A test kit containing a smartphone app that helps women test for urinary tract infections (UTI) and access fast-track treatment in the pharmacy without the need for a GP visit is being trialled in pharmacies in London, Sheffield and Cardiff.
The product combines a traditional dipstick test with the app and a virtual nurse to talk users through the test and has been approved by the European Union, and cleared by the US Food and Drug Administration (FDA).
The technology behind the Dip UTI test kit is being used within the NHS to monitor diabetes and kidney transplant patients and it has been adopted by the NHS Innovation Accelerator scheme.
UTI accounts for up to 3% of all GP visits and for as many as 10.2 million consultation in England alone. One in three women will experience a UTI before the age of 24 and one in two women will develop at least one infection in their lifetime, and only half of the women present with warning signs have an infection and would benefit from antibiotics – with as many as one in five women who present with severe symptoms will currently test negative for infection, despite having a UTI.
Symptoms include: urinary frequency, urgency, or feeling the need to pass urine despite having just done so; pain or discomfort on passing urine; urine that is smelly, cloudy or contains blood, lower abdominal pain, generally feeling tired, nauseous or clammy.
UTIs can be diagnosed on symptoms alone, but Public Health England endorses the Royal College of Practitioners guidelines, which recommend using a urine dipstick test to confirm the infection.
Dr Gill Jenkins a GP says: “The Dip UTI test kit is more accurate than visually reading the dipstick test, and accurate diagnosis is important on two counts. It reduces the risk of antibiotics being prescribed to women who don’t need them and it minimises the dangers associated with denying antibiotics to those who do need them.”
Some UTIs resolve themselves naturally, but can mean prolonged symptoms. It also carries the risk of the infection spreading up the urinary tract and involving the kidneys, which can lead to permanent organ damage or sepsis, and potentially requiring a longer course of antibiotic treatment.
As part of the new Test-and-Treat service, women who suspect they have a UTI will be assessed by a specially trained pharmacist. If there are no ‘red-flag’ symptoms or complications — such as diabetes — they will be offered the opportunity to buy the kit, which consists of a reagent ‘dipstick’, a specially designed colour-board, a concertinaed collection cup and user guide.
Once patients have downloaded the Dip UTI app, a virtual nurse called Emily talks them through the test and helps them to avoid common pitfalls associated with urine-analysis dipsticks — which traditionally rely on trained medical staff being able to assess which colour block on a guide is closest to the shade revealed on the reagent strip. A digital analyser is used to provide a more accurate testing programme given people see colours differently, leading to different interpretations of tests – with one study confirming discrepancies in 39.4% of the visual readings carried out by experienced laboratory staff.
Women’s health expert, Dr Catherine Hood adds: “Another issue which is rarely mentioned is the number of healthcare professionals who are colour blind. We know that around 8% of men and 0.5% of women of northern European ancestry are colour blind, so there must be thousands or healthcare professionals who use these diagnostic strips on a regular basis who have difficulty reading them.”
Virtual nurse Emily tells users exactly how long to dip the reagent strip, when to place it in the colour-board provided and when to use their phone to scan and confirm the results. Users cannot move to the next information screen without confirming they have understood and carried out the instructions at each stage.
In 720 checks, the Dip UTI test kit recorded an exact match in 99.64% of cases and the correct colour block in 100%. Another test, which compared results using 21 different phones, produced an exact match in 99.4% of samples. And to ensure different lighting conditions would not affect the result, 440 sticks were tested under 10 different illumination settings, resulting in 99.52% exact matches and 100% colour-block matching.
Katherine Ward, a fellow of the NHS Innovation Accelerator and the chief commercial officer of Healthy.io, the company behind the new test kit, says: “What is really exciting about the Dip UTI test kit is that it is not some incredibly expensive new technology, and it doesn’t try to reinvent the wheel. It is simply an intelligent way to allow customers to conduct the dipstick test themselves. By doing so they may significantly shorten the time for treatment.”