In Search of the SARS-CoV-2 Protection Correlate: Head-to-Head Comparison of Two Quantitative S1 Assays in Pre-characterized Oligo-/Asymptomatic Patients.

COVID-19 Direct virus neutralization assay S1 Quantitative serology SARS-CoV-2

Journal

Infectious diseases and therapy
ISSN: 2193-8229
Titre abrégé: Infect Dis Ther
Pays: New Zealand
ID NLM: 101634499

Informations de publication

Date de publication:
Sep 2021
Historique:
received: 25 03 2021
accepted: 28 05 2021
pubmed: 18 6 2021
medline: 18 6 2021
entrez: 17 6 2021
Statut: ppublish

Résumé

Quantitative serological assays detecting response to SARS-CoV-2 are needed to quantify immunity. This study analyzed the performance and correlation of two quantitative anti-S1 assays in oligo-/asymptomatic individuals from a population-based cohort. In total, 362 plasma samples (108 with reverse transcription-polymerase chain reaction [RT-PCR]-positive pharyngeal swabs, 111 negative controls, and 143 with positive serology without confirmation by RT-PCR) were tested with quantitative assays (Euroimmun Anti-SARS-CoV-2 QuantiVac enzyme-linked immunosorbent assay [EI-S1-IgG-quant]) and Roche Elecsys Quantitative anti-S1 serology correlated well with each other (true positives, 96%; true negatives, 97%). Antibody titers decreased over time (< 30 to > 240 days after initial positive RT-PCR). Agreement with GenScript-cPass was 96%/99% for true positives and true negatives, respectively, for Ro-RBD-Ig-quant and 93%/97% for EI-S1-IgG-quant. Ro-RBD-Ig-quant allowed distinct separation between positives and negatives, and less non-specific reactivity versus EI-S1-IgG-quant. Raw values (95% CI) ≥ 28.7 U/mL (22.6-36.4) for Ro-RBD-Ig-quant and ≥ 49.8 U/mL (43.4-57.1) for EI-S1-IgG-quant predicted NT > 1:5 in 95% of cases. Our findings suggest both quantitative anti-S1 assays (EI-S1-IgG-quant and Ro-RBD-Ig-quant) may replace direct neutralization assays in quantitative measurement of immune protection against SARS-CoV-2 in certain circumstances. However, although the mean antibody titers for both assays tended to decrease over time, a higher proportion of Ro-RBD-Ig-quant values remained positive after 240 days.

Sections du résumé

BACKGROUND BACKGROUND
Quantitative serological assays detecting response to SARS-CoV-2 are needed to quantify immunity. This study analyzed the performance and correlation of two quantitative anti-S1 assays in oligo-/asymptomatic individuals from a population-based cohort.
METHODS METHODS
In total, 362 plasma samples (108 with reverse transcription-polymerase chain reaction [RT-PCR]-positive pharyngeal swabs, 111 negative controls, and 143 with positive serology without confirmation by RT-PCR) were tested with quantitative assays (Euroimmun Anti-SARS-CoV-2 QuantiVac enzyme-linked immunosorbent assay [EI-S1-IgG-quant]) and Roche Elecsys
RESULTS RESULTS
Quantitative anti-S1 serology correlated well with each other (true positives, 96%; true negatives, 97%). Antibody titers decreased over time (< 30 to > 240 days after initial positive RT-PCR). Agreement with GenScript-cPass was 96%/99% for true positives and true negatives, respectively, for Ro-RBD-Ig-quant and 93%/97% for EI-S1-IgG-quant. Ro-RBD-Ig-quant allowed distinct separation between positives and negatives, and less non-specific reactivity versus EI-S1-IgG-quant. Raw values (95% CI) ≥ 28.7 U/mL (22.6-36.4) for Ro-RBD-Ig-quant and ≥ 49.8 U/mL (43.4-57.1) for EI-S1-IgG-quant predicted NT > 1:5 in 95% of cases.
CONCLUSIONS CONCLUSIONS
Our findings suggest both quantitative anti-S1 assays (EI-S1-IgG-quant and Ro-RBD-Ig-quant) may replace direct neutralization assays in quantitative measurement of immune protection against SARS-CoV-2 in certain circumstances. However, although the mean antibody titers for both assays tended to decrease over time, a higher proportion of Ro-RBD-Ig-quant values remained positive after 240 days.

Identifiants

pubmed: 34137000
doi: 10.1007/s40121-021-00475-x
pii: 10.1007/s40121-021-00475-x
pmc: PMC8208377
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1505-1518

