tetano
Editor, Senior Moderator
PLoS One
. 2022 Apr 1;17(4):e0266184.
doi: 10.1371/journal.pone.0266184. eCollection 2022.
Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria
Nnaemeka C Iriemenam[SUP] 1 [/SUP], Fehintola A Ige[SUP] 2 [/SUP], Stacie M Greby[SUP] 1 [/SUP], Augustine Mpamugo[SUP] 3 [/SUP], Ado G Abubakar[SUP] 4 [/SUP], Ayuba B Dawurung[SUP] 4 [/SUP], Mudiaga K Esiekpe[SUP] 4 [/SUP], Andrew N Thomas[SUP] 4 [/SUP], Mary U Okoli[SUP] 5 [/SUP], Samuel S Awala[SUP] 4 [/SUP], Blessing N Ugboaja[SUP] 4 [/SUP], Chicago C Achugbu[SUP] 5 [/SUP], Ifeanyichukwu Odoh[SUP] 4 [/SUP], Felicia D Nwatu[SUP] 4 [/SUP], Temitope Olaleye[SUP] 4 [/SUP], Loveth Akayi[SUP] 4 [/SUP], Oluwaseun O Akinmulero[SUP] 4 [/SUP], Joseph Dattijo[SUP] 4 [/SUP], Edewede Onokevbagbe[SUP] 3 [/SUP], Olumide Okunoye[SUP] 1 [/SUP], Nwando Mba[SUP] 5 [/SUP], Ndidi P Agala[SUP] 4 [/SUP], Mabel Uwandu[SUP] 2 [/SUP], Maureen Aniedobe[SUP] 2 [/SUP], Kristen A Stafford[SUP] 6 [/SUP], Alash'le Abimiku[SUP] 4 6 [/SUP], Yohhei Hamada[SUP] 7 [/SUP], Mahesh Swaminathan[SUP] 1 [/SUP], McPaul I Okoye[SUP] 1 [/SUP], Laura C Steinhardt[SUP] 8 [/SUP], Rosemary Audu[SUP] 2 [/SUP]
Affiliations
Abstract
Objective: 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.
Methods: 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).
Results: 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).
Conclusions: 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.
. 2022 Apr 1;17(4):e0266184.
doi: 10.1371/journal.pone.0266184. eCollection 2022.
Validation of xMAP SARS-CoV-2 Multi-Antigen IgG assay in Nigeria
Nnaemeka C Iriemenam[SUP] 1 [/SUP], Fehintola A Ige[SUP] 2 [/SUP], Stacie M Greby[SUP] 1 [/SUP], Augustine Mpamugo[SUP] 3 [/SUP], Ado G Abubakar[SUP] 4 [/SUP], Ayuba B Dawurung[SUP] 4 [/SUP], Mudiaga K Esiekpe[SUP] 4 [/SUP], Andrew N Thomas[SUP] 4 [/SUP], Mary U Okoli[SUP] 5 [/SUP], Samuel S Awala[SUP] 4 [/SUP], Blessing N Ugboaja[SUP] 4 [/SUP], Chicago C Achugbu[SUP] 5 [/SUP], Ifeanyichukwu Odoh[SUP] 4 [/SUP], Felicia D Nwatu[SUP] 4 [/SUP], Temitope Olaleye[SUP] 4 [/SUP], Loveth Akayi[SUP] 4 [/SUP], Oluwaseun O Akinmulero[SUP] 4 [/SUP], Joseph Dattijo[SUP] 4 [/SUP], Edewede Onokevbagbe[SUP] 3 [/SUP], Olumide Okunoye[SUP] 1 [/SUP], Nwando Mba[SUP] 5 [/SUP], Ndidi P Agala[SUP] 4 [/SUP], Mabel Uwandu[SUP] 2 [/SUP], Maureen Aniedobe[SUP] 2 [/SUP], Kristen A Stafford[SUP] 6 [/SUP], Alash'le Abimiku[SUP] 4 6 [/SUP], Yohhei Hamada[SUP] 7 [/SUP], Mahesh Swaminathan[SUP] 1 [/SUP], McPaul I Okoye[SUP] 1 [/SUP], Laura C Steinhardt[SUP] 8 [/SUP], Rosemary Audu[SUP] 2 [/SUP]
Affiliations
- PMID: 35363818
- DOI: 10.1371/journal.pone.0266184
Abstract
Objective: 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.
Methods: 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).
Results: 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).
Conclusions: 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.