Bergamaschi E
Laboratory of Industrial Toxicology, University of Parma Medical School, Italy.
Toxicol Lett. 1995 May;77(1-3):205-8. doi: 10.1016/0378-4274(95)03293-2.
Recently developed immunochemical methods offer many advantages, although they may suffer from problems in standardisation due to the difficulties in the characterisation of immunological reagents. The reliability of the results is influenced by the availability of reference materials, calibrators, reagent kits and instruments. Since inter-laboratory quality control programmes have been limited by the lack of standard reference materials, laboratories using immunoassays should, at least, implement an internal quality control programme aimed at avoiding systematic errors, and adhere to the rules for good laboratory practice. The exchange of home-made materials as well as the control over pre-analytical factors (selection, collection and storage of specimens) within collaborative studies could be useful to the harmonisation of the measurement procedures. This paper deals with whether such quality requirements are or can be fulfilled with regard to early markers of nephrotoxic effects based on the immunochemical determination of proteins and kidney-derived antigens in urine or serum.
最近开发的免疫化学方法有许多优点，尽管由于免疫试剂特性鉴定方面的困难，它们可能在标准化方面存在问题。结果的可靠性受到参考物质、校准品、试剂盒和仪器可用性的影响。由于实验室间质量控制计划因缺乏标准参考物质而受到限制，使用免疫测定法的实验室至少应实施旨在避免系统误差的内部质量控制计划，并遵守良好实验室规范的规则。在合作研究中交换自制材料以及对分析前因素（样本的选择、采集和储存）进行控制，可能有助于测量程序的统一。本文探讨了基于尿液或血清中蛋白质和肾脏衍生抗原的免疫化学测定，对于肾毒性早期标志物而言，此类质量要求是否已经或能够得到满足。
