van Thiel D, Marschner I, Wood W G, Habermann J, Scriba P C
J Clin Chem Clin Biochem. 1980 Nov;18(11):807-16.
The blood-spot thyrotropin RIA for detection of congenital hypothyroidism has been established as a screening programme. This article describes the problems in hand, namely optimisation of the method and a comparison of the performance in 7 commercial kits on the West German market. The following factors have been investigated: a. Shelf-life of standards and samples b. Effect of filter paper quality and weight c. Size of paper disc d. Blood sampling time e. Time of removal of paper disc f. Effect on the results of washing the precipitate. The commercial kits at present on the market differ widely in method and price. Apart from this, there was no agreement between the results obtained, and the difference between the standard concentration given by the firm compared with the reference standard MRC 68/38 varied from 22--185%. Methodological guidelines and quality control measures, both internal and external, are suggested.
用于检测先天性甲状腺功能减退症的血斑促甲状腺素放射免疫分析已被确立为一项筛查计划。本文描述了当前面临的问题,即方法的优化以及对西德市场上7种商用试剂盒性能的比较。已对以下因素进行了研究:a. 标准品和样本的保质期;b. 滤纸质量和重量的影响;c. 纸盘大小;d. 采血时间;e. 取出纸盘的时间;f. 洗涤沉淀物对结果的影响。目前市场上的商用试剂盒在方法和价格上差异很大。除此之外,所获得的结果之间也不一致,各公司给出的标准浓度与参考标准品MRC 68/38相比,差异在22%至185%之间。本文提出了方法学指南以及内部和外部质量控制措施。