Toxicology and Drug Monitoring Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USA.
Ther Drug Monit. 2010 Feb;32(1):107-11. doi: 10.1097/FTD.0b013e3181c4cebb.
Topiramate is a newer anticonvulsant used to treat epilepsy, migraines, bipolar disorder, posttraumatic stress, and other conditions. Serum topiramate concentrations are measured to determine optimal levels, address therapeutic failure or drug-drug interactions, and assess compliance. Two high-throughput assays for serum topiramate measurement were compared: the Seradyn fluorescence polarization immunoassay (FPIA) on an Abbott TDx/FLx instrument and a new immunoassay from ARK Diagnostics performed on an Olympus AU680 automated analyzer. Precision, linearity, limit of quantitation, carryover, spike recovery, and endogenous interferences were found to be acceptable for the ARK assay. These studies were complemented by comparison of 120 patient samples analyzed using both methods. The ARK immunoassay performed comparably to FPIA with minimal difference in serum topiramate concentrations within the therapeutic range (2.0-20 microg/mL). A slight systematic discordance was observed at higher concentrations (greater than 30 microg/mL) with ARK immunoassay results being on average 6% higher than FPIA. Thus, the ARK immunoassay appears to provide acceptable analytical performance and comparability to FPIA; furthermore, the assay is compatible with high-throughput autoanalyzers.
托吡酯是一种新型抗惊厥药物，用于治疗癫痫、偏头痛、双相情感障碍、创伤后应激和其他疾病。测量血清托吡酯浓度以确定最佳水平，解决治疗失败或药物相互作用，并评估依从性。比较了两种用于测量血清托吡酯的高通量检测方法：雅培 TDx/FLx 仪器上的 Seradyn 荧光偏振免疫测定（FPIA）和 ARK Diagnostics 的新免疫测定，在 Olympus AU680 自动分析仪上进行。ARK 测定的精密度、线性、定量下限、携带污染、刺突恢复和内源性干扰均可接受。这些研究通过比较两种方法分析的 120 个患者样本得到了补充。在治疗范围内（2.0-20 μg/mL），ARK 免疫测定与 FPIA 相比，血清托吡酯浓度差异最小，性能相当。在较高浓度（大于 30 μg/mL）时观察到轻微的系统差异，ARK 免疫测定结果平均比 FPIA 高 6%。因此，ARK 免疫测定似乎提供了可接受的分析性能和与 FPIA 的可比性；此外，该测定与高通量自动分析仪兼容。
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