Automated and virus variant-programmable surrogate test qualitatively compares to the gold standard SARS-CoV-2 neutralization assay
The ongoing emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants underscores the need for rapid, adaptable, high-throughput testing. However, assays for neutralizing antibodies, which are a good measure of viral protection, usually require cell culture and either infectious SARS-CoV-2 or pseudotyped viral particles. To circumvent the challenges of cell-based assays, SARS-CoV-2 surrogate virus neutralization tests (sVNTs) measure inhibition of the binding of the spike (S) protein receptor binding domain (RBD) to its receptor, human angiotensin-converting enzyme 2 (hACE2) by neutralizing antibodies. Here we tested a prototype automated microfluidic cartridge-based sVNT platform using SARS-CoV-2 wild-type (WT) and B.1.617.2 (Delta) variant RBDs. This sVNT showed a high correlation with cell-based neutralization assays for biospecimens collected post-COVID-19 vaccination and post-SARS-CoV-2 infection as well as for pre-pandemic SARS-CoV-2 negative sera. Thus, this assay, which takes less than 80 min, is a relatively simple, safe, and accurate alternative to traditional VNTs.
Authors
- Brian K. Agan (ORCID: https://orcid.org/0000-0002-5114-1669)
- Emilie Goguet (ORCID: https://orcid.org/0000-0001-6284-4346)
- Christopher C. Broder (ORCID: https://orcid.org/0000-0001-5382-0510)
- Nusrat J Epsi (ORCID: https://orcid.org/0000-0001-5363-075X)
- Stephanie A Richard (ORCID: https://orcid.org/0000-0002-0530-384X)
- Eric D. Laing (ORCID: https://orcid.org/0000-0002-5574-2584)
- Maggie L. Bartlett (ORCID: https://orcid.org/0000-0003-1793-1189)
- Simon Pollett (ORCID: https://orcid.org/0000-0002-4450-7028)
- Carol D. Weiss (ORCID: https://orcid.org/0000-0002-9965-1289)
- Edward Mitre (ORCID: https://orcid.org/0000-0001-7506-3266)
- Linwood Johnson
- Francisco Ramı́rez (ORCID: https://orcid.org/0000-0001-9670-486X)
- Christopher D. Heger
- Mark P. Simons (ORCID: https://orcid.org/0000-0002-4316-9709)
- Darci R. Smith (ORCID: https://orcid.org/0000-0002-0719-523X)
- David R. Tribble (ORCID: https://orcid.org/0000-0003-3077-9505)
- Kevin L. Schully (ORCID: https://orcid.org/0000-0001-5554-0133)
- Wei Wang (ORCID: https://orcid.org/0000-0001-8167-4899)
- Dina Ali
- Timothy H. Burgess
Institutions
- Henry M. Jackson Foundation (US)
- Naval Medical Research Command (US)
- Center for Biologics Evaluation and Research (US)
- United States Food and Drug Administration (US)
- Uniformed Services University of the Health Sciences (US)
- ProteinSimple (United States) (US)
- R&D Systems (United States) (US)
Publication Details
- Journal
- npj Viruses
- Published
- 2024-12-30
- DOI
- https://doi.org/10.1038/s44298-024-00083-9
- Citations
- 2
- Primary Topic
- SARS-CoV-2 and COVID-19 Research
- Type
- article
- Field-Weighted Citation Impact
- 0.78
Funders
- U.S. Department of Defense
- Henry M. Jackson Foundation
- Uniformed Services University of the Health Sciences
- U.S. Navy
- Defense Health Agency
- National Institute of Allergy and Infectious Diseases