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

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,能够保证检测质量,降低检测成本。

Objective To investigate the testing quality and re-use value of residtml reagents used in Roche E601 electrochemilumineseence immunoassay analyzer. Methods Alpha fetoprotein in specific sera was detected by residual reagents. The precision, accuracy, analytic measurement range and recovery rate of residual reagents were analysed. Results The within-run and between-run coefficients of variation （CV） of AFP measured by residual reagents in low and high levels of quality control products. The accuracy was within the allowance range. Measured values were highly correlated with theoretical values in the analytic measurement range test. The recovery rate was between 9%-110%. Conclusions Roche E601 analyzer, using the same lot number of residual reagents, can be mixed and recycled within the limited time. which also can ensure the testing quality and reduce costs.