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Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® GI Monitor assay on the UniCel® DxI 800 Immunoassay System
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Petra Stieber
Published/Copyright:
May 1, 2008
Abstract
Background: Gastrointestinal cancer antigen CA19-9 is known as a valuable marker for the management of patients with pancreatic cancer.
Methods: The analytical and clinical performance of the Access® GI Monitor assay (Beckman Coulter) was evaluated on the UniCel® DxI 800 Immunoassay System at five different European sites and compared with a reference method, defined as CA19-9 on the Elecsys System (Roche Diagnostics).
Results: Total imprecision (%CV) of the GI Monitor ranged between 3.4% and 7.7%, and inter-laboratory reproducibility between 3.6% and 4.0%. Linearity upon dilution showed a mean recovery of 97.4% (SD+7.2%). Endogenous interferents had no influence on GI Monitor levels (mean recoveries: hemoglobin 103%, bilirubin 106%, triglycerides 106%). There was no high-dose hook effect up to 115,000 kU/L. Clinical performance investigated in sera from 1811 individuals showed a good correlation between the Access® GI Monitor and Elecsys CA19-9 (R=0.959, slope=1.004, intercept=+0.17). GI Monitor serum levels were low in healthy individuals (n=267, median=6.0 kU/L, 95th percentile=23.1 kU/L), higher in individuals with various benign diseases (n=550, medians=5.8–13.4 kU/L, 95th percentiles=30.1–195.5kU/L) and even higher in individuals suffering from various cancers (n=995, medians=8.4–233.8 kU/L, 95th percentiles=53.7–13,902 kU/L). Optimal diagnostic accuracy for cancer detection against the relevant benign control group by the GI Monitor was found for pancreatic cancer [area under the curve (AUC) 0.83]. Results for the reference CA19-9 assay were comparable (AUC 0.85).
Conclusions: The Access® GI Monitor provides very good methodological characteristics and demonstrates an excellent analytical and clinical correlation with the Elecsys CA19-9. The GI Monitor shows the best diagnostic accuracy in pancreatic cancer. Our results also suggest a clinical value of the GI Monitor in other cancers.
Clin Chem Lab Med 2008;46:600–11.
Received: 2007-7-19
Accepted: 2007-10-4
Published Online: 2008-05-01
Published in Print: 2008-05-01
©2008 by Walter de Gruyter Berlin New York
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Keywords for this article
CA19-9 gastrointestinal cancer antigen;
diagnosis;
method comparison;
pancreatic cancer
Articles in the same Issue
- Editorial
- Comparability of tumor marker immunoassays: still an important issue for clinical diagnostics?
- Review
- The diagnostic role of autoantibodies in the prediction of organ-specific autoimmune diseases
- Validation and Outcome Studies
- Alternative antibody for the detection of CA125 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® OV Monitor assay on the UniCel® DxI 800 Immunoassay System
- Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® GI Monitor assay on the UniCel® DxI 800 Immunoassay System
- Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® BR Monitor assay on the UniCel® DxI 800 Immunoassay System
- Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards
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