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目的追踪评价使用期长达五年的ACS:180SE自动免疫分析仪的性能。方法依NCCLS推荐的EP10-T2文件(仪器性能初步评价),按高中低不同顺序连续5天测定FT4的浓度值,并将所得数据导入实验室评价专业软件1·50版EP10-A评价工具。结果连续五天测定三种浓度的FT4质控血清的偏差、批内和批间不精密度均小于1%,总不精密度均小于5%。未发现交叉污染、非线性和漂移等因素对仪器测定的精密度有显著性影响。结论ACS:180SE分析仪主要性能指标评价结果符合临床检测和分析的基本要求,可以继续投入临床使用。
Purpose To track the performance of the ACS: 180SE automated immunoassay analyzer for up to five years. Methods According to the NCCLS recommended EP10-T2 document (preliminary evaluation of instrument performance), the concentrations of FT4 were measured continuously for 5 days in different order of high, medium and low, and the data were imported into EP10-A evaluation tool of laboratory evaluation professional software version 1.50. Results The deviations of the three concentrations of FT4 control serum were determined for five consecutive days. The intra-assay and inter-assay inaccuracies were both less than 1% and the total inaccuracies were less than 5%. No cross-contamination, non-linearity and drift were found to have significant effects on the precision of the instrument. Conclusions The evaluation results of main performance indexes of ACS: 180SE analyzer meet the basic requirements of clinical testing and analysis, and can continue to be put into clinical use.