Are we about to see a new dawn for point-of-care testing?

Doug Hendrie

1/07/2020 4:04:44 PM

The potential of point-of-care testing has not been realised for decades – but that may be about to change.

Drawing blood
A point-of-care test being recommended for a new MBS item could open the door to faster testing done in general practices.

Though many of the tests are now as effective as tests done in pathology labs, the point-of-care sector has been hamstrung by scepticism over cost effectiveness and reliability of results, resistance from major pathology companies, and the lack of any Medicare rebate.
But that may be about to change.
For the first time, a Medicare Benefits Schedule (MBS) rebate looks likely to be approved for a point-of-care test monitoring diagnosed diabetes, after a key advisory body, the Medical Services Advisory Committee, supported the approach in March and a decision is pending.
That comes after Federal Health Minister Greg Hunt described point-of-care testing in general practice as inevitable at the RACGP’s GP18 conference. 
Professor Mark Morgan, Chair of the RACGP’s Expert Committee – Quality Care (REC–QC), told newsGP he is a ‘great supporter’ of point-of-care testing as long as there is evidence for the test’s efficacy.
‘The convenience and immediacy of being able to make clinical decisions with patients in the light of point-of-care testing is a great advantage over needing to test and then recall the patient,’ he said.  
South Australian point-of-care testing expert Rosy Tirimacco told newsGP that decentralising testing is long overdue as a way to tackle the entrenched rural–urban health gap.
For decades, Ms Tirimacco, the Operations and Research Manager at the Integrated Cardiovascular Clinical Network South Australia, has been working to put point-of-care  tests and training in place in rural hospitals and clinics around the state, starting with time-critical tests for suspected heart attack patients.
Point-of-care testing has drastically shortened the waiting time for crucial pathology results in rural areas – sometimes by days. And that, Ms Tirimacco says, has directly saved lives.
‘The benefits have been huge. We have reduced 30-day heart attack mortality by 22% in county areas. That’s very significant,’ she said.
Point-of-care testing in the remote Anangu Pitjantjatjara Yankunytjatjara (APY) Lands in South Australia’s north has also been ‘incredibly important’ for Aboriginal and Torres Strait Islander residents, Ms Tirimacco said.
In a 2014 Medical Journal of Australia article, Ms Tirimacco and her colleagues note that the point-of-care testing interventions had effectively ‘closed the gap in mortality’ between rural and urban South Australians for cardiac issues.
‘In South Australia, there are 65 hospitals. Only 10 of those have pathology labs,’ she said. ‘So without point-of-care testing, waiting times for results can be from four hours up to 48 hours or even longer over a weekend.
‘When you have a patient with symptoms suggestive of a heart attack, you need troponin results preferably within 30 minutes.
‘If you introduce a quality assured point-of-care test, you can benefit country patients quite significantly. If you don’t, those patients can have to be moved into a town or city with access to pathology.
‘By providing point-of-care testing, they can stay at their own local hospitals without incurring huge transport costs.
‘I personally feel we have a duty of care as health professionals to adopt this if it improves patient outcomes. If we want to turn a blind eye to it, it could affect patient health.
‘As time goes on, more and more of this pathology will be happening in patients’ homes as well – that’s a good thing if it’s a good test and linked to their GP. It can be an extension of the GP clinic, receiving results from a patient’s home. How good would that be?
‘There’s lots of innovation in this space that could happen if people stop putting hurdles in the way.’
Ms Tirimacco said younger doctors often experience a ‘cruel shock’ upon starting work in a rural hospital and being told that test results will take 24 hours, a situation that can have significant flow-on effects for the workforce.
‘Younger doctors expect quick results,’ she said. ‘To keep young doctors in the country, we have to give them the tools they’re used to operating with in the city. Otherwise they’re working in the dark.’
The Australasian Association for Clinical Biochemistry and Laboratory Medicine (AACB) has long supported the introduction of point-of-care testing as long as the tests are quality assured, strong frameworks are in place, and training is available.
Dr Andrew St John, Director of Australian Point-of-Care Testing Practitioners Network, told newsGP that point-of-care testing has long been held back by Government concerns that the expense may outweigh the benefits.
But he said that point-of-care testing offers many longer-term benefits that are not easily captured, such as reducing antibiotic overuse, or the cost savings of being able to test and treat rural patients in their own communities.
‘The Government still remains to be convinced of the economic benefits. Yes, testing is more expensive, but you have to look at the downstream benefits,’ Dr St John said.
‘Let’s say you use [point-of-care testing] to reduce the rate of antibiotic use. Antibiotics are cheap, but the real benefit is having less antibiotic resistance in the community.
We just haven’t done the right studies to capture the benefits.’
Point-of-care tests are being used in countries like the Netherlands to measure C-reactive protein for patients with acute coughs.
With that data, doctors can then make a clinical judgement on whether the cough is bacterial or viral and prescribe antibiotics only where warranted.  
‘When you look at rural and remote Australia, which often doesn’t have good access to pathology, the arguments are even more powerful,’ Dr St John said.
‘We have often advocated for a point-of-care testing rebate applicable only to rural and remote GPs.’  
In 2009, Australian researchers published results from one of the largest randomised controlled trials of point-of-care testing, with almost 5000 participants.
The Medical Journal of Australia study found that PoCT offered the same or better clinical effectiveness than central laboratory testing for three measurements – HbA1c, urinary albumin/creatinine ratio, and cholesterol and triglyceride – but not for international normalised ratio (INR) or high-density lipoprotein (HDL) cholesterol.
In a 2014 BMJ Open study, Australian GPs listed diabetes, acute cardiac disease and urinary tract infections as the top three conditions for which they would like point-of-care testing to aid diagnosis.
The study found that primary care doctors across Australia, Belgium, the Netherlands, the UK and the US all expressed a desire for point-of-care testing to help diagnose acute and chronic conditions. 
The RACGP supports making evidence-based point-of-care testing accessible in general practice through Medicare in a position statement, and has called for the removal of ‘unnecessary regulatory barriers to its adoption’.
‘Existing evidence supports a number of specific tests as clinically effective and as safe as laboratory testing,’ the position statement reads.
During the current coronavirus pandemic, the Therapeutic Goods Administration has sounded a note of caution about point-of-care serology tests for COVID-19, as these cannot determine if someone is infectious or has been recently infected.

