Borner K, Rietbrock N
J Clin Chem Clin Biochem. 1978 Jun;16(6):335-42.
This paper describes the evaluation of a heterogeneous enzymeimmunoassay (EIA, subtype ELISA) for the determination of digoxin in serum. Results are compared with those obtained from a radioimmunoassay (New England Nuclear, 125I-Digoxin). The limit of detection is 0.3 microgram/1 (0.4 nmol/1). The range of the test is from 0.3 unto 5.0 microgram/1 (0.4--6.4 nmol/1). Within-batch precision ranged from 7 to 11%, between-batch precision from 8--14%. Pure digoxin, added to solutions of albumin and pooled sera, gave recoveries between 87 and 106%. 116 sera from patients taking digoxin exclusively yielded no systematic difference compared to the results of a radioimmunoassay (RIA) (equation of the bivariate regression CELISA = 0.954 . CRIA + 0.14 (microgram/1) (0.18 nmol/1). Nevertheless marked differences between both tests were observed in individual cases. Digitoxin yielded in vitro and in vivo a cross-reactivity of 7 to 14% depending upon the concentration. In 68 sera from patients, taking digoxin plus spironolactone, we found results that were on average 0.48 microgram/1 (0.64 nmol/1) higher with the ELISA than with the RIA (p less than 0.01%). With respect to practicability the ELISA test for digoxin is very similar to the analogous RIA both using the solid phase technique.
本文描述了一种用于测定血清中地高辛的异质酶免疫分析（EIA，ELISA亚型）的评估。将结果与放射免疫分析（新英格兰核公司，125I-地高辛）所得结果进行比较。检测限为0.3微克/升（0.4纳摩尔/升）。检测范围为0.3至5.0微克/升（0.4 - 6.4纳摩尔/升）。批内精密度范围为7%至11%，批间精密度为8% - 14%。向白蛋白溶液和混合血清中添加纯地高辛，回收率在87%至106%之间。116份仅服用地高辛的患者血清与放射免疫分析（RIA）结果相比未显示出系统性差异（双变量回归方程CELISA = 0.954·CRIA + 0.14（微克/升）（0.18纳摩尔/升））。然而，在个别情况下观察到两种检测方法之间存在明显差异。洋地黄毒苷在体外和体内产生的交叉反应率为7%至14%，具体取决于浓度。在68份服用地高辛加螺内酯的患者血清中，我们发现ELISA检测结果平均比RIA高0.48微克/升（0.64纳摩尔/升）（p < 0.01%）。就实用性而言，地高辛的ELISA检测与类似的RIA非常相似，两者均采用固相技术。
