Analytical Evaluation of the Clinical Chemistry Analyzer AU 480 Beckman Coulter

摘要

Background: Method verification is a one-time process to determine performance characteristics before a test system is utilized for patient testing. Objective: To evaluate the analytical performance of five analytes-glucose (glu), cholesterol (chol), creatinine (crea), aspartate aminotransferase, (AST) and alanine aminotransferase (ALT) on AU 480 Beckman Coulter clinical chemistry analyzer. Methods and Materials: Analytical evaluation of analyzer included the determination of within-run, within-laboratory imprecision, and Trueness. Beckman Coulter control level-one and control level-two, near medical decision points were used. It was done according to (CLSI) clinical laboratory standard institute (EP15-A2), which suggests two levels, run 3 times per run for 5 days (15replicates in all). Result: The results showed low within-run imprecision (level 1-ALT=1.5%, AST=1.3%, chol=0.5%, crea=0.2%, glu=0.7%, level 2- ALT=1.0%, AST=1.3%, chol=0.6%, crea=0.9%, glu=0.4%) and within-laboratory imprecision (level 1-ALT=2.6%, AST=0.9%, chol=0.7%, crea=0.2%, glu=0.8%, level 2- ALT=1.9%, AST=1.0%, chol=0.6%, crea=0.8%, glu=0.5%) and the assigned values were found to be within trueness verification intervals (level 1 at 95% CI: ALT=46.5U/L[22.7-66.6], AST=50.4U/L[29.1-76.5], chol=156mg/dl[107.1-197.1], crea=1.19mg/dl [0.96-2.03], glu=103mg/dl [69.8-136.3]) and (level 2 at 95% CI: ALT=133U/L [60.5-187.3], AST=148U/L [81.3-220.3], chol=285mg/dl [186.2-349.8], crea=5.35mg/dl [3.46-8.3], glu=239mg/dl [163-320.5]). Conclusion: AU 480 Beckman Coulter clinical chemistry analyzer is suitable for analytical measurement of analytes-AST, ALT, cholesterol, creatinine, and glucose. If laboratories use CLSI and other guidelines, which are published on issues of biological variations, in addition to the manufacturer's claims, it may help laboratories not to waste unnecessary time and money for repeating of experiment.