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Rubio-Acero, R.* ; Castelletti, N. ; Fingerle, V.* ; Olbrich, L.* ; Bakuli, A.* ; Wölfel, R.* ; Girl, P.* ; Müller, K.* ; Jochum, S.* ; Strobl, M.* ; Hoelscher, M.* ; Wieser, A.*

In search for the SARS-CoV-2 protection correlate: A head-to-head comparison of two quantitative S1 assays in a group of pre-characterized oligo-/asymptomatic patients.

Infect. Dis. Ther., DOI: 10.1007/s40121-021-00475-x (2021)
Verlagsversion DOI
Open Access Gold
Creative Commons Lizenzvertrag
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: 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. 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: 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. Supplementary Information: The online version contains supplementary material available at 10.1007/s40121-021-00475-x.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Covid-19 ; Direct Virus Neutralization Assay S1 ; Quantitative Serology ; Sars-cov-2; Antibody
ISSN (print) / ISBN 2193-8229
e-ISSN 2193-6382
Verlag Springer
Verlagsort 236 Grays Inn Rd, 6th Floor, London Wc1x 8hl, England
Begutachtungsstatus Peer reviewed
Förderungen Bavarian State Ministry of Science and the Arts
University Hospital; Ludwig-MaximiliansUniversita t Munich
Helmholtz Centre Munich
University of Bonn
University of Bielefeld
German Ministry for Education and Research
Medical Bio-defense Research Program of the Bundeswehr Medical Service
Roche Diagnostics