Amateur "biohackers" are making their own experimental COVID-19 test kits, which purport to diagnose the disease in just 30 minutes, and which patients can potentially perform themselves.

Key points: Australian amateur scientists have copied an American idea to create a rapid COVID-19 test kit

Australian amateur scientists have copied an American idea to create a rapid COVID-19 test kit Meow Ludo Meow Meow is hopeful regulators will expedite approval of the test

Meow Ludo Meow Meow is hopeful regulators will expedite approval of the test The test does not require the expensive equipment that the current testing method does

The design copies experimental work conducted in the US and China, but has not yet been assessed by any regulatory bodies.

The tests are designed to be used almost anywhere, without any specialised equipment, but to date have only been performed on a limited number of human samples.

Some experts say the diagnostic test is promising, but they also warn of the potentially serious risks of using tests made by amateurs.

"It would be helpful to have more tests, and especially rapid tests — possibly even those done at home," said Dr Angela Rasmussen, a virologist from Columbia University in New York.

"What if a patient testing that homemade test gets a false negative result, assumes they are not infected, and goes on to infect others?" she said.

As suspected cases of COVID-19 surge globally, the ability for doctors to test for the underlying virus has been severely hampered by a shortage of test kits.

Producing a rapid diagnostic test has been the focus of many groups around the world, as it could help quickly identify infected people, and stop them spreading the disease further.

Meow Ludo Meow Meow is an amateur scientist who tinkers with bio-technology. ( ABC News: Michael Slezak )

Meow Ludo Meow Meow is a biohacker who helps run the citizen science lab Biofoundary in Sydney.

He and his fellow biohackers — amateur scientists who tinker with bio-technology — began creating the experimental test last week.

"Hopefully we can get these tests rolled out across the country and especially in places like cruise ships and airplanes where there's the urgent need for point-of-care testing, which we're currently not doing," he said.

He said he had been advised by legal experts that, under emergency provisions, tests like his could be used without the usual assessments required by the regulators.

At least two other rapid COVID-19 diagnosis tests have been approved in the past week by Australia's Therapeutic Goods Administration, under expedited arrangements.

One is a proprietary test that purports to return results in 45 minutes, and the other is an antibody test, which is not ideal for diagnosis, since it will miss cases with early disease.

Meow Ludo Meow Meow has ordered enough materials to produce up to 500 test kits, which he hopes to use to validate the method on human samples, and determine whether or not it works.

He plans to work with people who have already tested positive for COVID-19, to see whether those individuals get the same positive result when self-administering his test.

But he hopes groups with more resources, such as big pathology labs, universities or biotech companies, will take up his test and validate it independently, before ultimately making the test widely available.

"We've been contacted by some hospitals and we're being contacted by some people within response teams that should be able to verify our tests by running them alongside the tests that are already being conducted," he said.

The ABC has seen an email confirming Biofoundary had been contacted by the NSW Health COVID-19 Response Project, who are looking for resources to help with their planned "drive-thru clinics".

Biofoundary's test validation project is "open source", meaning all their plans and data are being shared publicly.

The design of the test

The design of the rapid test used by Biofoundary is a copy of one reported by scientists from the University of Pennsylvania in the US.

"I worked day and night to figure this out in just two weeks," said Jinzhao Song, an engineer at the University of Pennsylvania, who developed the design being used by the biohackers.

"On January 20, I heard that it was a human-to-human transmitted disease. I thought it [was] a very serious epidemic so I immediately started work on it."

He and his collaborators confirmed the test worked on simulated human samples — samples created in the lab, not collected from people.

Dr Jinzhao Song created a test in two weeks and tested it on simulated human samples. ( Supplied: Jinzhao Song )

They posted their results online, but these have not yet been peer-reviewed.

Other groups have since gone further and tested similar designs on human samples.

Researchers from New England Biolabs in the US, in collaboration with the Wuhan Institute of Virology in China, have posted their results, including confirmation using samples from a small number of patients in Wuhan.

