7738_xml
20210129080000
assa
nadiag@assaf.org.za
assa
South African Journal of Science
S. Afr. J. Sci
1996-7489
01292021
117
1/2
Performance assessment of four HIV self-test devices in South Africa: A cross-sectional study
Mohammed
Majam
Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
https://orcid.org/0000-0003-0302-5353
Alex E.
Fischer
Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
https://orcid.org/0000-0002-6882-7245
Naleni
Rhagnath
Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
https://orcid.org/0000-0003-1798-7887
Vanessa
Msolomba
Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
https://orcid.org/0000-0002-4063-7167
Willem D.F.
Venter
Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
https://orcid.org/0000-0002-4157-732X
Laura
Mazzola
Halteres Associates, San Francisco, California, USA
https://orcid.org/0000-0001-8404-3443
Samanta T.
Lalla-Edward
Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
https://orcid.org/0000-0003-3597-1643
HIV self-testing (HIVST) has been introduced to supplement existing HIV testing methods to increase the number of people knowing their HIV status. Various HIVST kits have been developed; however, in many countries, their entry into the market is contingent on either being listed as World Health Organization (WHO) prequalified diagnostics/products or being approved by that country’s health device regulator or both. In this cross-sectional study, we evaluated the usability, sensitivity and specificity of HIVSTs, as directed by the WHO prequalification literature. A boxed, sealed HIVST kit was provided to enrolled lay users with no further instruction, who then performed the test under observation. For each HIVST, a product-specific semi-structured checklist was used to calculate a usability index, while the sensitivity and specificity of each HIVST were calculated by comparing the HIVST results to the ‘gold standard’ – fourth-generation ELISA laboratory blood test. The average usability index was 97.1% (95.9–97.8%), while the average sensitivity and specificity were 98.2% (96.8–99.3%) and 99.8% (99.4–100.0%), respectively. We also diagnosed 507 (15.1%) HIV-positive participants from the general population. The average usability index, sensitivity and specificity were all comparatively high, and these results corroborate previous usability and performance studies from other regions. These results suggest HIVSTs are appropriate for the South African market and can assist manufacturers with readying their devices for final WHO prequalification evaluation.
01292021
1
10.17159/sajs.2016/crossmark
sajs.co.za
false
2019-12-17
2020-08-25
2021-01-29
Bill and Melinda Gates Foundation
http://dx.doi.org/10.13039/100000865
OPP1132929
Tanya Shewchuk
https://creativecommons.org/licenses/by/4.0/
10.17159/sajs.2021/7738
20210129080000
https://www.sajs.co.za/article/view/7738
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https://www.sajs.co.za/article/view/7738/10813
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https://www.sajs.co.za/article/view/7738/10813
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https://www.sajs.co.za/article/view/7738/10813
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https://www.sajs.co.za/article/view/7738/10813
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https://www.sajs.co.za/article/view/7738/10813
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https://www.sajs.co.za/article/view/7738/10813
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https://www.sajs.co.za/article/view/7738/10813