心肌肌钙蛋白I/肌红蛋白/肌酸激酶同工酶定性检测试剂盒(胶体金免疫层析法)技术审评规范要点概述

Overview of the Evaluation Guidance of the Cardiac Troponin I/Myoglobin/Creatine Kinase Isoenzyme Qualitative Kit (Colloidal Gold Immunochromatographic)

心肌肌钙蛋白I/肌红蛋白/肌酸激酶同工酶这三项指标是判断心梗的重要依据,目前该类定性体外诊断试剂尚无行业标准发布。本文从说明书、产品标准、临床试验等方面对该试剂盒审评工作中遵循的一些基本原则进行简要概述,以帮助注册申报人更好地把握产品的技术要点,有效指导注册申报工作。

Cardiac troponin I/myoglobin/creatine kinase isoenzyme is an important basis for myocardial infarction judgment, there is no industry standard is published for these qualitative in vitro diagnostic reagents. A brief overview of some basic principles in the evaluation about the brochures, the product standards, the clinical trials and other aspects describes in this paper. We hope it will help the manufacturer grasp of the key points of the product and help the registration application effectively.