The COVID-19 pandemic pushed point-of-care testing (POCT) into the limelight as routine at-home antigen testing became the norm across the world.
More recently, as outbreaks of Group A Streptococcus — or Strep A — hit the headlines at the end of 2022, attention has turned to wider availability of POCT in the UK.
Considering the rise of antimicrobial resistance (AMR) and how diagnostic technology is becoming ever more sophisticated and affordable, many experts are asking why the NHS is not making better use of POCT when making prescribing decisions.
In 2016, economist Lord Jim O’Neill warned in his government-commissioned review that AMR was one of the biggest health, economic and security threats facing humanity that should be at the forefront of politician’s minds.
Lord O’Neill concluded there needed to be a “step change” in the diagnostic technology to help reduce the use of antibiotics, pointing out it was “incredible” that antibiotics were still prescribed in the same way they were when they were introduced in the 1950s.
Then, in December 2021, the Academy of Medical Sciences urged policymakers to capture the focus and energy of its response to COVID-19 and apply it to AMR.
But in June 2022, Lord O’Neill told the House of Commons Science and Technology Committee that advances in greater use of diagnostics had been “woeful”.
“It is alarming to me still, especially having gone through COVID-19, how we are not embedding state-of-the-art technology right in the middle of our health systems,” he told MPs. “You can really make a huge difference about whether an antibiotic is needed or not and the right kind of antibiotic.”
There has been no shortage of pilot schemes and studies showing the benefit of POCT — which includes any medical device or system that enables diagnosis, monitoring or screening of patients at the time and place of care by appropriately trained users — in both GP surgeries and pharmacies. Most commonly, these initiatives involve respiratory and urinary tract infections, but they have rarely been adopted more widely, even after positive results.
Doris-Ann Williams, chief executive of the British In Vitro Diagnostics Association, says finances tend to be the main barrier. “There’s lots of evidence from Northern Europe to show that, with some [POCTs], you can reduce the amount of antibiotic use. But because antibiotics have remained really cheap, it’s much easier if you’re a busy GP just to prescribe.
“It is a frustration for industry that no one seems to do anything with a pilot, whether it’s successful or not. Changing practice is so difficult.”
One example is the use of C-reactive protein (CRP) as an inflammatory marker to help spot more severe lower respiratory tract infections. In its 2014 guideline on the diagnosis and management of pneumonia in adults, the National Institute for Health and Care Excellence (NICE) advised GPs to consider a point-of-care CRP test if a diagnosis has been made and it is not clear whether antibiotics should be prescribed. This guideline was withdrawn in 2020, when COVID-19 pneumonia was the prevalent form of the condition and there were concerns that different recommendations in the COVID-19 guidelines would cause confusion, including around CRP testing. The guideline has now been reinstated and is in the process of being updated, including a review of the evidence on use of CRP testing.
Jonathan Cooke, visiting professor in infectious diseases and immunity at Imperial College London, has been advising policy makers in this field for 20 years. He says adopting testing in a far more routine, widespread way has been a real “stumbling block” for the UK, despite other countries in Europe reporting it has helped to drive down antibiotic prescribing.
In early 2023, a review of CRP POCT use to limit antibiotic overuse found that GPs regularly perform CRP POCT in Switzerland, Norway and the Netherlands, because testing is reimbursed. The Netherlands also has the lowest rates of antibiotic prescribing in Europe.
The review panel concluded that CRP testing could “represent a cornerstone in the fight against antimicrobial resistance”. The paper showed that the barriers were financial and logistical, rather than resulting from a lack of evidence.
Similarly, a review of evidence — the results of which were published in 2020 — revealed that an “overwhelming” number of studies show that use of CRP tests cuts antibiotic use in patients presenting with respiratory tract infections.
In 2019, a pilot study, led by Cooke in Manchester that involved community pharmacy referral for CRP testing, led to only 10% of patients being given an antibiotic. Almost two-thirds (63%) of patients had very low CRP values and were deemed to have self-limiting illness, yet would likely have been given an antibiotic if the scheme was not in place.
“The evidence around CRP point-of-care testing is very robust. But I think people have made a decision that it’s not particularly worthy to do it,” he says.
From a health economics perspective, Cooke says the thinking is often flawed, because if you are only taking into account the cost of an avoided course of antibiotics rather than the overall economic costs of dealing with AMR, your result is skewed.
“Jim O’Neill predicted that, by 2050, antimicrobial resistance was going to cost us US$100 trillion a year.
“I think NICE is culpable in all this because it is the standard setter. It doesn’t actually put an economic price on antibiotic resistance and that’s a major, major omission,” he adds.
John Schneider, chief executive of business management consultant company Avalon Health Economics, conducted a cost–benefit analysis of POCTs referenced by NICE guidelines, including CRP, and the potential for reduced antibiotic prescribing in 2019. He concluded there are “substantial cost savings” to be made.
Schneider says the UK has always had a high bar for showing cost effectiveness and value, and it is possible there was some “early scepticism” from clinicians around the value of POCT. The criteria for adoption have always been clinical effectiveness, including test accuracy, followed by budget impact.
“POCT is often considered a luxury until it is needed, then clinicians switch gears and call it an absolute necessity. It’s the old ‘leaky roof problem’ — when its sunny, the roof is just fine, and when it rains, it’s too wet out to work on the roof.”
