CAJ | 학술논문

缺血修饰白蛋白（ischemia modified albumin，IMA）是急性冠状动脉综合征（acute coronary syndrome，ACS）的危险性分层及排除诊断的重要参考指标，目前无国家标准品亦无行业标准发布，为规范IMA测定试剂注册技术审评工作，特制定该技术审评指导原则。本文从适用范围、命名、检验原理、主要技术指标、临床试验要求等方面进行概述，旨在统一技术审评要求，指导申请人注册申报。
결혈수식백단백（ischemia modified albumin，IMA）시급성관상동맥종합정（acute coronary syndrome，ACS）적위험성분층급배제진단적중요삼고지표，목전무국가표준품역무행업표준발포，위규범IMA측정시제주책기술심평공작，특제정해기술심평지도원칙。본문종괄용범위、명명、검험원리、주요기술지표、림상시험요구등방면진행개술，지재통일기술심평요구，지도신청인주책신보。
Ischemia modiifed albumin (IMA) is an important reference indicators of risk stratifying acute coronary syndrome(ACS) to rule out ACS. Currently, there is no national standard existed, no industry standard is published. In order to standardize the technical review of (IMA) assay reagent’s registration, we formulated the guiding principles. A brief overview of Scope, name, inspection principles, the main technical indicators, clinical testing requirements and other aspects describes in this paper, we hope it wil uniform the technical review requirements, and help the registration application effectively.