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Comparability of six different immunoassays measuring SARS-CoV-2 antibodies with neutralizing antibody levels in convalescent plasma: From utility to prediction.
Lamikanra, Abigail; Nguyen, Dung; Simmonds, Peter; Williams, Sarah; Bentley, Emma M; Rowe, Cathy; Otter, Ashley David; Brooks, Tim; Gilmour, Kimberly; Mai, Annabelle; Dadhra, Jusvinder; Csatari, Mabel; Ziyenge, Sheba; Oliveira, Marta; Ploeg, Rutger; Tsang, Pat; Zambon, Maria; Gopal, Robin; Xiao, Julie Huiyuan; Townsend, Alain; Roberts, David; Harvala, Heli.
  • Lamikanra A; Clinical, Research and Development Departments, NHS Blood and Transplant, Oxford, UK.
  • Nguyen D; Nuffield Department of Medicine, Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Simmonds P; Nuffield Department of Medicine, Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Williams S; Nuffield Department of Medicine, Peter Medawar Building for Pathogen Research, University of Oxford, Oxford, UK.
  • Bentley EM; National Institute for Biological Standards and Control (NIBSC), South Mimms, UK.
  • Rowe C; Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, UK.
  • Otter AD; Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, UK.
  • Brooks T; Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, UK.
  • Gilmour K; Laboratory Services and NIHR BRC Departments, Great Ormond Street Hospital, London, UK.
  • Mai A; Laboratory Services and NIHR BRC Departments, Great Ormond Street Hospital, London, UK.
  • Dadhra J; Laboratory Services and NIHR BRC Departments, Great Ormond Street Hospital, London, UK.
  • Csatari M; Laboratory Services and NIHR BRC Departments, Great Ormond Street Hospital, London, UK.
  • Ziyenge S; Nuffield Department of Surgical Sciences and BRC Surgical Theme, University of Oxford, Oxford, UK.
  • Oliveira M; Nuffield Department of Surgical Sciences and BRC Surgical Theme, University of Oxford, Oxford, UK.
  • Ploeg R; Research Laboratory Department, NHS Blood and Transplant, Oxford, UK.
  • Tsang P; Nuffield Department of Surgical Sciences and BRC Surgical Theme, University of Oxford, Oxford, UK.
  • Zambon M; Research Laboratory Department, NHS Blood and Transplant, Oxford, UK.
  • Gopal R; Clinical, Research and Development Departments, NHS Blood and Transplant, Oxford, UK.
  • Xiao JH; Virology Reference Department, National Infection Service, Public Health England, London, UK.
  • Townsend A; High Containment Microbiology Department, National Infection Service, Public Health England, London, UK.
  • Roberts D; MRC Human Immunology Unit, MRC Weatherall Institute, Radcliffe Department of Medicine, John Radcliffe Hospital, Oxford, UK.
  • Harvala H; MRC Human Immunology Unit, MRC Weatherall Institute, Radcliffe Department of Medicine, John Radcliffe Hospital, Oxford, UK.
Transfusion ; 61(10): 2837-2843, 2021 10.
Article in English | MEDLINE | ID: covidwho-1360538
ABSTRACT

BACKGROUND:

Convalescent plasma (CP) therapy for coronavirus disease (COVID-19) provides virus-neutralizing antibodies that may ameliorate the outcome of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The effectiveness of CP likely depends on its antiviral neutralizing potency and is determined using in vitro neutralizing antibody assays. STUDY DESIGN AND

METHODS:

We evaluated abilities of three immunoassays for anti-spike antibodies (EUROimmun, Ortho, Roche), a pseudotype-based neutralization assay, and two assays that quantify ACE2 binding of spike protein (GenScript and hemagglutination test [HAT]-based assay) to predict neutralizing antibody titers in 113 CP donations. Assay outputs were analyzed through linear regression and calculation of sensitivities and specificities by receiver operator characteristic (ROC) analysis.

RESULTS:

Median values of plasma samples containing neutralizing antibodies produced conversion factors for assay unitage of ×6.5 (pseudotype), ×19 (GenScript), ×3.4 (HAT assay), ×0.08 (EUROimmun), ×1.64 (Roche), and ×0.10 (Ortho). All selected assays were sufficient in identifying the high titer donations based on ROC analysis; area over curve ranged from 91.7% for HAT and GenScript assay to 95.6% for pseudotype assay. However, their ability to predict the actual neutralizing antibody levels varied substantially as shown by linear regression correlation values (from 0.27 for Ortho to 0.61 for pseudotype assay).

DISCUSSION:

Overall, the study data demonstrate that all selected assays were effective in identifying donations with high neutralizing antibody levels and are potentially suitable as surrogate assays for donation selection for CP therapy.
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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Immunoassay / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / Antibodies, Viral Subject: Immunoassay / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / Antibodies, Viral Type of study: Prognostic study / Risk factors Language: English Journal: Transfusion Clinical aspect: Prediction / Prognosis Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Immunoassay / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / Antibodies, Viral Subject: Immunoassay / Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / Antibodies, Viral Type of study: Prognostic study / Risk factors Language: English Journal: Transfusion Clinical aspect: Prediction / Prognosis Year: 2021
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