酶联免疫法检测克伦特罗残留量的质量控制

Quality Control for the Determination of Clenbuterol Residues by ELISA

对酶联免疫法检测克伦特罗残留量的质量控制方法进行了探讨。应用酶联免疫法检测克伦特罗残留量可从克伦特罗试剂盒的检测下限、校正曲线的线性检验、精密度验证、以及添加克伦特罗标准品做回收率试验等方面来进行质量控制。结果表明，本方法的样品检测下限（定性检出）为0.03ng／mL，定量检测下限为0．1ng／mL；克伦特罗标准校正曲线Y=-0.1884X＋0．4159在0．1-8．1 ng／mL范围内具有良好的线性相关关系，相关系数为-0．9913；克伦特罗标准液的浓度分别为0.1、0．3、0．9、2.7、8．1 ng／mL时，变异系数分别为3．7％、5.3％、9．7％、9．2％、8．7％，在3．7％～9．7％的范围内；当克伦特罗标准品添加水平分别为0。5、1．0 ng／mL时，平均回收率分别为84％、90％，在80％-100％的范围内。上述指标均符合残留分析质量控制的要求。

The quality control method for the determination of Clenbuterol was investigated by ELISA. Quality control for the determination of Clenbuterol residues by ELISA may be actualized by evaluating the limit of detection, the limit of quantification, the standard calibration curve, the precision validation of Clenbuterol ELISA test kit, the rate of recovery of Clenbuterol standards. Conclusions could be drawn that the limit of detection is 0.03ng/mL, the limit of quantification is 0.1ng/ mL; the standard calibration curve is rectilineal in the range of 0.1ng/mL-8.1ng/mL whose coefficient of correlation is -0.9913 which has a good linear relationship; When the concentrations of Clenbuterol standards are 0.1ng/mL, 0.3ng/mL, 0.9ng/mL, 2.7ng/mL, 8.1ng/mL, the coefficient of variation is 3.7%, 5.3%, 9.7%, 9.2%, 8.7% respectively in the range of 3.7%-9.7%; When the concentrations of Clenbuterol standards in the spike sample are 0.5ng/mL, 1.0ng/mL, the average rate of recovery is 84%, 90% respectively in the range of 80%-100%. The above parameters are accorded with the requirements of guide on the quality control of residues analysis issued by our country.