Clinical Performance Evaluation of an IVD Product

This case study presents a clinical performance evaluation of an in vitro diagnostic device for SARS-CoV-2, conducted according to the In Vitro Diagnostics Regulation (IVDR) 2017/746. The study, carried out by CRO TRIGA-S GmbH over eight months in 2022, aimed to assess the safety and performance of the device in compliance with IVDR criteria. The evaluation included two main parts: the first part focused on diagnostic sensitivity and specificity compared to a CE-marked RT-PCR test, while the second part assessed the ability of laypersons to correctly use and interpret the test results. The study involved 431 participants and utilized both paper-based and electronic data collection methods. The experiences of data managers and clinical research associates (CRAs) in using the electronic case report form (eCRF) system are documented, highlighting the advantages of digital solutions in enhancing data quality, monitoring, and collaboration during the clinical trial process. The findings underscore the importance of innovative technologies in improving clinical performance evaluations.