title: Individual reference ranges of CA 15-3, MCA and CEA in recurrence of breast cancer.
abstract: The long-term intra-individual variation of the title tumour markers was studied in the group of 33 patients which developed no relapse. The average biological intra-individual CV was 11.2% for CA 15-3 and 14.9% for MCA whereas those of CEA strongly depended on the concentration. The intra-individual standard deviation of CEA was independent of concentration and amounted to 0.23 g/L. Individual reference ranges the analytes were much smaller than the group reference ranges. Individual reference limits were calculated on the basis of the average intra-individual variation. In 21 of the 22 patients who developed recurrence during the follow-up period, individual reference limits of CA 15-3 and/or CEA were exceeded 1 to 31 months (median 10 months) before clinical evidence (diagnostic sensitivity 95%). Group reference limits were exceeded only in 13 patients (diagnostic sensitivity 60%) and occurring later. The diagnostic specificity was 97%. MCA did not provide additional information. The combination of CA 15-3 and CEA is an excellent for detection and exclusion of recurrence in the follow-up of breast cancer patients if decision-making is based on individual reference limits. Improvement of the long-term analytical quality of the tumour marker assays, particularly in the low concentration range is necessary.
authors.affiliation: R&D Laboratory Systems, Boehringer Mannheim Diagnostics, Tutzing, Germany.
authors.forename: W G
authors.initials: WG
authors.lastname: Hölzel
authors.forename: R
authors.initials: R
authors.lastname: Beer
authors.forename: W
authors.initials: W
authors.lastname: Deschner
authors.forename: A
authors.initials: A
authors.lastname: Griesmacher
authors.forename: M M
authors.initials: MM
authors.lastname: Müller
mesh_terms: D000328:Adult; D000368:Aged; D015295:Antigens, Tumor-Associated, Carbohydrate / Q000097:blood*; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis; D002272:Carcinoembryonic Antigen / Q000097:blood*; D005260:Female; D006801:Humans; D008875:Middle Aged; D012008:Recurrence; D012016:Reference Values; D012680:Sensitivity and Specificity
chemical_list: D015295:Antigens, Tumor-Associated, Carbohydrate; D002272:Carcinoembryonic Antigen; C057387:mucinous carcinoma-associated antigen