Trueness evaluation of 13 routine measurements for serum uric acid / 中华检验医学杂志

ABSTRACT

Objective To evaluate the trueness of 13 routine measurements for serum uric acid and the role of reference method in improving harmonization and trueness among routine measurement systems. Methods The research is related to the reagent evaluation.Usingisotope dilution liquid chromatography tandem mass spectrometry ( ID-LC/MS/MS) method as the comparison method, Wako, Sekisui, DiaSys, Maker,Dirui,Leadman,BSBE,Biosina,Mindray,MedicalSystem,LongMarch,and Kehua 13 kinds of uric acid kits were chosen as the evaluation methods with Hitachi 7170A as the analyzer.serum uric acid in 40 fresh frozen serawere collected from clinical laboratory of Beijing hospital in 2014,coveringboth physiological and pathological status ( 80 -940 μmol/L ) .19 kinds of prepared materials and the 40 fronzen sera were measuredby comparison method and evaluation methods and linear regression analysis was made for the results.The performance of evaluation methods was revealed and recalibration was performed on every evaluation methodby the linear regression equation.The variation of percent bias(%) of the uric acid values in 19 preparation materials was compared.Results All test methods demonstrated good precision ( CV0.998, P<0.01) with the comparison method when measuring uric acid values in 40 fresh frozen sera The meanpercent bias was 0.17% ( -3.06% -7.31%).After recalibration, 4 of 19 samples with no matrix effect values percent bias reduced and met the demands of quality ( <4.8%) induced from biological variation.Conclusion All test methods demonstrated good trueness and their calibration traceability was verified.Recalibration using reference method or standard reference materials contributes to harmonization among methods.