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Concordance analysis of paired cancer antigen (CA) 15-3 and 27.29 testing

  • Epidemiology
  • Published:
Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Purpose

Cancer antigens (CA) 15-3 and 27.29 are used in the clinical management of many breast cancer patients. Given that immunoassays for CA 15-3 and CA 27.29 target epitopes on the same glycoprotein—Mucin 1 (MUC1)—the present analysis was conducted to evaluate the potential concordance of tumor marker results when both tests were ordered by providers on the same specimens.

Methods

A retrospective limited dataset of paired CA 15-3 (Roche Diagnostics) and CA 27.29 (Siemens Diagnostics) test results was obtained from a national clinical reference laboratory. Concordance according to reference interval (RI) status and percent (%) change between consecutive test results was analyzed.

Results

37,652 paired results from 12,470 distinct patients were obtained. The correlation between CA 15-3 and CA 27.29 results was high (correlation coefficient: Pearson, 0.967), although across the dataset a significant difference between CA 15-3 and CA 27.29 results was observed (P < 0.05). RI concordance between CA 15-3 and CA 27.29 results was observed in 93.7% of pairs (35,280 of 37,652). Correlation was also observed in the % change of CA 15-3 and CA 27.29 results between consecutive specimens for individual patients. Using doubling or halving thresholds (i.e., 100% increase or 50% decrease), concordance in % change was observed between CA 15-3 and CA 27.29 in approximately 90% of cases. Individual patient results trended similarly across both markers over time.

Conclusion

While generally concordant, CA 15-3 and CA 27.29 results should not be used interchangeably. The present report provides no evidence for added value in performing both tests routinely for individual patients.

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Abbreviations

AMR:

Analytical measurement range

ASCO:

American Society of Clinical Oncology

CA:

Cancer antigen

CLIA:

Clinical Laboratory Improvement Amendments

IRI:

Inside the reference interval

MUC1:

Mucin 1

ORI:

Outside the reference interval

PEM:

Polymorphic epithelial mucin

RI:

Reference interval

RIA:

Radioimmunoassay

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Acknowledgements

The authors would like to thank David Davis for assistance with data extraction and management. Preliminary data were presented at the 2016 Academy of Clinical Laboratory Physicians and Scientists (ACLPS) Annual Meeting in Birmingham, AL (June 3, 2016); corresponding meeting abstract published in the American Journal of Clinical Pathology (AJCP 2017 Mar 1;147(suppl 2):S159-S160).

Funding

This study was not supported through external funding.

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Author notes

  1. David C. Lin

    Present address: Department of Pathology and Laboratory Medicine, Ann & Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

Authors and Affiliations

  1. ARUP Laboratories, Department of Pathology, University of Utah, 500 Chipeta Way, MC 115, Salt Lake City, UT, 84108, USA

    David C. Lin & Jonathan R. Genzen

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  1. David C. Lin
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Correspondence to Jonathan R. Genzen.

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Conflict of interest

J. R. G. has served as principal investigator for contract research to ARUP Laboratories sponsored by Fujirebio Diagnostics.

Ethical approval

Experiments comply with the current laws of the country in which they were performed.

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Lin, D.C., Genzen, J.R. Concordance analysis of paired cancer antigen (CA) 15-3 and 27.29 testing. Breast Cancer Res Treat 167, 269–276 (2018). https://doi.org/10.1007/s10549-017-4513-0

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  • DOI: https://doi.org/10.1007/s10549-017-4513-0

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