Rapid COVID-19 testing devices rushed onto the Australian market are far less accurate than their manufacturers have claimed, and the expert leading a government-initiated review said that they should not be used to detect acute cases.
In the early stages of the pandemic, the federal government allowed a large number of rapid COVID-19 testing devices onto the market with relatively little scrutiny.
The devices detect antibodies produced in response to COVID-19 and can return results at the point of care within 15 minutes, without the need for laboratory testing.
Australian authorities have relied on a different, more accurate type of testing — genetic testing — throughout the pandemic response.
They also planned to supplement genetic testing by purchasing 1.5 million rapid tests, including from one company with a highly questionable background.
A report in April showed that the government had arranged to buy 500,000 rapid tests from Promedical, a company run by a convicted rapist and former business partner of Australian Cabinet minister Stuart Robert.
The company had no previous experience in diagnostics and was tied to a collapsed deal to supply testing to Puerto Rico.
The government later engaged the Doherty Institute to conduct a post-market review of the rapid testing devices approved for listing on the Australian register of therapeutic goods.
The Doherty Institute has so far examined eight separate devices, most of which were manufactured in China, as part of a series of ongoing reviews. In each case, the institute has found the testing devices to be far less accurate in detecting the virus than the claims made by manufacturers.
In one case, an antibody test produced by South Korean-firm GenBody Inc claimed to have a sensitivity — or accuracy in detecting the antibodies — of 89.3 percent and 88 percent.
The Doherty Institute’s testing found the sensitivity of the testing to be 38.5 percent.
The institute did find that the accuracy of the tests improved the greater the duration since the onset of symptoms.
“It was noted that based on testing specimens 14 days post-onset of symptoms two of the eight devices would meet the manufacturer’s stated performance claims,” the Australian Department of Health said.
Soon after the initial outbreaks of the virus, proponents of rapid testing suggested they could be used as an initial screening device to detect COVID-19, which could later be confirmed by a genetic test.
Deborah Williamson, who is leading the institute’s post-market review, said that the devices are not suitable for that purpose.
“Overall, they’ve not been as sensitive as we would have expected, and certainly the sensitivity in the early stages of infection strongly suggests they shouldn’t be used in the acute stages of the illness,” Williamson said.
“That’s not out of keeping with what other groups have found globally, so there’s no surprises there,” she added.
The government had previously suggested the antibody tests would be in general practice clinics by April.
In May, Australian Minister of Health Greg Hunt said that the antibody tests purchased by Australia were of “the highest quality,” but added that the government would wait for the expert review to ensure they were safe and accurate.
“We do know that some countries were provided tests and equipment in the early days which may not have been fully accurate,” he said at the time.
“We’ve made sure that it is our health authorities, following the highest procurement standards, that have made the procurement,” he said.
The department said it only purchased one million rapid tests from two suppliers. The devices were manufactured by Onsite and VivaDiag.
The success in “flattening the curve” meant that the rapid tests “have not yet been required,” it said.
“These tests have not been purchased for the purpose of, and should not be used to, diagnose acute infection of COVID19,” the department said in a statement.
The Doherty Institute’s reports involved two point of care tests that had been approved by the Therapeutic Goods Administration, it said.
The institute studies confirmed point of care tests were of “limited use” for diagnosing acute COVID-19 cases, it added.
“However, the sensitivity of these tests has been demonstrated to improve with increasing duration from symptom onset and are sufficiently accurate that a positive result in a symptomatic patient could be presumed to be positive for COVID-19” should be confirmed by laboratory testing, the department said.
There might be potential uses for the devices in the future, but they should not be used in detecting current cases of COVID-19, Williamson said.
“Really the key use here is more of a look to see who has been exposed previously, rather than who has the illness right now,” she said.
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