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

2021; Adis, Springer Healthcare; Volume: 10; Issue: 3 Linguagem: Inglês

10.1007/s40121-021-00475-x

2193-8229

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

COVID-19 Clinical Research Studies

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® Anti-SARS-CoV-2 S [Ro-RBD-Ig-quant]), which were compared with each other and confirmatory tests, including wild-type virus micro-neutralization (NT) and GenScript®cPass™. Square roots R of coefficients of determination were calculated for continuous variables and non-parametric tests were used for paired comparisons.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.