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Clin Biochem. 2011 Sep;44(13):1128-36. doi: 10.1016/j.clinbiochem.2011.06.009. Epub 2011 Jun 17.

Analytical performance and clinical concordance of the cancer biomarkers CA 15-3, CA 19-9, CA 125 II, Carcinoembryonic Antigen, and Alpha-Fetoprotein on the Dimension Vista® System.

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  • 1University of Maryland School of Medicine, Baltimore, MD, USA.



We examined analytical characteristics of new CA 15-3, CA 19-9, CA 125 II, Carcinoembryonic Antigen (CEA), and Alpha-Fetoprotein (AFP) assays on the Dimension Vista® System.


Imprecision studies used CLSI-EP5-A2, Limit of Blank and Limit of Detection used CLSI-EP17 and measurement ranges were determined. Method comparisons were evaluated with Passing-Bablok, least-squares regression and residual plots. Reference intervals were determined and valid specimen types, lot-to-lot variability and sample storage stability were defined. Clinical monitoring patterns for each tumor marker in patients were examined.


Reproducibility for each method was <6.5%. Limits of Blank and Detection were low. Comparisons between methods showed slopes ranging from 0.89 to 1.32 with low y-intercepts and scatter. Minimal lot-to-lot variability was documented; serum/plasma specimens provide valid results; sample stability at -70°C was >9months. Clinical monitoring patterns correlated with established methods in >89% of cases.


Measurement of CA 15-3, CA 19-9, CA 125 II, CEA and AFP on the Dimension Vista® System is an attractive alternative.

Copyright © 2011. Published by Elsevier Inc.

[PubMed - indexed for MEDLINE]
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