Evaluation of the accuracy, exclusivity, limit-of-detection and ease-of-use of the LumiraDx SARS-CoV-2 test - A rapid, antigen-detecting point-of-care tool for the diagnosis of SARS-CoV-2 [Research Data]

This repository includes data from a prospective, multi-centre diagnostic accuracy study. The study was conducted at two sites in Germany, Heidelberg and Berlin. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub analyses accordingly to viral load, days of symptoms and symptoms. In addition, further data from the participants were collected during interviews