Establishment of an evaluation panel for the decentralized technical evaluation of the sensitivity of 31 rapid detection tests for SARS-CoV-2 diagnostics (preprint)

ABSTRACT

Background The detection of SARS-CoV-2 with rapid diagnostic tests has become an important tool to identify infected people and break infection chains. These rapid diagnostic tests are usually based on antigen detection in a lateral flow approach. Aims & Methods While for PCR diagnostics the validation of a PCR assay is well established, for antigen tests e.g. rapid diagnostic tests there is no common validation strategy. Here we present the establishment of a panel of 50 pooled clinical specimens that cover a SARS-CoV-2 concentration range from approximately 1.1 × 10 9 to 420 genome copies per mL of specimen. The panel was used to evaluate 31 rapid diagnostic tests in up to 6 laboratories. Results Our results show that there is significant variation in the detection limits and the clinical sensitivity of different rapid diagnostic tests. We conclude that the best rapid diagnostic tests can be applied to reliably identify infectious individuals who are presenting with SARS-CoV-2 loads correlated to 10 6 genome copies per mL of specimen. Infected individuals displaying SARS-CoV-2 genome loads corresponding to less than 10 6 genome copies per mL will be identified by only some rapid diagnostics tests, while many tests miss these viral loads to a large extent. Conclusions Sensitive RDTs can be applied to identify infectious individuals with high viral loads, but not to identify infected individuals.