便携式生化分析仪及配套干式微管生物芯片肝功能试剂盘性能评价

Performance evaluation of portable analyzer and reagent disc kit for liver function tests

目的对便携式全自动快速生化分析仪及配套干式微管生物芯片肝功能试剂盘进行性能评价。方法参照美国临床和实验室标准化协会(CLSI)颁布的EP10-A2文件,连续5d按特定顺序检测高、中、低值标本,计算测定结果的绝对偏倚、总不精密度,对检测结果回归曲线的截距、斜率及非线性、携带污染和漂移进行多元回归分析。结果各项目同浓度水平标本检测结果的绝对偏倚和总不精密度均在允许范围内,截距、斜率、非线性、携带污染、漂移均无统计学意义(P>0.05)。结论便携式生化分析仪及配套肝功能试剂盘准确度、精密度、线性良好,携带污染率较低,稳定性好,能满足临床应用要求。

Objective To evaluate the performance portable analyzer and reagent disc kit for liver function tests.Methods According to EP10-A2 document of Clinic and Laboratory Standards Institute,specimens with high,medium and low concentrations were measured continuously in a specific order for 5days.The bias and the total imprecision were calculated,and the intercept,slope rate,non linearity,carryover contamination and drift were analyzed by using multiple regression analysis.Results The bias and precision of specimens with high,medium and low concentrations were all within acceptable ranges.No significant difference was showed in intercept,slope rate,non linearity,carryover contamination and drift（P〈0.05）.Conclusion Portable analyzer and reagent disc kit for liver function tests could be with fine precision,fine linearity,low carryover contamination and good stability,and could meet clinical application requirement.