Sommer R G, Belchak T L, Bloczynski M L, Boguslawski S J, Clay D L, Corey P F, Foltz M M, Fredrickson R A, Halmo B L, Johnson R D
Miles Inc., Diagnostics Division, Elkhart, IN 46515.
Clin Chem. 1990 Feb;36(2):201-6.
An enzyme-labeled immunometric assay has been developed for measuring digoxin concentrations in serum or plasma. Unitized, compartmentalized reagents are used with an automated sample-processing instrument. The enzyme activity of the processed sample, which is directly proportional to the digoxin concentration, is measured by using a reagent strip and the Ames Seralyzer reflectance photometer. The test takes less than 15 min, and digoxin concentrations are calculated from a two-point calibration line stored in the instrument. Within-run CVs for controls at four concentrations ranged from 2.3% to 3.8%; between-run CVs were from 1.5% to 2.6%. Results obtained with clinical serum samples correlated well (r greater than 0.96) with those obtained by fluorescent polarization immunoassay (Abbott TDx) and RIA (Clinical Assays and NML). This rapid and convenient method for monitoring digoxin concentrations in serum or plasma is particularly well suited for decentralized sites such as emergency rooms, urgent-care centers, and physicians' offices.
已开发出一种酶标记免疫测定法,用于测定血清或血浆中的地高辛浓度。使用单位化、分隔式试剂与自动样品处理仪器。处理后的样品的酶活性与地高辛浓度成正比,通过使用试剂条和艾姆斯自动分析仪反射光度计进行测量。该测试耗时不到15分钟,地高辛浓度根据仪器中存储的两点校准线计算得出。四个浓度的对照品批内变异系数范围为2.3%至3.8%;批间变异系数为1.5%至2.6%。临床血清样品的检测结果与荧光偏振免疫测定法(雅培TDx)和放射免疫分析法(临床检测和国家医学图书馆)的结果相关性良好(r大于0.96)。这种监测血清或血浆中地高辛浓度的快速便捷方法特别适用于急诊室、紧急护理中心和医生办公室等分散场所。