采用 Cobas Integra 游离苯妥英测定试剂盒校准品验证 Cobas c501 分析仪上的游离苯妥英测定试剂盒，通过与 TDx 分析仪上的荧光偏振免疫法测定游离苯妥英的性能进行比较。
Validation of a free phenytoin assay on Cobas c501 analyzer using calibrators from Cobas Integra free phenytoin assay by comparing its performance with fluorescence polarization immunoassay for free phenytoin on the TDx analyzer.
机构信息
Department of Pathology and Laboratory Medicine, University of Texas-Houston Medical School and Laboratory Services, Memorial-Hermann Hospital at the Texas Medical Center, Houston, TX, USA.
出版信息
J Clin Lab Anal. 2013 Jan;27(1):1-4. doi: 10.1002/jcla.21536.
For many years, fluorescence polarization immunoassay (FPIA) on the TDx analyzer has been used for determination of free phenytoin concentration. Recently Abbott Laboratories decided to discontinue the TDx analyzer and related assays on this analyzer. Free phenytoin assay is also available from Roche Diagnostics for application on the Cobas Integra analyzer (fluorescence polarization assay) but not on Cobas c510 analyzer. Free phenytoin calibrators from the Cobas Integra free phenytoin assay and the reagents from the KIMSphenytoin assay were used for the determination of free phenytoin on the Cobas c501 analyzer. The intra-run and inter-run precisions were both <7.2%. The assay was linear from 0.2 to 4 μg/ml. The free phenytoin assay on the Cobas c501 was compared with the FPIAassay on the TDx analyzer using sera from 25 patients receiving phenytoin (phenytoin concentration between 0.3 and 3.7 μg/ml). The following regression equation was observed: y = 0.9899 x + 0.0408 (r = 0.98, n = 25). In conclusion, the free phenytoin assay on the Cobas c501 analyzer is a valid alternative to free phenytoin assay on the TDx analyzer.
多年来，TDx 分析仪上的荧光偏振免疫分析（FPIA）一直用于测定游离苯妥英的浓度。最近，雅培实验室决定停止 TDx 分析仪及其相关检测。罗氏诊断公司也提供游离苯妥英检测，可应用于 Cobas Integra 分析仪（荧光偏振检测），但不适用于 Cobas c510 分析仪。Cobas Integra 游离苯妥英检测的游离苯妥英校准品和 KIMSphenytoin 检测的试剂用于 Cobas c501 分析仪上的游离苯妥英测定。批内和批间精密度均<7.2%。检测线性范围为 0.2 至 4μg/ml。使用 25 名接受苯妥英治疗的患者（苯妥英浓度为 0.3 至 3.7μg/ml）的血清，将 Cobas c501 上的游离苯妥英检测与 TDx 分析仪上的 FPIA 检测进行了比较。观察到以下回归方程：y=0.9899x+0.0408（r=0.98，n=25）。总之，Cobas c501 分析仪上的游离苯妥英检测是替代 TDx 分析仪上的游离苯妥英检测的有效方法。
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