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Multiple rapid antigen test sponsors under investigation


Matt Woodley


23/06/2022 2:23:35 PM

The revelation comes alongside TGA confirmation that a company has been fined more than $100,000 for ‘serial non-compliance’.

Rapid antigen test.
All sponsors of medical devices approved by the TGA are required to provide evidence of safety and performance to the regulator when requested.

A number of rapid antigen test sponsors are being investigated for serial non-compliance, the Therapeutic Goods Administration (TGA) has revealed.
 
One sponsor, Hough Pharma, has already been issued with eight infringement notices totalling $106,560 for allegedly failing to provide information related to the safety and performance of three COVID-19 rapid antigen tests, while multiple other companies are under investigation for ‘similar non-compliance’.
 
While the lack of post-marketing surveillance means it is impossible to determine whether the tests are performing as advertised, RACGP COVID Working Group member Associate Professor Charlotte Hespe told newsGP there is evidence that new COVID strains, such as BA.2 and BA.5, are not being picked up by many of the products currently on the market.
 
‘It’s a bit like masks – there were a number being sold as being compliant with the P2/N95 ratings and they weren’t at all,’ she said.
 
‘You would hope that when you’re buying the tests that you are getting what you’re paying for. But, again, I imagine that there are a number of suppliers who are just sourcing it without really checking for themselves either.
 
‘The key message is if you’ve got symptoms but you’ve received a negative RAT, don’t assume that you’re in the clear, go and get a PCR – particularly if you’ve had contact with other people that have either got COVID or flu.’   
 
Hough Pharma’s test was approved for use in Australia in October last year – prior to the emergence of Omicron variants – and is claimed to have ‘high sensitivity’, which equates to ‘clinical sensitivity greater than 90% PPA’ [positive percent agreement].
 
PPA is the proportion of individuals who tested positive to COVID-19 using a rapid antigen test, compared to those who returned a positive result using a more sensitive PCR test.
 
According to the Therapeutic Goods Act 1989, all sponsors of medical devices approved by the TGA are required to provide evidence of safety and performance to the regulator when requested and within the specified timeframe.
 
Sponsors of rapid antigen tests must also ensure that telephone helpline or online operators are available to provide customer support services from 9.00 am to 7.00 pm (AEST), seven days a week.
 
‘In addition to not meeting deadlines for providing information to the TGA, the lack of customer support [offered by Hough Pharma] has been reported by consumers and verified by TGA investigations,’ the release stated.
 
‘This support is vital for consumers who purchase these tests who may have questions about the test, how it is performed or interpretation of results.
 
‘This compliance action serves as a reminder to companies to take their obligations seriously. Suppliers of therapeutic goods must meet their ongoing post-market safety, performance vigilance, and monitoring commitments.’
 
The Department of Health did not confirm how many sponsors are under investigation prior to publication, but the TGA release suggests many are not fulfilling these requirements.
 
Dr Anita Muñoz, who is also on the college’s COVID Working Group, told newsGP the fact that there are potentially multiple companies not meeting compliance obligations is a cause for ‘great concern’.
 
‘Post-marketing evaluation data is an expectation of our industry and I think it is reasonable for the TGA to expect that those companies continue to monitor the performance of their product,’ she said.
 
‘It should be made absolutely clear that if you want to engage in the Australian healthcare system, then you need to be prepared to maintain our standards.
 
‘If you’re not prepared to do that, then you should not seek any business within Australia.’
 
Meanwhile, Associate Professor Hespe says it is important that people do not rely solely on rapid antigen test results and urged those with ongoing symptoms to access PCR testing as well.
 
‘For me, it’s about being able to treat people,’ she said.
 
‘If I know you’ve got COVID or the flu and you qualify for antivirals then I can access it, but I can’t do that without a positive test.’
 
Being tested soon after symptoms present is critical, she said, as antivirals are only effective when used early on in the course of the disease.
 
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antivirals COVID-19 rapid antigen tests TGA Therapeutic Goods Administration


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