Emergency Don’t Let It Happen in Indonesia, Australia Withdraws Fake Covid-19 Test Kits

Some home Covid-19 test kits developed in Australia have been recalled in the United States following an increase in false positives.

Brisbane-based Ellume developed the test and earlier this year signed a $300 million deal with America to supply rapid at-home antigen tests.

It received a US Food and Drug Administration (FDA) emergency use authorization late last year, and now the test can be available for home use in Australia from November 1.

The company has recalled a small number of test kits, which were distributed from April to August this year, and produced between February and June.

Ellume said of the 3.5 million tests sent to the US, an estimated 190,000 have been withdrawn.

It said the number of tests that returned false-positive results represented less than 1 percent of all tests.

“Ellume technology allows companies to disable affected tests to ensure they are not used by customers,” he said.

The company said it found that more false positives were reported compared to what was observed in clinical testing.

Ellume chief executive and founder Dr Sean Parsons said it was isolated to a specific lot number.

“In recent weeks, we have noted an increased possibility that Ellume COVID-19 Home Tests of certain product lots could give false positive results,” Dr Parsons said in a statement.

“After a thorough investigation, we isolated the cause and confirmed that this false positive occurrence was limited to certain lots.”

The recalled test has been distributed by retailers and the US Department of Defense.

The FDA said it was working with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue was resolved.

“For this test, a ‘false positive’ is a test result that shows a person has the virus when they don’t actually have it,” it said in a statement.

“The negative results don’t appear to be affected by manufacturing issues,” he continued.

The company gets a contract of 302 million US dollars

Home testing is not available in Australia as federal law prohibits home testing for Covid-19 from being sold in the country.

But now, rapid antigen tests could be available starting next month, after Health Secretary Greg Hunt announced manufacturers could apply for approval from the Therapeutic Goods Administration (TGA) for the test to be used at home.

To date, the TGA has approved 33 rapid tests that can be used under the supervision of a healthcare professional.

Mr Hunt pointed out that approval for a home test could be given within a month.

In February, the Brisbane biotech company was awarded a US$302 million contract with the US Department to increase production to 640,000 tests per day.

The company was the first to receive FDA emergency use authorization approval in December 2020.

The test kit involves the user taking a swab of their nose and applying it to the kit which gives them results within 20 minutes.

Ellume begins shipping in January 2021.

The Brisbane facility located in the Richlands employs approximately 450 staff.