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A cross-reactive monoclonal antibody as universal detection antibody in autoantibody diagnostic assays

  • Diagnostics of Autoimmune Diseases involve screening of patient samples for containing autoantibodies against various antigens. To ensure quality of diagnostic assays a calibrator is needed in each assay system. Different calibrators as recombinant human monoclonal antibodies as well as chimeric antibodies against the autoantigens of interest are described. A less cost-intensive and also more representative possibility covering different targets on the antigens is the utilization of polyclonal sera from other species. Nevertheless, the detection of human autoantibodies as well as the calibration reagent containing antibodies from other species in one assay constitutes a challenge in terms of assay calibration. We therefore developed a cross-reactive monoclonal antibody which binds human as well as rabbit sera with similar affinities in the nanomolar range. We tested our monoclonal antibody S38CD11B12 successfully in the commercial Serazym (R) Anti-Cardiolipin-beta 2-GPI IgG/IgM assay and could thereby prove the eligibility ofDiagnostics of Autoimmune Diseases involve screening of patient samples for containing autoantibodies against various antigens. To ensure quality of diagnostic assays a calibrator is needed in each assay system. Different calibrators as recombinant human monoclonal antibodies as well as chimeric antibodies against the autoantigens of interest are described. A less cost-intensive and also more representative possibility covering different targets on the antigens is the utilization of polyclonal sera from other species. Nevertheless, the detection of human autoantibodies as well as the calibration reagent containing antibodies from other species in one assay constitutes a challenge in terms of assay calibration. We therefore developed a cross-reactive monoclonal antibody which binds human as well as rabbit sera with similar affinities in the nanomolar range. We tested our monoclonal antibody S38CD11B12 successfully in the commercial Serazym (R) Anti-Cardiolipin-beta 2-GPI IgG/IgM assay and could thereby prove the eligibility of S38CD11B12 as detection antibody in autoimmune diagnostic assays using rabbit derived sera as reference material.show moreshow less

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Author details:Steffi Luetkecosmann, Thomas Faupel, Silvia Porstmann, Tomas Porstmann, Burkhard Micheel, Katja HanackORCiDGND
DOI:https://doi.org/10.1016/j.cca.2019.09.003
ISSN:0009-8981
ISSN:1873-3492
Pubmed ID:https://pubmed.ncbi.nlm.nih.gov/31493374
Title of parent work (English):Clinica chimica acta
Publisher:Elsevier
Place of publishing:Amsterdam
Publication type:Article
Language:English
Year of first publication:2019
Publication year:2019
Release date:2020/10/02
Tag:Assay calibration; Autoimmune diagnostics; Cross reactivity; Detection; Monoclonal antibody
Volume:499
Number of pages:6
First page:87
Last Page:92
Funding institution:Federal Ministry for Economic Affairs and Energy (BMWi)Federal Ministry for Economic Affairs and Energy (BMWi) [KF2144007CS4]
Organizational units:Mathematisch-Naturwissenschaftliche Fakultät / Institut für Biochemie und Biologie
DDC classification:5 Naturwissenschaften und Mathematik / 57 Biowissenschaften; Biologie / 570 Biowissenschaften; Biologie
Peer review:Referiert
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