Current status and standardization conception of the testing quality of therapeutic drug monitoring samples
10.3760/cma.j.cn114452-20210511-00300
- VernacularTitle:治疗药物监测样本检测质量现状和标准化构想
- Author:
Qi GUO
1
;
Weiyan ZHOU
;
Tianjiao ZHANG
;
Ying YAN
;
Chuanbao ZHANG
Author Information
1. 北京协和医学院研究生院 北京医院国家老年医学中心 国家卫生健康委临床检验中心 北京市临床检验工程技术研究中心，北京 100730
- Keywords:
Therapeutic drug monitoring;
Cyclosporine A;
Tacrolimus;
Carbamazepine;
Phenytoin;
Valproic acid;
Standardization;
Liquid chromatography-tandem mass spectrom
- From:
Chinese Journal of Laboratory Medicine
2021;44(8):674-678
- CountryChina
- Language:Chinese
-
Abstract:
Accurate determination of drug concentration in blood samples is a necessary prerequisite for therapeutic drug monitoring (TDM) and the implementation of precise drug treatment, and it is also one of the important tasks of clinical laboratories.TDM plays an important role in clinical treatment in immunosuppressants (cyclosporine A, tacrolimus), psychotropic drugs (valproic acid, carbamazepine) and other drugs that require monitoring of drug concentration. There are many types of methods used for TDM for the detection of drug concentration in blood samples. At present, only a few immuno-assay methods were approved for marketing with detection systems and kits, most methods used for TDM are high performance liquid chromatography or liquid chromatography-tandem mass spectrometry which belong to laboratory developed tests (LDTs). Detection of TDM samples has many problems, such as incomparable testing results and large bias between different testing systems, including the biasbetween both different methods and different laboratories using the same method. There are several reasons:(1) the traceability chain has not been established, (2) the methods have not yet been standardized, (3) the coverage of the EQA plan is insufficient, (4) the awareness of TDM laboratories to participate in the EQA plan is insufficient, (5) TDM standardization is still in its infancy. These problems restrict the clinical application of TDM and the development of related research work. In order to solve these problems, it is necessary to: (1) Establish a reference system to realize the traceability of the test results; (2) While gradually increasing the TDM EQA plan items, the Trueness evaluation plan should be carried out as soon as possible; (3) Standardized TDM sample testing Technology; (4) Strengthen laboratory management and establish a complete quality management system.
