Background

Since the beginning of the COVID-19 pandemic, numerous Ag-RDTs have appeared on the market. On their homepage, the Federal Institute for Drugs and Medical Devices (BfArM) provides a list of Ag-RDTs that fulfill certain minimum requirements. These requirements were jointly determined by the Paul-Ehrlich-Institute (PEI) and Robert-Koch-Institute (RKI) to include a sensitivity of >70% and a specificity >97% (Paul-Ehrlich-Institute, 2021).

Manufacturer independent evaluations are important to provide an objective assessment of a test’s accuracy. Thus far only evaluations by the tests’ manufacturers themselves are summarized. Therefore, on this webpage we try to give an overview on the data published by manufacturer independent researchers. Using the linked calculator, it is also possible to convert the shown sensitivity and specificity into the concrete amount of true and false test results.

We are aware that some of the studies presented below differ widely in their methods. Thus, we advise especially for Ag-RDTs that have only been evaluated by a small amount of studies to judge their sensitivity not only based on clinical accuracy below, but also to take their limit of detection as found in analytical studies into consideration.

* Values differ from those provided in the respective manuscript due to missing or contradictory data.

Abbreviations: NP = nasopharyngeal; OP = oropharyngeal; AN = anterior nasal; MT = mid turbine; LRT = lower respiratory tract; CI = confidence interval