US approval of new HIV test prompts calls for local action

After the US Food and Drug Administration (US FDA) last week approved the use of the first over-the-counter home testing kit for HIV, a number of leading local HIV/AIDS organisations have shared their frustration over a lack of progress on the local introduction of new technologies such as rapid HIV testing.

Last Tuesday, the US FDA approved the use of the OraQuick test developed by OraSure Technologies which offers users results of their HIV status 20-40 minutes after taking a mouth swab.

While approving the new testing kit for home use, the US FDA said it did have some concern over the accuracy of OraQuick as the test identifies HIV antibodies in saliva which cannot be detected up to three months from the time of infection.

Clinical studies involving OraQuick have shown while it is accurate 92 per cent of the time when detecting people with the HIV virus, about one person in 5,000 would get a false positive test while about one person in 12 could receive a false negative.

ACON CEO Nicolas Parkhill told SX while he still held concerns over whether self-testing technologies provided appropriate support measures for people who test positive, the FDA’s approval of OraQuick marked an important milestone in attempts to halt the rate of transmission of HIV.  

“The approval by the US FDA of home HIV testing kits has significant implications for advancing HIV testing here in Australia and around the world because oral swab tests provide fast results and are much cheaper and easier to administer,” he said.

Parkhill also said ACON would continue to strongly lobby for the improved access and introduction of proven services which help prevent the transmission of the virus such as rapid HIV testing which already takes place in a number of overseas countries.

“It continues to frustrate us that we know HIV testing needs to be scaled up significantly in order to reduce transmissions rates, and that to date, there has been little progress in the introduction of new technologies or new service models to assist in this,” he said.

Phillip Keen, HIV Health Policy and Program Analyst at the National Association of People Living with HIV/AIDS (NAPWA), echoed similar frustrations and said the organisation was planning a research study of home HIV testing in Australia.

“Home HIV testing would be an attractive option for some people who may not wish to test at a clinic, and it may make it easier to people who should test regularly to do so. However, home tests are not as reliable as clinic-based tests, so they would not be attractive to all,” he told SX.

“NAPWA is calling for urgent action to reinvigorate the Australian HIV response, including the introduction of new testing technologies and other innovations in how testing is provided.”

Currently there are more than 21,000 people in Australia living with diagnosed HIV while close to 7,000 people have died because of AIDS-related illnesses since the 1980s.