ABSTRACT
Objective There is no enzyme multiplied immunoassay technique ( EMIT) reagent for therapeutic drug monito-ring ( TDM) in our country.The aim of this study was to compare the properties of self-developed kits and commercially imported kits in TDM, and to evaluate their feasibilities for routine TDM. Methods The sensitivities, accuracies and precisions of self-developed kits, Viva-E kit and AXSYM kits were evaluated by determining the quality control samples of carbamazepine, valproic acid and phe-nobarbital.Self-developed kits, Viva-E kit and AXSYM kits were employed to determine the concentrations of clinical serum samples of 83 cases of carbamazepine, 80 cases of valproic acid and 72 cases of phenobarbital separately, and the results were compared and analyzed. Results Recoveries of carbamazepine, valproic acid and phenobarbital were more than 90% for the three different kits. The recoveries of self-developed kits for the three drugs were in the range of 98.7%-103.9% and the limits of quantification of the self-developed kits for carbamazepine, valproic acid and phenobarbital were 2, 10, 5μg/mL, respectively.Precision was lower than 10%and its average relative deviation was less than 3%after single point correction.There were good correlations (R2>0.985) and no significant statistical difference between self-developed kits and AXSYM kits (P>0.05).Upper and lower 95%limits of agreement in Bland-Altman plots were (-1.32,1.26), (-15.24,15.17) and ( -3.69,3.00) for carbamazepine, valproic acid and phenobar-bital, respectively.About 5%of the points failed in the 95%confidence interval. Conclusion The self-developed kits showed good performance and are suitable for clinical use in TDM.