In Search of the SARS-CoV-2 Protection Correlate: Head-to-Head Comparison of Two Quantitative S1 Assays in Pre-characterized Oligo-/Asymptomatic Patients
Rubio-Acero R, Castelletti N, Fingerle V, Olbrich L, Bakuli A, Woelfel R, Girl P, Mueller K, Jochum S, Strobl M, Hoelscher M, Wieser A (2021)
Publication Type: Journal article
Publication year: 2021
Journal
Book Volume: 10
Pages Range: 1505-1518
Journal Issue: 3
DOI: 10.1007/s40121-021-00475-x
Abstract
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.
Involved external institutions
Ludwig-Maximilians-Universität (LMU)
Germany (DE)
Deutsches Zentrum für Infektionsforschung (DZIF)
Germany (DE)
Roche Diagnostics GmbH
Germany (DE)
Germany (DE)
Deutsches Zentrum für Infektionsforschung (DZIF)
Germany (DE)
Roche Diagnostics GmbH
Germany (DE)
How to cite
APA:
Rubio-Acero, R., Castelletti, N., Fingerle, V., Olbrich, L., Bakuli, A., Woelfel, R.,... Wieser, A. (2021). In Search of the SARS-CoV-2 Protection Correlate: Head-to-Head Comparison of Two Quantitative S1 Assays in Pre-characterized Oligo-/Asymptomatic Patients. Infectious Diseases and Therapy, 10(3), 1505-1518. https://doi.org/10.1007/s40121-021-00475-x
MLA:
Rubio-Acero, Raquel, et al. "In Search of the SARS-CoV-2 Protection Correlate: Head-to-Head Comparison of Two Quantitative S1 Assays in Pre-characterized Oligo-/Asymptomatic Patients." Infectious Diseases and Therapy 10.3 (2021): 1505-1518.
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