This standard outlines the procedures for conducting next-generation sequencing (NGS) in the context of in vitro diagnostic testing, specifically focusing on the detection of human RNA. It provides detailed guidance on the workflow involved in such testing, ensuring consistency and reliability in the results. The document addresses key aspects such as sample preparation, sequencing protocols, data analysis, and quality control measures. It is designed to support laboratories in implementing standardized practices for RNA-based NGS applications. The content is structured to facilitate the application of these procedures in both research and clinical settings. Additionally, it includes recommendations for documentation and traceability throughout the testing process.
*** Please note: This description may not be accurate, please refer to the official documentation.