Coronavirus tests being rushed to Australia can deliver results within three hours – The Guardian

Roche has rushed to develop a coronavirus test where results can be returned within three hours. That allows for 384 tests in an eight-hour shift. Photograph: Luis Ascui/Getty Images

One of the worlds biggest suppliers of coronavirus tests is about to rush new equipment onto the Australian market that can deliver results within three hours.

Australia, like many nations across the globe, is facing some pressure on its ability to test for coronavirus due to what health authorities say is unprecedented demand on laboratories.

Roche, a multinational medical device company, says it has rushed to develop a new test to support the urgent need for patient testing during the novel coronavirus pandemic.

Roche says results can be returned within three hours of testing. That allows for 384 tests in an eight-hour shift.

The process, known as the cobas SARS-CoV-2 test, was rushed onto the market using emergency authorisations provided by medical device regulators, including the US Food and Drug Administration and Australias Therapeutic Goods Administration.

The new testing kits are expected to begin arriving in Australia by Wednesday. Together with an older test already in use, known as the MagNA Pure 96, Roche says this will inject 100,000 new testing kits into Australian laboratories.

The demand for Covid-19 tests in Australia is unprecedented and our teams have been working relentlessly to meet demands, the company said on Monday.

Roche will be reordering both test kits frequently, based on Australian patient needs. We will continue to have both tests available in Australia, to ensure maximum coverage and patient reach.

We are continuing to work with Australian laboratories and the federal government to ensure locations of greatest need are prioritised and people at the highest risk of Covid-19 have access to these tests.

The Australian Medical Association on Monday warned that variable supply of a standard reagent was contributing to pressures on testing capacity in some states and territories. The reagent, a chemical substance used to extract nucleic acid from samples, is critical to the testing process.

A lack of reagent has also contributed to the poor testing capacity in the United States, and the Food and Drug Administration has said it is working across the clock to resolve the issue.

Last week, the chief medical officer, Brendan Murphy, said supply issues affecting testing were temporary and were being urgently addressed.

Its a temporary issue, but it relates to the fact that a number of countries where these consumables are made have probably put export controls over them to keep them for their own use, he said. We will work through it. Weve got world-leading medical technology and will fix that issue, but it has caused a temporary issue with the scale of the testing that we can do at the moment.

On Monday, the deputy chief medical officer, Paul Kelly, said the issue was not with testing kits, but with consumables. Kelly also said it was temporary and would be addressed with urgency.

Roche said in its statement it has been working day and night to boost supply of testing kits.

Globally, we are going to the limits of our production capacity to make sure large quantities of tests are available for countries most in need, the statement said.

Appropriate testing is absolutely key during this uncertain time.

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Coronavirus tests being rushed to Australia can deliver results within three hours - The Guardian