title: Comparison of different immunoassays for CA 19-9.
abstract: We compared six routinely employed immunoassay kits: Architect i2000 and AxSYM, Abbott Laboratories; Elecsys 2010, Roche Diagnostics; ELSA, CIS-BioInternational; Immulite 1, Diagnostic Products Corporation; and IRMA-mat, Byk-Sangtec Diagnostica. Using all analytical systems, we measured identical groups of clinical samples completed with selected control samples. The repeatability of measurements (coefficient of variation) ranged from 2.1% (Elecsys 2010) to 6.7% (ELSA). The parameters of Passing-Bablok regression show significant systematic differences among analytical systems. Data from a Bland-Altman diagram suggest that these differences project onto other, still more significant individual differences among individual samples. Though the cut-off values differ between various systems, no similar clinical efficacy appears to be attained. The behavior of individual systems is quite different for identical control materials and does not necessarily duplicate the calibration for biological samples. The results of determining CA 19-9 cannot be extrapolated from one analytical technique to another, even in cases where the same monoclonal antibody is used. Standardization of CA 19-9 measurement systems is necessary to allow use of the results for the purposes of evidence-based medicine.
authors.affiliation: Institute of Clinical Biochemistry, General University Hospital and 1st Faculty of Medicine, Charles University, Prague, Czech Republic. petr.stern@vfn.cz
authors.forename: P
authors.initials: P
authors.lastname: Stern
authors.forename: B
authors.initials: B
authors.lastname: Friedecky
authors.forename: V
authors.initials: V
authors.lastname: Bartos
authors.forename: D
authors.initials: D
authors.lastname: Bezdickova
authors.forename: J
authors.initials: J
authors.lastname: Vavrova
authors.forename: J
authors.initials: J
authors.lastname: Uhrova
authors.forename: L
authors.initials: L
authors.lastname: Rozprimova
authors.forename: T
authors.initials: T
authors.lastname: Zima
authors.forename: V
authors.initials: V
authors.lastname: Palicka
mesh_terms: D018395:CA-19-9 Antigen / Q000097:blood* / Q000276:immunology; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods* / Q000592:standards; D016014:Linear Models; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D018395:CA-19-9 Antigen; D011933:Reagent Kits, Diagnostic