Rapid antigen testing on its way to pharmacy

Rapid antigen self-testing is expected to be widely available in pharmacy, following new TGA advice

The Therapeutic Goods Administration announced on Tuesday that it will allow companies to formally apply for TGA regulatory approval to legally supply their self-tests for use at home.

The TGA says that following “extensive” consultation, it will make the new regulation by Friday, 1 October, allowing the tests to be used from Monday, 1 November 2021.

“This is an important step in supporting the National Plan to transition Australia’s National COVID-19 Response and aligns with the timeframe where it is expected that approximately 70 % of Australians will be double vaccinated,” the TGA said.

As with all testing kits, the individual tests will require TGA approval and inclusion in the ARTG.

“One of the critical parts of the national plan is to make sure that people will be able to go about their daily activities safely, and so I’m delighted that the TGA has now recommended that home testing will be available from 1 November, obviously subject to individual tests being approved as being safe and effective,” Health Minister Greg Hunt told reporters.

“This is an important additional protection for Australians: home testing to support Australians and to support the national plan.”

He said that this would happen in “two steps… one is that we have to have individual applications approved—so specific tests have to be shown to be safe and effective”.

“At this stage, they’ve had over 70 expressions of interest and 33 tests have already been approved for supervised use,” Mr Hunt said.

“So, they will now be considered and made available if, if found to be safe and effective.

“The second thing is obviously to ensure that each of the states and territories is in a position to accept that.

“But from a national perspective, home testing will be available from 1 November.”

He told reporters that, “at this stage it would be something that people acquired—unless it was in a workplace arrangement—from their pharmacy”.

“So it would be like all other tests at the current time.”

He said that when people test positive, what happens next would be “subject to state-based public health orders” with specific rules to be determined by the Chief Medical Officer and the state chief health officers.

When asked whether the tests would attract a PBS subsidy, he said that the Government was “providing them in specific settings”.

“We have been using them at a Commonwealth level in aged care at Howard Springs for those that… have been returning from India,” Mr Hunt said.

The Pharmacy Guild welcomed the move, saying rapid antigen self-testing kits will become another tool in the fight to suppress COVID-19 in Australia.

National President Trent Twomey said he expected that upon approval, test kits would be widely available through community pharmacies across Australia.

“We need to utilise all available resources in this once-in-a-century fight against this pandemic,” Mr Twomey said.

“As the Federal Minister for Health, Greg Hunt, has made clear, all necessary checks and balances must be undertaken to ensure safety and effectiveness of these tests; and also the regulatory process will involve State and Territory Governments.

“Community pharmacists have helped accelerate vaccinations against COVID-19, especially now that Moderna vaccine stocks are available.

“Pharmacists will continue to deliver resources to the community in the fight against COVID and the effort to restore our Australian way of life—at least to a ‘new normal’,” Mr Twomey said.

Professor Adrian Esterman, Chair of Biostatistics and Epidemiology at the University of South Australia, said that while the tests were not generally as accurate as the polymerase chain reaction test, this was less important in situations where their use was ideal – and that he did not see why there should be “too much objection” to their use.

“PCR tests work by looking for fragments of the virus in the swab sample,” he said.

“They require complicated analytic equipment only found in pathology laboratories and need expert lab technicians to run the equipment. Each PCR test takes about six hours to run, so it is not surprising that tests are returned usually after 24 hours.

“Rapid antigen tests are almost the opposite. They work by looking for proteins called antigens on the surface of the virus.

“They come in a test kit, a bit like the ones used for pregnancy, have results available in about 15 minutes, and are inexpensive.

“In the UK, packets of 10 test kits are available free of charge from chemist shops for home use. They are also provided free in several states in the USA.

“The TGA at the moment, only allow their use if supervised by a health professional, and there is some evidence that the results are a bit more accurate if this is done.

“With respect to accuracy, they are not as good as the PCR test, and tend to produce more false positives and false negatives, especially when there is not much COVID about. However, if someone has a positive rapid antigen test result, then they should immediately go for a PCR test.

“Finally, rapid antigen tests work best when there is a high viral load, that is in the first two to three days before symptoms develop, and in the first week after symptoms.

“Rapid antigen tests are ideal for airports, transport hubs, industry settings, schools, etc. Their slightly poorer accuracy is less important in these situations.

“They are not widely available in Australia, yet a popular one used in the USA is made in Queensland!”

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  1. Alison Aylott

    Potentially infectious people coming into our pharmacies to purchase a kit? I think the use of rapid antigen tests is extremely useful, just concerned about the potential exposure of pharmacy staff.

    • Michael Ortiz

      Hello Alison There are a number of systematic reviews around about the accuracy of Rapid antigen testing. The test accuracy depends the individual test and on viral load. These test are about 80% correct if the result is positive (sensitivity) and 99% correct if negative (specificity)

      The real issues with home testing is what happens if someone tests positive. What are the legal obligations of the patient? particularly where there are financial implications of testing positive.

      Some test come support with a mobile phone app to interpret the result which could then report positive and negative tests.

      • Alison Aylott

        Thanks for the response, Michael. I understand the issues as you outlined, but my concern is that if someone is going to a pharmacy to purchase a test, then that person may not be testing to prove they are Covid-19 negative, but may think they have contracted the virus and want to home test instead of getting a PCR test – in this case, exposing pharmacy staff to risk.

        • United we stand

          According to the Dougherty report by May 2022 we will have 50,000 cases per day in Australia. I think the government is preparing to live with the virus and will focus on hospitalisation rather than case numbers.

          I don’t think exposing pharmacy staff to the virus is their main concern since at least in theory, pharmacy staff should all be vaccinated by then.

  2. Leopold Hamulczyk

    This may lead to a huge number of false positives. I would like to know what the sensitivity and specificity and the PPV and NPV of these tests are. Anyone with any knowledge of biostatistics will realise how many false positives test like this will produce, even with rather high sensitivities and specificities, in a condition with low prevalence. I played with some made-up numbers last year and was astounded at the possibilities. At least with viral genotyping we can be sure that the person has tested positive, but with rapid antigen testing you will easily find far more false positives than real positives.

  3. Jim Tsaoucis

    1. Price
    2. Relies on honesty of public to act on result….Hmmmmm
    3. Vending machines like for Needle Syringe Program …that’s very doable and suits most with concerns

  4. Peter Allen

    Tooo slow TGA.
    Bring it on soon. Time wasted is risks increased
    You’ve had plenty of time already to write the rules. You could have used overseas experiences and recommendations. Or is the Aussie wheel different, requiring re-invention.

    We might not say Making jobs for the boys or protecting your bums. But we might think that.

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