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Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
01, 2022;146 105061.

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, Bernadette Kutima, Kennedy Mwai, Henry K Karanja, John N Gitonga, Daisy Mugo, Sophie Uyoga, James Tuju, Lynette I Ochola-Oyier, Francis Ndungu, Philip Bejon, Ambrose Agweyu, Ifedayo M O Adetifa, J Anthony G Scott, George M Warimwe
Author Information
  1. James Nyagwange: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya. Electronic address: jnyagwange@kemri-wellcome.org.
  2. Bernadette Kutima: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  3. Kennedy Mwai: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, 27 St Andrews Road, Parktown 2193, Johannesburg, South Africa.
  4. Henry K Karanja: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  5. John N Gitonga: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  6. Daisy Mugo: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  7. Sophie Uyoga: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  8. James Tuju: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  9. Lynette I Ochola-Oyier: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  10. Francis Ndungu: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  11. Philip Bejon: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya; Nuffield Department of Medicine, Oxford University, OX3 7BN, Oxford, United Kingdom.
  12. Ambrose Agweyu: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
  13. Ifedayo M O Adetifa: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya; Department of Infectious Diseases Epidemiology, London School of Hygiene and Tropical Medicine, WC1E 7HT, Keppel Street, London, United Kingdom.
  14. J Anthony G Scott: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya; Department of Infectious Diseases Epidemiology, London School of Hygiene and Tropical Medicine, WC1E 7HT, Keppel Street, London, United Kingdom.
  15. George M Warimwe: KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya; Nuffield Department of Medicine, Oxford University, OX3 7BN, Oxford, United Kingdom.
PMID: 34973474 DOI: 10.1016/j.jcv.2021.105061

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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Grants

  1. /Wellcome Trust
  2. MR/S005293/1/Medical Research Council

MeSH Term

Antibodies, Viral
COVID-19
Cross-Sectional Studies
Enzyme-Linked Immunosorbent Assay
Humans
Immunoglobulin G
Kenya
SARS-CoV-2
Sensitivity and Specificity
Seroepidemiologic Studies
Spike Glycoprotein, Coronavirus

Chemicals

Antibodies, Viral
Immunoglobulin G
Spike Glycoprotein, Coronavirus
Journal Article Research Support, Non-U.S. Gov't
Article has an altmetric score of 6

Word Cloud

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