title: Quantification of MUC1 in breast cancer patients. A method comparison study.
abstract: OBJECTIVE
  To compare the performance of four serum assays for the quantification of MUC1 in breast cancer patients.
  
  
  METHODS
  A total of 282 serum samples were evaluated with two automated (Boehringer Mannheim Enzymun-Test CA 15-3 and Chiron ACS BR) and two manual assays (Centocor CA 15-3 radioimmunoassay [RIA] and Biomira Truquant BR RIA). Sera were obtained from healthy controls (n=50), patients with benign (n=25) and malignant breast disease (n=77) and patients with other malignancies (n=69). In addition, sera from pregnant women (n=56) and patients with liver cirrhosis (n=5) were included.
  
  
  RESULTS
  Intraassay coefficients of variation (C.V.s) were highest for the manual Centocor CA 15-3 assay (7.4% for values below 50 kU/l and 8.1% for values above 180 kU/l). Interassay C.Vs were highest for the manual Truquant BR assay (11.7% for the lower concentration values and 18.6% for the higher concentration values). False positive rates ranged between 0% for the Centocor CA 15-3 RIA and 14% for the ACS BR assay (cut-off: 30 kU/l). In monitoring breast cancer patients all four assays show similar patterns, although absolute MUC1 values found may differ up to 50%.
  
  
  CONCLUSIONS
  For monitoring purposes all assays perform equally well, however, automated assays show lower inter- and intraassay variability, especially in the higher value range. Therefore we recommend the use of the same, automated, assay for quantification of MUC1 during the follow-up of breast cancer patients.
authors.affiliation: Department of Obstetrics and Gynecology, Academic Hospital Vrije Universiteit, Amsterdam, The Netherlands.
authors.forename: G G
authors.initials: GG
authors.lastname: Bon
authors.forename: G J
authors.initials: GJ
authors.lastname: van Kamp
authors.forename: R A
authors.initials: RA
authors.lastname: Verstraeten
authors.forename: S
authors.initials: S
authors.lastname: von Mensdorff-Pouilly
authors.forename: J
authors.initials: J
authors.lastname: Hilgers
authors.forename: P
authors.initials: P
authors.lastname: Kenemans
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D001941:Breast Diseases / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood* / Q000175:diagnosis; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D007124:Immunoenzyme Techniques / Q000379:methods / Q000592:standards*; D008163:Luminescent Measurements; D018396:Mucin-1 / Q000097:blood*; D009369:Neoplasms / Q000097:blood; D011247:Pregnancy; D011863:Radioimmunoassay / Q000379:methods / Q000592:standards*; D012016:Reference Values; D012044:Regression Analysis; D015203:Reproducibility of Results; D018709:Statistics, Nonparametric
chemical_list: D014408:Biomarkers, Tumor; D018396:Mucin-1