Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies

Maryam Khan, Carolina Rosadas, Ksenia Katsanovskaja, Isaac D. Weber, Justin Shute, Samreen Ijaz, Federica Marchesin, Eleanor McClure, Salem Elias, Barnaby Flower, He Gao, Rachael Quinlan, Charlotte Short, Annachiara Rosa, Chloe Roustan, Maya Moshe, Graham P. Taylor, Paul Elliott, Graham S. Cooke, Peter CherepanovEleanor Parker, Myra O. McClure, Richard S. Tedder*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

At-home sampling is key to large scale seroprevalence studies. Dried blood spot (DBS) self-sampling removes the need for medical personnel for specimen collection but facilitates specimen referral to an appropriately accredited laboratory for accurate sample analysis. To establish a highly sensitive and specific antibody assay that would facilitate self-sampling for prevalence and vaccine-response studies. Paired sera and DBS eluates collected from 439 sero-positive, 382 sero-negative individuals and DBS from 34 vaccine recipients were assayed by capture ELISAs for IgG and IgM antibody to SARS-CoV-2. IgG and IgM combined on DBS eluates achieved a diagnostic sensitivity of 97.9% (95%CI 96.6 to 99.3) and a specificity of 99.2% (95% CI 98.4 to 100) compared to serum, displaying limits of detection equivalent to 23 and 10 WHO IU/ml, respectively. A strong correlation (r = 0.81) was observed between serum and DBS reactivities. Reactivity remained stable with samples deliberately rendered inadequate, (p = 0.234) and when samples were accidentally damaged or ‘invalid’. All vaccine recipients were sero-positive. This assay provides a secure method for self-sampling by DBS with a sensitivity comparable to serum. The feasibility of DBS testing in sero-prevalence studies and in monitoring post-vaccine responses was confirmed, offering a robust and reliable tool for serological monitoring at a population level.

Original languageEnglish
Article number1885
Number of pages11
JournalScientific Reports
Volume12
Issue number1
DOIs
Publication statusPublished - 3 Feb 2022

Bibliographical note

Funding Information: The study was jointly funded by MRC and UKRI (MC_PC_19078 Serological detection of past SARS-CoV-2 infection by non-invasive sampling for field epidemiology and quantitative antibody detection) and supplemented by internal Imperial departmental funding and supported by NIHR BRC of Imperial College Healthcare NHS Trust. The REACT programme is funded by DHSC. GC is supported by an NIHR Professorship. This work is supported by the Francis Crick Institute, which receives its core funding from Cancer Research UK (FC001061), the UK Medical Research Council (FC001061), and the Wellcome Trust (FC001061).

Open Access: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

Publisher Copyright: © The Author(s) 2022

Citation: Khan, M., Rosadas, C., Katsanovskaja, K. et al. Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies. Sci Rep 12, 1885 (2022).

DOI: https://doi.org/10.1038/s41598-022-05640-x

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