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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Public Library of Science (PLoS)
2022-01-01
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Series: | PLoS ONE |
Online Access: | https://doi.org/10.1371/journal.pone.0266184 |
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author | 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 |
author_facet | 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 |
author_sort | Nnaemeka C Iriemenam |
collection | DOAJ |
description | <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. |
first_indexed | 2024-04-12T14:37:22Z |
format | Article |
id | doaj.art-b45ebf3e11d44d259b490c6b50a24f4e |
institution | Directory Open Access Journal |
issn | 1932-6203 |
language | English |
last_indexed | 2024-04-12T14:37:22Z |
publishDate | 2022-01-01 |
publisher | Public Library of Science (PLoS) |
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series | PLoS ONE |
spelling | doaj.art-b45ebf3e11d44d259b490c6b50a24f4e2022-12-22T03:29:01ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01174e026618410.1371/journal.pone.0266184Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria.Nnaemeka C IriemenamFehintola A IgeStacie M GrebyAugustine MpamugoAdo G AbubakarAyuba B DawurungMudiaga K EsiekpeAndrew N ThomasMary U OkoliSamuel S AwalaBlessing N UgboajaChicago C AchugbuIfeanyichukwu OdohFelicia D NwatuTemitope OlaleyeLoveth AkayiOluwaseun O AkinmuleroJoseph DattijoEdewede OnokevbagbeOlumide OkunoyeNwando MbaNdidi P AgalaMabel UwanduMaureen AniedobeKristen A StaffordAlash'le AbimikuYohhei HamadaMahesh SwaminathanMcPaul I OkoyeLaura C SteinhardtRosemary Audu<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.https://doi.org/10.1371/journal.pone.0266184 |
spellingShingle | 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 Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria. PLoS ONE |
title | Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria. |
title_full | Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria. |
title_fullStr | Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria. |
title_full_unstemmed | Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria. |
title_short | Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria. |
title_sort | validation of xmap sars cov 2 multi antigen igg assay in nigeria |
url | https://doi.org/10.1371/journal.pone.0266184 |
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