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

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