Highly specific IgM and IgG ELISA tests for detection of anti-SARS-CoV-2 antibodies in human sera (SARS-CoV-2-Serologie)

In the context of the current COVID-19 pandemic, sensitive and specific serological tests for the detection of SARS-CoV-2-specific antibodies in human sera are a mandatory prerequisite for epidemiological studies, the retrospective evaluation of molecular testing sensitivity and the performance of vaccine studies. Furthermore, the economic and social burden of shutdowns and social distancing could be alleviated by securely identifying individuals having developed SARS-CoV-2 immunity. Due to the existence of several other human pathogenic Corona viruses, a considerable percentage of false positive test results caused by cross-reactive antibodies can be expected if conventional tests methods (e.g. indirect ELISA or IIFT) are applied. Therefore, the Bernhard Nocht Institute for Tropical Medicine (BNITM, Hamburg) aims at developing a highly sensitive and specific SARS-CoV-2 ELISA employing a patented ELISA technology (EP2492689, EP3207375) that allows efficient suppression of cross-reactive signals and has already been successfully applied to a similarly challenging task, i.e. serological differential diagnosis of flavivirus infections. Following test validation using a comprehensive collection of well characterized COVID-19 patient samples (including longitudinal serum samples allowing observation of seroconversion in individual patients) and negative control sera, an independent comparative evaluation of the newly developed tests will be performed in cooperation with the Foundation for Innovative New Diagnostics (FIND).