Could OTC diagnostics unlock one of the most challenging hidden diseases of our time?

In this online exclusive, David Fraser, product manager Lateral Flow Services at BBI Solutions, discusses how easily-accessible diagnostic options could help lessen the burden on global health services.

Irritable Bowel Disease (IBD) is one of the most persistent and challenging health conditions of our time.

The disease, which currently has no cure, affects over 300,000 people in the UK, and is believed to be caused by a combination of multiple factors, including genetic predisposition and environmental triggers.

The cost of IBD to the NHS has been estimated at about £720 million per annum, based on the prevalence and an average cost of £3,000 per year per patient.

It presents a significant financial burden, with the lifetime medical costs associated with the care of IBD comparable to major chronic diseases such as diabetes mellitus or cancer.

Ulcerative Colitis is one of the main forms of IBD. This chronic condition causes inflammation and ulceration of the inner lining of the rectum and colon (the large bowel).

Ulcerative Colitis presents with numerous uncomfortable and embarrassing symptoms including diarrhoea, constipation, bloating, and trapped wind. Unfortunately, these symptoms are identical to Irritable Bowel Syndrome (IBS): a common, treatable condition of the digestive system.

Perhaps because of these symptoms, it is largely a hidden disease, and one that causes stigma, fear and isolation — people with chronic Ulcerative Colitis often go undiagnosed and suffer in silence, maybe believing they are just experiencing unpleasant symptoms which will pass.

There is however, a clear way to mark out chronic Ulcerative Colitis and screen out people with IBS or mild illnesses which might present similar symptoms, like a straightforward stomach upset.

Calprotectin is a protein biomarker that is present in the faeces when intestinal inflammation occurs — this is a key indicator for IBD. A simple lateral flow test using an anti-calprotectin antibody easily determines whether calprotectin is in a faecal sample — alerting people to the fact that it is likely that they have a chronic condition.

Faecal calprotectin testing is helping to improve patient care and save money for the NHS. This method is already widely used by doctors and surgeries across national health services, and is an effective, rapid and affordable diagnostic tool.

However, for people with symptoms including persistent gastrointestinal problems, like diarrhoea, constipation, bloating, and stomach cramps, which could be easily treated - there often isn’t an easy option to check whether they have IBD without visiting a doctor.

Although there is a clear process in place for people to be tested for IBD by their doctor or a medical professional; due to the stigma attached to the symptoms related to the condition, a new approach which simplifies the diagnostic pathway would deliver huge benefits for people who may be too embarrassed to go to see their doctor.

Given the simplicity of a faecal calprotectin test, this could be easily provided over the counter at pharmacies, giving people a more comfortable, convenient and private option to test themselves at home and check whether they are presenting with raised calprotectin levels.

This would enable people suffering with diarrhoea or constipation to quickly and easily pick up a test along with the over the counter medication they need to treat their presenting condition — like constipation, for example. The inclusion of an easy to use lateral flow test and simple to use smartphone application for the detection of calprotectin within the package they are purchasing, would provide the consumer with assurance that they do not have a serious underlying condition which is causing their symptoms, while boosting people’s confidence that they have chosen the appropriate course of treatment for their illness.

Once people have picked up a diagnostic test over the counter in a drug store or pharmacy and taken the test at home, this would provide an initial diagnosis which would enable them to make an informed decision on their future care pathway and guide them to see a health professional should the results indicate raised calprotectin levels.

Introducing this kind of diagnostic option in an over the counter pharmacy scenario could help to identify people suffering with serious conditions. This would improve health and wellbeing, while ensuring that people with more common illnesses, like an upset stomach, are able to be confident that they have chosen the right course of over the counter medication.

Providing more informative, easily-accessible diagnostic options, which harness the potential that technology presents, could open up new care pathways and ultimately, play an important role in lessening the burden on our global health services.

For more information, please visit https://www.bbisolutions.com/services/lateral-flow-assay-development/consumer-health.html