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Automated, flow-based chemiluminescence microarray immunoassay for the rapid multiplex detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (CoVRapid CL-MIA).
Klüpfel, Julia; Koros, Rosa Carolina; Dehne, Kerstin; Ungerer, Martin; Würstle, Silvia; Mautner, Josef; Feuerherd, Martin; Protzer, Ulrike; Hayden, Oliver; Elsner, Martin; Seidel, Michael.
  • Klüpfel J; Institute of Hydrochemistry, Chair of Analytical Chemistry and Water Chemistry, Technical University of Munich, Elisabeth-Winterhalter-Weg 6, 81377, Munich, Germany.
  • Koros RC; Institute of Hydrochemistry, Chair of Analytical Chemistry and Water Chemistry, Technical University of Munich, Elisabeth-Winterhalter-Weg 6, 81377, Munich, Germany.
  • Dehne K; ISAR Bioscience GmbH, Semmelweisstr. 5, 82152, Planegg, Germany.
  • Ungerer M; ISAR Bioscience GmbH, Semmelweisstr. 5, 82152, Planegg, Germany.
  • Würstle S; Institute of Hydrochemistry, Chair of Analytical Chemistry and Water Chemistry, Technical University of Munich, Elisabeth-Winterhalter-Weg 6, 81377, Munich, Germany.
  • Mautner J; Helmholtz Zentrum München, German Research Center for Environmental Health, Haematologikum, Research Unit Gene Vectors and Technical University of Munich, Children's Hospital, Marchioninistraße 25, 81377, Munich, Germany.
  • Feuerherd M; Institute of Virology, Technical University of Munich / Helmholtz Zentrum München, Trogerstr. 30, 81675, Munich, Germany.
  • Protzer U; Institute of Virology, Technical University of Munich / Helmholtz Zentrum München, Trogerstr. 30, 81675, Munich, Germany.
  • Hayden O; Institute of Virology, Technical University of Munich / Helmholtz Zentrum München, Trogerstr. 30, 81675, Munich, Germany.
  • Elsner M; German Center for Infection Research (DZIF), Munich partner site, 81675, Munich, Germany.
  • Seidel M; Heinz-Nixdorf-Chair for Biomedical Electronics, Technical University of Munich, TranslaTUM, Einsteinstr. 25, 81675, Munich, Germany.
Anal Bioanal Chem ; 413(22): 5619-5632, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-2174032
ABSTRACT
In the face of the COVID-19 pandemic, the need for rapid serological tests that allow multiplexing emerged, as antibody seropositivity can instruct about individual immunity after an infection with SARS-CoV-2 or after vaccination. As many commercial antibody tests are either time-consuming or tend to produce false negative or false positive results when only one antigen is considered, we developed an automated, flow-based chemiluminescence microarray immunoassay (CL-MIA) that allows for the detection of IgG antibodies to SARS-CoV-2 receptor-binding domain (RBD), spike protein (S1 fragment), and nucleocapsid protein (N) in human serum and plasma in less than 8 min. The CoVRapid CL-MIA was tested with a set of 65 SARS-CoV-2 serology positive or negative samples, resulting in 100% diagnostic specificity and 100% diagnostic sensitivity, thus even outcompeting commercial tests run on the same sample set. Additionally, the prospect of future quantitative assessments (i.e., quantifying the level of antibodies) was demonstrated. Due to the fully automated process, the test can easily be operated in hospitals, medical practices, or vaccination centers, offering a valuable tool for COVID-19 serosurveillance. Graphical abstract.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoassay / COVID-19 Serological Testing / SARS-CoV-2 / Antibodies, Viral Type of study: Diagnostic study Topics: Vaccines Limits: Humans Language: English Journal: Anal Bioanal Chem Year: 2021 Document Type: Article Affiliation country: S00216-021-03315-6

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoassay / COVID-19 Serological Testing / SARS-CoV-2 / Antibodies, Viral Type of study: Diagnostic study Topics: Vaccines Limits: Humans Language: English Journal: Anal Bioanal Chem Year: 2021 Document Type: Article Affiliation country: S00216-021-03315-6