迈克IS1200全自动化学发光测定仪的性能评价

Evaluation on performance of MAKER IS1200 automated chemiluminescence analyzer

目的对迈克IS1200全自动化学发光测定仪的性能进行评价。方法按照美国临床和实验室标准协会文件的要求,通过一系列实验设计,在IS1200上对乙肝5项、艾滋、丙肝和梅毒共8项进行检测,评价其精密度、试剂开瓶稳定性、线性和参考区间,与雅培i2000全自动化学发光分析仪的检测结果进行方法学比对。结果除乙型肝炎E抗原低值的总精密度略高于判断标准15%外,其余指标均符合要求;各项目的试剂开瓶稳定性良好;定量项目乙型肝炎表面抗体检测范围内的线性良好(r2>0.95);参考区间验证中,各项目均未发现离群值;方法学比对中,除丙型肝炎病毒抗体外,其他项目与雅培i2000全自动化学发光分析仪的相关性良好。结论迈克IS1200全自动化学发光测定仪的检测性能良好,满足实验室免疫检测工作的需求。

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 8items of hepatitis B 5indexes,AIDS,hepatitis C and syphilis according to the requirements of CLSI documents,the detection results were performed the methodological comparison with those detected by Abbott i2000 automated chemiluminescence analyzer.Results Except the total precision of HBEAG low value was slightly 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（r^2〉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.