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CORONA - SARS-CoV-2-VLP-IVD - Development of a certified in vitro diagnostic (IVD) for the reliable determination of COVID-19-specific immune responses in human serum; subproject 4: Development and validation of a SARS-CoV-2-VLP ELISA and certification as an in vitro diagnostic (IVD).

  • Funded by Bundesministerium für Bildung und Forschung [German Federal Ministry of Education and Research] (BMBF)
  • Total publications:0 publications

Grant number: 03COV01D

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Key facts

  • Disease

    COVID-19

  • Start & end year

    2020
    2021

  • Known Financial Commitments (USD)

    $162,113.25

  • Funder

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

  • Principal Investigator

    Kai Schulze-Forster

  • Research Location

    Germany

  • Lead Research Institution

    CellTrend Gesellschaft mit beschränkter Haftung

  • Research Priority Alignment

    N/A

  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Diagnostics

  • Special Interest Tags

    N/A

  • Study Type

    Non-Clinical

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Not Applicable

  • Vulnerable Population

    Not applicable

  • Occupations of Interest

    Not applicable

Abstract

CellTrend will develop and validate a SARS-COV2-VLP ELISA as part of the project. Based on the data obtained, the IvD will then be approved. It is the goal of the project to develop a stable, robust and practical immunoassay for use in a routine laboratory. The technical target parameters for the SARS-COV2-VLP ELISA are 99.5% sensitivity and 99.5% specificity. Due to the unchanged pandemic situation, production capacities of 400,000 kits/month will be established.