Application of improved comparability verification method in performance verification of instruments and equipment / 中国输血杂志

ABSTRACT

【Objective】 To explore the viability of improved comparability verification method for the performance verification of automatic biochemical analyzer in blood centers. 【Methods】 According to the relevant requirements of User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2) and Guideline for Comparability Verification of Quantitative Results with One Health Care System(WS/T 407-2012), the performance of the newly purchased Beckman Coulter AU480 automatic biochemical analyzer was confirmed by means of comparability verification, and compared with the current Olympus AU400 automatic biochemical analyzer. 【Results】 The detection results given by Beckman AU480 biochemical analyzer on 5 samples for ALT detection performance test were significantly correlated with the target value (R2=0.998), and the trueness verification results met the requirements.The CV of medium and high ALT levels was 2.36% and 1.20%, respectively, within the acceptable standard range(<5%), and the precision verification results meet the requirement.The comparison deviation of two devices for medium and high ALT levels was 0.47% and 1.62%, respectively, within the acceptable standard range (<5%). The detection results of ALT from 40 blood donors given by two devices were significantly correlated (R2=0.956), and the precision verification results met the requirements.In the validation of linear evaluation, there was a good linear relationship between the expected and measured results (r=0.997)among samples with 6 levels of concentrations. 【Conclusion】 The comparability verification method is suitable for the performance verification of automatic biochemical analyzer in blood centers.