Severe Acute Respiratory Syndrome Coronavirus 2 Seroassay Performance and Optimization in a Population With High Background Reactivity in Mali
Published by Oxford University Press for the Infectious Diseases Society of America 2021..
BACKGROUND: False positivity may hinder the utility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests in sub-Saharan Africa.
METHODS: From 312 Malian samples collected before 2020, we measured antibodies to the commonly tested SARS-CoV-2 antigens and 4 other betacoronaviruses by enzyme-linked immunosorbent assay (ELISA). In a subset of samples, we assessed antibodies to a panel of Plasmodium falciparum antigens by suspension bead array and functional antiviral activity by SARS-CoV-2 pseudovirus neutralization assay. We then evaluated the performance of an ELISA using SARS-CoV-2 spike protein and receptor-binding domain developed in the United States using Malian positive and negative control samples. To optimize test performance, we compared single- and 2-antigen approaches using existing assay cutoffs and population-specific cutoffs.
RESULTS: Background reactivity to SARS-CoV-2 antigens was common in prepandemic Malian samples. The SARS-CoV-2 reactivity varied between communities, increased with age, and correlated negligibly/weakly with other betacoronavirus and P falciparum antibodies. No prepandemic samples demonstrated functional activity. Regardless of the cutoffs applied, test specificity improved using a 2-antigen approach. Test performance was optimal using a 2-antigen assay with population-specific cutoffs (sensitivity, 73.9% [95% confidence interval {CI}, 51.6-89.8]; specificity, 99.4% [95% CI, 97.7-99.9]).
CONCLUSIONS: We have addressed the problem of SARS-CoV-2 seroassay performance in Africa by using a 2-antigen assay with cutoffs defined by performance in the target population.
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:224 |
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| Enthalten in: |
The Journal of infectious diseases - 224(2021), 12 vom: 15. Dez., Seite 2001-2009 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Woodford, John [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 07.01.2022 Date Revised 08.11.2023 published: Print UpdateOf: medRxiv. 2021 Mar 12;:. - PMID 33758883 Citation Status MEDLINE |
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| doi: |
10.1093/infdis/jiab498 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM331535661 |
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| 100 | 1 | |a Woodford, John |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Severe Acute Respiratory Syndrome Coronavirus 2 Seroassay Performance and Optimization in a Population With High Background Reactivity in Mali |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 07.01.2022 | ||
| 500 | |a Date Revised 08.11.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a UpdateOf: medRxiv. 2021 Mar 12;:. - PMID 33758883 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published by Oxford University Press for the Infectious Diseases Society of America 2021. | ||
| 520 | |a BACKGROUND: False positivity may hinder the utility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests in sub-Saharan Africa | ||
| 520 | |a METHODS: From 312 Malian samples collected before 2020, we measured antibodies to the commonly tested SARS-CoV-2 antigens and 4 other betacoronaviruses by enzyme-linked immunosorbent assay (ELISA). In a subset of samples, we assessed antibodies to a panel of Plasmodium falciparum antigens by suspension bead array and functional antiviral activity by SARS-CoV-2 pseudovirus neutralization assay. We then evaluated the performance of an ELISA using SARS-CoV-2 spike protein and receptor-binding domain developed in the United States using Malian positive and negative control samples. To optimize test performance, we compared single- and 2-antigen approaches using existing assay cutoffs and population-specific cutoffs | ||
| 520 | |a RESULTS: Background reactivity to SARS-CoV-2 antigens was common in prepandemic Malian samples. The SARS-CoV-2 reactivity varied between communities, increased with age, and correlated negligibly/weakly with other betacoronavirus and P falciparum antibodies. No prepandemic samples demonstrated functional activity. Regardless of the cutoffs applied, test specificity improved using a 2-antigen approach. Test performance was optimal using a 2-antigen assay with population-specific cutoffs (sensitivity, 73.9% [95% confidence interval {CI}, 51.6-89.8]; specificity, 99.4% [95% CI, 97.7-99.9]) | ||
| 520 | |a CONCLUSIONS: We have addressed the problem of SARS-CoV-2 seroassay performance in Africa by using a 2-antigen assay with cutoffs defined by performance in the target population | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, N.I.H., Intramural | |
| 650 | 4 | |a Africa | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
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| 650 | 7 | |a Immunoglobulin G |2 NLM | |
| 650 | 7 | |a Spike Glycoprotein, Coronavirus |2 NLM | |
| 650 | 7 | |a spike protein, SARS-CoV-2 |2 NLM | |
| 700 | 1 | |a Sagara, Issaka |e verfasserin |4 aut | |
| 700 | 1 | |a Dicko, Alassane |e verfasserin |4 aut | |
| 700 | 1 | |a Zeguime, Amatigue |e verfasserin |4 aut | |
| 700 | 1 | |a Doucoure, M'Bouye |e verfasserin |4 aut | |
| 700 | 1 | |a Kwan, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Zaidi, Irfan |e verfasserin |4 aut | |
| 700 | 1 | |a Doritchamou, Justin |e verfasserin |4 aut | |
| 700 | 1 | |a Snow-Smith, Maryonne |e verfasserin |4 aut | |
| 700 | 1 | |a Alani, Nada |e verfasserin |4 aut | |
| 700 | 1 | |a Renn, Jonathan |e verfasserin |4 aut | |
| 700 | 1 | |a Kosik, Ivan |e verfasserin |4 aut | |
| 700 | 1 | |a Holly, Jaroslav |e verfasserin |4 aut | |
| 700 | 1 | |a Yewdell, Jonathan |e verfasserin |4 aut | |
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| 700 | 1 | |a Sadtler, Kaitlyn |e verfasserin |4 aut | |
| 700 | 1 | |a Duffy, Patrick |e verfasserin |4 aut | |
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