基于技术审评的第二类化学发光免疫类体外诊断试剂(盒)相关问题研究

Study on Chemiluminescent Immunoassay in Vitro Diagnostic Kit(Kit)Based on Medical Devices Technical Review

针对按第二类医疗器械管理的化学发光免疫类体外诊断试剂(盒)产品,结合国内外免疫自动化检测系统发展现状,以环孢霉素和他克莫司检测试剂盒(化学发光法)为例,从产品技术审评角度,对不同种类化学发光免疫试剂原理进行深入研究,探讨注册申报常见问题,以期对审评员及企业注册申报人员提供思路和帮助。

In this essay,from the perspective of medical devices technical review,an in-depth study on different chemiluminescence immune reagents and the common problems in registration declaration were presented for the classⅡchemiluminescent immunoassay in vitro diagnostic products,based on the development of the immune automatic detection system at home and abroad,taking cyclosporin and tacrolimus test kits(chemiluminescence method)as examples in order to provide ideas and help for the reviewers and enterprise registration personnel.