Four Rapid Antigen Test (RAT) brands have been pulled from sale.
NowCheck by Life Bioscience, Covifind by Safe Interact, CovClear by Medi-Stats, and BD Veritor System for Rapid Detection test from Becton Dickinson have all been removed for non-compliance.
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The Therapeutic Goods Administration (TGA) announced this week plans to crack down on RAT brands who haven’t provided updated medical advice that proves their kits work with newer and emerging strains.
“A variant of the virus arises from mutations in the SARS-CoV-2 virus of the genome and may alter the structure of the expressed viral protein. As a result, test kits may no longer be able to sensitively detect the virus, leading to false negative results,” the TGA said in a statement.
The TGA has also noted that investigations are ongoing, meaning more brands may find themselves listed as non-compliant in the coming weeks.
This comes in the wake of a fresh spike in Covid case numbers, with mutating strains continuing to be discovered.
In addition to the four tests pulled from sale, PCL COVID19 Rapid test by Haemokinesis has been suspended amid an investigation, while Hough Pharma has received over $100,000 in infringement notice fines amid the crackdown.
“To date, the majority of RATs are compliant,” a Department of Health spokesperson told 7news.com.au.
“This means they met the regulatory requirements at the time they were approved by the TGA and then sponsors submitted ongoing data to demonstrate their test continues to perform against variants.”
Two third parties, Doherty Institute for Infection and Immunity and a Medical Research lab run by St Vincent’s have been appointed to test RATs on an ongoing basis, in line with World Health Organisation (WHO) requirements.
The TGA will continue to update its website with any non-compliant test brands discovered during the ongoing review.
This comprehensive review comes amid a winter spike in Covid case numbers, leading to a record number of hospitalisations due to the virus in June.
Correction: An earlier version of this article implied RAT tests from some of the brands listed may be ineffective, as opposed to non-compliant.
Becton Dickinson said in a statement:
“While it is accurate that BD has voluntarily withdrawn its rapid antigen test in Australia, that withdrawal is for future sales only. Any customers with existing, unexpired tests in their inventory are permitted to use them.
“BD made a commercial decision to voluntarily withdraw the test after determining it did not want to incur the costs associated with additional clinical data being required to provide additional evidence that it worked as intended on variants of SARS-CoV-2. This does not mean the test is ineffective.”
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