酶放大免疫分析法监测万古霉素血药浓度的质控评估

Evaluation of Quality Control for the Therapeutic Drug Monitoring of Vancomycin by the Enzyme- multiplied Immunoassay Technique

目的：评估酶放大免疫分析法（Emit）监测患者全血中万古霉素浓度的质量,建立并改进本单位实验室条件下万古霉素药物浓度监测的质量控制方法.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2012年9月至2013年4月万古霉素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,万古霉素低（L）、中（M）、高（H）三种浓度质控日内差、日间差的相对标准偏差（RSD）在0.6％～2.1％,平均回收率在105.8％～114.3％,符合《中国药典》生物样品监测规定.随行质控L、M、H的RSD分别为0.7％、2.2％和2.5％,适合本单位的质控规则为12S/13S/32S/51s/7tr.结论：Emit法监测万古霉素血药浓度具有较好的精密度、准确度,是一种操作简便、可行的测定方法,但是必须做好质量控制,制订规范,确保测定结果准确、可靠.

Objective：To evaluate the quality of enzyme-multiplied immunoassay technique （Emit） for the therapeutic drug monitoring （TDM） of vancomycin and to establish and improve the method of quality control for the TDM of vancomycin in this lab.Methods：Researches on prospective and internal quality control were carried out with standard quality control samples.TDM results of control samples from September 2012 to April 2013 were retrospectively studied and statistically analyzed.A new quality control rule was established.Results：The inter-and intra-day RSD of low,middle and high concentrations of vancomycin quality control samples （batch number 57311-3） ranged from 0.6％～2.1％,and the average recoveries were in the range of 105.8％～114.3％.This was up to the requirements of biological sample determination in Chinese Pharmacopoeia.RSD of the low,middle and high concentrations of control samples from September 2012 to April 2013 were 0.7％,2.2％ and 2.5％,respectively.The new quality control rule was 12S,13S,32S,51S,7tr.Conclusion：Emit is suitable for the TDM of vancomycin with good accuracy and precision,but the quality control must be done carefully.