An orally taken test for HIV might slow increasing infection rates if the Therapeutic Goods Administration approved it for use in Australia, according to research published in the Medical Journal of Australia.
In Australia's largest multicentre trial, the OraQuick Advance Rapid HIV-1/2 Antibody Test (ORT) was given to 1074 Sydney men who have sex with men (MSM) and other people at high-risk aged over 18 years of age who attended 8 public, private and community sites in 2013. The ORT is a painless, simple two-step process that involves a swab from the mouth placed into a developer solution, Preliminary results are available in 20 minutes. It is important to note that the ORT is a screening test and does not replace the available diagnostic blood tests available in Australia. The Food and Drug Administration approved the ORT for clinical use in 2004 and home testing in 2012 in the United States.
The results confirmed that the ORT is both sensitive and specific when compared with the standard fourth generation HIV enzyme immunoassay (EIA), and also highly acceptable to the patients.
Three-quarters (74.0%) of the participants found the ORT less stressful than giving a conventional blood sample. Nearly all (99.2%) said they would have an ORT again and 99.4% said they would recommend ORT to their peers. However, they were not asked whether having to pay for the test would affect their decision to be tested again. Most (69.1%) said approval by the Therapeutic Goods Administration would "encourage testing".
"The incidence of HIV in Australia has steadily increased since the nadir of 724 infections in 1999, to a 15-year high of 1236 cases in 2013", the researchers, led by Associate Professor Derek Chan, a staff specialist at the Albion Centre, part of South Eastern Sydney Local Health District, wrote.
"This increase has happened despite 90% uptake of antiretroviral therapy among patients with HIV, more of them attaining undetectable viral load (58% in 2004 compared with 88% in 2013) and ongoing prevention efforts (safer sex promotion, testing campaigns, post-exposure prophylaxis)." Increasing HIV testing rates is a key part of addressing this increase, and the ORT may facilitate this by removing barriers to testing.
The ORT was conducted by trained staff or site investigators and the result was interpreted by two staff members: as reactive or non-reactive or invalid. All participants consented to both the ORT and the available confirmatory EIA test performed by the study site laboratory. There were 11 true-positive ORT results, two false-negative (non-reactive) results (both were early infections), one false-positive (reactive) result (due to reader error) and 1060 true negative (or true nonreactive) results. Participants with non-reactive results were asked the survey questions, while those with reactive results were not surveyed and received immediate counselling and medical review.
The sensitivity of the ORT may be reduced by - reader error and early infection. Using serological tests to confirm only the reactive ORT results is practical in the general population at low risk of HIV infection. However, during early HIV infection the sensitivity of the ORT is decreased and the authors recommend that clinicians consider confirmatory tests in high-risk populations. Recent exposure, symptoms of seroconversion and consideration of the "window period" should guide this decision.
The researchers concluded that: "HIV rapid tests such as the ORT can play a key role in early diagnosis, initiation of antiretroviral therapy and preventing transmission, particularly among MSM and individuals at high risk".
"This will deliver clear individual and public health benefits. As is the case in the US, we believe the ORT is an appropriate alternative rapid test to tackle Australia's HIV epidemic.
"The main advantage of the ORT is the simple two-step process making it ideal for home testing."