Evaluation of the performance of a multiplexed serological assay in the detection of SARS-CoV-2 infections in a predominantly vaccinated population

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dc.contributor.author

Asamoah-Boaheng, Michael

Barakauskas, Vilte

Kirkham, Tracy L.

Demers, Paul A.

Karim, Mohammad Ehsanul

Lavoie, Pascal M.

Citlali Marquez, Ana

Jassem, Agatha N.

Jenneson, Sandra

MacDonald, Christopher

Grunau, Brian

Goldfarb, David M.

dc.date.accessioned

2025-02-06T14:49:14Z

dc.date.available

2025-02-06T14:49:14Z

dc.date.issued

2022-02-23

dc.description.abstract - en

<p>SARS-CoV-2 seroprevalence studies may be complicated by vaccination efforts. It is important to characterize the ability of serology methods to correctly distinguish prior infection from postvaccination seroreactivity. We report the performance of the Meso Scale Discovery (MSD) V-PLEX COVID-19 Coronavirus Panel 2 IgG assay. Using serum samples from a prospective cohort of paramedics, we calculated the performance of the V-PLEX nucleocapsid (“N”) assay to classify prior SARS-CoV-2 infections, defined as a (i) history of a positive SARS-CoV-2 PCR test or (ii) positive serology results using the Roche Elecsys total nucleocapsid anti-SARS-Cov-2 assay. We calculated sensitivity and specificity at the optimal threshold (defined by the highest Youden index). We compared subgroups based on vaccination status, and between models that excluded prior infections 3 to 12 months before sample collection. Of 1119 participants, 914 (81.7%) were vaccinated and 60 (5.4%) had evidence of a preceding SARS-CoV-2 infection. Overall and within vaccinated and unvaccinated subgroups, the optimal thresholds were 828 AU/mL, 827 AU/mL, and 1324 AU/mL; with sensitivities of 0.95 (95% CI: 0.94 to 0.96), 0.95 (0.94 to 0.96), 0.94 (0.92 to 0.96) and specificities of 0.88 (0.86 to 0.90), 0.87 (0.85 to 0.89), and 0.94 (0.89 to 0.98), respectively. N-assay specificity was significantly better in unvaccinated (versus vaccinated) individuals (P = 0.005). Overall optimal thresholds based on the AUC values were higher for samples from unvaccinated participants, especially when examining infections within the preceding 9 months (5855 versus 1704 AU/mL). Overall, V-PLEX nucleocapsid assay cutoff values were higher among unvaccinated individuals. Specificity was also significantly higher among unvaccinated individuals. Different thresholds were required to achieve optimal test performance, especially for detecting SARS-CoV-2 infections within the preceding 9 months.</p> <p>IMPORTANCE Among a cohort of adult paramedics in Canada, we investigated the performance of nucleocapsid (N) antibody detection (measured with a V-PLEX assay) to identify previous COVID-19 infections and compared differences among vaccinated and unvaccinated. Our data indicate that vaccinated and unvaccinated groups require different thresholds to achieve optimal test performance, especially for detecting COVID-19 within the preceding 9 months. Overall, specificity was significantly higher among unvaccinated, compared to vaccinated individuals.</p>

dc.description.sponsorship

This study was supported by funding from the Government of Canada through the COVID-19 Immunity Task Force. M.E.K. is supported in part by a Scholar Award from the Michael Smith Foundation for Health Research, partnered with the Center for Health Evaluation and Outcome Sciences. B.G. is supported by the Michael Smith Foundation for Health Research.

dc.identifier.doi

https://doi.org/10.1128/spectrum.01454-21

dc.identifier.issn

2165-0497

dc.identifier.pubmedID

35196794

dc.identifier.uri

https://open-science.canada.ca/handle/123456789/3398

dc.language.iso

en

dc.publisher - en

American Society for Microbiology

dc.rights - en

Creative Commons Attribution 4.0 International (CC BY 4.0)

dc.rights - fr

Creative Commons Attribution 4.0 International (CC BY 4.0)

dc.rights.openaccesslevel - en

Gold

dc.rights.openaccesslevel - fr

Or

dc.rights.uri - en

https://creativecommons.org/licenses/by/4.0/

dc.rights.uri - fr

https://creativecommons.org/licenses/by/4.0/deed.fr

dc.subject - en

Health

Coronavirus diseases

Immunization

dc.subject - fr

Santé

Maladie à coronavirus

Immunisation

dc.subject.en - en

Health

Coronavirus diseases

Immunization

dc.subject.fr - fr

Santé

Maladie à coronavirus

Immunisation

dc.title - en

Evaluation of the performance of a multiplexed serological assay in the detection of SARS-CoV-2 infections in a predominantly vaccinated population

dc.type - en

Article

dc.type - fr

Article

local.acceptedmanuscript.articlenum

e01454-21

local.article.journalissue

1

local.article.journaltitle - en

Microbiology Spectrum

local.article.journalvolume

10

local.pagination

1-7

local.peerreview - en

Yes

local.peerreview - fr

Oui

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