"Using the right test(s) in the right place and time"

May 2021 saw Abingdon Health’s Director of Global Sales, Leigh Thomas, join Angus Urquhart (Sales Director at Katalyst Laboratories) and Robert Miller (President at Drummond Scientific) to discuss the positive future for the lateral flow industry.

lateral flow assay experts discussing positive market predictionsThe basic technology that underlies lateral flow tests has been used since the 1960’s. However, the COVID-19 pandemic has brought lateral flow to the forefront of many healthcare agendas and into the public vernacular.

Despite the historic multi-industry use of lateral flow, widespread use with COVID-19 and the market’s growth projections of $10.2bn by 2025 (marketsandmarkets.com), there is still a lack of education surrounding when, why and where to appropriately deploy lateral flow testing. Also, the direct comparison between lab testing and lateral flow tests during the COVID-19 pandemic has exasperated the confusion surrounding lateral flow ‘best practice’.

The subject of lateral flow accuracy has also been a talking point the world over. Something the speakers from the ‘what’s next for lateral flow’ webinar succinctly tackled head on.

During the webinar, the speakers highlighted how the technology has been used successfully for many years and how the COVID-19 pandemic has accelerated the future growth of the market.

Who was the what’s next for lateral flow webinar for?

Nathan Sharpe from Charlton Morris hosted the lateral flow event posing questions important to organisations who fall in to one of the following categories:

  • Have a lateral flow assay (LFA) concept and need future market-validation to proceed with an assay development and manufacturing project
  • Looking for insight into the next market opportunity
  • Looking to enter their market with a lateral flow test

Why has it taken a global pandemic to properly appreciate lateral flow?

Angus opened the session by rightly noting lateral flow technology is not new. Noting, “back in 2017…there were 276m rapid tests for malaria supplied globally”. To add to this, UNICEF increased its procurement of malaria rapid diagnostic tests (mRDTs) from 3.8 million tests in 2008 to approximately 13 million in 2015.

“Lateral flow has been in most consumers’ lives, just in a different format”, added Robert. COVID-19 has brought the test into the public’s vernacular as the technology can been “used as a gate to enter schools or for coming back to work. I think the importance [of lateral flow] has certainly become much more present”.

Leigh continued by saying, “some industries and verticals have been reliant on lateral flow to great effect for a number of years”. Highlighting infectious disease testing, law enforcement roadside drugs of abuse (DOA) testing and workplace DOA testing in the USA as a few examples. “Essentially lateral flow is a quick and cost-effective aid to diagnosis when its required.”

Leigh went on to answer Nathan’s question directly by stating, “the pandemic has been a huge threat to the economies, that’s what has brought lateral flow to the forefront. Like anything, when something is threatened you reach for something that will get you out of the problem as soon as possible. That is why it is new to some markets but for many markets it has been a staple tool…because it’s portable, rapid and easy to use.”

lateral flow test for testing plant pathogens and diaseasesLateral flow testing is all around us and many people will not realise it. The use of lateral flow technology in pregnancy testing is well-known, although probably not by name. Many will be unaware some companies test for mycotoxins with lateral flow rapid tests. Potatoes are screened for commercially damaging pathogens with LFAs. Some industries use LFAs for detecting fraud or quality control markers, in food testing or fuel testing for example. These examples are in addition to self-testing for sexual health and mass malaria testing.

You can hear the panel’s responses to this question here: https://www.youtube.com/watch?v=NXxAw3U87D0&t=201s

How can we overcome lateral flow technology’s inaccurate reputation?

Nathan opened this section by asking, “because it [lateral flow] is quick and cost effective is this the reason why it has got its reputation…people see it as a simplistic test so therefore not as accurate?”.

“It is a simple test and simple test to operate, but is not a simple test to develop and manufacture”, added Leigh. Before going on to say, “let’s not perpetuate the myth with the question. The reputation for inaccuracy is only in certain areas and in terms of the uninitiated. It’s certainly a generalisation that’s been placed across lateral flow.” Alluding to the fact that lateral flow is unfairly compared with other diagnostic platforms. “We’ve seen different [diagnostic] technologies played off against one another in this pandemic. All diagnostic tests have a role to play and a place in a testing regime.”

Leigh summed up by saying responsible reporting and regulation, education of the market, and a focus on high-quality materials is key for maintain accuracy. Stating, “do be aware of cheap imitations. Lateral flow tests are complex devices that rely on biologicals and complex materials. You can’t compromise on quality with shortcuts”.

large batch of rapid tests being automatically packed in desiccated foilsBoth Robert and Angus agreed with Leigh, and Angus added, “there are some good, effective lateral flow tests out there. There are also, frankly, some tests that are not so good…some that have been adopted on a major scale. You see headlines reporting lateral flow tests aren’t giving accurate results and it’s often because they are poorly manufactured. Regulation is key here. If you want to operate as a testing company, you need to have UKAS accreditation…if you want to sell lateral flow tests you can do that without any form of regulation at all. That is a problem for the industry.”

