A model for results comparison on two different biochemistry analyzers in laboratory accredited according to the ISO 15189

Abstract

Introduction: Laboratories accredited according to ISO 15189 standard which have two or more different analyzers or procedures for examinations, should define mechanism for comparison of results. The objective of this study was to present the model for comparison of emergency tests on two different types of automated general biochemistry analyzers. Materials and methods: General biochemistry emergency tests were measured in serum and urine on two automated analyzers Olympus AU2700 and Olympus AU640 (Olympus, Hamburg, Germany) during 60 day period. Olympus AU2700 was used as the reference analyzer and Olympus AU640 as a backup system. Control samples on two levels were used for result comparison. Results: Average 60-day period bias was within acceptance criteria for all analyzes included in this model of comparability assessment. Only low control concentrations for some tests were exceeding allowable biases in less than 2% cases and high level controls were never exceeding allowable biases. Conclusions: This model of results comparison ensures continuous analytical quality of laboratory reports and improves overall efficiency of laboratory services.