New rapid Covid-19 testing kit can return results in 15 minutes but not yet available in Australia – The Guardian

The federal health department says it sees merit in a newly developed rapid Covid-19 testing kit able to return results within 15 minutes, which experts say could help relieve significant pressure on pathology services.

Australias chief medical officer, Brendan Murphy, has warned the country faces extreme pressure supplying enough testing kits as the rate of infection continues to skyrocket, warning last week that the number of pathology testing kits, reagents and swabs was deteriorating rapidly with some regions now completely out of supplies.

The government has so far refused to say how many testing kits remain in the country, although the health minister, Greg Hunt, said on Tuesday the supply was sufficient for current requirements.

As the virus spread in Wuhan, Chinese researchers developed a more rapid point of care screening test, which detects antibodies that emerge some time after Covid-19 symptoms appear. A study in the peer-reviewed Journal of Medical Virology said the test could return results within 15 minutes, much faster than the current standard testing.

The test known as the COVID-19 IgG/IgM Rapid Test Kit is not currently in use in Australia, but the Guardian understands some companies are seeking to supply it onto the market.

A spokeswoman for the Department of Health said the rapid test had merit and that there were no compelling reasons not to use it based on the described science and methodology.

But she said the company behind it, the Nantong Egens Biotechnology Company Ltd, had not yet approached the regulator, the Therapeutic Goods Administration, for assessment and approval.

Such a device would need to be approved through the TGAs in-vitro diagnostics regulatory scheme before use, the department said.

The company has had the test validated by laboratories in Europe and China. But the spokeswoman said the same would need to occur in Australia.

Tests also require validation by testing laboratories in the Australian context before use, she said.

The Department of Health, in collaboration with the Public Health Laboratory Network, is monitoring the development of test kits and methodologies and their performance as they are used more widely around the world.

In Australia, a company called COVID-19 Rapid is representing three manufacturers seeking to get TGA approval for the rapid tests. A company spokesman said: Our TGA consultants have told us that unlike the US and Europe, securing approval will take too long and be very expensive.

Experts approached by the Guardian said the testing had potential benefits and drawbacks. The testing does not require a laboratory, which could help alleviate pressure on Australias pathology services and the rest of the health system.

Peter White, a virologist from the University of New South Wales, said if it were possible for rapid tests to be used by people at home it would help take the burden off an already strained health system.

These tests will be useful for sure, they could keep infected people out of the health system and they do also provide peace of mind, he said.

There are certainly some advantages. If someone thinks they have the virus and can do the test at home in 15 minutes thats someone who isnt presenting at a hospital, GP or pathology lab.

Even if you received a false positive, if you were able to take the precaution of having it backed up with [a traditional test] it would be good. If people received a negative result, they might be less inclined to visit the clinic which is going to free up hospital resources.

But, he stressed, the tests were not always as reliable as those currently being used in Australia. Because rapid test kits look for antibodies associated with the virus rather than the virus itself, they could record false-negatives if used at the wrong time.

The question is how significant those limitations are. It depends really on how many true cases you detect. Does it detect every positive, or does it miss 5%? he said

Because if you have to back up every test with a lab pathology test it might defeat the purpose a little bit.

Bill Bowtell, an infectious diseases expert from the Kirby Institute, said while there was no shortage of medical supply companies looking to profit off the Covid-19 crisis, the TGA would need to consider the kits closely.

In the end, anybody with anything to sell is in the market and their interest is to make the biggest claims, he said.

I think thats the case with a lot of the things that well see coming onto the market. Theres uncertainty because it didnt come to market after stringent testing, it came to the market because theres a feeling of my god we need it.

In normal circumstances you wouldnt touch it with a barge pole but this is what happens when theres a crisis.

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New rapid Covid-19 testing kit can return results in 15 minutes but not yet available in Australia - The Guardian