体外诊断试剂干扰物质的研究探讨  

Research and Exploration of Interfering Substances in In Vitro Diagnostic Reagents

作　　者：周游 ZHOU You(Shanghai Medical Device and Cosmetics Evaluation and Verifi cation Center,Shanghai 200020)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《中国医疗器械信息》2024年第1期53-55,共3页China Medical Device Information

摘　　要：对临床实验室检测的干扰会造成检测结果的不一致,从而对患者造成困惑和伤害。实验室通常无法轻易检测到由干扰引起的误差。为了避免这个问题,制造商应在产品设计阶段进行充分的干扰物质研究。常见的干扰包括血红蛋白、胆红素和脂质、类风湿因子、生物素等。文章对常见干扰物质的干扰机制进行总结,并结合审评经验,剖析干扰物质的研究关注点,供相关从业人员进行参考。Interferences with clinical laboratory tests can create discrepancies in test results which can lead to patient harm.The error caused by interference cannot be easily detected in the laboratory.In order to avoid this problem,manufacturers should conduct sufficient research on interference substances in the product design stage.Common interference includes hemoglobin,bilirubin and lipids,rheumatoid factor,biotin,etc.This paper summarizes the interference mechanism of common interference substances,and analyzes the research focus of interference substances,based on our review experience,this paper provide for recommendations to relevant practitioners.

关 键 词：体外诊断试剂 干扰物质 注册审评 

分 类 号：TH776[机械工程—仪器科学与技术]