What is the difference between a lateral flow smartphone reader and a handheld reader with a digital platform?
In part 1, we briefly looked at the most commonly used readers, namely bench top and portable solutions. In this blog, we’ll focus on the portable solutions and compare them in a bit more detail to help inform your decision.
Both solutions we’ll look at have their advantages depending on the end product’s intended use and the regulatory requirements of the market.
Handheld standalone reader with digital connectivity
- great for individual & field testing
- established optical detection technology
- reproducible image quality
- minimal training required
- data management capability
Smartphone reader with embedded connectivity
- familiar technology, can be used by anyone, anywhere
- great for consumer diagnostics & lifestyle assays
- high connectivity
- data management capability d
- high regulatory scrutiny
The biggest factor influencing your choice might be regulatory
Generally, lateral flow tests used for diagnosing diseases and conditions in humans are classed as medical devices or in-vitro diagnostic devices. If this is the case with your test, both your firmware and accompanying software will have to be developed to a certain standard and be compliant with strict regulations.
For lateral flow tests aimed at the lifestyle market (food allergen tests for example) there are far fewer regulatory requirements so a smartphone system is at an advantage.
For further guidance on the US regulatory landscape, you can check out this blog we co-authored with Abingdon Health. For the EU market equivalent, check out this blog.
For the regulated in-vitro diagnostics applications, camera quality is important to consider. This is an area where handheld optical readers are a trusted solution as they offer a higher degree of control over the image interpretation and guarantee consistent accuracy of results.
However, smartphone digital cameras are improving all the time and may soon be able to rival those of standalone readers. One option is to construct a housing around the camera to take more controlled, stable images or to use a specified smartphone model with a good quality camera.
We often hear clients’ concerns around loss of data and information. Clients in food production and in healthcare have pointed out that losing data can have significant repercussions and can lead to loss of revenue. Information loss happens often during shift handovers and when there isn’t a reliable and connected digital system in place.
With home use, self testing and near-patient testing, users are already likely to own a smartphone and be familiar with using apps for a variety of purposes. A technology they are already familiar with and feel confident using is at an advantage because it requires very little prior training. With smartphones, this training can be done in the app, at the point of use.
To minimise data entry (i.e. transcription) errors, the process has to be automated and made as easy as possible for the end user, whether they are a patient, a nurse or a quality control worker in a food production plant.
Different end users will have varying abilities, a user tutorial can be included in the user interface app – we call this visual Instructions for Use (IFU) and it’s a feature that comes with the Transform™ app.
This will ensure the error-free use of the lateral flow testing kit and is a feature that both handheld and smartphone readers can benefit from. In lifestyle diagnostic applications and veterinary diagnostics, this kind of system is more easily adopted due to less regulatory scrutiny.
A concern often voiced about smartphone readers is that software needs to be validated continuously with changing operating systems and new smartphone models being introduced.
Although this is true, it is not exclusive to smartphone readers. Handheld units which use an off-the-shelf connectivity platform (like Bond’s Transform™) also need to ensure that any software updates are done as required, and that the supporting documentation is in line with international standards and continuously meets the evolving regulatory requirements.
What’s more, there is a mechanism through which incremental updates to the software can be done without needing to resubmit or revalidate your lateral flow test.
When it comes to updating and validating software, there are specific dependencies with both types of readers. This is a big topic on which we are currently putting together some more detailed information to follow in part 3 of this series.
So, which one should I choose?
There is no one-size-fits-all solution. Ultimately your choice of reader – smartphone or handheld – will depend on your regulatory requirements and the intended use of your test. In any case, the accompanying digital platform that you use will be considered Software as a Medical Device (SaMD) and will also have to adhere to ISO 13485.
There is a need in the lateral flow market for all types of readers, but even more prominent is the need for real-time, data-driven solutions which is led by the end users and global health bodies.
Lateral flow technology has the huge potential to help authorities detect, manage and control the spread of disease outbreaks by deploying timely measures, but it can only do so when connected to a digital ecosystem that is powered by data aggregation, cloud algorithms and instant feedback.
Bond Digital Health’s state-of-the-art platform works with all types of readers, transforming lateral flow technologies into smart, digitally connected diagnostic devices. We work in partnerships with early adopters who recognise that real-time data is the future.
If you are developing a lateral flow test or reader, whether smartphone or handheld, get in touch and see how our technology can transform your product.