PATH-led evaluation of four HIV diagnostic products helps advance HIV self-testing efforts

February 1, 2023 by PATH

PATH and partners found four blood-based HIV self-test kits to be acceptable, feasible, and accurate in testing for HIV in Vietnam

Hanoi, Vietnam, February 1, 2023—A new study published in PLOS Global Public Health has demonstrated high acceptability, feasibility, and accuracy of four blood-based HIV self-testing (HIVST) products in Vietnam. This provides essential evidence to inform the scale-up of HIVST in Vietnam and other low- and middle-income countries (LMICs).

HIVST—which involves collecting one’s own oral fluid or blood specimen and using a rapid HIV test kit to determine the presence of HIV antibodies—has been recommended by the World Health Organization since 2016 as a safe, accurate, and effective way to reach people who might not otherwise test. However, barriers prevent the adoption and scale-up of HIVST in LMICs (and scale-up of blood-based HIVST in particular), including concerns around accuracy, feasibility, acceptability, and cost of the tests. Offering greater HIVST product choice to those who seek HIV testing could increase testing uptake and access to essential HIV prevention and treatment services.

PATH, in collaboration with Ezintsha/Wits Health Consortium at the University of Witwatersrand in Johannesburg, South Africa, and the Pasteur Institute in Ho Chi Minh City, Vietnam, conducted a cross-sectional study in Ho Chi Minh City to evaluate the usability and performance of four blood-based HIVST devices: INSTI (bioLytical Laboratories, Canada), SURE CHECK (Chembio Diagnostic Systems, USA), BioSURE (BioSure Ltd., United Kingdom), and CheckNOW (Abbott Diagnostics, USA).

The results indicated extremely high acceptability of the tests, with approximately 94 percent of participants reporting desire to use the test in the future and willingness to recommend the test to their peers. In addition, 91 percent of participants successfully completed the self-tests, and the evaluated products showed high sensitivity and specificity—two key indicators used to determine the accuracy and potential use of diagnostic tests. Users’ preferred average price point for HIVST was on par with the price of HIVST in Vietnam’s public sector but lower than current private-sector prices in the country.

“This study is part of an overall effort to design and deliver innovative HIV testing approaches in Vietnam and across LMICs. Findings from this study provide strong evidence for promoting self-testing as an essential strategy in achieving the UNAIDS 95-95-95 targets and global goal of ending AIDS by 2030,” said Vu Ngoc Bao, MD, Senior Technical Director at PATH, who led this study and provides technical leadership in HIV testing innovations in Southeast Asia.

HIVST helps break down barriers that prevent access to HIV testing among populations most at risk, making it a crucial strategy for ending AIDS by 2030. PATH and its partners will use results from this study to inform catalytic market and service delivery interventions that increase access to affordable and user-preferred blood-based HIVST.

This study was made possible through the generous support of the Bill & Melinda Gates Foundation and Abbott Laboratories.