title: Clinical laboratory investigation of the Sanofi ACCESS CK-MB procedure and comparison to electrophoresis and Abbott IMx.
abstract: This evaluation was undertaken to verify the application protocol for the CK-MB assay on the ACCESS Immunoassay Analyzer (Sanofi Diagnostics Pasteur, Chaska, MN). The results show that the ACCESS CK-MB assay total imprecision was 6.8% to 9.1%. Analytical linearity of the ACCESS CK-MB assay was excellent in the range of < 1-214 micrograms/L. A comparison of the ACCESS CK-MB assay with the IMx (Abbott Laboratories, Abbott Park, IL) method shows good correlation r = 0.990 (n = 108). Linear regression analysis yielded Y = 1.36X-0.3, Sx/y = 7.2. ACCESS CK-MB values also correlated well with CK-MB by electrophoresis with r = 0.968 (n = 132). The linear regression equation for this comparison was Y = 1.08X + 1.4, Sx/y = 14.1. The expected non-myocardial infarction range of CK-MB determined by the ACCESS system was 1.3-9.4 micrograms/L (mean = 4.0, n = 58). The ACCESS CK-MB assay would appear to be rapid, precise and clinically useful.
authors.affiliation: Department of Chemistry and Biochemistry, University of Windsor, Ontario, Canada.
authors.forename: G D
authors.initials: GD
authors.lastname: Mao
authors.forename: K
authors.initials: K
authors.lastname: Adeli
authors.forename: A B
authors.initials: AB
authors.lastname: Eisenbrey
authors.forename: J D
authors.initials: JD
authors.lastname: Artiss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001797:Blood Protein Electrophoresis / Q000379:methods* / Q000592:standards; D002138:Calibration; D003402:Creatine Kinase / Q000097:blood* / Q000592:standards; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques / Q000592:standards; D007527:Isoenzymes; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D007527:Isoenzymes; D011933:Reagent Kits, Diagnostic; D003402:Creatine Kinase