Performance Evaluation of CEA Assay on Beckman Coulter UniCel DxI 800

Abstract

Abstract Carcinoembryonic antigen (CEA) is a glycoprotein normally found in embryonic entodermal epithelium. Increased levels may be found in patients with primary colorectal cancer or other malignancies. CEA levels are not useful in screening the general population for undetected cancers. However, CEA levels provide important information about patient prognosis, recurrence of tumors after surgical removal, and effectiveness of therapy. The aim of this study was to assess the analytical performance of CEA assay on a Beckman Coulter UniCel DxI 800. The linearity, sensitivity, reference range, precision, and accuracy were evaluated following CLSI guidelines. The within-run and between-run precisions were assessed by analyzing QC material at low and high levels of concentrations. The accuracy was assessed by comparison of 152 patient serum CEA on DXI with CEA on a previously established ADVIA Centaur System. The analytical measurement range was determined to be linear between 0.00 and 951.3 ng/mL with a slope of 0.976 and intercept of 0.075. The limit of blank (LOB) was determined as 0.03 ng/mL and the limit of detection (LOD) was 0.1 ng/mL. The reference range was verified as 0.0 to 3.0 ng/mL (nonsmokers) and 0.0 to 5.0 ng/mL (smokers). The within-run CVs for CEA were 4.4% at the low level of 2.239 ng/mL and 2.5% at the high level of 38.1 ng/mL. The between-run CVs at low and high levels were 4.4%, and 4.0%, respectively. Comparison of CEA on the Beckman Coulter UniCel DxI 800 with CEA on the ADVIA Centaur System of 152 patient samples showed the slope was 1.541 (95% CI, 1.515-1.567) with an intercept of 0.17 and a correlation coefficient of 0.9943 (Deming). The mean bias between Beckman and ADVIA was 6.49 (41.71%). In summary, our data demonstrate that CEA assay on the Beckman Coulter UniCel DxI 800 has good linearity and precision. There is also good correlation between CEA tested on the Beckman Coulter UniCel DxI 800 and on the ADVIA Centaur System with a positive bias.