Multicenter study of methods and variations intacrolimus detection in China
10.3760/cma.j.cn421203-20201214-00425
- VernacularTitle:他克莫司药物浓度检测结果的多中心差异性研究
- Author:
Song CHEN
1
;
Lin XIE
;
Peixiang LAN
;
Zhishui CHEN
;
Zhonghua CHEN
;
Gang CHEN
Author Information
1. 华中科技大学同济医学院附属同济医院器官移植研究所 器官移植教育部重点实验室 国家卫生健康委员会器官移植重点实验室 中国医学科学院器官移植重点实验室，武汉 430032
- Keywords:
Kidney transplantation;
Tacrolimus;
Blood drug level
- From:
Chinese Journal of Organ Transplantation
2021;42(3):147-152
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To improve the level of detection method and quality control at different transplant centers in China and comprehensively analyze the data of tacrolimus(Tac)detection in multiple transplant centers and provide data supports.Methods:Low, medium and high concentration commercial quality control products in triplicate samples were delivered to 34 domestic organ transplantation centers and testing repeated for 2~3 times during different time periods. The detection results of 240 quality control samples were summarized. The methods, accuracy and stability of Tac detection results were analyzed.Results:In international standard laboratories, mean±standard deviation(SD)of Tac detection results of low/medium/high concentration commercial quality control products was(4.70±0.325), (8.46±0.548)and(13.50±0.966)respectively. Here the results were (4.79±0.605), (8.49±0.948)and(13.99±1.604)respectively. In contrast, SD and degree of variation of international standard data were smaller, indicating that the accuracy and stability of international standard laboratories in detecting Tac were higher. SD of Tac concentrations detected by international standard laboratory for low/medium/high concentrations was approximately 0.3, 0.5 and 1.0 respectively, i.e.International first-class level. Here SD was approximately 0.5, 1.0 and 1.5 respectively, i.e. Chinese industry level.Conclusions:The "Chinese industry level" is recommended. Before using a new batch of "testing reagents" , "standard control samples" must be employed for calibrating the calculated curve. The calculated curve should be re-calibrated at least once per month. And clinicians should be consulted frequently.
