title: A multi-center quality control study of different CA15-3 immunoassays.
abstract: A long-term multi-center quality control study of CA15-3 determinations based on measurements of liquid BIOREF CA15-3 control sera was conducted in 17 participating laboratories. Seven different CA15-3 assays were applied using the appropriate automatic immunoanalyzers. CA15-3 means were determined for BIOREF low, medium and high level control sera. Values were 19.3 +/- 2.7 kU/l, 75.2 +/- 11.4 kU/l and 162.9 +/- 37.1 kU/l, respectively. Inter-assay imprecisions were calculated for each of the controls for each laboratory and for each of the methods, with coefficients of variation (CV) ranging from 2.9-15.5%. As a means of evaluation of assay linearity concentration ratios (high/medium, medium/low, high/low) were calculated and found to be in good agreement with reference values throughout the study. Individual long-term time courses of CA15-3 control measurements provided evidence for variability of test results due to changes in assay calibration. Comparisons with CV data obtained with BIOREF controls 17 years ago demonstrate significant improvements of CA15-3 assay precision in recent years. In conclusion, test-independent reference material can be used for CA15-3 quality control and in particular enables applicants to check for long-term stability of CA15-3 assay performance.
authors.affiliation: Krankenhaus Dresden-Friedrichstadt, Institut für Klinische Chemie und Labormedizin, Dresden, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Hubl
authors.forename: Thomas
authors.initials: T
authors.lastname: Demant
authors.forename: Steffen
authors.initials: S
authors.lastname: Albrecht
authors.forename: Nils
authors.initials: N
authors.lastname: Bewarder
authors.forename: Gabriele
authors.initials: G
authors.lastname: Grunow
authors.forename: Ruprecht
authors.initials: R
authors.lastname: Keller
authors.forename: Rainer
authors.initials: R
authors.lastname: Klapdor
authors.forename: Karl-Jürgen
authors.initials: KJ
authors.lastname: Klos
authors.forename: Klaus
authors.initials: K
authors.lastname: Kruse
authors.forename: Robert
authors.initials: R
authors.lastname: Müller
authors.forename: Ilona
authors.initials: I
authors.lastname: Päge
authors.forename: Reinhard
authors.initials: R
authors.lastname: Schmidt
authors.forename: Heidrun
authors.initials: H
authors.lastname: Stolle
authors.forename: Johannes
authors.initials: J
authors.lastname: Wiefelspütz
authors.forename: Egon
authors.initials: E
authors.lastname: vom Baur
authors.forename: Jörg
authors.initials: J
authors.lastname: Zinsmeyer
authors.forename: Manfred
authors.initials: M
authors.lastname: Zwirner
mesh_terms: D006801:Humans; D007106:Immune Sera / Q000032:analysis*; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D018396:Mucin-1 / Q000097:blood*; D011786:Quality Control; D012016:Reference Values; D015203:Reproducibility of Results
chemical_list: D007106:Immune Sera; D018396:Mucin-1