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.