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J-103 Performance and usability of the OraQuick® HIV Self-test, an oral fluid based HIV self-test, in South Africa

Reed, Michael, PhD*; Majam, Mohammed, MBA, BSc

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 2018 - Volume 77 - Issue - p 51
doi: 10.1097/01.qai.0000532640.01171.34
Abstracts: PDF Only

With 30% of persons living with HIV globally still not knowing their status, increasing access to HIV testing using self-tests is an approach to achieving the United Nations' target goal of diagnosing 90% of all people living with HIV by 2020. The OraQuick HIV Self-Test is an oral fluid based self-test providing results in as little as 20 minutes and is the first self-test to receive WHO Prequalification (July 2017). WHO Prequalification allows access to high quality, easy to use, accurate HIV self-testing in countries wishing to broaden their HIV testing and treatment programs.

This talk describes the results and observations of studies conducted in South Africa to demonstrate ease of use and generation of accurate results in the hands of a lay user. The OraQuick® HIV Self-Test results were compared to results from a fourth Gen EIA with sensitivity of 100% (n=76) and specificity of 99.1% (n=324). A separate comprehension study was conducted to assess lay users' ability to understand information provided on the outer packaging and product insert. Comprehension scores were high 99.5% (n=200) for all critical and safety related concepts. Understanding of the next steps for positive results was 97.5% (n=200) [1].

Many studies have shown and continue to demonstrate that the OraQuick HIV Self-Test is a robust test that provides accurate and reliable results. Incorporating an easy to use oral fluid test into current HIV testing strategies can increase the number of individuals testing, especially those hard to reach high risk populations currently not accessing testing.

*OraSure Technologies, Inc.; and

Wits Reproductive Health and HIV Institute

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