Ke X, Shen L S
Department of Clinical Laboratory, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2021 Apr 6;55(4):545-550. doi: 10.3760/cma.j.cn112150-20200828-01166.
Tumor markers (TM) detection is of great significance in tumor screening, monitoring and treatment intervention, which puts forward higher requirements for its detection quality. TM traceability is very important in the process of reagent production and clinical laboratory testing, which can help improving the reliability and comparability of TM testing. Based on the current principles and classification system of metrology traceability in the world, this paper reviews the quality requirements of reference materials and reference measurement methods related to protein and nucleic acid of TM, as well as the problems existing in the international convention reference measurement procedure and traceability system of TM, so as to provide a new idea for the quality assurance work of TM detection.
肿瘤标志物(TM)检测在肿瘤筛查、监测及治疗干预中具有重要意义,这对其检测质量提出了更高要求。TM溯源在试剂生产及临床实验室检测过程中非常重要,有助于提高TM检测的可靠性和可比性。本文基于当前国际上计量溯源的原理和分类体系,综述了与TM蛋白质和核酸相关的参考物质及参考测量方法的质量要求,以及TM国际约定参考测量程序和溯源体系中存在的问题,以期为TM检测的质量保证工作提供新思路。