Rapid HIV testing approved
Rapid HIV testing, which promises results in under half-an-hour, is set to become a reality next year and beyond with the Therapeutic Goods Administration (TGA) today approving the first rapid HIV test for use in Australia.
The Determine HIV Combo test produced by medical diagnostics and health management company Alere was approved by the TGA this morning following an approval process of over two years, which included a number of trials in selected clinics.
Making the announcement alongside Parliamentary Secretary, Catherine King, who is responsible for the TGA, Health Minister Tanya Plibersek said rapid HIV testing was required with there being 1,137 new HIV diagnoses in Australia in 2011, an increase of more than eight per cent over the number in 2010.
“It is expected that this simple, first line screening, will encourage vulnerable people to be tested more regularly and to undertake further assessment if there is a positive result, enabling treatment to commence if there is a confirmed positive diagnosis,” Plibersek said.
The TGA’s approval was warmly welcomed by the Australian Federation of AIDS Organisations (AFAO), with its executive director Rob Lake saying it was a “significant step” toward meeting the goals outlined in the Melbourne Declaration unveiled in October which includes targets of a 50 per cent reduction in sexual transmission of HIV by 2015.
“Making HIV testing simpler and more accessible for gay men, the most affected community in Australia, will help make the testing experience easier and encourage them to test more often,” Lake said.
“Rapid HIV testing will help make HIV testing easier, increase the level of testing, and enable earlier diagnosis, so it’s very welcome news.”
Research from overseas shows that the speed and convenience of rapid testing encourages more people to get tested more regularly, with regular testing regarded as one of the keys to reducing HIV transmission rates. All positive results picked up by the rapid tests will require confirmation by an alternative method using a diagnostic laboratory test.
Nicolas Parkhill, the CEO of ACON, one of the many groups that have for years been lobbying for the tests’ approval, said the next step of the process was now rolling out rapid HIV testing at sites across the state and country.
“How people will be able to access rapid testing is the next challenge,” Parkhill said.
“Issues such as the cost, who will pay for it, who will be able to administer the test and the locations where it will be delivered all need to be clarified.”
One of the TGA’s conditions of registration will be that rapid testing kits will only be supplied to accredited testing sites, with the accreditation system at this stage still in development.
“In partnership with other community-based HIV organisations, ACON is advocating for a system that will make rapid testing widely available in community as well as clinical settings, as this will significantly increase the number of sites from where people can access the tests,” Parkhill said.
Living Positive Victoria Executive Officer Brent Allan told Gay News Network that in Victoria, the availability of the rapid test will speed up the development of the community based point of care testing clinics.
“In surveys in Australia, people have said if the tests were easier, more convenient and less time consuming they would test more often.
“Well now we will have that and this is great news for them.”
Allan however suggested that governments will need to continue working with HIV organisations in order to develop other successful strategies targeting people who may be at a high risk of infection.
“This isn’t going to tackle the men who have sex with men community. They are not community attached and may still live closeted lifestyles so infections that reside in that population probably won’t be drawn out by this,” he told Gay News Network.
“In order to get those hidden infections that are residing in the Australian public we need lots of different technologies that attend to lots of different people’s anxieties around testing.”
The NSW Government had advocated for the introduction of rapid testing among other initiatives under its new HIV Strategy for 2012-2015 launched on World AIDS Day earlier this month, which the likes of AFAO and ACON have now pointed to as providing a policy framework that all levels of government throughout Australia can replicate.
“With several more HIV tests awaiting approval by the TGA, we are optimistic that in 2013, we will see major expansion of HIV testing,” Lake said.