The origins of lateral flow technology go all the way back to the 1960s and the discovery of the antibody-antigen immunoassay reaction combined with thin layer chromatography (TLC). But the technology as we know it today was first properly developed in the late 1980s when three researchers filed separate patents within months of each other for what is now considered the basis of the lateral flow platform.
All three patents were looking for a way to develop an over-the-counter home pregnancy test, and more than 30 years on that remains the most widespread and well-known application of lateral flow technology.
Lateral flow is, at its core, a simple technology; a paper-based strip test used to confirm the presence or absence of a target analyte without the need for specialist lab equipment. Low-cost and easy to use, it is ideal for home and point of care testing.
However, because of this simplicity and its age, lateral flow has something of a perception problem. It is often seen as an old, basic technology lacking in innovation. There are also questions over its performance and capability, especially when it comes to sensitivity, multiplexing, quantification and speed. I’ve also heard it said that it’s not a particularly ‘sexy’ technology.
As someone who has worked with lateral flow technology for more than 16 years, I feel it is my duty to dispel some of these myths. The technology may be more than 30 years old, but that does not mean it is outdated, and it is wrong to think it hasn’t evolved.
It’s true to say there was little innovation at first. Because of the competing filings, it took more than a decade for a patent to be issued, and the last of these only expired in 2013. So, for most of its lifetime the lateral flow test was essentially the same technology. However, since the patents started expiring in 2006, there have been and continue to be many innovations, from new reagents and labels to the development of multiplexed tests and digital test reader systems.
Today, lateral flow tests are used across the world in many different settings, including medical, veterinary, food and drink and environmental. The lateral flow diagnostic test market is
The future of the lateral flow market is strong, particularly for medical applications. The movement towards personalised medicine, combined with rising public healthcare costs and a global shortage of healthcare workers, is driving demand for new point-of-care test devices. This means we will see new lateral flow tests developed for the consumer market. Tests are already available for a variety of allergies, male and female fertility, conditions like diabetes, and more recently HIV self-testing kits have gone on sale to consumers in several countries, including the US and the UK.
We will also see new tests developed for the rapid identification of infectious diseases, which will be particularly useful in poor and remote areas where laboratory facilities are not available and where accurate results are required urgently.
Lateral flow is a collaborative technology in that it requires input from several sources to be successful – a process that in itself promotes innovation and new ways of working. Sona Nanotech, the company I lead, is a good example of this. We produce unique gold nanoparticles, of varying colours, shaped like rods that are perfect for use in lateral flow tests. We have partnered with a number of companies that offer complementary technology, such as digital test reader devices and cloud-based data storage systems to combine with our conjugation and development services to offer lateral flow test developers either together or individually.
I think we are on the cusp of a major growth in the use of lateral flow technology in human medical diagnostics. In today’s world, medical professionals face many demands and pressures and must operate in an environment that expects them to be as accurate, quick and cost-effective as possible. Lateral flow offers a low-cost, user-friendly, rapid solution.
Test developers are taking the performance of lateral flow diagnostics to the next level to meet these requirements. Their tests are increasingly becoming multiplexed, quantified and have improved sensitivity and better overall robustness and performance. Coupled with the evolution of portable reader technology and the development of secure cloud-based data storage and analytics, this is helping lateral flow to reach its true potential.
So, lateral flow may be old, but there is a lot of life left in it yet.
Darren Rowles is CEO and president of Sona Nanotech
A version of this piece was originally published on MedTech Engine