目的 探讨呼吸道多项病原体核酸检测试剂的性能评估及临床试验研究要点,为产品研发和注册申报提供指导性建议。方法 根据呼吸道多项病原体核酸检测试剂的产品特点和预期用途、国家食品药品监管部门的政策法规要求以及笔者从事体外诊断试剂产品技术审评工作的经验总结,以举例方式阐述性能研究要点及方法。结果 性能评估要点包括最低检测限、分析特异性、精密度、企业参考品的验证;临床试验研究要点包括样本总量及阳性样本数量、基因型、对照产品的选择、结果统计分析方法等。结论 性能评估及临床试验是评价产品性能的重要环节,是评估产品上市前安全性和有效性的重要途径,是产品注册技术审评的重要内容,申请人在产品研发及注册过程中应充分考虑评价方法的科学性和全面性,借鉴本文内容紧扣产品特点和预期用途进行充分的验证。
Abstract
OBJECTIVE To discuss essential points in performance evaluation and clinical trial of respiratory multi-pathogen nucleic acid assay, providing constructive suggestions for product research and development as well as regulatory registration. METHODS Based on the features and intended use of the assay, requirements of national food and drug regulatory division and personal experiences in examining IVD products to demonstrate essential points and approaches in performance evaluation and clinical trial by illustrating examples. RESULTS The verification of the limit of detection, analytical specificity, precision and the enterprise references were included in the performance evaluation. The total number of samples and the number of positive sample, genotype, reference products and statistical analysis etc. were included in the clinical trial study. CONCLUSION The performance evaluation and the clinical trial study are an important part of the estimation of product performance. They are an important way to assess the safety and effectiveness of the product before the product goes into the market and also an important part of the technical review in the product registration. Applicants should take full account of scientific and comprehensive evaluation METHODS in product development and registration process, and based on the product characteristics and intended use to verify the product adequately.
关键词
呼吸道病原体 /
多重聚合酶链反应 /
体外诊断 /
注册申报 /
评价研究
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Key words
respiratory pathogen /
multiplex polymerase chain reaction /
in vitro diagnosis /
registration declaration /
evaluation research
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中图分类号：
R95
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参考文献
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