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. 2022 Jan:146:105061.
doi: 10.1016/j.jcv.2021.105061. Epub 2021 Dec 27.

Comparative performance of WANTAI ELISA for total immunoglobulin to receptor binding protein and an ELISA for IgG to spike protein in detecting SARS-CoV-2 antibodies in Kenyan populations

James Nyagwange  1 , Bernadette Kutima  2 , Kennedy Mwai  3 , Henry K Karanja  2 , John N Gitonga  2 , Daisy Mugo  2 , Sophie Uyoga  2 , James Tuju  2 , Lynette I Ochola-Oyier  2 , Francis Ndungu  2 , Philip Bejon  4 , Ambrose Agweyu  2 , Ifedayo M O Adetifa  5 , J Anthony G Scott  5 , George M Warimwe  4
Affiliations

Comparative performance of WANTAI ELISA for total immunoglobulin to receptor binding protein and an ELISA for IgG to spike protein in detecting SARS-CoV-2 antibodies in Kenyan populations

James Nyagwange et al. J Clin Virol. 2022 Jan.

Abstract

Many SARS-CoV-2 antibody detection assays have been developed but their differential performance is not well described. In this study we compared an in-house (KWTRP) ELISA which has been used extensively to estimate seroprevalence in the Kenyan population with WANTAI, an ELISA which has been approved for widespread use by the WHO. Using a wide variety of sample sets including pre-pandemic samples (negative gold standard), SARS-CoV-2 PCR positive samples (positive gold standard) and COVID-19 test samples from different periods (unknowns), we compared performance characteristics of the two assays. The overall concordance between WANTAI and KWTRP was 0.97 (95% CI, 0.95-0.98). For WANTAI and KWTRP, sensitivity was 0.95 (95% CI 0.90-0.98) and 0.93 (95% CI 0.87-0.96), respectively. Specificity for WANTAI was 0.98 (95% CI, 0.96-0.99) and 0.99 (95% CI 0.96-1.00) while KWTRP specificity was 0.99 (95% CI, 0.98-1.00) and 1.00 using pre-pandemic blood donors and pre-pandemic malaria cross-sectional survey samples respectively. Both assays show excellent characteristics to detect SARS-CoV-2 antibodies.

Keywords: IgG; Immunoassay; SARS-CoV-2; Serology; Total immunoglobulin.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig 1
Fig. 1
Distribution of OD ratios of the KWTRP ELISA in 2020 and in 2021 using 467 gold standard negatives as a test population. The cut-off for positivity is shown with the dotted lines.
Fig 2
Fig. 2
ROC curves for WANTAI and KWTRP ELISAs using all gold standard positives and all gold standard negatives as a test population.
Fig 3
Fig. 3
Reproducibility of the WANTAI (A) and KWTRP (B) ELISAs by examining the raw ODs and coefficient of variation for the negative and positive controls for all the test runs done during the comparison. WANTAI negative control ODs were expected to be ≤ 0.100 and ≥1 for positive controls while the KWTRP negative control ODs were expected to be < 0.2 and >3 for positive controls. Performance of both ELISAs was as expected with little inter-assay variation.
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