"This simple and sensitive method provides an opportunity to facilitate virus detection in the field without a requirement for complex diagnostic infrastructure," they reported.

The same technology has been proven to work for other viruses and bacterial infections, and the ABC spoke with experts who expect it will work for the virus causing COVID-19 too.

Jinzhao Song and his team want the test they have created to be shared widely. ( Supplied )

Yet another group from Michigan in the US has also posted results using a similar design, on simulated patient samples, and claim it works.

Dr Jinzhao Song thinks it will be nine months before anyone in the US will get regulator approval there for the test.

But he is hopeful that scientists in other countries will pick up his design, and ultimately seek approval from their own nations' governing authorities.

"We don't want intellectual property," he said.

"For this kind of epidemic, clearly you really want to help people. So we don't want to rely on this kind of thing to earn money."

His research group has a patent for one of its test designs, but has deliberately chosen to make it freely available for the greater good.

How the test works

Tests currently performed by doctors around the world use a process called PCR (Polymerase Chain Reaction), which looks for particular viral genes, and then multiplies them so they can be more easily observed.

It's a very accurate test, and is considered the "gold standard" for COVID-19.

But the test is complicated.

Genetic material needs to be extracted from the person's sample and purified. Then any viral genes present are multiplied, using a process that requires carefully running the sample through a series of temperature cycles.

Identifying whether the resulting sample is positive or negative usually requires another piece of specialist equipment.

Much of this process can be automated, but the required machinery is expensive, which limits the number of tests that can be performed simultaneously, and the number of locations at which the test can be analysed.

As a result, scaling up our ability to test in very large numbers is challenging.

Researchers in the US and China have worked to replace PCR tests for COVID-19 with a process called LAMP (Loop-Mediated Isothermal Amplification). The basic idea is the same: it multiplies the number of particular viral genes in a sample so they can be observed.

But LAMP is designed to be much simpler, faster and cheaper than PCR.

LAMP tests can be conducted in a simple heat bath, meaning almost any lab or hospital could theoretically do the test.

The results are confirmed by a dye that changes colour — allowing them to be read with the naked eye.

Meow Ludo Meow Meow talks his colleague Andrew Gray in Melbourne through how to make the test kit. ( ABC News: Michael Slezak )

The result takes just 30 minutes, and as a result, has the potential to allow a huge number to be done quickly, concurrently and in almost any location.

According to Dr Song, the test could potentially be done at home, using warm water and a kitchen thermometer.

"You can even use an oven at home if your oven is accurate enough for temperature," he said.

The same technique for multiplying genes has been used to diagnose other diseases, with approval from regulators.

A similar LAMP test for tuberculosis is also recommended for use by the World Health Organisation.

Lindomar Pena from the Department of Virology at the Oswaldo Cruz Foundation in Brazil has done extensive work on LAMP diagnosis tests, including validating a LAMP test for the Zika virus.

He said the process was extremely sensitive, meaning if it's well designed and conducted, it's highly unlikely to miss any case.

But that same sensitivity means the test will sometimes return false positives.

Dr Lindomar said that while that's problematic in many instances, it's not for COVID-19.

"You want as many positives as possible, to control it and trace all the contacts," Dr Lindomar said.

He said missing cases of COVID-19 would be a big problem, but falsely identifying some cases would not.

The importance of regulations

Dr Rasmussen from Columbia University had some concerns about the possibility of biohackers carrying out this work without official validation — something they say they will only do if others don't try to validate the test.

"While citizen science is fine in some circumstances, there's a real problem with conducting human trials without any kind of oversight," Dr Rasmussen said.

"The trials may be poorly designed, in which case they are useless."

Dr Lindomar said it could be an interesting way to conduct testing for mild illness, but agreed it would be inappropriate to use any unvalidated test on severe cases, where clinical treatment could depend on an accurate diagnosis.

Meow Ludo Meow Meow will continue to push professional labs to take up the test and try to validate it.

In the meantime, he's pushing ahead.

"What's most important is that everyone does everything that they can to save the most amount of lives," he said.