Date Published: April 15, 2019
Publisher: Public Library of Science
Author(s): Walter Devillé, Hugo Tempelman, Bruno Verhasselt.
HIV-self-testing (HIVST) could be a strategy to get more people tested for HIV in resource limited settings. One of the prerequisites of a successful HIVST programme is the availability of an easy to use, valid HIV-test which is robust against field conditions and procedural errors by untrained lay users.
The primary objective of this study was to evaluate the ability of untrained persons to correctly interpret the OraQuick HIV Self-Test results with oral fluid compared with results obtained by trained users using the matched lot OraQuick Rapid HIV-1/2 Antibody Test and blinded to the results of the Self-Test. Sensitivity of the OraQuick HIV Self-Test in untrained users was 101 in 102 (99.02%; 95%CI = 93.88–99.95%)—and specificity– 1,241 in 1,241 (100.0%; 95%CI = 99.62–100.0%). Forty-eight Self-Tests were excluded in the accuracy analysis (due to a result read as invalid, not sure or ambiguous) resulting in a test system failure rate of 3.45% (95% CI 2.56%-4.55%). At least one observation of difficulty or error with one or more of the test steps were seen in 1,193 (84.6%) participants. Age, education and health literacy were independently associated with the sum score of procedural errors and difficulties. Four tests did not provide a valid result as determined by the trained user’s interpretation of the Self-Test.
The OraQuick HIV Self-Test provides reliable and repeatable results in a rural field environment in spite of procedural errors.
In 2014, UNAIDS launched the global campaign 90-90-90 aiming that at least 90% of people infected by HIV should be aware of their status by 2020 . If the campaign resulted in having 90% of HIV positive persons in treatment and 90% virological suppressed, it would be a step toward preventing the further spread of the epidemic. Globally 70% of HIV infected people are aware of their status . In South-Africa, still experiencing one of the major HIV epidemics, various HIV testing efforts and strategies resulted in 2014, in 48% of the estimated 7 million HIV+ persons being on antiretroviral treatment and 79% of treated patients being virally suppressed . In 2015, more than 10 million people in South-Africa were tested for HIV (19% of the population) .
The primary endpoint was to establish the performance of the OraQuick HIV Self-Test using oral fluid in the hands of an untrained user in a rural setting in a population with a relatively lower educational level. Sensitivity (99.02%) and specificity (100.0%) were high. Validity figures were similar to the ones in a supervised oral Self-Test study in rural Kwazulu-Natal, whereby the Self-Test was demonstrated to the participants by counsellors, with a sensitivity of 98.7% and specificity of 100% [15, 21]. Studies reporting the validity of the OraQuick Rapid HIV-1/2 Antibody Test in Zambia and Malawi reported respectively a sensitivity of 98.7 and 93.6% and a specificity of 99.8 and 99.9% [22, 23].
The OraQuick HIV Self-Test seems to be robust and provide reliable results in a rural population. Self-testing remains prone to procedural errors and difficulties requiring a robust test. Self-Test instructions and procedures require simple steps, easy devices and simple and clear pictural instructions to be tested in various target populations. Still the performance of self-testing in private circumstances in local African populations might need more evidence.