Australian regulators have urgently approved rapid Covid-19 testing kits that allow doctors to screen patients for the virus within 15 minutes at clinics and hospitals.
After the Guardian revealed last week that a number of companies were seeking to supply a rapid testing kit for the virus into the Australian market, the Therapeutic Goods Administration has granted four approvals to companies to sell the product locally.
The approvals allow the first “point of care” Covid-19 screening products to be supplied in Australia, and could allow doctors to significantly increase the number of people able to be tested for the virus.
One of the companies that secured TGA approval is Melbourne-based MD Solutions, which will begin importing the tests within a fortnight. The company plans to supply about 500,000 kits in its initial shipment, though that could increase depending on demand.
The tests are designed for initial screening only and require two drops of blood. They do not require laboratory processing before a result is returned.
In a statement, the health department said the “expedited” approval of the testing kits was “based on evidence provided to the TGA at the time of application”.
“All approvals are subject to conditions that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of approval,” a department spokesman said.
“The Doherty Institute has been engaged to assist with the post-market assessment of new coronavirus rapid screening tests to inform their best use.”
Doctors and global authorities have urged nations including Australia to expand testing for the virus in a bid to contain its continuing spread throughout the world.
Last week the director general of the World Health Organization, Tedros Adhanom Ghebreyesus, warned countries were not testing enough for the virus and likened the approach to “fighting a fire blindfolded”.
While Australia has previously faced shortages of testing kits, on Monday the chief medical officer, Brendan Murphy, said testing capabilities were improving and that testing criteria should be expanded.
Chinese researchers developed the rapid “point of care” screening test as the virus spread in Wuhan. The test detects antibodies that emerge some time after Covid-19 symptoms appear, though MD Solutions said in a statement that the test “can be used at any point in a suspected infection”.
A study in the peer-reviewed Journal of Medical Virology said the antibody tests could return results within 15 minutes, much faster than the current standard testing, which relies on a laboratory process involving the extraction of RNA.
MD Solutions is working with a US company, CTK Biotech, which launched the testing kits earlier this month.
In a statement, the MD Solutions chief executive, Xavier Lawrence, said the test “currently has the best validation of any rapid kit on the market”. The test, he said, had been validated after five days of infection as a more than 96.9% sensitivity and 99.4% specificity.
“The manufacturer has 30 years of experience of supplying these devices to third world nations where point of care testing is standard practice and used for its many advantages,” he said
“First responders, critical industries including health care, aged care, ambulance need a safe, quick and easy way to test themselves. Availability of the test will support workplace health and safety and economic risks that businesses need to manage.”
While Australian health officials say the tests have merit, some experts have expressed concerns about the kits and their efficacy.
The kits are yet to be fully tested by the TGA and their approval into the Australian market comes with the condition that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months.
The World Health Organization, in a February report on Covid-19, described accurate antibody testing as important in facilitating early diagnosis, and said rapid and accurate point-of-care testing was a way to “markedly improve early detection and isolation of infected patients, and, by extension, identification of contacts”.
“Development of rapid and accurate point-of-care tests which perform well in field settings are especially useful if the test can be incorporated into presently commercially available multiplex respiratory virus panels,” the report said. “This would markedly improve early detection and isolation of infected patients and, by extension, identification of contacts.”
In a speech last week Ghebreyesus said that while there had been “a rapid escalation in social distancing measures”, such as school closures, there had not been an “urgent enough escalation in testing, isolation and contact tracing – which is the backbone of the response”.
“As I keep saying, all countries must take a comprehensive approach,” he said.
“But the most effective way to prevent infections and save lives is breaking the chains of transmission. And to do that, you must test and isolate. You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected.
“We have a simple message for all countries: test, test, test. Test every suspected case.”