Rapid Antigen Testing available in Australia from November

Taking a Covid test from the comfort of your own home and getting the result in the space of just 20 minutes will soon be a reality for every Australian.

Taking a Covid-19 test from the comfort of your own home and getting the result in the space of just 20 minutes will soon be a reality for every Australian.

Do-it-yourself rapid antigen tests, which have been used around the world for months, will be available in Australia from November 1, The Daily Telegraph can reveal.

Various rapid antigen tests will be available for sale in Australia from November 1. Picture: Tim Hunter.

Pending the approval of specific test kits by the Therapeutic Goods Administration (TGA), long car queues followed by days in isolation waiting for the traditional PCR test will be a thing of the past.

TGA head Professor John Skerritt said the regulator was working with manufacturers, states and territories “as a priority” to ensure systems were in place for the “reliable safe use of these tests at home”.

“It is anticipated that 70 per cent of Australians across the country will be double vaccinated, triggering phase B of the National plan by the end of October,” he said.

“Therefore a new regulation will be made … permitting the sale and use of home tests after 1 November 2021.”

Professor John Skerritt says the TGA will approve individual tests for use in Australian homes. Picture: NCA NewsWire / Gary Ramage

Prof Skerritt said individual tests would still require approval, but a review of data had “already commenced”.

In contrast to countries like the US and UK where home tests are widely available, Australia has so far mandated they only be used under the direct supervision of a qualified health professional.

Health Minister Greg Hunt previously expressed hopes the home tests be available in Australia before Christmas, but the new regulation means they will hit shelves much sooner.

Speaking on Monday Prof Skerritt said the TGA had been waiting on a green-light from the government to progress approvals.

However a spokesman for Mr Hunt said the government had already tasked the TGA with assessing the safety and efficacy of the rapid tests.

Throughout September the TGA has had an expressions of interest register for manufacturers wanting to sell home tests in Australia, but no formal application process had been opened.

Prof Skerritt said government go-ahead primarily depended on three things: having a home test kit ready, a decision on when it was “less of a big deal” to miss some positive cases, and what kind of reporting system would be used to record test results.

Rapid antigen tests are currently conducted under supervision at the Randwick Racecourse. Jockey Kathy O'Hara holds up her negative result. Picture: Justin Lloyd.

The rapid tests are less sensitive than the “gold standard” PCR system currently used in Australia, while allowing people to test themselves at home increases the potential for fraud.

Asked if the delay in rolling out rapid antigen tests for home use in Australia was a deliberate strategy until there were higher levels of vaccination in the community, Prof Skerritt said: “correct”.

He said false negatives or people hiding positive Covid-19 tests became “less important” once Australia had high vaccine rates.

“If you’re on an aeroplane full of people going off to Cairns for a holiday, and there’s someone who has lied about a positive rapid antigen test, or concealed it, it’s less of a big deal if 80 per cent of the people on that plane are vaccinated,” he said. 

Infectious disease physician at the Australian National University Professor Sanjaya Senanayake said while the PCR tests were more sensitive than rapid antigen ones, the risk of missing a positive case could be reduced through repeated testing.

“If there are people who for whatever reason would not go out and get a PCR test … or are routinely tested and it’s not easy to get a standard test every time … at home testing would pick up some cases,” he said.

“We’re going to need a combination of the two.”

Holy Family Services Aged Care home staff member Ocian Gurung undertaking a rapid antigen test before starting her shift. Picture: Tim Hunter.

Aged care homes such as Holy Family Services at Marayong in Sydney’s west have already been trialling rapid antigen tests under supervision for the last month.

Holy Family Services chief executive Alexandra Davis said testing all 90 staff before work each day had been successful.

“It’s relatively simple and quick and it provides us with greater confidence that the staff are coming to work Covid-19 negative,” Holy Family Services CEO Alexandra Davis said.

“It also reinforces the protection for our residents from Covid-19, which is our main goal.”