Breast cancer marker CA549: A multicenter study

D. W. Chan, R. A. Beveridge, A. Bhargava, P. M. Wilcox, M. J. Kennedy, M. K. Schwartz

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13 Scopus citations


A multicenter study of CA549, a marker for breast cancer, was conducted using sera from 1721 patients with benign and malignant conditions by an immunoradiometric assay, BRESMARQ.(TM) Acceptable assay performance was demonstrated by studies of intra-assay (2.2% to 12% coefficient of variation [CV]), interassay (4.1% to 11.8% CV), and interlaboratory (4.8% to 8.7% CV) precision; sensitivity (.3 kU/L); linearity; recovery; high-dose hook effect (up to 10,000 kU/L); and interferences (human antimouse antibodies; protein, bilirubin, hemoglobin levels; lipid and cancer therapeutic agents). A reference interval of 0-12.5 kU/L (women) and 0-11.9 kU/L (men) was established from 746 healthy persons. The distribution of values exceeding the reference range for benign conditions was as follows: pregnant and lactating women (2%); benign breast disease (5%); and seven other benign diseases, including liver (24%), lung (19%), prostate (14%), colon, endometrial, gastric, and ovarian (< 10%). For nonbreast cancers, the distribution was Hodgkin's (7%), colon (10%), endometrial (15%), gastric (15%), lymphoma (15%), prostate (20%), ovarian (39%), and liver (45%). For breast cancer, the distribution was stage I (5%), stage II (14%), stage III (32%), and stage IV (74%). The receiver-operating characteristic analysis demonstrated the usefulness of CA549 as a marker in stage IV breast cancer.

Original languageEnglish (US)
Pages (from-to)465-470
Number of pages6
JournalAmerican journal of clinical pathology
Issue number4
StatePublished - Jan 1 1994


  • Breast cancer
  • CA549
  • Cancer marker
  • Monoclonal antibodies
  • Mucin

ASJC Scopus subject areas

  • Pathology and Forensic Medicine


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