News

Is it time to consider self-testing for respiratory illness?


Evelyn Lewin


5/03/2020 4:36:37 PM

At-home diagnostic medical devices have been floated as a potential way to ease the strain on public health, but experts say concerns remain.

Person using a glucose monitor
Glucose monitors are a form of self-testing IVDs that are used regularly in Australia.

At-home self-testing for a variety of conditions is currently in use in Australia.
 
Pregnancy and ovulation tests, glucose monitors and test strips for diabetes monitoring, and cholesterol testing devices are examples of such tests commonly approved for these purposes.
 
Considering the rise in cases of COVID-19, and the potential implications for already under pressure public health services, the question must be asked: Is it time to look at potentially developing at-home self-testing for respiratory illness?
 
The 2019 Review of the regulation of certain self-testing in vitro diagnostic medical devices in Australia was released by the Therapeutic Goods Administration (TGA) in September last year.
 
Currently, self-testing in vitro diagnostic medical devices (IVD) that test ‘for the presence of, or exposure to, pathogenic organisms or transmissible agents (apart from Human Immunodeficiency Virus, HIV), including agents that cause notifiable infectious diseases’ are not available in Australia.
 
Public health authorities such as the South Australian Communicable Disease Control Branch (CDCB) have thrown their support behind the idea of self-testing of notifiable diseases, noting the potential benefit of more accessible testing and earlier intervention, while the government is currently investigating new ways to ease the potential burden coronavirus will have on public health.
 
However, the RACGP holds concerns over IVDs’ reliability, the ability of patients to properly interpret results, the lack of clinical oversight, and the potential for overdiagnosis.
 
Dr Evan Ackermann, immediate past chair of the RACGP Expert Committee – Quality Care (REC–QC), told newsGP it may be time to re-evaluate how respiratory tract infections are tackled in the current landscape – but that there may be better options than IVDs.
 
He said while validated self-testing of respiratory diseases may help relieve the current burden on the health system posed by this virus, it would need to be accompanied by a clinical opinion.
 
‘If you self-test and then get a clinical opinion, that’s much better because of the false negative rates with a lot of these tests,’ he said.
 
‘A simple telehealth consult with a patient’s GP would be optimal.’
 
Dr Ackermann said that clinical opinion is vital to put the test result into context.
 
‘So if you said, “I’ve just been to Iran, I’ve got a cough, cold, runny nose, I’ve self-tested and it’s come up negative, are you happy that I haven’t got the disease?” Well, you’d be saying, “no, because false negative rates and all those sorts of things, you should be formally tested for COVID-19”.
 
‘It’s important get a clinical opinion with it, not just the test.’
 
He is also keen to note that there is no such self-test currently available for use, and that any test that may be developed for this kind of purpose would need to undergo rigorous testing for reliability.
 
Another issue that needs addressing, Dr Ackermann said, is re-evaluating the role of GPs and how to perform consultations in the current landscape.
 
The question, he said, is how to ‘best utilise’ general practices in this new environment.
 
‘What general practice is going to have to do now is consider how they manage respiratory tract infections during this time,’ he said.  
 
Dr Ackermann said while it is standard practice during influenza season for GPs to treat patients ‘fairly normally’ other than engaging in hygiene measures such as handwashing, if coronavirus reaches a pandemic or epidemic status, GPs may need to engage in more telehealth consultations.
 
‘If we’re in this pandemic environment for respiratory tract infections, then telehealth is a very important tool,’ he said.
 
‘You can ring your own GP, that GP can do a triage service, that GP generally knows you, they know your risk factors and all those things, they can do a history as a triage process and say, “look, I think you are okay just to stay at home for a while, here’s a medical certificate”.’
 
Conversely, if a GP assesses their patient to be at risk, he or she can then organise appropriate personal protection equipment to be available for properly assessing that patient.
 
‘If the coronavirus spreads more, general practices are going to have to look at the systems of care on how they treat respiratory tract infections, because the coronavirus is going to be part of it,’ he said.
 
‘Having a discussion about how to utilise general practice effectively in this pandemic or epidemic environment is an important discussion to have.’
 
After the TGA updated its 2019 review, it was met with many submissions.
 
The Consumers Health Forum (CHF) of Australia made a submission in December 2019, in support of self-testing IVDs for infectious diseases for supply and use in Australia.
 
‘We do not believe there are any particular infectious diseases for which self-testing should be prohibited. We believe that on balance the benefits of self-testing will outweigh the risks,’ CHF wrote.
 
They also indicated the need for risk mitigation strategies, stating that all self-testing kits must instruct the user to speak to a doctor to get a confirmatory clinical diagnosis.
 
Meanwhile, the Victorian Department of Health and Human Services (DHHS) also broadly supports access to self-testing IVDs for infectious diseases that provide reliable and acceptable results.
 
‘Access to self-testing IVDs has the potential to positively impact the number of people who have an infection who know their disease status,’ they stated.
 
‘Once a person becomes aware of their infection, they are more likely to seek treatment and thereby prevent ongoing transmission.’
 
In the RACGP’s submission to the TGA review in December 2019, the college sought to re-introduce exclusions to certain self-testing kits for home use for notifiable infectious diseases.
 
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coronavirus COVID-19 respiratory illness TGA Therapeutic Goods Administration



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