Evaluation of quality control for therapeutic drug monitoring of tacrolimus by enzyme-multiplied immunoassay technique

Le résumé fourni par la source

Objective:To evaluate the quality of enzyme-multiplied immunoassay technique(EMIT) for therapeutic drug monitoring(TDM) of tacrolimus,establish and improve the quality control method for TDM of tacrolimus.Methods:Researches on prospective and internal quality control were carried out on standard quality control samples.Results of TDM of control samples in 2008 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(4.3,8.9,18.0 ng/ml) of tacrolimus,which was quality control sample of batch number 7190,ranged from 1.8%-11.2%,and the average recovery rates were in the range of 90.5%-114.0%.This was up to the requirements of biological sample determination in Chinese Pharmacopoeia.RSD of the low,middle and high concentrations(3.8,7.5,15.0 ng/ml) of control samples in 2008(the batch number was 2250) were 21.8%,14.2% and 15.5%,respectively.The new quality control rule was 12S/13S/22S/41S/7tr.Conclusion:EMIT method is suitable for TDM of tacrolimus with good accuracy and precision.However,it is susceptible to several factors,especially temperature.Therefore,the quality control must be done carefully.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.