罗氏电化学发光免疫分析仪残余试剂质控及 回收价.PDF

《现代仪器与医疗》 2013 年 第 19 卷 第 1 期 检验检测 罗氏电化学发光免疫分析仪残余试剂质控及 回收价值评价 Evaluation of quality control and recovery value of residual reagents used in Roche electrochemiluminescence immunoassay analyzer 摘? 要? 目的 探讨罗氏E601 电化学发光免疫分析仪残余试剂回收的检测质量和再 利用价值。方法 采用回收的残余试剂检测特定血清中甲胎蛋白的含量，进行精密度、 准确度、分析测量范围及回收试验。结果 回收的残余试剂检测低、高浓度质控血清 1 2 1 批内、批间变异系数均符合相关标准；准确度试验结果在允许范围内；分析测量范 苏?维 *? 李?明 ? 丑广程 ? 冯惠清1? 陈占良1 围试验中实测值与理论值呈高度相关；回收率90%~110%。结论 罗氏E601 电化学 Su Wei1 Li Ming2 发光免疫分析仪使用的同批号残余试剂在规定时限内可进行混合回收再利用，能够 Chou Guangcheng1 保证检测质量，降低检测成本。 Feng Huiqing1 关键词? 电化学发光免疫分析仪 残余试剂 甲胎蛋白 Chen Zhanliang1 Abstract Objective To investigate the testing quality and re-use value of residual reagents （1.河北大学附属医院检验科 used in Roche E601 electrochemiluminescence immunoassay analyzer. Methods Alpha ? 保定? 071000；2.河北大学 fetoprotein in specific sera was detected by residual reagents. The precision, accuracy, 附属医院感染性疾病科? 保定? ? 071000） analytic measurement range and recovery rate of residual reagents were analysed. Results (1. Clinical Laboratory of Affiliated The within-run and between-run coefficients of variation (CV) of AFP measured by residual Hospital of Hebei University, Baod- reagents in low and high levels of quality control products. The accuracy was within the ing 071000; 2. Infectious Diseases allowance range. Measured values were highly correlated with theoretical values in the ana- Department of Affiliated Hospital of lytic measurement range test. The recovery rate was between 9%~110%. Conclusions Roche Hebei University, Baoding 071000) E601 analyzer, using the same lot number of residual reagents, can be mixed an