(Image: Gorkie/Private Media)

In an interview in Paris last June, Prime Minister Scott Morrison pointed to the daily rapid antigen tests that he and the travelling press pack had been using as a key weapon in Australia’s path forward.

Nine days later Sydney’s lockdown began, and over the next few months the pandemic strategy became singularly fixated on vaccinations. RATs were largely forgotten. Not approved for home use until November, widely dismissed as less accurate than “gold standard” PCR tests, they were assumed to play a marginal role in Australia’s “national plan”, marked for “potential use” once more than 70% of the eligible population was vaccinated.

But when the time for RATs arrived, their shift from a less adequate diagnostic tool to both a centrepiece of the COVID response and the most sought-after commodity in the country happened almost overnight. And despite warnings — from medical experts, business groups, unions and suppliers — Australia simply wasn’t ready.

Slow to approve

When Morrison arrived in Europe in the middle of 2021, the continent was awash with RATs. By April last year, months before “freedom day” the British government had started mailing them to people free, and making them widely available. In Germany they operated as a condition of entry to many venues.

But despite pressure in recent weeks, Morrison has refused to make them free.

Before RATs were approved for home use on November 1, they were still part of Australia’s pandemic response plan. But their use had been largely limited to specific settings under supervision — certain returning travellers and workers in local government areas of concern during the New South Wales lockdown.

By the time the Therapeutic Goods Administration made its announcement about allowing self-tests in September, there had been plenty of people looking overseas and wondering why they weren’t available. In August, the Australian Industry Group called for them to be used to get people back to work. Australian Council of Trade Unions secretary Sally McManus had been raising the issue as far back as June. 

Some of the delay comes down to the TGA taking a typically cautious approach to granting approval. In Britain, regulators had granted approval for home antigen testing in December 2020. The United States suffered similar regulatory and supply-related challenges in shifting its testing regime from PCRs to RATs last year. But the Food and Drug Administration still granted emergency use authorisation to some home tests in April 2020. In July last year, the TGA’s line was that RATs were too unreliable for widespread use.

While RATs are being approved — a reflection of how the pandemic has evolved in Australia since mid-2021 — regulatory hurdles are still in place. Several local RAT manufacturers still can’t sell to the domestic market because they are awaiting TGA approval, and are struggling with processes they say are far more stringent than in Europe.

Brisbane manufacturer Ellume is a case in point. It’s yet to submit its application to the TGA, and won’t supply the domestic market until at least mid-2022. It first has to satisfy American demand after winning a $300 million US government contract in February last year. The Americans simply got there first.

Curse of the less reliable

The TGA’s cautious approach wasn’t the only hurdle. RATs are less sensitive as a diagnostic tool than PCRs. But dogmatic belief in this hindered widespread planning for where and how they could be used until it was too late.

Some of the campaign against RATs came from those with a vested interest in undermining them. The Royal College of Pathologists of Australasia, for example, who handle PCR testing, repeatedly warned rapid tests weren’t good enough.

Through to mid-2021, Morrison and chief medical officer Professor Paul Kelly maintained RATs weren’t appropriate for the suppression phase of the national plan. While they hinted they’d be part of future pandemic management, the chaos of the past few weeks suggests this wasn’t planned for. In South Australia RATs were banned until December. Western Australia made them legal only last week. 

For months, the messages from state and federal governments and health bureaucrats was that self-tests weren’t good enough. By the time Australia had moved to skyrocketing case numbers and personal responsibility and the messaging on RATs had pivoted, there weren’t enough tests to go around. 

This week the government hurriedly bought $62 million worth of tests. By the time they arrive, the wave may have peaked.

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Editor’s note: this story was updated to reflect the fact that Ellume is still finalising its TGA application.