title: Comparison of fifteen immunoassays for the measurement of serum MUC-1/CA 15-3 in breast cancer patients.
abstract: BACKGROUND
  Quality control results for serum MUC-1/CA 15-3 assays have always shown large discrepancies.
  
  
  METHODS
  This multicentre study of 15 methods (labelled M1-M15) measured coded sera from 35 patients with breast cancer without recurrence (group 1), 46 patients at 1st metastasis (group 2), and 39 patients with advanced metastases (group 3). Results were compared using parametric statistics, ANOVA, principal component analysis, and receiver operating characteristic (ROC) curves.
  
  
  RESULTS
  Mean MUC-1/CA 15-3 concentrations varied widely (75.1-303.0 U/mL, 24.8%) among methods. The false positive (FP) rate for group 1 was 8/521 (1.5%); for group 2 and group 3 false negative (FN) results were 21/680 (3.1%) and 11/583 (1.9%), respectively. Using the ROC cut-offs, we found no FPs for group 1 and no FNs for group 3. However, group 2 showed 16 FNs. All p-values for Pearson's correlation were <0.0001 between methods, except for M11. When comparing methods using different antibodies, discordance rates reached a maximum of 15.2%. Principal component analysis revealed a grouping of methods using: CanAg monoclonal antibodies (mAbs) (M2, M7 and M12); Centocor/Fujirebio mAbs (M3-M6, M8-M10, M14-M15) and Biomira mAbs (M1 and M13); and Centocor/Fujirebio mAbs (M11).
  
  
  CONCLUSIONS
  Results were more consistent among methods using the same antibody type. Principal component analysis showed that antibody type was the strongest determinant of immunoassay results.
authors: Laboratoire d'Oncobiologie, Centre René-Huguenin, Saint-Cloud, France. labonco@crh1.org
authors: Marie-France
authors: MF
authors: Pichon
authors: Gaëlle Le
authors: GL
authors: Brun
authors: Kamel
authors: K
authors: Hacene
authors: Jean-Pierre
authors: JP
authors: Basuyau
authors: Jean-Marc
authors: JM
authors: Riedinger
authors: Nicole
authors: N
authors: Eche
authors: Yvonne
authors: Y
authors: Fulla
authors: Natacha
authors: N
authors: Charlier-Bret
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000473:pathology; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008875:Middle Aged; D018396:Mucin-1 / Q000097:blood*; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D012008:Recurrence
chemical_list: D018396:Mucin-1