Analysis of the imprecision of internal quality control of therapeutic drug monitoring in whole blood in China, February,2014
10.13699/j.cnki.1001-6821.2015.18.024
- VernacularTitle:2014年2月全国全血治疗药物监测的室内质量控制结果分析
- Author:
Kun ZHONG
1
;
Wei WANG
;
Fa-Lin HE
;
Zhi-Guo WANG
Author Information
1. 北京医院 卫生部临床检验中心
- Keywords:
therapeutic drug monitoring in whole blood;
internal quality control;
coefficient of variation;
cyclosporine A;
tacrolimus;
sirolimus
- From:
The Chinese Journal of Clinical Pharmacology
2015;(18):1877-1880
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the coefficient of variations ( CV) of internal quality control ( IQC ) of therapeutic drug monitoring in whole blood ( cyclosporine A, tacrolimus, sirolimus), and compare with the quality specification derived from allowable total error (TEa).Methods Data had been collected by web -based submission system , the labo-ratories which enrolled in 2014 therapeutic drug monitoring in whole blood external quality assessment (EQA) program had attended.The da-ta was included:the CV of February of 2014 and long-term cumulative data , method and instrument , etc.Microsoft Excel 2007 and SPSS 13.0 had been used to analyze the data .The evaluation standard of EQA was considered as TEa (25%), 1/3TEa (8.33%) and 1/4TEa were deter-mined to be the evaluation standard of CV of IQC .Results The 116 ,
108 and 21 laboratories reported effective results of lot 1 of IQC material of cyclosporine A , tacrolimus and sirolimus , respectively while 59 , 56 and 4 of lot 2. About half laboratories used Bio -Rad measurement system (40.7%-57.1%) .There was no significant difference ( P>0.05 ) of the acceptable rate of CV between test items except accumulative CV evaluated by 1/4TEa (P<0.05).There was no significant difference of the acceptable rate of CV between different measurement systems for cyclosporine A ( P>0.05 ) .There was significant difference between different measurement systems for ( P<0.01 ) tacrolimus except accumulative CV evaluated by 1/4 TEa ( P>0.05 ) . Conclusion The acceptable rates of sirolimus were higher than cyclosporine A and tacrolimus .There was no signifi-cant difference of the acceptable rate of CV between different measurement systems for cyclosporine A but not for tacrolimus.It is an effective method for clinical laboratories to improve test quality by monitoring the current and cumu-lative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification .
