Comparative sensitivity evaluation for 122 CE-marked SARS-CoV-2 antigen rapid tests

Autor: Andreas Puyskens, Heinrich Scheiblauer, Katrin Zwirglmaier, Michael D. Mueller, Andreas Nitsche, Constanze Lange, Angela Filomena, Olivia Knauer, Micha Nuebling, Victor M. Corman, Christian Drosten, Petra Emmerich
Rok vydání: 2021
Předmět:
DOI: 10.1101/2021.05.11.21257016
Popis: ObjectiveIndependent evaluation of the sensitivity of CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) offered in Germany.MethodThe sensitivity of 122 Ag RDT was adressed using a common evaluation panel. Minimum sensitivity of 75% for panel members with CTResultsThe sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with CT ConclusionThis comparative evaluation succeeded to distinguish less sensitive from better performing Ag RDT. Most of the Ag RDT evaluated appear to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.
Databáze: OpenAIRE