In December 2022, when media stories about deadly Strep A infections added pressure to already stretched GPs, the NHS-funded sore throat test and treat service in Wales was already up and running, ready to deal with uncomplicated sore throats.
The initial pilot in 2018 showed that less than 20% of consultations led to the supply of antibiotics. GP consultation rates fell from 0.71 per 1,000 patients before the service was launched to 0.36 per 1,000 patients four months after it was introduced, and patients and pharmacists were satisfied[10,11]. When the COVID-19 pandemic put a stop to the ‘test’ part of the service, antibiotic prescriptions shot up. What worked best in the face of Strep A, they found, was using a validated scoring method to support identification of bacterial infection, called FeverPAIN plus a POCT.
At the time of publication, researchers were still analysing data from the sore throat test and treat service in Wales for December 2022. However, Efi Mantzourani, reader in pharmacy practice at Cardiff University, says data already show that there were 7,000 sore throat consultations carried out during that month.
Mantzourani believes there is scope for greater use of POCT in pharmacy, as long as it is evidence-based and done in a thoughtful way. One of the problems in wider adoption of POCT is the lack of formal evaluation of pilot schemes, she says.
“We can do so much more if it’s introduced properly. I don’t think the question is why are we not using point of care testing, I think the question is what is its role and how can we optimise that.”
The Department of Health and Social Care said in May 2021 that an NHS sore throat test and treat service for England was “in development stages and under review”.
The layers of bureaucracy in England have been a barrier to introducing POCT, says Cooke. “England has atrocious decision making because there’s so many different interested parties advising this and the other. In Wales and Scotland, the pathway is much shorter, and the evidence is actually listened to.”
In Scotland, women aged over 16 years with uncomplicated urinary tract infections (UTIs) can seek advice and treatment from a pharmacist through the ‘Pharmacy First’ scheme, which follows Scottish Intercollegiate Guidelines Network guidance to do a dipstick test in the presence of two or more urinary symptoms.
A pilot study in the North-East of England and North Cumbria has followed a similar approach. More than 400 pharmacists have been involved in the programme across the north of the country, with early indications suggesting it has reduced antibiotic use.
In July 2022, The Pharmaceutical Journal exclusively reported that NHS England had halted work to roll out a nationally-funded pilot for pharmacy management of uncomplicated UTIs, over concerns around antimicrobial resistance when POCT is not used.
Innovations in testing
It is clear that the NHS needs a better test for UTIs. NHS England has a workstream looking at diagnostics, while the National Institute for Health Research Innovation Observatory in Newcastle, Tyne and Wear, has the task of horizon scanning for what is new or soon to be available for respiratory infections and UTIs.
In December 2022, NICE published the scope of a rapid review to assess the potential clinical and cost-effectiveness of POCTs for UTIs to improve on the current dipstick testing.
It seems that COVID-19 has been both a blessing and a curse for POCT innovation. While it opened the public consciousness to what could be achieved, it also set back the clock on antibiotic stewardship while attention and resource was directed elsewhere.
Stephen Hughes, consultant antimicrobial pharmacist at Chelsea and Westminster NHS Trust and member of the Royal Pharmaceutical Society antimicrobial expert advisory group, says there is a lot of excitement around molecular testing in secondary care, which can detect specific RNA sequences in a specimen, given hospitals have invested in all the equipment to do COVID-19 PCR testing that is now laying idle.
Panels that can distinguish between COVID-19, influenza A and respiratory syncytial virus are already in use. The practical and logistical questions about how to scale that up and avoid the tests being used in the wrong way are currently being grappled with, he says.
“It is important to remember that the test doesn’t give you a diagnosis, it gives you some information. People can expect too much and no test is perfect,” he says.
Hughes’ hospital is one of many in the UK taking part in a trial of POCT for Group B Strep for women in labour. The polymerase chain reaction test, best known for its global use detecting COVID-19 during the pandemic, can be administered by midwives and help guide antibiotic use.
However, the important part of the trial will be whether the test changes outcomes, says Hughes.
A team at University College Hospital London is trialling the Biofire molecular test, which can identify a range of specific bacterial pathogens in a patient with pneumonia but also look for resistance mechanisms. With results in an hour, clinicians do not have to wait for a culture to be grown in a laboratory, which can take up to three days.
Yet, as molecular tests become ever more sensitive, pathogens that are present but not actually causing infection could be picked up, which is another reason why POCTs need to be considered as part of the full clinical picture.
Procalcitonin is another inflammatory marker being studied in an A&E environment for its use in guiding antibiotic prescribing in potential sepsis.
“We teach medics and pharmacists to be very cautious prescribers and they will probably offer antibiotics just in case because they don’t want to get it wrong and that is understandable,” says Hughes, adding that POCTs can provide some reassurance and add “further confidence” that they can hold back on prescribing that antibiotic.
The UK five-year action plan for antimicrobial resistance, published on 24 January 2019, did make some reference to use of rapid and accurate tests at the point of care, particularly around incentivising better research and development in this area. A call for evidence to inform the development of the next five-year action plan closed in January 2023.
Nonetheless, there needs to be political will to make meaningful progress, says Williams.
“They have got to see this with the same imperative as climate change, otherwise, in 20 years or so, we’re going to get to the point where they can’t do simple operations any longer. It’s putting medicine backwards.”
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