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

Simon N. Onsongo; Kephas Otieno; Shannen van Duijn; Emily Adams; Mervis Omollo; Isdora A. Odero; Alloys K'Oloo; Nathalie Houben; Emmanuel Milimo; Robert Aroka; Hellen C. Barsosio; Fredrick Oluoch; Albert Odhiambo; Simon Kariuki; Tobias F.Rinke de Wit

doi:https://doi.org/10.1016/j.diagmicrobio.2021.115591

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

Simon N. Onsongo, Kephas Otieno, Shannen van Duijn, Emily Adams, Mervis Omollo, Isdora A. Odero, Alloys K'Oloo, Nathalie Houben, Emmanuel Milimo, Robert Aroka, Hellen C. Barsosio, Fredrick Oluoch, Albert Odhiambo, Simon Kariuki, Tobias F.Rinke de Wit

Research output: Contribution to journal › Article › Academic › peer-review

8 Citations (Scopus)

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.

Original language	English
Article number	115591
Journal	Diagnostic microbiology and infectious disease
Volume	102
Issue number	2
DOIs	https://doi.org/10.1016/j.diagmicrobio.2021.115591
Publication status	Published - Feb 2022

Keywords

COVID-19 testing
Developing country
Point of care testing
SARS COV-2

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Onsongo, S. N., Otieno, K., van Duijn, S., Adams, E., Omollo, M., Odero, I. A., K'Oloo, A., Houben, N., Milimo, E., Aroka, R., Barsosio, H. C., Oluoch, F., Odhiambo, A., Kariuki, S., & de Wit, T. F. R. (2022). Performance of a rapid antigen test for SARS-CoV-2 in Kenya. Diagnostic microbiology and infectious disease, 102(2), Article 115591. https://doi.org/10.1016/j.diagmicrobio.2021.115591

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title = "Performance of a rapid antigen test for SARS-CoV-2 in Kenya",

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.",

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author = "Onsongo, {Simon N.} and Kephas Otieno and {van Duijn}, Shannen and Emily Adams and Mervis Omollo and Odero, {Isdora A.} and Alloys K'Oloo and Nathalie Houben and Emmanuel Milimo and Robert Aroka and Barsosio, {Hellen C.} and Fredrick Oluoch and Albert Odhiambo and Simon Kariuki and {de Wit}, {Tobias F.Rinke}",

note = "Funding Information: The Netherlands Ministry of Foreign Affairs supported this work through a core grant to Health Insurance Fund Foundation, which supports PharmAccess Foundation and by complementary grants from Achmea Foundation and Pfizer Foundation. The CommCare mobile data collection software was provided by Dimagi free of charge. BioNote Inc provided free RDTs for evaluation. Many thanks to all staff who supported this project. Funding Information: Achmea Foundation, Pfizer Foundation, Dimagi and the Netherlands Ministry of Foreign Affairs supported this project. The funding sources did not have any role in study design, data collection, analysis, interpretation, summarizing the data or decision to submit the manuscript for publication. Publisher Copyright: {\textcopyright} 2021 The Authors",

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AU - Odero, Isdora A.

AU - K'Oloo, Alloys

AU - Houben, Nathalie

AU - Milimo, Emmanuel

AU - Aroka, Robert

AU - Barsosio, Hellen C.

AU - Oluoch, Fredrick

AU - Odhiambo, Albert

AU - Kariuki, Simon

AU - de Wit, Tobias F.Rinke

N1 - Funding Information: The Netherlands Ministry of Foreign Affairs supported this work through a core grant to Health Insurance Fund Foundation, which supports PharmAccess Foundation and by complementary grants from Achmea Foundation and Pfizer Foundation. The CommCare mobile data collection software was provided by Dimagi free of charge. BioNote Inc provided free RDTs for evaluation. Many thanks to all staff who supported this project. Funding Information: Achmea Foundation, Pfizer Foundation, Dimagi and the Netherlands Ministry of Foreign Affairs supported this project. The funding sources did not have any role in study design, data collection, analysis, interpretation, summarizing the data or decision to submit the manuscript for publication. Publisher Copyright: © 2021 The Authors

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N2 - 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.

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

Abstract

Keywords

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