A maker of COVID-19 rapid tests is recalling thousands of kits due to a high rate of false positives.
Australian manufacturer Ellume announced over the weekend it was recalling about 200,000 of its at-home tests that are approved for use in the U.S.
The test was believed to be a game changer because it comes with a nasal swab analyzer that connects to an app on users’ smartphones and can provide results within 15 minutes.
But as many as one-quarter of all results could be telling people they’re infected with COVID-19 when they actually are not.
Australian manufacturer Ellume said it is recalling nearly 200,000 of its COVID-19 rapid test kits (pictured), which were the first completely at-home kit to received FDA authorization
Officials from the company said one of the kits’ raw materials is causing test results to come back as false positives. Pictured: COVID-19 home test kits are seen inside the Ellume laboratory in Brisbane, Australia, February 2021
According to The New York Times, the 200,000 kits account for 5.6 percent of the 3.5 million kits Ellume has sent to the U.S.
Ellume CEO Dr Sean Parsons say the company first learned of the problem in mid-September and said it was being caused by one the kits’ raw materials.
He did not reveal which ingredient was behind the issue because he didn’t want to divulge how the test works.
‘I’m very sorry that this has happened,’ Parsons told The Times.
‘We’re all about chasing accuracy, and to have these false positives is disappointing.’
The Times reports that 427,000 kits – half of which have already been used – were affected by the issue.
Parsons told the newspaper that the kits resulted in 42.000 positives, of which up to 25 percent may be false positives.
Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold-standard approach of tests that look for the genetic material of the virus.
The kit includes a nasal swab, a chemical solution and a testing strip.
The nose sample is collected with a special adapter that can shortened when being used on young children.
Next, a few drops of the solution are added to the sample, which is placed in a small device that connects via Bluetooth to a smart phone app.
The app then displays the results and helps interpret them. Users can also connect with a health professional via the app.
The test comes with a nasal swab analyzer that connects to an app on users’ smartphone, and gives results in 15 minutes
The problem affected 427,000 kits – half of which have already been used – and resulted in 42.000 positives, of which up to 25% may be inaccurate. Pictured: How the Ellume app reveals if a patient is positive for COVID-19 or not
In a clinical study, the test demonstrated 96 percent overall accuracy, correctly identifying 95 percent of positive cases and 97 percent of negative cases.
In December 2020, it was the first completely at-home test kit to receive emergency use authorizations from the U.S. Food and Drug Administration (FDA).
Parsons told The Times that Ellume is currently asking all U.S. retailers to remove the kits from their shelves and their online stores.
Affected lots have been listed online and any customers with a test kits from one of the lots can ask for a replacement.
Customers who attempt to use one of the affected kits will get a notification from the app about the recall.
Parsons also told The Times that ‘extra controls’ are being implemented so a similar problem does not occur again.
Source: Health & wellbeing | The Guardian