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Iriemenam, Nnaemeka C; Ige, Fehintola A; Greby, Stacie M; Mpamugo, Augustine; Abubakar, Ado G; Dawurung, Ayuba B; Esiekpe, Mudiaga K; Thomas, Andrew N; Okoli, Mary U; Awala, Samuel S; Ugboaja, Blessing N; Achugbu, Chicago C; Odoh, Ifeanyichukwu; Nwatu, Felicia D; Olaleye, Temitope; Akayi, Loveth; Akinmulero, Oluwaseun O; Dattijo, Joseph; Onokevbagbe, Edewede; Okunoye, Olumide; Mba, Nwando; Agala, Ndidi P; Uwandu, Mabel; Aniedobe, Maureen; Stafford, Kristen A; Abimiku, Alash'le; Hamada, Yohhei; Swaminathan, Mahesh; Okoye, McPaul I; Steinhardt, Laura C; Audu, Rosemary
PloS one, 04/2022, Letnik: 17, Številka: 4Journal Article
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. 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). 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). 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.
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