In Clinical Trials Of IVD Reagents, How To Deal With Inconsistent Test Results? What Should Be Paid Attention To?

In the clinical trial protocol, the basis for the determination of inconsistence between the investigational reagent and the comparator (similar product/reference methods etc.) in the clinical trial should be clearly explained. The inconsistent results should be comprehensively analyzed in the clinical trial to indicate whether it affects the evaluation of the clinical performance of the product. If samples with inconsistent results are confirmed using clinical reference standards or other appropriate methods, the confirmation results should not be used to change the original statistical analysis results. The clinical trial protocol should specify the clinical reference standards or other methods used for confirmation; the final confirmed result or judgment should be presented in the clinical trial report.