pemberton; Jonathon D. Howe; Emma J. Crosbie
• Keywords: Immunoassay; Medicine (General); Biomarker; HE4; Article; 3. Good health; Chemistry; 03 medical and health sciences; R5-920; 0302 clinical medicine; Ovarian cancer detection; QD1-999

The use of Human Epididymis Protein 4 (HE4) as a biomarker for ovarian cancer is gaining traction, providing the impetus development high throughput automated HE4 assay that comparable to conventional manual enzyme immunometric-assay (EIA). aim this study was compare two immunoassay methods measurement serum HE4. 1348 samples were analysed using both EIA and chemiluminescent (CLEIA) methods. values compared Passing-Bablok regression agreement assessed Lin's concordance correlation coefficient (CCC). absolute percentage bias CLEIA determined. There moderate between (CCC 0.929, 95%CI 0.923-0.936). demonstrated an overestimation [constant 4.44 (95%CI 2.96-5.68), slope 1.04 1.02-1.07)]. method had mean 16.25% method. significantly overestimated EIA, which could impact clinical interpretation patient management. Further studies are required develop appropriate cut-off depending on population being investigated analytic used.