Jandreski M A, Shah J C, Garbincius J, Bermes E W
Department of Pathology, Loyola University Medical Center, Maywood, IL 60153.
J Clin Lab Anal. 1991;5(6):415-21. doi: 10.1002/jcla.1860050610.
Five therapeutic drug assays, carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid, were evaluated using an automated random access system for performing thin dry film multilayer competitive immunoassays, the OPUS analyzer. All reagents for the therapeutic drug assays are contained in a coated multilayer film chip encased within a plastic bar-coded test module and require no external or supplementary reagents. A serum or plasma sample is applied to the test module by the instrument and the fluorescence intensity from the module is measured after 6 minutes. We found the OPUS assays acceptable for clinical use. Within-run coefficient of variations were 2.3-6.7%, between-run, 2.9-7.6%. These methods correlated well with the Abbott TDx, having correlation coefficients of 0.92-0.97. Because of the instrument design and the stability of the reagents, weekly calibration is not needed and samples can be run immediately upon receipt in a random access fashion or can be batched together.
使用用于执行薄干膜多层竞争性免疫测定的自动化随机存取系统OPUS分析仪，对五种治疗药物分析方法（卡马西平、苯巴比妥、苯妥英、茶碱和丙戊酸）进行了评估。治疗药物分析的所有试剂都包含在一个涂覆的多层膜芯片中，该芯片封装在一个塑料条形码测试模块内，无需外部或补充试剂。仪器将血清或血浆样本应用于测试模块，并在6分钟后测量模块的荧光强度。我们发现OPUS分析方法可用于临床。批内变异系数为2.3 - 6.7%，批间变异系数为2.9 - 7.6%。这些方法与雅培TDx相关性良好，相关系数为0.92 - 0.97。由于仪器设计和试剂的稳定性，无需每周校准，样本收到后可以立即以随机存取方式运行，也可以批量运行。
