均相酶扩大免疫分析法监测地高辛血浓度的质量控制与评价

Evaluation of Quality Control for Digoxin TDM by Emit

目的:评价和控制均相酶扩大免疫分析法(Emit)监测患者地高辛血浓度的质量。方法:以标准质控为样本,进行预防性质量控制和室内质量控制研究。对2008年血药浓度监测中随行质控样本的测定值进行统计学分析,做回顾性的质量控制研究,同时建立新的质控规则。结果:Emit法在本单位实验条件下,地高辛低(L)、中(M)、高(H)三种浓度质控日内、日间RSD在2.19%～6.30%之间,平均回收率在97.92%～104.19%之间,符合《中国药典》生物样品检测规定。2008年随行质控的RSD,L、M、H分别为14.45%、14.11%和11.30%,适合本单位的质控规则为1_(2S)/1_(3S)/2_(2S)/4_(1S)/7tr。结论:Emit法监测地高辛血药浓度是一种较理想的测定方法,但是该法的影响因素较多,特别是温度,必须做好质量控制。

Objective： To evaluate quality of Emit method for Digoxin TDM. Establish and improve the quality control rule for Digoxin TDM under this lab. Method： Standard control was used,the whole monitoring course underwent both prospective quality control study and indoor quality control. The digoxin control data determined together with the patient samples last year were perforted statistical analysis and retrospective quality control, ancl a new quality control method was built. Result： The mean recoveries of the low, medium and high control samples of Digoxin in indoor ancl outdoor were at 97.92%-104. 19% ,with RSDs at 2. 19% -6. 30%. which accorded with the requirement for biological sample determination stated in the Chinese Pharmacopoeial. The RSDs of the low, medium and high control data determined together with the patient samples last year were 14. 45% , 14. 11% , 11.30%. respectively, The new quality control method was 12s, 13s,22s ,41s,Ttr. Conclusion： Emit method has good accuracy and precision for Digoxin TDM, it is a comparatively stable method, but which is influenced by several factors especially through temperature, Quality control must be done well.