Performance Analysis of Serodiagnostic Tests to Characterize the Incline and Decline of the Individual Humoral Immune Response in COVID-19 Patients: Impact on Diagnostic Management
Ronald von Possel,
Babett Menge,
Christina Deschermeier,
Carlos Fritzsche,
Christoph Hemmer,
Hilte Geerdes-Fenge,
Micha Loebermann,
Anette Schulz,
Erik Lattwein,
Katja Steinhagen,
Ralf Tönnies,
Reiner Ahrendt,
Petra Emmerich
Affiliations
Ronald von Possel
Department for Virology, Bernhard Nocht Institute for Tropical Medicine, 20359 Hamburg, Germany
Babett Menge
Institute for Experimental Immunology, EUROIMMUN Medizinische Labordiagnostika AG, 23560 Lübeck, Germany
Christina Deschermeier
Diagnostics Development Laboratory, Bernhard Nocht Institute for Tropical Medicine, 20359 Hamburg, Germany
Carlos Fritzsche
Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, 18057 Rostock, Germany
Christoph Hemmer
Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, 18057 Rostock, Germany
Hilte Geerdes-Fenge
Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, 18057 Rostock, Germany
Micha Loebermann
Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, 18057 Rostock, Germany
Anette Schulz
Institute for Experimental Immunology, EUROIMMUN Medizinische Labordiagnostika AG, 23560 Lübeck, Germany
Erik Lattwein
Institute for Experimental Immunology, EUROIMMUN Medizinische Labordiagnostika AG, 23560 Lübeck, Germany
Katja Steinhagen
Institute for Experimental Immunology, EUROIMMUN Medizinische Labordiagnostika AG, 23560 Lübeck, Germany
Ralf Tönnies
medac GmbH, 22880 Wedel, Germany
Reiner Ahrendt
medac GmbH, 22880 Wedel, Germany
Petra Emmerich
Department for Virology, Bernhard Nocht Institute for Tropical Medicine, 20359 Hamburg, Germany
Serodiagnostic tests for antibody detection to estimate the immunoprotective status regarding SARS-CoV-2 support diagnostic management. This study aimed to investigate the performance of serological assays for COVID-19 and elaborate on test-specific characteristics. Sequential samples (n = 636) of four panels (acute COVID-19, convalescent COVID-19 (partly vaccinated post-infection), pre-pandemic, and cross-reactive) were tested for IgG by indirect immunofluorescence test (IIFT) and EUROIMMUN EUROLINE Anti-SARS-CoV-2 Profile (IgG). Neutralizing antibodies were determined by a virus neutralization test (VNT) and two surrogate neutralization tests (sVNT, GenScript cPass, and EUROIMMUN SARS-CoV-2 NeutraLISA). Analysis of the acute and convalescent panels revealed high positive (78.3% and 91.6%) and negative (91.6%) agreement between IIFT and Profile IgG. The sVNTs revealed differences in their positive (cPass: 89.4% and 97.0%, NeutraLISA: 71.5% and 72.1%) and negative agreement with VNT (cPass: 92.3% and 50.0%, NeutraLISA: 95.1% and 92.5%) at a diagnostic specificity of 100% for all tests. The cPass showed higher inhibition rates than NeutraLISA at VNT titers below 1:640. Cross-reactivities were only found by cPass (57.1%). Serodiagnostic tests, which showed substantial agreement and fast runtime, could provide alternatives for cell-based assays. The findings of this study suggest that careful interpretation of serodiagnostic results obtained at different times after SARS-CoV-2 antigen exposure is crucial to support decision-making in diagnostic management.
