Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria.

<h4>Objective</h4>There is a need for reliable serological assays to determine accurate estimates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroprevalence. Most single target antigen assays have shown some limitations in Africa. To assess the performance of a multi-...

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Main Authors: Nnaemeka C Iriemenam, Fehintola A Ige, Stacie M Greby, Augustine Mpamugo, Ado G Abubakar, Ayuba B Dawurung, Mudiaga K Esiekpe, Andrew N Thomas, Mary U Okoli, Samuel S Awala, Blessing N Ugboaja, Chicago C Achugbu, Ifeanyichukwu Odoh, Felicia D Nwatu, Temitope Olaleye, Loveth Akayi, Oluwaseun O Akinmulero, Joseph Dattijo, Edewede Onokevbagbe, Olumide Okunoye, Nwando Mba, Ndidi P Agala, Mabel Uwandu, Maureen Aniedobe, Kristen A Stafford, Alash'le Abimiku, Yohhei Hamada, Mahesh Swaminathan, McPaul I Okoye, Laura C Steinhardt, Rosemary Audu
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0266184
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Summary:<h4>Objective</h4>There is a need for reliable serological assays to determine accurate estimates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroprevalence. Most single target antigen assays have shown some limitations in Africa. To assess the performance of a multi-antigen assay, we evaluated a commercially available SARS-CoV-2 Multi-Antigen IgG assay for human coronavirus disease 2019 (COVID-19) in Nigeria.<h4>Methods</h4>Validation of the xMAP SARS-CoV-2 Multi-Antigen IgG assay was carried out using well-characterized SARS-CoV-2 reverse transcription polymerase chain reactive positive (97) and pre-COVID-19 pandemic (86) plasma panels. Cross-reactivity was assessed using pre-COVID-19 pandemic plasma specimens (213) from the 2018 Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS).<h4>Results</h4>The overall sensitivity of the xMAP SARS-CoV-2 Multi-Antigen IgG assay was 75.3% [95% CI: 65.8%- 82.8%] and specificity was 99.0% [95% CI: 96.8%- 99.7%]. The sensitivity estimate increased to 83.3% [95% CI: 70.4%- 91.3%] for specimens >14 days post-confirmation of diagnosis. However, using the NAIIS pre-pandemic specimens, the false positivity rate was 1.4% (3/213).<h4>Conclusions</h4>Our results showed overall lower sensitivity and a comparable specificity with the manufacturer's validation. There appears to be less cross-reactivity with NAIIS pre-pandemic COVID-19 specimens using the xMAP SARS-CoV-2 Multi-Antigen IgG assay. In-country SARS-CoV-2 serology assay validation can help guide the best choice of assays in Africa.
ISSN:1932-6203