Mologic has been collaborating with Wales Kidney Research Unit (WKRU) to develop PERiPLEX, a rapid diagnostic test for peritonitis.
Nearly half a million people in Wales suffer from kidney disease, and more than one in ten people admitted to hospital suffer a sudden loss of kidney function as part of their illness.
For people with chronic kidney disease or kidney failure, dialysis is the only means of day-to-day survival.
Many receive peritoneal dialysis – a form of the procedure which removes waste products from the blood via a catheter as they pass through vessels lining the peritoneal cavity inside the abdomen.
Unlike haemodialysis, which involves the filtering of a person’s blood through a machine, people commonly receive peritoneal dialysis while at home – but it carries a greater risk of infection. In these cases, people should seek emergency medical attention, as left untreated, these infections can prove fatal.
Through the growing understanding of the unique immune ‘fingerprint’ that different bugs leave at infection sites, researchers can now identify them far quicker than via conventional testing.
At the Wales Kidney Research Unit (WKRU) researchers have been using this knowledge to help develop a rapid, point-of-care diagnostic test for people who receive peritoneal dialysis and believe they may have an infection.
WKRU investigator Dr Matthias Eberl has collaborated with industry partner Mologic to develop PERiPLEX® test. The test can be performed at home by either a patient or carer and can give an early warning of a developing infection. Mologic obtained CE-marking for PERiPLEX® in early 2017 and the product is now being marketed for sale.
Patients with suspected infection may have to be admitted and kept in hospital for assessment and treatment with antibiotics until laboratory tests confirm the diagnosis, which Mologic estimate can add up to £15,000 to the cost of dialysis treatment.
Prompt identification of an infection at an early stage could lead to early treatment with the right antibiotic and an improved outcome for the patient, who could potentially be treated at home.
PERiPLEX® was developed with support from Health and Care Research Wales, the National Institute for Health Research (NIHR), the Medical Research Council, Kidney Research UK and the European Commission.
Utilising the immune system’s response to different microbes, known as biomarkers, in order to identify bugs is well established and has the potential to allow doctors to diagnose patients and treatments without delay. This, in turn, leads to better outcomes for patients and reduces the unnecessary use of antibiotics, which costs the NHS millions each year and contributes to antimicrobial resistance, a major global healthcare problem.
The usual way of identifying the cause of infection in the body is to take a sample and try to grow the offending bug in a laboratory. But this method is time consuming and does not provide conclusive evidence that the sample grown is the one responsible for the infection, meaning doctors often have to prescribe stronger antibiotics to kill a large number of bugs.
Dr Eberl explains:
“The immune system is extremely sophisticated and it can recognise any foreign agent that gets in contact with your body and distinguish between pathogens and any other bacteria in the environment. By using that sensitivity we’re trying to develop diagnostic assays (tests) which would then help to identify the organism that people are infected with.”
“This is really important because the usual diagnosis is made by culture. Basically, you take a sample from the patient and send it to the lab and they try and grow some bacteria from that. This is a pretty laborious process. It takes time and, in most cases, it takes two to three days until you have the result because it takes time to process the sample and for the bacteria to grow.”
“It’s not a very precise method and it’s very slow. The problem with that is if you have a serious acute infection – such as sepsis or acute peritonitis – it’s a medical emergency and patients have to be treated immediately. You can’t afford to wait two to three days to find out what these people are really infected with.
“According to the guidelines the recommendation is that you treat patients with broad spectrum antibiotics. So you give them drugs that would basically kill anything a patient could possibly be infected with.
“In most cases this works because it targets every single species that could be the cause of the infection but it just means you overuse broad spectrum antibiotics which leads to resistance and you expose patients to unnecessary drugs.
“Broad spectrum antibiotics may come with side effects and may damage your kidneys or other organs. It’s also expensive for the NHS, so any method that would help you identify the cause of infection better and earlier will help with tailoring the prescription so it’s more specific, causes less side effects and is cheaper.”
The Wales Kidney Research Unit aims to deliver an All-Wales strategy for the study of diagnosis, prevention, treatment and social context of kidney disease.
Funded by Health and Care Research Wales, WKRU’s modus operandi provides core infrastructure enabling researchers, clinical staff, patients, families and carers to work together, to answer important health and social care research questions, and to develop state-of-the-art services that benefit population needs.
Health and Care Research Wales is a national organisation funded and overseen by the Welsh Government’s Research and Development Division. It provides an infrastructure to support and increase capacity in research and development (R&D), runs a range of responsive funding schemes and manages the NHS R&D funding allocation.
Health and Care Research Wales’ infrastructure and portfolio of funded programmes consolidates, updates and builds on what has been created and delivered to date, placing Wales at the international forefront of health and social care research.
The infrastructure allows a sharper focus on Wales’ current and emerging areas of excellence and will ensure an integrated, interdisciplinary, interagency, all-Wales approach, from research development to changes in practice based on research evidence.
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