Performance of a rapid antigen test for SARS-CoV-2 in Kenya

doi:10.1016/j.diagmicrobio.2021.115591

Multicenter Study

. 2022 Feb;102(2):115591.

doi: 10.1016/j.diagmicrobio.2021.115591. Epub 2021 Nov 1.

Performance of a rapid antigen test for SARS-CoV-2 in Kenya

Affiliations

¹ Department of Pathology, Aga Khan Hospital, Kisumu, Kenya; Department of Pathology, Maseno University, Private Bag, Maseno, Kenya. Electronic address: simonya@live.com.
² Malaria Branch, KEMRI/Centre for Global Health Research (CGHR), Kisumu, Kenya.
³ Department Global Health University of Amsterdam, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
⁴ Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.
⁵ Department of Research & Learning, Pharmaccess Foundation, Amsterdam, The Netherlands.
⁶ Department of Health, Kisumu County, Kisumu, Kenya.
⁷ Department Global Health University of Amsterdam, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands; Department of Research & Learning, Pharmaccess Foundation, Amsterdam, The Netherlands.

PMID: 34920265
PMCID: PMC8558097
DOI: 10.1016/j.diagmicrobio.2021.115591

Multicenter Study

Performance of a rapid antigen test for SARS-CoV-2 in Kenya

Simon N Onsongo et al. Diagn Microbiol Infect Dis. 2022 Feb.

. 2022 Feb;102(2):115591.

doi: 10.1016/j.diagmicrobio.2021.115591. Epub 2021 Nov 1.

Authors

Affiliations

¹ Department of Pathology, Aga Khan Hospital, Kisumu, Kenya; Department of Pathology, Maseno University, Private Bag, Maseno, Kenya. Electronic address: simonya@live.com.
² Malaria Branch, KEMRI/Centre for Global Health Research (CGHR), Kisumu, Kenya.
³ Department Global Health University of Amsterdam, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
⁴ Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.
⁵ Department of Research & Learning, Pharmaccess Foundation, Amsterdam, The Netherlands.
⁶ Department of Health, Kisumu County, Kisumu, Kenya.
⁷ Department Global Health University of Amsterdam, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands; Department of Research & Learning, Pharmaccess Foundation, Amsterdam, The Netherlands.

PMID: 34920265
PMCID: PMC8558097
DOI: 10.1016/j.diagmicrobio.2021.115591

Abstract

Testing for SARS-CoV-2 in resource-poor settings remains a considerable challenge. Gold standard nucleic acid tests are expensive and depend on availability of expensive equipment and highly trained laboratory staff. More affordable and easier rapid antigen tests are an attractive alternative. This study assessed field performance of such a test in western Kenya. We conducted a prospective multi-facility field evaluation study of NowCheck COVID-19 Ag-RDT compared to gold standard PCR. Two pairs of oropharyngeal and nasopharyngeal swabs were collected for comparative analysis. With 997 enrolled participants the Ag-RDT had a sensitivity 71.5% (63.2-78.6) and specificity of 97.5% (96.2-98.5) at cycle threshold value <40. Highest sensitivity of 87.7% (77.2-94.5) was observed in samples with cycle threshold values ≤30. NowCheck COVID-19 Ag-RDT performed well at multiple healthcare facilities in an African field setting. Operational specificity and sensitivity were close to WHO-recommended thresholds.

Keywords: COVID-19 testing; Developing country; Point of care testing; SARS COV-2.

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References

1. Africa CDC New guidance to expand rapid antigen testing for COVID-19 response in Africa released. Africa CDC. 2020 https://africacdc.org/news-item/new-guidance-to-expand-rapid-antigen-tes... Available at: Accessed July 17, 2021.
1. Botti-Lodovico Y, Rosenberg E, Sabeti PC. Testing in a pandemic — improving access, coordination, and prioritization. N Engl J Med. 2021;384:197–199. doi: 10.1056/NEJMp2025173. - DOI - PubMed
1. Ebrahimi M, Harmooshi NN, Rahim F. Diagnostic utility of antigen detection rapid diagnostic tests for Covid- 19: a systematic review and meta-analysis. MedRxiv. 2021 doi: 10.1101/2021.04.02.21254714. 2021.04.02.21254714. - DOI - PMC - PubMed
1. Eshghifar N, Busheri A, Shrestha R, Beqaj S. Evaluation of analytical performance of seven rapid antigen detection kits for detection of SARS-CoV-2 virus. Int J Gen Med. 2021;14:435. doi: 10.2147/IJGM.S297762. - DOI - PMC - PubMed
1. Gates B. Responding to Covid-19 — a once-in-a-century pandemic? N Engl J Med. 2020;382:1677–1679. doi: 10.1056/NEJMp2003762. - DOI - PubMed

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[1] Africa CDC New guidance to expand rapid antigen testing for COVID-19 response in Africa released. Africa CDC. 2020 https://africacdc.org/news-item/new-guidance-to-expand-rapid-antigen-tes... Available at: Accessed July 17, 2021.

[2] Africa CDC New guidance to expand rapid antigen testing for COVID-19 response in Africa released. Africa CDC. 2020 https://africacdc.org/news-item/new-guidance-to-expand-rapid-antigen-tes... Available at: Accessed July 17, 2021.

[3] Botti-Lodovico Y, Rosenberg E, Sabeti PC. Testing in a pandemic — improving access, coordination, and prioritization. N Engl J Med. 2021;384:197–199. doi: 10.1056/NEJMp2025173. - DOI - PubMed

[4] Botti-Lodovico Y, Rosenberg E, Sabeti PC. Testing in a pandemic — improving access, coordination, and prioritization. N Engl J Med. 2021;384:197–199. doi: 10.1056/NEJMp2025173. - DOI - PubMed

[5] Ebrahimi M, Harmooshi NN, Rahim F. Diagnostic utility of antigen detection rapid diagnostic tests for Covid- 19: a systematic review and meta-analysis. MedRxiv. 2021 doi: 10.1101/2021.04.02.21254714. 2021.04.02.21254714. - DOI - PMC - PubMed

[6] Ebrahimi M, Harmooshi NN, Rahim F. Diagnostic utility of antigen detection rapid diagnostic tests for Covid- 19: a systematic review and meta-analysis. MedRxiv. 2021 doi: 10.1101/2021.04.02.21254714. 2021.04.02.21254714. - DOI - PMC - PubMed

[7] Eshghifar N, Busheri A, Shrestha R, Beqaj S. Evaluation of analytical performance of seven rapid antigen detection kits for detection of SARS-CoV-2 virus. Int J Gen Med. 2021;14:435. doi: 10.2147/IJGM.S297762. - DOI - PMC - PubMed

[8] Eshghifar N, Busheri A, Shrestha R, Beqaj S. Evaluation of analytical performance of seven rapid antigen detection kits for detection of SARS-CoV-2 virus. Int J Gen Med. 2021;14:435. doi: 10.2147/IJGM.S297762. - DOI - PMC - PubMed

[9] Gates B. Responding to Covid-19 — a once-in-a-century pandemic? N Engl J Med. 2020;382:1677–1679. doi: 10.1056/NEJMp2003762. - DOI - PubMed

[10] Gates B. Responding to Covid-19 — a once-in-a-century pandemic? N Engl J Med. 2020;382:1677–1679. doi: 10.1056/NEJMp2003762. - DOI - PubMed

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Performance of a rapid antigen test for SARS-CoV-2 in Kenya

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Performance of a rapid antigen test for SARS-CoV-2 in Kenya

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