Article Category:
Research Article

The Performance of a Rapid Coronavirus Disease 2019 Antigen Test in Rural Gabon

Saskia Dede Davi Center of Tropical Medicine, Bernhard-Nocht Institute for Tropical Medicine & I. Dept. of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany;
German Center for Infection Research, Partner Site Hamburg-Lübeck-Borstel-Riems, Hamburg, Germany;
Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;

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Dearie Glory Okwu Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;

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Lillian Rene Endamne Center of Tropical Medicine, Bernhard-Nocht Institute for Tropical Medicine & I. Dept. of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany;

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Teite Rebecca Hildebrandt Center of Tropical Medicine, Bernhard-Nocht Institute for Tropical Medicine & I. Dept. of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany;
German Center for Infection Research, Partner Site Hamburg-Lübeck-Borstel-Riems, Hamburg, Germany;

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Rella Zoleko-Manego Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;

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Ghyslain Mombo-Ngoma German Center for Infection Research, Partner Site Hamburg-Lübeck-Borstel-Riems, Hamburg, Germany;
Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;
Department of Implementation Research, Bernhard-Nocht Institute for Tropical Medicine, Hamburg, Germany;

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Maradona Daouda Agbanrin Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;

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Rafiou Adamou Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;

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Ayola Akim Adegnika Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;
Institut für Tropenmedizin, Eberhard-Karls-Universität Tübingen, Tübingen, Germany

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Selidji Todagbe Agnandji Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;
Institut für Tropenmedizin, Eberhard-Karls-Universität Tübingen, Tübingen, Germany

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Michael Ramharter Center of Tropical Medicine, Bernhard-Nocht Institute for Tropical Medicine & I. Dept. of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany;
German Center for Infection Research, Partner Site Hamburg-Lübeck-Borstel-Riems, Hamburg, Germany;
Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon;

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Johannes Mischlinger Center of Tropical Medicine, Bernhard-Nocht Institute for Tropical Medicine & I. Dept. of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany;
German Center for Infection Research, Partner Site Hamburg-Lübeck-Borstel-Riems, Hamburg, Germany;

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DOI:
https://doi.org/10.4269/ajtmh.24-0230
Volume/Issue:
Ahead of Print
Open access
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Access to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing is limited in rural sub-Saharan Africa. We evaluated the performance of the Siemens CLINITEST® rapid coronavirus disease 2019 antigen test under real-life conditions during the pandemic in rural Gabon. From August 2021 to February 2022, 277 participants were tested in Sindara and Lambaréné, Gabon, via outpatient mobile services. Of these participants, 54.6% were female, with a median age of 29 years (interquartile range: 12–55). The test performance was analyzed for the main population and for SARS-CoV-2 infected sub-populations at both study sites (Lambaréné and Sindara). We further evaluated subpopulations with higher viral loads using a cycle threshold (Ct) value restricted to <35, 30, 25, and 20. Overall test sensitivity in the main population was 33.3% (95% CI: 23.6–44.3%), improving to 83.3% (95% CI: 35.9–99.6%) with a Ct value of <20. Specificity across all populations was 100% (190/190; 95% CI: 98.1–100%). The prevalence of polymerase chain reaction-defined SARS-CoV-2 was 31.4%. The positive predictive value was 100% (95% CI: 88.1–100%), and negative predictive value was 76.6% (95% CI: 70.8–81.7%). Sensitivity in Sindara was 71.4% (95% CI: 29–96.3%) and 30% (95% CI: 20.3–41.3%) in Lambaréné. The Siemens CLINITEST® demonstrated high specificity but low sensitivity overall. However, it exceeded the WHO-defined quality criteria of 80% in participants with high viral loads, making it a useful tool in resource-limited settings.

Author Notes

Data availability: The datasets generated and analyzed for this study cannot be shared because the data are still being used for further manuscripts. Once all analyses are complete, the data will be available upon request.

Financial support: The German Agency for International Cooperation GmbH funded this study. This work was also supported by the German Center for Infection Research, the Deutsche Gesellschaft für Internationale Zusammenarbeit (grant number 81281913). The funders had no role in the study’s design, conduct, analysis, or interpretation.

Disclosures: Ethical approval for this study was granted by the Institutional Ethical Committee of Centre de Recherches Médicales de Lambaréné (reference number: CEI – 002/2021, date of approval: June 30, 2021). All study procedures were conducted in accordance with good clinical and laboratory practice and the ethical principles of the Helsinki Declaration of 1964. The confidentiality, anonymity, and privacy of all records were guaranteed at all levels of this study through the use of specific codes. Written informed consent was obtained from all study participants before inclusion.

Authors’ contributions: Conceptualization: M. Ramharter, A. A. Adegnika, and R. Adamou; formal analysis: J. Mischlinger and S. D. Davi; funding acquisition: S. D. Davi and M. Ramharter; investigation: S. D. Davi, T. R. Hildebrandt, D. G. Okwu, and L. Endamne; methodology: J. Mischlinger, M. Ramharter, and S. D. Davi; project administration: J. Mischlinger, M. Ramharter, S. D. Davi, D. G. Okwu, G. Mombo-Ngoma, and R. Zoleko-Manego; resources: G. Mombo-Ngoma, R. Zoleko-Manego, M. Ramharter, A. A. Adegnika, and S. T. Agnandji; supervision: G. Mombo-Ngoma, R. Zoleko-Manego, M. Ramharter, J. Mischlinger, A. A. Adegnika, S. T. Agnandji, and M. D. Agbanrin; writing—original draft: S. D. Davi; writing—review and editing: M. Ramharter and J. Mischlinger.

Current contact information: Saskia Dede Davi, Lillian Rene Endamne, Teite Rebecca Hildebrandt, Michael Ramharter, and Johannes Mischlinger, Center for Tropical Medicine Bernhard-Nocht Institute for Tropical Medicine & I. Dep. Of Medicine, University Medical Center Hamburg, Hamburg, Germany, E-mails: saskia.davi@ctm.bnitm.de, elilianrene@gmail.com, teite.hildebrandt@ctm.bnitm.de, ramharter@ctm.bnitm.de, and johannes.mischlinger@ctm.bnitm.de. Dearie Glory Okwu, Rella Zoleko-Manego, Ghyslain Mombo-Ngoma, Maradona Daouda Agbanrin, Rafiou Adamou, Ayola Akim Adegnika, and Selidji Todagbe Agnandji, Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon, E-mails: dearieokwu@yahoo.com, manegorella@yahoo.fr, ghyslain.mombo-ngoma@bnitm.de, daouda_agbanrin@yahoo.fr, adamourafiou@gmail.com, aadegnika@cermel.org, and agnandjis@cermel.org.

Address correspondence to Johannes Mischlinger, Bernhard Nocht Institute for Tropical Medicine, Bernhard-Nocht-Straße 74, 20359 Hamburg, Germany. E-mail: johannes.mischlinger@ctm.bnitm.de
Copyright:
© The author(s) 2025
Received:
18 Apr 2024
|
Accepted:
21 Oct 2024
|
Published Online:
18 Feb 2025
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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