In this section, you’ll find answers to the most frequently asked questions (FAQ) about the next generation diagnostics technology developed by NovarumTM DX.
What is mHealth?
mHealth is an abbreviation for mobile health – a concept which recognises how mobile devices will support a new era of digital healthcare.
Which rapid tests can the smartphone diagnostic solution read?
Most visually read tests. Diagnostic tests include lateral flow assays, ELISA, colorimetric, colony counts, agglutination, urine dipsticks and biochemical paper-based assays. If you have a digital device like a glucose meter and want to record the data directly from the screen then we have a solution for that too.
Who actually uses the smartphone to read the test?
User-adoption is quick due to our intuitive mobile app interface. With built-in instructions and guidance on how to conduct rapid tests correctly, patients can use their own mobile phone to perform tests and manage their conditions. Researchers and technicians can also perform diagnostic tests out in the field, in circumstances where infrastructure is poor and healthcare remote. Other user types may include healthcare workers (e.g. physicians, nurses), Support engineers, and QC laboratory operators.
What happens to my test results?
Test results can be shared with healthcare professionals, or specific end-users, online. Data is accessible via a secure desktop portal which stores information such as test result, time and date stamp and geolocation. Data can be analysed to enable patient monitoring and to optimise timely treatment decisions, or track the spread of an infectious disease in real-time for example.
What phone models and operating systems support this reader solution?
Novarum’s software solution can operate on all smartphones for both Android and iOS devices.
Is the smartphone reader solution only applicable to medical?
No. Smartphone readers have potential across a range of rapid tests within: agriculture, environmental, food safety, fuel testing, toxicology and veterinary to name a few.
How does smartphone diagnostics compare to benchtop readers in a lab?
Smartphone diagnostics can provide instant and accurate results, saving considerable processing time in comparison to conventional laboratory testing methods. However, we also have clients who deploy smartphone technology in their laboratory environment to support existing test procedures.
What additional hardware is required to turn the smartphone into a diagnostic reader?
None. Novarum’s technology enables the accurate reading and sharing of rapid test results with no additional hardware. We develop a ‘mobile eco-system’ comprising the smartphone test reader software and an end-user portal which collates all test results.
What is the technology behind this solution?
Novarum’s Model Fitter AnalysisTM approach and multi-frame analysis approach transforms a smartphone camera into a diagnostic test reader. The technology includes novel approaches to three stages of reading a test result – detecting the test geometry, extracting the relevant data from the image, and translating that measurement into an actionable result. Processes we call detection, analysis and interpretation. Novarum holds a portfolio of patents surrounding this specialist image-capture technology including granted patents in the US, China, Russia and Japan, and applications pending in the UK, Europe, Brazil, Canada, India and South Korea.
Can the smartphone solution provide only qualitative test results?
No, our approaches can provide qualitative, semi-quantitative or fully quantitative measurements of a test device.
What happens if there is no device connectivity?
Our approach is designed to work without any back-end services or sending large (expensive) data streams back to a server. Most of our applications send small amounts of data to a server for archiving purposes, but if a connection is not available the results are simply queued until one becomes available. In fact, we can even configure the app so that some or all data is not sent over 3G/4G connections and is held until WiFi is available. An option which can be particularly useful in resource poor settings.
What operating standards are adhered to during mobile app development?
Novarum is certified to ISO 13485:2016 for Medical Device Quality Management Systems (QMS). As part of our ISO certification we develop to IEC 62304 software lifecycle management. Even if your application is non-medical we believe these robust, traceable processes will ensure you get a high quality product that your users can trust.
How are mobile medical apps regulated?
We’ve written a white-paper on this topic, which is available for download.
Is this solution already in the marketplace?
Yes. Read our case studies to learn more about how our pioneering technology has already assisted our customers across a range of industries.
Can we download the Novarum Demo app from the Google Play or Apple Store?
No. Our mobile app development is bespoke using Novarum’s patented reader solution. However, many of client’s apps are available. Email email@example.com to learn more about getting a demonstration of our technology.
How much does the smartphone reader solution cost?
The cost of our smartphone readers and app development is project specific, almost certainly costing less than developing a hardware based solution. However, building robust, high quality medical device software requires specialist expertise. We offer an ROI calculator which helps determine your projected revenue from adopting a smartphone-enabled solution for point of care testing. Contact Novarum to learn more: firstname.lastname@example.org