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Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa

The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portl...

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Autores principales: Majam, Mohammed, Rhagnath, Naleni, Msolomba, Vanessa, Singh, Leanne, Urdea, Michael S., Lalla-Edward, Samanta Tresha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8534357/
https://www.ncbi.nlm.nih.gov/pubmed/34679514
http://dx.doi.org/10.3390/diagnostics11101816
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author Majam, Mohammed
Rhagnath, Naleni
Msolomba, Vanessa
Singh, Leanne
Urdea, Michael S.
Lalla-Edward, Samanta Tresha
author_facet Majam, Mohammed
Rhagnath, Naleni
Msolomba, Vanessa
Singh, Leanne
Urdea, Michael S.
Lalla-Edward, Samanta Tresha
author_sort Majam, Mohammed
collection PubMed
description The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland OR, USA) device by novice users was assessed and reported on, to inform for the implementation of such devices in South Africa and elsewhere. Convenience sampling was used. Participants used the Asante HIVST device and recorded their interpretation of their results. Participants’ interpretations were compared with those of trained professionals and, thereafter, verified using the rapid diagnostic testing algorithm. Out of the eligible participants, 410 of the 524 (78.2%) were between the ages of 18–35. The usability assessment indicates that 100% of participants used the HIVST device’s information leaflet. However, 19/524 (3.6%) of participants who yielded an invalid result due to critical errors were excluded from the primary efficacy analysis. The average usability score was 98.1%. The sensitivity and specificity results were, 94.7% and 99.8%, respectively. This study shows that the Asante HIV self-test, and similar devices, can be valuable in providing convenient HIV self-testing and immediately available results. To accommodate a greater number of inexperienced users, the instructions may need to be revised.
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spelling pubmed-85343572021-10-23 Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa Majam, Mohammed Rhagnath, Naleni Msolomba, Vanessa Singh, Leanne Urdea, Michael S. Lalla-Edward, Samanta Tresha Diagnostics (Basel) Article The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland OR, USA) device by novice users was assessed and reported on, to inform for the implementation of such devices in South Africa and elsewhere. Convenience sampling was used. Participants used the Asante HIVST device and recorded their interpretation of their results. Participants’ interpretations were compared with those of trained professionals and, thereafter, verified using the rapid diagnostic testing algorithm. Out of the eligible participants, 410 of the 524 (78.2%) were between the ages of 18–35. The usability assessment indicates that 100% of participants used the HIVST device’s information leaflet. However, 19/524 (3.6%) of participants who yielded an invalid result due to critical errors were excluded from the primary efficacy analysis. The average usability score was 98.1%. The sensitivity and specificity results were, 94.7% and 99.8%, respectively. This study shows that the Asante HIV self-test, and similar devices, can be valuable in providing convenient HIV self-testing and immediately available results. To accommodate a greater number of inexperienced users, the instructions may need to be revised. MDPI 2021-10-01 /pmc/articles/PMC8534357/ /pubmed/34679514 http://dx.doi.org/10.3390/diagnostics11101816 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Majam, Mohammed
Rhagnath, Naleni
Msolomba, Vanessa
Singh, Leanne
Urdea, Michael S.
Lalla-Edward, Samanta Tresha
Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa
title Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa
title_full Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa
title_fullStr Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa
title_full_unstemmed Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa
title_short Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa
title_sort assessment of the sedia hiv self-test device: usability and performance in the hands of untrained users in johannesburg, south africa
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8534357/
https://www.ncbi.nlm.nih.gov/pubmed/34679514
http://dx.doi.org/10.3390/diagnostics11101816
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