How TestCard Technology Gives Clinical Grade Results
Written by
Kayleigh Maxwell
TestCard uses the power of an everyday smartphone to put clinical grade testing into a patient’s hands. The groundbreaking TestCard UTI test kit gives patients a way to share their detailed medical results healthcare professionals need in an affordable, fast and accurate way.
The global pandemic has accelerated the public’s need to take their health into their own hands. NHS Digital estimates that 27 million GP appointments have been lost between March and August 2020*. It’s more important than ever for people to be able to engage in at-home testing so that they can get a faster route to treatment.
Traditionally UTI dip tests use the human eye to see results in a non-lab environment. The flaws of reading a dip test by eye are easily understood – the differentiation of colour in different lighting conditions and environments, and the inherent subjectivity of comparing colours by eye. To avoid these difficulties health professionals refer samples to a laboratory, where a scanner can ‘see’ more accurate results.
Medical results detail for healthcare professionals
The main TestCard UTI test kit results screen shows a straightforward answer for the patient so they know if they need to seek professional advice. There are detailed urinalysis results available that show the levels of nitrites, leukocytes and pH in your urine which can be shared with health professionals to plan the right treatment and medication for a patient with a Urinary Tract Infection.
Dr Andrew Botham, TestCard Chief Scientific Officer and Founder said, “This was an important feature for TestCard – we know patients want answers to their questions, not nonsensical numerical results, but at the same time we know that health professionals will need more in-depth information to best manage their patients.”
Proving the TestCard technology
The clinical scanning technology developed by TestCard can be used to perform a wide range of tests supporting numerous disease states. The following pilot study was carried out to compare TestCard’s dipstick reading for the simultaneous quantification of 10 different parameters. In cases where there was an “non-agreement” between methods, a visual inspection was carried out to determine the “correct” result. The pilot study compared the detailed results from the TestCard’s read alongside a Roche Urisys 1100 fixed terminal scanner, a technology widely used in hospitals and clinics.
For all parameters assessed TestCard provided equivalent accuracy of measurement (except for pH where a greater accuracy was seen at higher pH values) compared to the fixed terminal scanner. The TestCard clinical scanning technology did show better precision or reproducibility of measurement when compared to the fixed terminal scanner.
Testing in different lighting
TestCard showed excellent results in nine different lighting conditions (and darkness). Lighting was increased and directly applied at potentially inferring angles. The maximum light level used was >30,000 lux direct sunlight.
The result mean response for all 10 test parameters measured did not vary significantly (defined as <15% delta E variance and no change is analyte concentration) in colour across the 9 lighting conditions.
Results for specific gravity, pH, leukocytes and nitrites
The pilot programme provided paired comparisons of 13 different urine control concentrations repeated on 10 separate occasions for all 10 analytes. Across all 10 analytes measured there was good or excellent correlation in reporting and detail. This confirms TestCard provides results as reliable as the gold standard dipstick reading methodology used in laboratories and hospitals.
Specific Gravity
Specific Gravity displayed good agreement between methods at each concentration transition point. Testcard appeared to show a greater consistency in reporting of control sample levels.
pH
pH displayed good agreement between methods at each concentration transition point. TestCard reported higher values for b10 and b11, these were visually confirmed showing TestCard to be more accurate and higher pH levels. Testcard additionally appeared to show a greater consistency in reporting overall with a higher precision.
Leukocytes
Leukocytes were erratic for both methods. This was as a result of the commercially available control material used. The methods still displayed good agreement at all concentration transition points and TestCard displayed a smaller spread for each control level than the fixed terminal scanner.
Nitrites
Nitrites displayed good agreement between methods at transition points. Testcard appeared to show a greater consistency in reporting.
At-home testing for a faster route to treatment
We have more treatments, more tests, and more people than ever before. But people still need to leave their homes to attend GPs or Emergency rooms to access healthcare. This simply isn’t scalable and digital technology allows us to move from the “one-size fits all” approach we have come to expect. TestCard is able to provide different routes to the same gold standard treatment destinations and put information into the hands of healthcare professionals quickly, accurately and in an affordable way.
The TestCard UTI test kit is the first of our planned products. Our mission is to make a range of affordable at-home testing available across the world.
*Between March and August 2019, there were 146.2 million appointments made at GP surgeries in England. But between March and August 2020, there were 119.5 million appointments made - though the data is still experimental due to the effects of the pandemic.