Steijns Linda S W, Bouw Jan, van der Weide Jan
Department of Clinical Chemistry, St Jansdal Hospital, 3840 AC Harderwijk, The Netherlands.
Ther Drug Monit. 2002 Jun;24(3):432-5. doi: 10.1097/00007691-200206000-00017.
The authors evaluated the fluorescence polarization (FP) assay on the COBAS INTEGRA 700 using COBAS INTEGRA reagent system cassettes for estimating the antiepileptic drugs valproic acid, phenytoin, carbamazepine, and phenobarbital in serum. The study comprised the determination of precision, method comparison performed against a conventional HPLC assay and linearity studies, according to the National Committee for Clinical Laboratory Standards (NCCLS) protocols. Precision results were well acceptable for all FP assays. Intra-assay coefficients of variation (CVs) were from 1.3% to 2.4% for valproic acid, from 0.8% to 2.8% for phenytoin, from 1.7% to 3.3% for carbamazepine, and from 1.3% to 2.3% for phenobarbital. Interassay CVs for these drugs ranged from 1.5% to 2.6%, from 2.9% to 6.5%, from 1.8% to 3.7% and from 1.5% to 3.2%, respectively. Results of the FP assays showed excellent correlation with those from HPLC: r = 0.99 for valproic acid, r = 0.98 for phenytoin, r = 0.98 for carbamazepine and r = 0.99 for phenobarbital. Linearity was satisfactory, with all CVs below the acceptable level. With the COBAS INTEGRA 700 analyzer FP assays are fully automated, which is less laborious and saves time compared with HPLC. Moreover, the fast measuring procedure is convenient in short turnaround time (STAT) analysis. It is an analytically reliable and rapid system, which can be used successfully for the therapeutic monitoring of antiepileptic drugs in serum.
作者使用COBAS INTEGRA试剂系统试剂盒，在COBAS INTEGRA 700上对荧光偏振（FP）分析法进行了评估，以测定血清中的抗癫痫药物丙戊酸、苯妥英、卡马西平和苯巴比妥。该研究根据美国国家临床实验室标准委员会（NCCLS）的方案，进行了精密度测定、与传统高效液相色谱（HPLC）分析法的方法比较以及线性研究。所有FP分析法的精密度结果均可接受。丙戊酸的批内变异系数（CV）为1.3%至2.4%，苯妥英为0.8%至2.8%，卡马西平为1.7%至3.3%，苯巴比妥为1.3%至2.3%。这些药物的批间CV分别为1.5%至2.6%、2.9%至6.5%、1.8%至3.7%和1.5%至3.2%。FP分析法的结果与HPLC法的结果显示出极佳的相关性：丙戊酸的r = 0.99，苯妥英的r = 0.98，卡马西平的r = 0.98，苯巴比妥的r = 0.99。线性良好，所有CV均低于可接受水平。使用COBAS INTEGRA 700分析仪，FP分析法实现了完全自动化，与HPLC相比，工作量更小且节省时间。此外，快速测量程序在急诊（STAT）分析中很方便。它是一个分析可靠且快速的系统，可成功用于血清中抗癫痫药物的治疗监测。
