Weak correlation between antibody titers and neutralizing activity in sera from SARS-CoV-2 infected subjects
Open accessPublished version of a preprint
Abstract
Plenty of serologic tests for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) have been developed so far, thus documenting the importance of evaluating the relevant features of the immune response to this viral agent. The performance of these assays is currently under investigation. Amongst them, LIAISON® SARS‐CoV‐2 S1/S2 IgG by DiaSorin and Elecsys Anti‐SARS‐CoV‐2 cobas® by Roche are currently used by laboratory medicine hospital departments in Italy and many other countries. In the present study, we firstly compared two serologic tests on serum samples collected at two different time points from 46 laboratory‐confirmed coronavirus disease‐2019 (COVID‐19) subjects. Secondly, 85 negative serum samples collected before the SARS‐CoV‐2 pandemic were analyzed. Thirdly, possible correlations between antibody levels and the resulting neutralizing activity against a clinical isolate of SARS‐CoV‐2 were evaluated. Results revealed that both tests are endowed with low sensitivity on the day of hospital admission, which increased to 97.8% and 100% for samples collected after 15 days for DiaSorin and Roche tests, respectively. The specificity evaluated for the two tests ranges from 96.5% to 100%, respectively. Importantly, a poor direct correlation between antibody titers and neutralizing activity levels was evidenced in the present study. These data further shed light on both potentials and possible limitations related to SARS‐CoV‐2 serology. In this context, great efforts are still necessary for investigating antibody kinetics to develop novel diagnostic algorithms. Moreover, further investigations on the role of neutralizing antibodies and their correlate of protection will be of paramount importance for the development of effective vaccines.
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The LIAISON assay has clinical sensitivity and specificity above 98%.
“This Food and Drug Administration-authorised assay has a clinical sensitivity and specificity above 98%.14”
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- Authors
- Criscuolo, E., Diotti, R. A., Strollo, M., Rolla, S., Ambrosi, A., Locatelli, M., Burioni, R., Mancini, N., Clementi, M., & Clementi, N.
- Affiliations
- Vita-Salute San Raffaele University (IT)
- IRCCS Ospedale San Raffaele (IT)
- Corresponding author
- Clementi, Nicola
- ORCID
- Venue
- Journal of Medical Virology
- Publisher
- Wiley
- Published
- 2020-11
- Volume
- 93
- Issue
- 4
- Pages
- 2160-2167
- ISSN
- 0146-6615 (ISSN-L)
- 1096-9071
- PMC
- PMC7675753
- OpenAlex
- W3093275168
- Cited by
- 62
- References
- 23
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 6 · 2023: 7 · 2022: 22 · 2021: 18 · 2020: 6
- FWCI
- 1.74
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Journal of Medical Virology (publishedVersion)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion, other-oa)
- IrInSubria (University of Insubria) (submittedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- SARS-CoV-2, COVID-19 pandemic, serological tests, neutralizing antibodies, antibody titers, sensitivity and specificity, antibody kinetics, correlates of protection, vaccine development
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Testing, Animals, Antibodies, Viral, Chlorocebus aethiops, Humans, Immunoglobulin G, Italy, Sensitivity and Specificity, Serologic Tests, Vero Cells, Antibodies, Neutralizing, Pandemics
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