Application of CLSI’s EP15A3 guideline in Accu-chek Inform II method verification

Abstract

Method validation is an essential laboratory requirement to ensure reliable test results for diagnosis and treatment. This study aims to evaluate the determination of blood glucose level method by the Accu-chek Inform II analyzer at Hanoi Medical University Hospital. Method and materials: Internal control materials were provided by the manufacturer to conduct experiments to evaluate the precision, accuracy and linearity of blood glucose testing on the Accu-chek Inform II analyzer according to the guideline EP15A3 of the Clinical and Laboratory Standards Institute. Results: The within-run precision and within-laboratory precision of two experimental quality control levels are less than the manufacturer’s claim, the observed mean is not within the verification interval, but the Bias is less than the allowable Bias. The accuracy and precision of the blood glucose test performed on the Accu-chek Inform II analyzer used at the Hanoi Medical University Hospital were confirmed in accordance with the manufacturer’s claims.