Tsanaclis L M, Wilson J F
Cardiff Bioanalytical Services Limited, Cardiff Medicentre, Heath Park, United Kingdom.
Ther Drug Monit. 1997 Aug;19(4):420-6. doi: 10.1097/00007691-199708000-00010.
The precision and accuracy of analytical methods currently in use for therapeutic drug monitoring were evaluated from proficiency test data provided by laboratories participating in the international Healthcontrol external quality assessment scheme for a range of eight antiepileptic drugs, theophylline, caffeine, and digoxin. Different analytical systems were assessed after grouping according to the reagent source and the analyzer used. The majority of analytical methods produced comparable levels of performance with coefficient of variation of < 10% and accuracy within +/-7% of the spike value. Emit reagents were implemented successfully on diverse analyzers but data from the Cobas Mira were generally in the technique group with significantly lower precision. Bias problems were evident for a number of FPIA assays for specific drugs. For example, caffeine interference was present in theophylline measurements by Sigma FPIA reagents whereas use of nonhuman matrix caused a negative bias in Abbott FPIA measurements of carbamazepine. Measurements in the group with highest positive bias were produced by Roche FPIA reagents for phenytoin, phenobarbitone, and carbamazepine. Chromatographic and turbidimetric techniques performed satisfactorily. The variable performance of the different reagent/analyzer combinations demonstrates the value of the narrower technique classification in the assessment of assay performance.
利用参与国际卫生控制外部质量评估计划的实验室提供的能力验证数据，对目前用于治疗药物监测的分析方法针对一系列8种抗癫痫药物、茶碱、咖啡因和地高辛的精密度和准确度进行了评估。根据试剂来源和所用分析仪进行分组后，对不同的分析系统进行了评估。大多数分析方法的性能水平相当，变异系数<10%，准确度在加标值的±7%范围内。Emit试剂在多种分析仪上成功应用，但来自Cobas Mira的数据通常在技术组中，精密度显著较低。特定药物的一些荧光偏振免疫分析（FPIA）测定存在偏差问题。例如，Sigma FPIA试剂在茶碱测量中存在咖啡因干扰，而使用非人基质在雅培FPIA卡马西平测量中导致负偏差。罗氏FPIA试剂对苯妥英、苯巴比妥和卡马西平的测量产生了偏差最高的一组数据。色谱法和比浊法技术表现令人满意。不同试剂/分析仪组合的性能差异表明，在评估分析性能时采用更细化的技术分类具有价值。
