The Australasian Society for HIV Medicine (ASHM) welcomes yesterday's TGA approval of the first point of care HIV test for use in Australia. The Alere Determine HIV Combo test is now registered for use as a preliminary screening test.hr id="system-readmore" />
"This is a welcome and long overdue development," said ASHM Vice President Mr Philip Cunningham. "ASHM has been working in partnership with the sector for many years to deliver a new era of HIV testing to affected communities in Australia. This is another bullet in the armoury for improving HIV screening among at-risk communities."
Point of care tests - also known as rapid HIV tests - allow for on-the-spot HIV screening with results delivered while you wait. ASHM considers their introduction to be an important step in improving rates of testing, particularly in those that might be reluctant to come forward, and has worked hard to develop a framework for the introduction of point of care tests into the community.
"Rapid testing will increase the likelihood that people at risk will come forward for HIV testing and be tested frequently. Diagnosing HIV early is a priority, as this is when the infection is most contagious, and making testing easier also facilitates the identification of HIV at this crucial stage. In short, early diagnosis means earlier treatment, a healthier life, and less risk of transmission," says Cunningham.
Restrictions remain regarding the use of the test. The Alere Determine HIV Combo test is only licensed to be performed by accredited laboratories or by trained health professionals working for certain organisations under specific conditions.
"This is not an over the counter test," explains Cunningham. "This test is only available for use by accredited locations and individuals who have appropriate training to enable them to interpret the results accurately and deliver a positive result. The challenge now is to get the accreditation process implemented."
International research has shown that professional training has an impact on the quality and accuracy of rapid tests. ASHM is developing a Nationally Endorsed Curriculum for point of care testing education; accreditation standards for training providers and standards for certification of authorised operators. An interim panel has been established to oversee its development and will convene in the New Year. The draft document can be viewed at www.ashm.org.au/images/ASHMNews/Dec2012/ASHM_News_30_11_2012.pdf.
"The introduction of rapid HIV tests into Australia is an important step in addressing Action Area 1 of the Melbourne Declaration, which specifically calls for increasing access to, and uptake of, voluntary HIV testing in Australia. We now need to make its use a reality," concluded Cunningham.
About ASHM
ASHM is a peak organisation of health professionals in Australia and New Zealand who work in HIV, viral hepatitis and sexually transmissible infections (STIs). ASHM draws on its experience and expertise to support the health workforce and to contribute to the sector, domestically and internationally.
ASHM support for HIV screening
ASHM has developed a range of resources to facilitate HIV screening, including the Testing Portal, with information about testing, informed consent and delivering results to patients; publications such as Decision-making in HIV and the GPs and HIV booklet and HIV online learning module and the unique Time of HIV Diagnosis Program.
Friday, 4 July, 2025