Rapid HIV Test Approved in Australia

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PDF printable version of Rapid HIV Test Approved in Australia (PDF 174 KB)

17 December 2012

A new, on the spot rapid screening test for HIV, which will be able to give a preliminary result within a half an hour, has been approved by the Therapeutic Goods Administration for marketing in Australia, the Minister for Health, Tanya Plibersek, and the Parliamentary Secretary for Health and Ageing, Catherine King, announced today.

The Alere Determine Combo HIV 1/2 Ag/Ab is the first test approved for marketing in Australia that can be used as a point of care test for HIV.

Minister Plibersek said she had been closely following the independent evaluation of this rapid test for HIV by the TGA for some time as it will undoubtedly assist vulnerable people to quickly assess their possible HIV status.

In Australia between 1985 and 30 December 2011 there have been 31,645 HIV infections, 10,797 cases of AIDS and 6,843 deaths.

An estimated 24,731 people were living with diagnosed HIV infection in Australia at the end of 2011.

The number of new HIV diagnoses in Australia in 2011 was 1,137, an increase of 8.2% over the number in 2010. While the number of new diagnoses had been relatively stable at around 1000 over the previous five years there has been a gradually increase over the past 12 years, from 719 diagnoses in 1999.

While the increase rate of new HIV infections is still low by international standards, any increase is of concern. Rapid testing is designed to improve the early detection capability compared to antibody tests alone which can take between 2-3 weeks to 3 months.

“Rapid testing is being used internationally to ensure that people newly infected with HIV can quickly access treatment,” said Ms Plibersek.

“That means better health for the patient and a lower risk of passing on the virus.

"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," she said.

Parliamentary Secretary Catherine King, who is responsible for the TGA, said point of care tests are performed near to, or at the side of, a patient by trained health professionals or care providers. These people have received training so they can interpret test results and advise patients of the results.

"The test will not be available for self-testing at home and the company, as part of the marketing approval, must ensure the product is only supplied to organisations that have been appropriately trained and that participate in a quality assurance program in accordance with the National HIV Testing Policy," Ms King said.

"This will ensure the results are correctly interpreted, that counselling and support is provided to patients and that all positive results are confirmed through referral to a laboratory.

"This is consistent with the current arrangements under the Therapeutic Goods (Excluded Purposes) Specification 2010 which prohibits IVDs for self-testing for serious diseases such as HIV from being legally supplied in Australia."

The test is used as a screen for HIV in the point of care setting. While point of care tests can provide rapid results they are a preliminary screen only. All positive results require confirmation by an alternative method using a diagnostic laboratory test.

The preliminary screening test requires only a finger prick of blood which is transferred to a test card. The test card detects the presence of HIV antigen and antibodies in the blood sample and the result is available within 20-30 minutes.

Supply of the rapid test kit has been limited to ensure that the test is only made available for use by trained health professionals in healthcare settings.

It will be the responsibility of the sponsor, Alere, to distribute the kit to organisations, including laboratories, who meet the requirement of being able to provide appropriate services including care and counselling.