Back to Search Start Over

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

Authors :
Mohammed Majam
Naleni Rhagnath
Vanessa Msolomba
Leanne Singh
Michael S. Urdea
Samanta T. Lalla-Edward
Source :
Diagnostics, Vol 11, Iss 9, p 1727 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

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.

Details

Language :
English
ISSN :
20754418
Volume :
11
Issue :
9
Database :
Directory of Open Access Journals
Journal :
Diagnostics
Publication Type :
Academic Journal
Accession number :
edsdoj.64573a6f20f43db9f53ce42c69565d0
Document Type :
article
Full Text :
https://doi.org/10.3390/diagnostics11091727