Saccoia N C, Hackett L P, Morris R G, Ilett K F
Department of Clinical Pharmacology, Queen Elizabeth Hospital, Woodville South, Australia.
Ther Drug Monit. 1996 Dec;18(6):672-7. doi: 10.1097/00007691-199612000-00008.
Digoxin assays in plasma from patients treated with the drug have played an integral role in its therapeutic management. Commercial digoxin immunoassays have been criticized for poor performance owing to various interferences and limited sensitivity. The present study compared the performance of a new enzyme-multiplied immunoassay technique (EMIT 2000) to fluorescence polarization immunoassay (FPIA) and radioimmunoassay (RIA) in two separate Australian centers. Comparisons were made using standard indices of precision and accuracy, samples taken from patients, quality-assurance samples, and cord blood samples from neonates, in which high concentrations of digoxin-like immunoreactive substances (DLIS) would be anticipated. The results confirmed satisfactory precision and accuracy for therapeutic drug monitoring purposes, a sensitivity of < 0.1 microgram/L, and very low DLIS interference, as assessed by assay of neonatal cord blood samples.
对接受该药物治疗的患者血浆进行地高辛检测，在其治疗管理中发挥了不可或缺的作用。商业用地高辛免疫测定法因各种干扰和灵敏度有限而性能不佳，受到了批评。本研究在澳大利亚的两个独立中心，比较了一种新的酶放大免疫测定技术（EMIT 2000）与荧光偏振免疫测定法（FPIA）和放射免疫测定法（RIA）的性能。使用精密度和准确度的标准指标、取自患者的样本、质量保证样本以及新生儿脐带血样本进行比较，预计新生儿脐带血样本中会含有高浓度的地高辛样免疫反应物质（DLIS）。通过对新生儿脐带血样本的检测评估，结果证实该检测方法在治疗药物监测方面具有令人满意的精密度和准确度，灵敏度<0.1微克/升，且DLIS干扰极低。
