Ann Lab Med.  2018 Jul;38(4):355-361. 10.3343/alm.2018.38.4.355.

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800

• Park J
• Lee S
• Kim Y
• Choi A
• Lee H
• Lim J
• Kim Y
• Han K
• Oh EJ

• KMID: 2408075
• DOI: http://doi.org/10.3343/alm.2018.38.4.355

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.

Keyword

Carcinoembryonic antigen; Electrochemiluminescence; ADVIA Centaur XP; ARCHITECT i2000sr; Elecsys E170; Unicel DxI800; Between-assay comparison

MeSH Terms

Bias (Epidemiology)
Biomarkers, Tumor
Breast Neoplasms
Carcinoembryonic Antigen*
Disease Progression
Immunoassay*
Lung
Statistics as Topic
Biomarkers, Tumor
Carcinoembryonic Antigen

Figure

• 

  Fig. 1 Method comparison of four carcinoembryonic antigen (CEA) immunoassays by Deming regression analysis. Results are in ng/mL. Black solid lines are from Deming regression. Black dashed lines are x=y. Comparison of CEA concentrations between ARCHITECT i2000sr and ADVIA Centaur XP (A), Elecsys E170 and ADVIA Centaur XP (B), UniCel DxI800 and ADVIA Centaur XP (C), Elecsys E170 and ARCHITECT i2000sr (D), UniCel DxI800 and ARCHITECT i2000sr (E), and UniCel DxI800 and Elecsys E170 (F).

• 

  Fig. 2 Method comparison of four carcinoembryonic antigen (CEA) immunoassays using Bland-Altman plots in 393 serum samples. The solid line indicates the % difference from the averages of two assays. Dashed lines indicate the upper and lower 95% confidence limits of % difference between two analyzers. The red lines are the acceptable bias limits of 30.0%. Comparison of CEA concentrations between ADVIA Centaur XP and ARCHITECT i2000sr (A), ADVIA Centaur XP and Elecsys E170 (B), ADVIA Centaur XP and UniCel DxI800 (C), ARCHITECT i2000sr and Elecsys E170 (D), ARCHITECT i2000sr and UniCel DxI800 (E), and Elecsys E170 and UniCel DxI800 (F).

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