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Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites

HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy o...

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Autores principales: Majam, Mohammed, Rhagnath, Naleni, Msolomba, Vanessa, Singh, Leanne, Urdea, Michael S., Lalla-Edward, Samanta T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8465151/
https://www.ncbi.nlm.nih.gov/pubmed/34574068
http://dx.doi.org/10.3390/diagnostics11091727
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author Majam, Mohammed
Rhagnath, Naleni
Msolomba, Vanessa
Singh, Leanne
Urdea, Michael S.
Lalla-Edward, Samanta T.
author_facet Majam, Mohammed
Rhagnath, Naleni
Msolomba, Vanessa
Singh, Leanne
Urdea, Michael S.
Lalla-Edward, Samanta T.
author_sort Majam, Mohammed
collection PubMed
description HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy of the device in comparison to other HIV rapid diagnostic tests (RDT), was assessed to be able to guide the development and adoption of the device in Senegal and South Africa. Using convenience sampling, potential participants were recruited from catchment areas where HIV was prevalent. Trained users performed an HIV test on participants using an Oral HIVST. The professional user’s interpretation of results was then measured against the results of various other RDTs. The South African study had 1652 participants and the Senegalese, 500. Most of the participants in each study were 18–35 years old. Senegal had a higher number of females (346/500, 69.2%) compared to South Africa (699/1662, 42.1%). Asante displayed very high sensitivity and specificity when tested against other devices. In the final enzyme-linked immunosorbent assay (ELISA) comparison, in South Africa, the sensitivity: specificity was 99.1:99.9% and in Senegal, 98.4:100.0%. Senegal further identified 53/63 (84.1%) with HIV-1, 8/63 (12.7) with HIV-2 and 2/63 (3.2%) with HIV-1/2 co-infections. Professional or trained users’ interpretations of Asante results correlated strongly to results when using various RDTs, the ELISA assay and Western blot tests, making it a dependable HIV testing instrument.
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spelling pubmed-84651512021-09-27 Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites Majam, Mohammed Rhagnath, Naleni Msolomba, Vanessa Singh, Leanne Urdea, Michael S. Lalla-Edward, Samanta T. Diagnostics (Basel) Article HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy of the device in comparison to other HIV rapid diagnostic tests (RDT), was assessed to be able to guide the development and adoption of the device in Senegal and South Africa. Using convenience sampling, potential participants were recruited from catchment areas where HIV was prevalent. Trained users performed an HIV test on participants using an Oral HIVST. The professional user’s interpretation of results was then measured against the results of various other RDTs. The South African study had 1652 participants and the Senegalese, 500. Most of the participants in each study were 18–35 years old. Senegal had a higher number of females (346/500, 69.2%) compared to South Africa (699/1662, 42.1%). Asante displayed very high sensitivity and specificity when tested against other devices. In the final enzyme-linked immunosorbent assay (ELISA) comparison, in South Africa, the sensitivity: specificity was 99.1:99.9% and in Senegal, 98.4:100.0%. Senegal further identified 53/63 (84.1%) with HIV-1, 8/63 (12.7) with HIV-2 and 2/63 (3.2%) with HIV-1/2 co-infections. Professional or trained users’ interpretations of Asante results correlated strongly to results when using various RDTs, the ELISA assay and Western blot tests, making it a dependable HIV testing instrument. MDPI 2021-09-20 /pmc/articles/PMC8465151/ /pubmed/34574068 http://dx.doi.org/10.3390/diagnostics11091727 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 T.
Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites
title Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites
title_full Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites
title_fullStr Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites
title_full_unstemmed Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites
title_short Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites
title_sort usability and clinical performance characteristics of the asante hiv1/2 test by trained users in two african sites
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8465151/
https://www.ncbi.nlm.nih.gov/pubmed/34574068
http://dx.doi.org/10.3390/diagnostics11091727
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