Investigateurs

Emad Alamoudi (E)
Jared Anderson (J)
Valeria Baldassare (V)
Maximilian Baumann (M)
Marieke Behlen (M)
Marc Becker (M)
Jessica Beyerl (J)
Rebecca Böhnlein (R)
Isabel Brand (I)
Anna Brauer (A)
Vera Britz (V)
Jan Bruger (J)
Friedrich Caroli (F)
Lorenzo Contento (L)
Alina Czwienzek (A)
Flora Deák (F)
Emma Dech (E)
Laura Dech (L)
Maximillian N Diefenbach (MN)
Jana Diekmannshemke (J)
Anna Do (A)
Gerhard Dobler (G)
Ute Eberle (U)
Juergen Durner (J)
Ute Eberle (U)
Judith Eckstein (J)
Tabea Eser (T)
Philine Falk (P)
Jonathan Frese (J)
Stefanie Fischer (S)
Felix Forster (F)
Turid Frahnow (T)
Jonathan Frese (J)
Günter Fröschl (G)
Christiane Fuchs (C)
Mercè Garí (M)
Marius Gasser (M)
Sonja Gauder (S)
Otto Geisenberger (O)
Christof Geldmacher (C)
Kristina Gillig (K)
Elias Golschan (E)
Vitus Grauvogl (V)
Jessica Michelle Guggenbuehl Noller (JM)
Celina Halfmann (C)
Tim Haselwarter (T)
Jan Hasenauer (J)
Arlett Heiber (A)
Matthias Herrmann (M)
Stefan Hillmann (S)
Christian Hinske (C)
Janna Hoefflin (J)
Tim Hofberger (T)
Michael Höfinger (M)
Larissa Hoffmann (L)
Sacha Horn (S)
Kristina Huber (K)
Christian Janke (C)
Ursula Kappl (U)
Charlotte Kiani (C)
Isabel Klugherz (I)
Norah Kreider (N)
Inge Kroidl (I)
Arne Kroidl (A)
Magdalena Lang (M)
Clemens Lang (C)
Silvan Lange (S)
Ekaterina Lapteva (E)
Michael Laxy (M)
Ronan Le Gleut (R)
Reiner Leidl (R)
Felix Lindner (F)
Alexander Maczka (A)
Alicia Markgraf (A)
Paula Matcau (P)
Rebecca Mayrhofer (R)
Anna-Maria Mekota (AM)
Hannah Müller (H)
Dafni Metaxa (D)
Leonie Pattard (L)
Ivana Paunovic (I)
Claire Pleimelding (C)
Michel Pletschette (M)
Michael Pritsch (M)
Stephan Prückner (S)
Kerstin Puchinger (K)
Konstantin Pusl (K)
Peter Pütz (P)
Katja Radon (K)
Elba Raimúndez (E)
Julius Raschka (J)
Jakob Reich (J)
Friedrich Riess (F)
Camila Rothe (C)
Elmar Saathoff (E)
Nicole Schäfer (N)
Yannik Schälte (Y)
Paul Schandelmaier (P)
Lara Schneider (L)
Sophie Schultz (S)
Mirjam Schunk (M)
Lars Schwettmann (L)
Heidi Seibold (H)
Peter Sothmann (P)
Paul Stapor (P)
Jeni Tang (J)
Fabian Theis (F)
Verena Thiel (V)
Sophie Thiesbrummel (S)
Eva Thumser (E)
Niklas Thur (N)
Julian Ullrich (J)
Julia Waibel (J)
Claudia Wallrauch (C)
Simon Winter (S)
Julia Wolff (J)
Pia Wullinger (P)
Tobias Würfel (T)
Patrick Wustrow (P)
Houda Yaqine (H)
Sabine Zange (S)
Eleftheria Zeggini (E)
Thomas Zimmermann (T)
Lea Zuche (L)

Informations de copyright

© 2021. The Author(s).

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Auteurs

Raquel Rubio-Acero (R)

Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, Leopoldstr. 5, 80802, Munich, Germany.

Noemi Castelletti (N)

Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, Leopoldstr. 5, 80802, Munich, Germany.
Institute of Radiation Medicine, Helmholtz Zentrum München, 85764, Neuherberg, Germany.

Volker Fingerle (V)

German Center for Infection Research (DZIF), Partner Site, Munich, Germany.
Bavarian Health and Food Safety Authority (LGL), Oberschleissheim, Germany.

Laura Olbrich (L)

Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, Leopoldstr. 5, 80802, Munich, Germany.
German Center for Infection Research (DZIF), Partner Site, Munich, Germany.

Abhishek Bakuli (A)

Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, Leopoldstr. 5, 80802, Munich, Germany.

Roman Wölfel (R)

German Center for Infection Research (DZIF), Partner Site, Munich, Germany.
Bundeswehr Institute of Microbiology, 80937, Munich, Germany.

Philipp Girl (P)

German Center for Infection Research (DZIF), Partner Site, Munich, Germany.
Bundeswehr Institute of Microbiology, 80937, Munich, Germany.

Katharina Müller (K)

German Center for Infection Research (DZIF), Partner Site, Munich, Germany.
Bundeswehr Institute of Microbiology, 80937, Munich, Germany.

Simon Jochum (S)

Roche Diagnostics GmbH, 82377, Penzberg, Germany.

Matthias Strobl (M)

Roche Diagnostics GmbH, 82377, Penzberg, Germany.

Michael Hoelscher (M)

Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, Leopoldstr. 5, 80802, Munich, Germany.
German Center for Infection Research (DZIF), Partner Site, Munich, Germany.
Center for International Health (CIH), University Hospital, LMU Munich, 80336, Munich, Germany.

Andreas Wieser (A)

Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität (LMU) Munich, Leopoldstr. 5, 80802, Munich, Germany. Wieser@mvp.lmu.de.
German Center for Infection Research (DZIF), Partner Site, Munich, Germany. Wieser@mvp.lmu.de.

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