COVID-19 rapid test maker recalls about 200,000 kits in the US because as many as A QUARTER of results may be false positives

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  • Australian manufacturer Alum said it is recalling about 200,000 of its COVID-19 rapid test kits
  • The test comes with a nasal swab analyzer that connects to an app on users’ smartphones, and gives results in 15 minutes
  • Company officials said the test results are coming back as false positives due to one of the raw materials of the kit
  • The problem affected 427,000 kits – half of which have already been used – and resulted in 42,000 positives, of which up to 25% could be false
  • Customers who attempt to use one of the affected kits will receive a notification about the recall from the app and can request a replacement kit

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A manufacturer of COVID-19 rapid tests is recalling thousands of kits due to the high rate of false positives.

Australian manufacturer Alum announced over the weekend that it is recalling about 200,000 of its home tests that have been approved for use in the US.

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The test was touted to be a game changer as it comes with a nasal swab analyzer that connects to an app on users’ smartphones and can provide results within 15 minutes.

But one-quarter of all results can tell people they have been infected with COVID-19 when they actually are not.

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Australian manufacturer Alum said it is recalling about 200,000 of its COVID-19 rapid test kits (pictured), which were the first completely at-home kits to receive FDA authorization.

Company officials said the test results are coming back as false positives due to one of the raw materials of the kit.  Image: COVID-19 home testing kits are seen inside the Alum laboratory in Brisbane, Australia, February 2021

Company officials said the test results are coming back as false positives due to one of the raw materials of the kit. Image: COVID-19 home testing kits are seen inside the Alum laboratory in Brisbane, Australia, February 2021

According to the new York TimesAlum has 5.6 percent of the 200,000 kits shipped to the US.

Dr. Sean Parsons, CEO of Alum, says the company first discovered the problem in mid-September, adding that it was being caused by the raw material of the kit.

He did not specify what factor was behind the issue as he did not want to explain how the test worked.

Parsons told The Times, ‘I am very sorry that this has happened.

‘We’re all about the pursuit of accuracy, and it’s frustrating to have these false positives.’

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 could be false positives.

Alum’s test looks for viral proteins shed by COVID-19, which differs from the gold-standard approach of testing that looks for the virus’s genetic material.

The kit includes a nasal swab, a chemical solution, and a test strip.

The nasal sample is collected with a special adapter that can be shortened when 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 to interpret them. Users can also connect with a health professional through the app.

The test comes with a nasal swab analyzer that connects to an app on users' smartphones, and gives results in 15 minutes

The test comes with a nasal swab analyzer that connects to an app on users’ smartphones, 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% could be false.  Image: How the Elume app reveals whether a patient is positive for COVID-19

The problem affected 427,000 kits – half of which have already been used – and resulted in 42,000 positives, of which up to 25% could be false. Image: How the Elume app reveals whether a patient is positive for COVID-19

In one 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 home test kit to receive emergency use authorization from the US Food and Drug Administration (FDA).

Parsons told The Times that Elume is currently asking all US retailers to remove the kit from their shelves and from their online store.

Affected lots are listed Online And any customer who has a test kit in one of the lots can ask to replace it.

Customers who attempt to use one of the affected kits will receive a notification about the recall from the app.

Parsons also told The Times that “additional controls” are being implemented so that a similar problem does not happen again.

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