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

  • Funded by Bundesministerium für Bildung und Forschung [German Federal Ministry of Education and Research] (BMBF)
  • Total publications:5 publications

Grant number: 01KI20210

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2021
  • Known Financial Commitments (USD)

    $582,524.22
  • Funder

    Bundesministerium für Bildung und Forschung [German Federal Ministry of Education and Research] (BMBF)
  • Principle Investigator

    Pending
  • Research Location

    Germany, Europe
  • Lead Research Institution

    Bernhard-Nocht-Institut für Tropenmedizin (BNITM), Hamburg
  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Diagnostics

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Not applicable

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

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).

Publicationslinked via Europe PMC

Last Updated:38 minutes ago

View all publications at Europe PMC

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.

Fcγ-Receptor-Based Enzyme-Linked Immunosorbent Assays for Sensitive, Specific, and Persistent Detection of Anti-SARS-CoV-2 Nucleocapsid Protein IgG Antibodies in Human Sera.

Seroprevalence of SARS-CoV-2 in urban settings in three sub-Saharan African countries (SeroCoV): a study protocol for a household-based cross-sectional prevalence study using two-stage cluster sampling.

Longitudinal detection of SARS-CoV-2-specific antibody responses with different serological methods.

Limited specificity of commercially available SARS-CoV-2 IgG ELISAs in serum samples of African origin.