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一种新型洋地黄毒苷酶免疫测定法的临床评估

Clinical evaluation of a new digitoxin enzyme-immunoassay.

作者信息

Hoffsümmer B, Hubbuch A, Jilek F, Mattersberger J, Schaller G

出版信息

J Clin Chem Clin Biochem. 1986 Aug;24(8):589-95. doi: 10.1515/cclm.1986.24.8.589.

DOI:10.1515/cclm.1986.24.8.589
PMID:3531387
Abstract

A solid-phase enzyme-immunoassay for the determination of the digitoxin concentration in human serum (Enzymun-Test Digitoxin) was developed, and subsequently evaluated in seven laboratories. The test is based on the competition principle. Polystyrene tubes coated with anti-digitoxin antibodies (from sheep) were used as the solid phase. In the concentration range 10-40 micrograms/l, the coefficient of variation for the majority of laboratories was between 2 and 7%. The day-to-day precision only slightly differed from the within-run precision. The measuring range was between 4 and 60 micrograms/l. Enzymun-Test Digitoxin showed good agreement with three known methods for digitoxin determination. No influence on the values was observed in lipaemic, uraemic and icteric samples, dysproteinaemia sera and in the presence of various digoxin derivatives. The new enzyme-immunoassay permits the practical and reliable determination of serum digitoxin and is suited for use in routine analysis.

摘要

开发了一种用于测定人血清中洋地黄毒苷浓度的固相酶免疫测定法(酶免疫试验洋地黄毒苷),随后在七个实验室进行了评估。该测试基于竞争原理。使用包被有抗洋地黄毒苷抗体(来自绵羊)的聚苯乙烯管作为固相。在10 - 40微克/升的浓度范围内,大多数实验室的变异系数在2%至7%之间。日间精密度与批内精密度仅略有差异。测量范围为4至60微克/升。酶免疫试验洋地黄毒苷与三种已知的洋地黄毒苷测定方法显示出良好的一致性。在脂血、尿毒症、黄疸样本、异常蛋白血症血清以及存在各种地高辛衍生物的情况下,未观察到对数值的影响。这种新的酶免疫测定法可实现血清洋地黄毒苷的实用且可靠的测定,适用于常规分析。

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Clinical evaluation of a new digitoxin enzyme-immunoassay.一种新型洋地黄毒苷酶免疫测定法的临床评估
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