Dobson S H, Gibson S, White A
Department of Clinical Biochemistry, University of Manchester, Hope Hospital, Salford, UK.
Ann Clin Biochem. 1989 Jan;26 ( Pt 1):96-101. doi: 10.1177/000456328902600115.
There is no generally accepted human international reference preparation for ACTH. The different centres offering clinical ACTH measurement therefore select assay standards from the limited range of human-purified and synthetic preparations currently available. We have examined the relative potencies of three synthetic ACTH standards in comparison with the NIBSC human-purified 1-39 (code 74/555) in a two-site immunoradiometric assay (IRMA) for ACTH. All of the standards produced parallel curves in the IRMA but there was a wide variation in potency between the preparations giving highly significant differences in quality control and patients' ACTH results. Standards supplied by the National Hormone and Pituitary Programme, Bachem UK Ltd and Universal Biologicals Ltd gave lower ACTH results than results calculated using the NIBSC preparation. The potency differences between these standards emphasise the need for a reference preparation and, in the meantime, the necessity to define normal reference ranges for each laboratory.
目前尚无普遍认可的促肾上腺皮质激素(ACTH)人类国际参考制剂。因此,提供临床ACTH检测的不同中心从目前可用的有限种类的人纯化和合成制剂中选择检测标准品。我们在一种用于ACTH的双位点免疫放射分析(IRMA)中,将三种合成ACTH标准品与NIBSC人纯化的1-39(编号74/555)的相对效价进行了比较。所有标准品在IRMA中均产生平行曲线,但制剂之间的效价存在很大差异,这在质量控制和患者ACTH结果方面产生了极显著差异。由国家激素和垂体项目、Bachem英国有限公司和通用生物制品有限公司提供的标准品所得到的ACTH结果,低于使用NIBSC制剂计算得出的结果。这些标准品之间的效价差异凸显了参考制剂的必要性,同时也强调了各实验室确定正常参考范围的必要性。