真菌(1-3)-β-D葡聚糖测定试剂产品技术审评要点

Technical Evaluation Points of the Fungus(1-3)-β-D-Glucan Assay Kit

真菌(1-3)-β-D葡聚糖测定试剂盒人血清、血浆样本中真菌(1-3)-β-D葡聚糖浓度,临床上主要用于侵袭性真菌感染的辅助诊断。根据《体外诊断试剂注册与备案管理办法》、标准及指导原则等文件的要求,文章概述了该产品在技术审评过程中应关注的要点,以期帮助注册申请人更好地把握注册申报的要求。

Fungus(1-3)-β-D-glucan Assay Kit is a reagent for determining the concentration of(1-3)-β-D-glucan in human serum and plasma,and is used for auxiliary diagnosis of invasive fungal diseases in clinical.Based on the requirement in laws,regulations and standards,this paper aims to analyze the key point during technical evaluation,in order to provide help for product research and registration.