GPs will be able to test for influenza A, B and the SARS-CoV-2 virus using the same nasopharyngeal swab in a new Roche PCR test anticipated to launch by July–August.

Into the future
More broadly, however, there are positive signs for evidence-based point-of-care tests.
GPs will be able to test for influenza A, B and the SARS-CoV-2 virus using the same nasopharyngeal swab in a new Roche polymerase chain reaction (PCR) test anticipated to launch by July–August.
Roche Australia Diagnostics managing director Allison Rossiter told newsGP the new PCR test will give a result within 20 minutes.
Ms Tirimacco said this new test could be ‘incredibly useful’ for GPs, given the overlap in symptoms for flu and the virus that causes COVID-19.
The Federal Government relied on rapid point-of-care-testing to ensure the coronavirus pandemic was not reaching Aboriginal and Torres Strait Islander communities and slashing testing times to 45 minutes from as long as 10 days. To date, 31 of the 85 planned testing sites have been established across the nation.
US microbiologists Dr Paige Larkin and Associate Professor Omai Garner have flagged sexually transmissible infections as a promising new avenue for point-of-care testing, as a way to promptly diagnose and treat patients, with test development under way for trichomonas, chlamydia, and gonorrhoea.
Meanwhile, a new Food and Drug Administration-approved point-of-care hematology analyser, HemoScreen, has arrived in Australia, promising to be able to deliver lab-quality complete blood counts (CBC) within five minutes.
Dr Avishay Bransky is CEO of PixCell Medical, which received grants from the EU and Israel to undertake the research that underpins the HemoScreen platform.  
He told newsGP point-of-care testing has real potential for rural Australia.
‘In Australia, large portions of the population live in remote communities with no access to lab testing. This requires flying out blood samples or driving several hours to bring samples to a lab that may be located hundreds of miles away,’ he said.
‘There are almost a billion [CBC] tests ordered in the US each year, and the same in Europe. These tests are usually done on relatively complex instruments and mostly confined to laboratory settings. They are not available in low resource settings, such as remote areas.
‘Rural GPs would benefit from having real-time CBC results. If you can perform a test at the same time the physician sees the patient, it’s much more efficient.’
Dr Branksky said point-of-care testing is proving its worth amid the global pandemic.
‘During the pandemic, it’s widely acknowledged that decentralised testing is very important. This way, you can keep patients out of the hospitals and avoid relying on a central location,’ he said.
‘You don’t want healthcare systems to collapse as they have in some countries.
‘Many people are avoiding coming to the hospital at all. In many countries, hospitals are almost empty. People are at risk, but refrain from coming. That’s a real worry, especially for immunosuppressed oncology patients who need to come in for treatment or monitoring.
‘If you decentralise testing, you are able to monitor their state.’
Dr Bransky said there is a long-running debate in healthcare over whether to build large centralised pathology laboratories that could drive the per-test cost lower through economies of scale, versus lower volume decentralised testing regimens.
‘Decentralised tests are usually a bit more expensive, but they have the advantage that turnaround time is very short. The clinical outcome can be better because the physician can make more informed decisions.’
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Dr Annemie Beck   2/07/2020 9:30:59 AM

Living and working in an outer Metro area, we have a pathology collection center next door to our practice. However, testing are not done there, so our results also take multiple hours to become available even if marked urgent. For monitoring of Diabetes control through HbA1c, I am happy to wait even a few days, as it is still relatively easy to get the Metro patient back in the surgery a few days later. However, a rapid Trop T, WCC and CRP would be extremely beneficial to make more informed clinical decisions. At present any patient who has severe RIF pain without prior appendectomy, goes for urgent blood tests and imaging. Often imaging report states that appendix could not be visualized; appendicitis not be excluded. Please correlate with biochemical results. Even if the consultation was first thing in the morning, it often happens that I cannot reassure the parents of the child complaining about pain by 5 pm as I’m still waiting for results. So, tempting! Even in the city.

Dr Janice Margaret Bell   2/07/2020 10:50:57 AM

Long overdue. Keep up the great work Mark and the RACGP!

Dr Peter JD Spafford   2/07/2020 2:31:23 PM

As long as the Medicare rebate is not applied on a racial basis and available to ALL Australians and not just ATSI

Dr Louise Margaret Acland   2/07/2020 7:35:13 PM

The RACGP standards for General Practice Committee, which I chair, has developed a standard for point of care testing in general practice which has been accredited by ISQUA.
The development of this standard was a prerequisite needed before Medicare item numbers for point of care testing could be introduced.
Let’s hope we soon have these item numbers available to enhance our clinical decision making and patient safety.