他克莫司血药浓度监测的质控方法比较

Comparison of Quality Control Methods in Blood Concentration Monitoring of Tacrolimus

关键词:  他克莫司  质控  酶增强免疫分析法  血药浓度监测

Key words:  tacrolimus  quality control  EMIT  therapeutic drug monitoring

摘要:

目的 评价酶增强免疫分析法(enzyme-multiplied immunoassay technique，EMIT)监测患者全血中他克莫司浓度的质量，建立他克莫司血药浓度监测的质量控制方法，提高血药浓度监测的准确性。方法 对本实验室2013年6月—2014年7月的他克莫司血药浓度监测的随行质控结果进行回顾性评价与分析，建立常规中心线及控制限，并分析他克莫司血药浓度低、中、高质控品共计127个点，其中低浓度36点、中浓度52点、高浓度39点。结果 他克莫司低、中、高3水平的常规中心线分别为5.21，9.20，19.34 ng·mL^-1；CV分别为31.01%，22.84%，15.11%。Levey-jennings质控方法检出结果失控1次，Westgard多规则控制方法检出6次失控。结论 Westgard多规则控制方法有较高的误差检出率，优于以作为失控限的Levey-jennings质控方法，使用Westgard多规则控制方法来判断质控结果，提高了监测数据的可靠性，可以为临床提供准确的血药浓度监测结果。

Abstract:

OBJECTIVE To evaluate the quality of enzyme-multiplied immunoassay technique(EMIT) for therapeutic drug monitoring(TDM) of tacrolimus, establish the quality control method for TDM of tacrolimus, improve the accuracy of blood concentration monitoring. METHODS to retrospectively evaluate and analysis the quality control results which was accompanying with blood concentration monitoring of tacrolimus in our laboratory during June 2013 to July 2014, established conventional centerline and control limits, and analysis totaling 127 points, including 39 points in a higher concentration, 52 points in a middle concentration, 36 points in a lower concentrations. RESULTS The low, medium and high levels of conventional centerline were 5.21, 9.20, 19.34 ng·mL^-1, respectively; CV were 31.01%, 22.84%, 15.11%, respectively. Levery-Jennings control method detection 1 time out of control. Westgard multi-rules control method detection 6 times out of control. CONCLUSION Westgard multi-rule control methods have a higher error detection rate than Levey-jennings quality control methods. Westgard rules used to determine the quality control results, can improve the reliability of monitoring data, can provide accurate blood concentration monitoring results for clinical use.