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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

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Volume 45, Issue 1 (Jan 2007)


Interchangeability of measurements of CA 19-9 in serum with four frequently used assays: an update

Rita Passerini
  • Laboratory Medicine Unit, European Institute of Oncology, Milan, Italy
/ Daniela Riggio
  • Laboratory Medicine Unit, European Institute of Oncology, Milan, Italy
/ Michela Salvatici
  • Laboratory Medicine Unit, European Institute of Oncology, Milan, Italy
/ Laura Zorzino
  • Laboratory Medicine Unit, European Institute of Oncology, Milan, Italy
/ Davide Radice
  • Epidemiology and Biostatistics Division, European Institute of Oncology, Milan, Italy
/ Maria Teresa Sandri
  • Laboratory Medicine Unit, European Institute of Oncology, Milan, Italy
Published Online: 2007-01-24 | DOI: https://doi.org/10.1515/CCLM.2007.003


Background: CA 19-9 is a marker principally related to pancreatic and gall bladder cancer. Although its determination has no value in screening for these malignancies, it is used in post-operative monitoring and during chemotherapeutic treatment of confirmed disease. Measurements during follow-up must be comparable and must be performed with standard, validated methods.

Methods: We compared four routinely used analytical systems for CA 19-9 determination: the Architect i2000 and AxSYM systems from Abbott Laboratories, the Elecsys 1010 from Roche Diagnostics, and the KRYPTOR system from Brahms Diagnostics. We evaluated the analytical performance of the four systems and compared measurements of CA 19-9 values, which covered the whole analytical range.

Results: The analytical performance and accuracy of the four systems were fairly good, but Passing-Bablok regression and mountain plots showed significant differences in CA 19-9 values measured with the four platforms.

Conclusions: Our data indicate that during tumor follow-up, the use of the same system is appropriate to avoid the risk of a variation due to the method rather than the disease. Moreover, whenever a change in analytical equipment is required, careful analysis of CA 19-9 results must be undertaken.

Clin Chem Lab Med 2007;45:100–4.

Keywords: analytical performance; CA 19-9 determination; comparability; tumor marker


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About the article

Corresponding author: Rita Passerini, DSc, Laboratory Medicine Unit, European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy Phone: +39-02-57489348, Fax: +39-02-57489417,

Received: June 16, 2006

Accepted: September 28, 2006

Published Online: 2007-01-24

Published in Print: 2007-01-01

Citation Information: Clinical Chemical Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2007.003. Export Citation

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