抗核抗体检测试剂审评要点概述

Overview of the Evaluation Points of the Antinuclear Antibody Assay Kit

抗核抗体检测试剂是指一类利用间接免疫荧光法、免疫印迹法、化学发光法等基于抗原抗体反应原理,对人体样本中的抗核抗体进行体外定性和/或半定量和/或定量检测的试剂。文章从该类试剂的相关定义、检测方法、性能要求、说明书等方面进行简要概述,期望能够为注册申请人准备注册资料提供参考。

Antinuclear antibody test reagent referred to a kind of reagent which based on immunochemical techniques, such as indirect immunofluorescence assay, immunoblotting assay and chemiluminescence assay, to measure the autoimmune antibodies qualitatively and / or semi-quantitatively and / or quantitatively in samples from human. In this paper, the relevant definition, testing methods, performance requirements and instructions of reagent kits were briefly summarized, which was expected to provide reference for registered applicants to prepare registration materials.