Which leaves accurate tests, made by quality lateral flow manufacturers and sold via reputable partners, being undermined by tests that have not had the same level of quality control.

Hear the panel’s responses to this question here: https://www.youtube.com/watch?v=NXxAw3U87D0&t=497s

Where is the opportunity for lateral flow in the next 12 months?

After discussing the role of lateral flow alongside of that point of care tests, the panellists went on to discuss the next 12 months for lateral flow testing.

Leigh stated it is likely the pandemic will still be “present in different territories” owing mainly to the differing speeds of vaccine rollout and access to COVID-19 testing. Thus highlighting the need for “specific testing regimes for different environments”. However, PCR and antigen tests will not be the only solution with Leigh explaining, ”we’re seeing neutralising antibody testing coming to the fore, and the need to support vaccine passports and seroconversion post-infection”.

In terms of the wider lateral flow market outside of COVID-19 testing, the speakers agreed with Robert’s market feedback that “fewer steps in diagnosis are needed”. A need borne from many pre- and post-COVID market drivers and end-user needs. Something Leigh added to by saying, “advocates have been saying for a long time that health budgets are staying static, appointments are increasing, aging populations are increasing. There is so much pressure on healthcare that there has been a need to move triage and primary care out of the doctor’s office”. Near-patient and home testing with lateral flow technology is a solution to accommodate this need.

Leigh continued, “there has been resistance” to home testing within some circles. However, “the pandemic has fast-forwarded and accelerated” a change in policy with lateral flow home testing being used in the UK1 and USA2 for example.

AbC-19 rapid antibody test certificate appIn essence, the COVID-19 pandemic has shown in a short timeframe what can happen with the threat of a ruptured healthcare system. Raising the point that appropriate tools are needed across healthcare strategies to provide straightforward solutions that help manage budgets and aid the best possible outcomes for patients.

The speakers also covered the topic of apps and data usage: a growing area in lateral flow with the pandemic heightening the need for quick, accessible data. By driving data to clinicians and care givers, quickly and easily, enables primary care teams to be deployed against acute requirements and to aid early interventions.

Prevention is an important topic for budget planning and saving costs for healthcare providers. Let alone the multiple patient benefits. Rather than managing symptoms it is feasible that healthcare providers will look to use appropriate tools to prevent conditions escalating.

Hear the panel’s responses to this question here: https://www.youtube.com/watch?v=NXxAw3U87D0&t=1331s

Summary

There will be many scenarios where lateral flow will be adopted favourably with other platforms being best suited in other situations. In some cases, lateral flow will combine with other diagnostic technologies: decentralised molecular testing being one example.

Using the right test(s) in the right place and time, as part of the right testing regime, is key. Angus gave an example of one of his cruise liner clients who use COVID-19 PCR to test passengers’ days before boarding and lateral flow antigen testing upon boarding. In addition, Abingdon Health wrote about a worked example of using COVID-19 neutralising antibody tests for international travel and workplace testing.

However, for non-COVID testing, the pandemic has opened the eyes of the public and policymakers as to what diagnostic technologies are out there and what is possible. The demand for faster diagnostics and accessible data alongside the market drivers may continue to force the hand of healthcare providers into offering solutions that free up bottlenecks and give patients the best possible service. Busy or remote clinics or emerging nations, may now be able to use rapid diagnostic solutions they were previously unaware of in order to address any operational and patient outcome concerns.

Over the years, Abingdon Health has been writing articles about the many multi-industry benefits of lateral flow. The COVID-19 pandemic has now brought lateral flow to the attention of more people and it is likely more organisations will adopt the technology for routine processes. Quick testing, cost-effective results delivery and faster interventions are 3 of the many reasons why lateral flow testing will be more common.

Unfortunately not all of the panel’s lateral flow insights could be covered in this article. Hear every word from the 3 speakers by watching the video below or by downloading the what’s next for lateral flow podcast.

If you are working on a lateral flow project and need assistance with the next steps please contact Abingdon Health on +44 (0) 1904 406082 or by contacting us online.

References

  1. https://www.nhs.uk/conditions/coronavirus-covid-19/testing/regular-rapid-coronavirus-tests-if-you-do-not-have-symptoms/
  2. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic