临床化学体外诊断试剂分析性能评估要点探讨

Overview of the Evaluation Points for In Vitro Diagnostic Reagents of Clinical Chemistry

根据国家及地方食品药品监督部门的政策法规要求和作者从事体外诊断试剂产品审评工作的经验,阐述临床化学体外诊断试剂分析性能评估研究要点,为此类产品的研发和申报提供指导性建议。

According to the policies and regulations of the state food and drug supervision and administration department and my experience of in vitro diagnostic products technical review, the evaluation points of clinical chemistry kits were discussed, to provide recommendations for products development and research and registration declaration of such reagents.