A long way to go for the harmonization of four immunoassays for carcinoembryonic antigen

Zhang, Kuo; Huo, Hong; Lin, Guigao; Yue, Yuhong; Wang, Qingtao; Li, Jinming

doi:10.1016/j.cca.2015.12.029

Cited by 14 publications

(25 citation statements)

References 13 publications

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“…This might be due to the fact that these two immunoassay analyzers use a single monoclonal antibody for two-step sandwich immunoassay, while the other two assays use one or more different antibodies. Several comparative studies of CEA assays have been reported [ 12 15 18 19 20 ]. In one of these studies, CEA data obtained by Unicel DxI800 showed the highest degree of correlation with those measured by ADVIA Centaur XP [slope (95% CI), 0.910 (0.883 to 0.947); intercept (95% CI), −0.240 (−0.362 to −0.171)] [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

“…Despite ongoing standardization efforts, CEA concentrations from different manufacturers can vary owing to the lack of accurate calibration as well as differences in assay principle, the epitope used, antibody specificities, and the reagents used. Previous studies using individual samples and standard materials have reported that harmonization of CEA assays is far from being realized [ 15 16 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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BackgroundCarcinoembryonic 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.MethodsIn 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.ResultsDeming 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%).ConclusionsAgreements 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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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“…Using carcinoembryonic antigen (CEA) as a model analyte, we developed a label-free photoelectrochemical immunosensor for detection of CEA based on 2D TiO 2 nanosheets and carboxylated graphitic carbon nitride. CEA, a usual tumor marker, can be used for the early detection of recurrent diseases and indicate the effect of therapy in early breast cancer and gastrointestinal cancers as well as other tumor markers1920. Coupling carboxylated graphitic carbon nitride with 2D TiO 2 nanosheets can evidently extend the absorption range, increase the utilization of light energy, and promote the photocurrent intensity.…”

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confidence: 99%

Photoelectrochemical Immunosensor for Detection of Carcinoembryonic Antigen Based on 2D TiO2 Nanosheets and Carboxylated Graphitic Carbon Nitride

Wang

Zhang

et al. 2016

Sci Rep

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Carcinoembryonic antigen (CEA) was used as the model, an ultrasensitive label-free photoelectrochemical immunosensor was developed using 2D TiO2 nanosheets and carboxylated graphitic carbon nitride (g-C3N4) as photoactive materials and ascorbic acid as an efficient electron donor. 2D TiO2 nanosheets was sythsized by surfactant self-assembly method and proved to have higher photoelectrochemical signals than TiO2 nanoparticles. Firstly, carboxylated g-C3N4 could be attached to 2D TiO2 nanosheets through the bond formed between carboxyl group of carboxylated g-C3N4 and TiO2. And the photocurrent of g-C3N4/TiO2 drastically enhances compared to carboxylated g-C3N4 and TiO2. Then, antibody of CEA was bonded to TiO2 through the dentate bond formed between carboxyl group of anti-CEA and TiO2, leading to the decrease of the photocurrents. As proven by PEC experiments and electrochemical impedance spectroscopy (EIS) analysis, the fabrication process of the immunosensor is successful. Under the optimal conditions, the intensity decreased linearly with CEA concentration in the range of 0.01~10 ng/mL. The detection limit is 2.1 pg/mL. The work provides an effective method for the detection of tumor markers and can be extended for the application in food safety and environmental monitoring analysis.

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“…The differences in reference range for each immunoassay and instrument-specific calibration and working standard could result in inconsistent CEA results between assays. Precautions should be taken since CEA concentration from automated immunoassays is not comparable (10,15). The main limitation of our study is a small number of samples and the non-Gaussian distribution of CEA concentration present in the whole study population.…”

Section: Discussionmentioning

confidence: 93%

“…Automated immunoassays may have different methodology principle, antigens, epitopes, and reagents. Thus, CEA concentration obtained by different automated analyzers is different, and harmonization of CEA concentration results obtained using different immunoassays has not yet been achieved (10).…”

Section: Introductionmentioning

confidence: 99%

Comparison of chemiluminescent microparticle immunoassay (CMIA) with electrochemiluminescence immunoassay (ECLIA) for Carcinoembryonic antigen (CEA)

Serdarevic

Smajić

2018

JHSCI

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Introduction: Carcinoembryonic antigen (CEA) is used for monitoring of disease progression and treatment response in cancer patients. Our aim was to compare the performance of chemiluminescent microparticle immunoassay (CMIA) with electrochemiluminescence immunoassay (ECLIA) for CEA. Methods: A total of 115 samples were collected during routine diagnostic, prognostic and therapy monitoring procedures in patients with colorectal and pancreatic cancer. We used ARCHITECT i2000SR and Cobas E601 for CEA analysis in sera samples. Results: The correlation coefficient of 0.984 [95% CI: 0.972 to 0.991] for results obtained on both platforms was observed for CEA≤10 ng/mL group. Moreover, intercept of 0.9027 [95% CI: 0.705 to 1.099] and slope 0.8076 [95% CI: 0.765 to 0.8498] (p < 0.0001) was observed in this group. In CEA >10 ng/mL group we observed slope = 1.1986 [95%CI: 1.1474 to 1.2498] (p < 0.0001), intercept = -11.69 [-17.53 to - 5.84] and correlation coefficient of 0.985 [95% CI: 0.976 to 0.9914]. Mean differences between assays in group ≤10 ng/mL and >10 ng/mL were 0.2066 (95% CI: 0.0019 to 0.4113) and –2.66 (95% CI: -10.10 to 4.76) ng/mL, respectively. Conclusion: Although there were differences, based on 20 days precision tests, overall results showed a good analytical performance and correlation between CEA assays on ARCHITECT i2000SR and Cobas E601 platforms. Reference intervals appropriate for the method of CEA measurement should be used. The standardization and harmonization of serum CEA concentration assays are needed.

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A long way to go for the harmonization of four immunoassays for carcinoembryonic antigen

Cited by 14 publications

References 13 publications

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

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

Photoelectrochemical Immunosensor for Detection of Carcinoembryonic Antigen Based on 2D TiO2 Nanosheets and Carboxylated Graphitic Carbon Nitride

Comparison of chemiluminescent microparticle immunoassay (CMIA) with electrochemiluminescence immunoassay (ECLIA) for Carcinoembryonic antigen (CEA)

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