Ann Lab Med 2018; 38(4): 355-361  
Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800
Joonhong Park, M.D.1,2, Seungok Lee, M.D.1,2, Yeongsic Kim, M.D.1,2, Aeran Choi, M.T.3, Hyeyoung Lee, M.D.4, Jihyang Lim, M.D.1,2, Yonggoo Kim, M.D.1,2, Kyungja Han, M.D.1,2, and Eun-jee Oh, M.D.1,2
Department of Laboratory Medicine1, Catholic Laboratory Development and Evaluation Center2, College of Medicine, The Catholic University of Korea, Seoul; Department of Laboratory Medicine3, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul; Department of Laboratory Medicine4, Samkwang Medical Laboratories, Seoul, Korea
Corresponding author: Eun-jee Oh
Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel: +82-2-2258-1641
Fax: +82-2-2258-1719
E-mail: ejoh@catholic.ac.kr
Received: August 9, 2017; Revised: November 1, 2017; Accepted: February 20, 2018; Published online: July 1, 2018.
© Korean Society for Laboratory Medicine. All rights reserved.

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Abstract
Background: Carcinoembryonic antigen (CEA) is one of the tumor markers available for evaluating disease progression status after initial therapy and monitoring subsequent treatment modalities in colorectal, gastrointestinal, lung, and breast carcinoma. We evaluated the correlations and differences between widely used, automated CEA immunoassays at four different medical laboratories.
Methods: In total, 393 serum samples with CEA ranging from 3.0 to 1,000 ng/mL were analyzed on ADVIA Centaur XP (Siemens Diagnostics, Tarrytown, NY, USA), ARCHITECT i2000sr (Abbott Diagnostics, Abbott Park, IL, USA), Elecsys E170 (Roche Diagnostics, Indianapolis, IN, USA), and Unicel DxI800 (Beckman Coulter, Fullerton, CA, USA), and the results were compared. Deming regression, Passing-Bablok regression, and Bland-Altman analyses were performed to evaluate the data correlation and % differences among these assays.
Results: Deming regression analysis of data from Elecsys E170 and UniCel DxI800 showed good correlation (y=3.1615+0.8970x). According to Bland-Altman plot, no statistically significant bias (-1.78 ng/mL [95% confidence interval: -4.02 to 0.46]) was observed between Elecsys E170 and UniCel DxI800. However, the relative differences of CEA concentrations between assays exceeded the acceptable limit of 30%. Regarding the agreement of positivity with cut-off value 5.0 ng/mL, ARCHITECT i2000sr and Elecsys E170 showed the highest agreement (95.2%), whereas ADVIA Centaur XP and ARCHITECT i2000sr showed the lowest agreement (70.7%).
Conclusions: Agreements between automated CEA immunoassays are variable, and individual CEA concentrations may differ significantly between assays. Standardization of serum CEA concentrations and further harmonization are needed.
Keywords: Carcinoembryonic antigen, Electrochemiluminescence, ADVIA Centaur XP, ARCHITECT i2000sr, Elecsys E170, Unicel DxI800, Between-assay comparison



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