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Evaluation of Covid-19 antigen rapid diagnostic tests for self-testing in Lesotho and Zambia

Bresser, M.; Erhardt, R. M.; Shanaube, K.; Simwinga, M.; Mahlatsi, P. A.; Belus, J.; Schaap, A.; Amstutz, A.; Gachie, T.; Glass, T. R.; Kangolo, B.; 'Mota, J.; Floyd, S.; Katende, B.; Klinkenberg, E.; Ayles, H.; Reither, K.; Ruperez, M.

2022-12-23 public and global health
10.1101/2022.12.21.22283827 medRxiv
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BackgroundThe use of antigen rapid tests (Ag-RDTs) for self-testing is an important element of the COVID-19 control strategy and has been widely supported. However, scale-up of self-testing for COVID-19 in sub-Saharan Africa is still insufficient and there is limited evidence on the acceptability of self-testing and agreement between Ag-RDT self-testing and Ag-RDT testing by professional users. A joint collaboration (BRCCH-EDCTP COVID-19 Initiative) was established between Lesotho and Zambia to address these gaps in relation to Ag-RDT self-testing and contribute to increasing its use in the region. MethodsA cross-sectional study was conducted with qualitative and quantitative data analysis. Firstly, 11 in-depth cognitive interviews (5 in Zambia and 9 in Lesotho) were performed to assess the participants understanding of the instructions for use (IFU) for self-testing. In a second step, evaluation of test agreement between Ag-RDT self-testing and Ag-RDT testing by professional user using SD Biosensor STANDARD Q COVID-19 Ag-RDT was performed. In Zambia, usability and acceptability of self-testing were also assessed. ResultsCognitive interviews in Lesotho and Zambia showed overall good understanding of IFU. In Zambia, acceptability of self-testing was high, though some participants had difficulties in conducting certain steps in the IFU correctly. Agreement between Ag-RDT self-test and Ag-RDT by professional users in Lesotho (428 participants) and Zambia (1136 participants) was high, 97.6% (404/414, 95% CI: 95.6-99.8) and 99.8% (1116/1118, 95% CI: 99.4-100) respectively. ConclusionFindings from this study support the use of Ag-RDT self-testing within COVID-19 control strategies in sub-Saharan Africa, contributing to increase the testing capacity and access in hard-to reach settings.

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