In Clinical Trials Of IVD Reagents, If Sanger Sequencing Is Used As A Comparator, What Information Should Be Provided?

 In clinical trials of IVD reagents, if Sanger sequencing is used as a comparator, the detailed information and data for the establishment and verification of Sanger sequencing methods should be provided as attachment to the clinical trial report. The specific content includes:

1. Informational content
   • Brief introduction of the principle of the sequencing method, sequencing instrument, sequencing reagent and other reagents needed.
   • Detailed description about the primers used in the sequencing, including selection of target gene sequence, primer design, etc., and the trial data for primer molecular weight confirmation, purity­evaluation, and functional verification.
2. Validation data
   • Evaluate the analytical performance of the established Sanger sequencing method, especially the LoD. It is recommended that the analytical performance of the established sequencing method and the investigational reagent should be compared and analyzed to confirm the established sequencing method being suitable as a comparator for the clinical trial.
   • Proper positive and negative controls for sequencing methods should be established and performed in the clinical trials and the control data should be provided.
3. Sequencing results

Representative sequencing maps and data produced in the clinical trial should be submitted.