Evaluation on performance of MAKER IS 1200 automated chemiluminescence analyzer / 国际检验医学杂志

ABSTRACT

Objective To evaluate the performance of the MAKER IS1200 automated chemiluminescence analyzer .Methods A series of experiments were designed to evaluate the precision ,reagent open bottle stability ,linearity range and reference interval of the MAKER IS1200 automated chemiluminescence analyzer in 8 items of hepatitis B 5 indexes ,AIDS ,hepatitis C and syphilis ac‐cording to the requirements of CLSI documents ,the detection results were performed the methodological comparison with those de‐tected by Abbott i2000 automated chemiluminescence analyzer .Results Except the total precision of HBEAG low value was slight‐ly higher than 15% of the judgment standard ,other indexes conformed to the requirements ;the open bottle stability of various items of reagent was better ;the quantitative item HBSAB had good linearity within the detection range (r2 >0 .95);in the verification of reference interval ,no outlier was found in each item ;in the methodological comparison ,the other items had good correlation with those detected by the ABBOTT i2000 except anti‐HCV .Conclusion The MAKER IS1200 automated chemiluminescence analyzer has good detection performance and meets the requirements of immunoassay detection in laboratory work .