国内外克伦特罗ELISA检测试剂盒评价

根据B/B0-50%抑制浓度、检测范围、标准溶液浓度梯度、板内变异、板间变异、样品添加检验、实际样品检验等方面的比较结果对两种克伦特罗ELISA检测试剂盒(A: 中国兽医药品监察所研制, B: 德国 r-Biopharm公司研制)进行评价。结果表明,试剂盒A的50%抑制浓度低于1.0 ng/mL; 检测范围在0.10~3.0 ng/mL之间;标准溶液浓度梯度中包括1.0 ng/mL这一限定值;板内变异系数小于13.7%,板间变异系数小于8.8%;样品回收率在70%~110%之间;实际样品检验和试剂盒B检样的阳性符合率为95.5%。试验证明,试剂盒A与试剂盒B的水平相当。

Evaluation of the Clenbuterol ELISA Test Kits at Home and Abroad

The results of a comparative study on two ELISA test kits for clenbuterol were presented. Kit Awas made by China Institute of Veterinary Drug Control and kit B was bought from r-Biopharm company inGermany. Conclusion could be drawn that the quality of kit A was as well as that of kit B. The B/B0-50% isless than 1 ng/mL; the measuring range is 0.10~3.0 ng/mL; one of the standard solutions is 1 ng/mL which isthe cut-off value; the inter-assay variations is less than 13.7%; the intra-assay variations is less than 8.8%;the recovery is 70%~110% and the agreement percent of detection with kit B is 95.5%.