New expert service helps to optimize lateral flow assays for success

In this SelectScience^® interview, we speak with Sarah Nadin and Eileen Hannigan from the Assay Development team at Merck KGaA, Darmstadt, Germany, about the company’s new Assay Development Services, designed to help developers optimize their lateral flow assays (LFAs), overcome roadblocks, and expedite time to market. The new Assay Development Services provide a valuable opportunity to collaborate with a global leader in in vitro diagnostics (IVD) and access unparalleled expertise that can help maximize the success of LFAs. In this article, Nadin and Hannigan discuss the challenges of designing an effective LFA and explain how Merck is positioned to help developers as a raw materials provider. Plus, learn about the benefits of partnering with a lateral flow expert and the exciting expansion of the use of LFAs for future applications.

The principles behind LFAs are simple in concept and the technology has existed for decades. However, developing an effective and well-designed LFA suitable for commercial use is often challenging because there are many different interacting variables, making the development processes extremely complex and fraught with pitfalls. Some of the major components that must be considered include the physical properties of the raw materials, the chemistry, availability and cost of reagents, and the biological properties of antibodies. Therefore, LFA development requires expertise across a range of disciplines and without this breadth of knowledge, it can be difficult to bring an assay to market.

Partnering with experts to develop and optimize LFAs

As a long-standing supplier of raw materials for LFAs, particularly lateral flow membranes, Merck has now introduced Lateral Flow Assay Development Services led by Sarah Nadin, Head of Assay Development Services, and Eileen Hannigan, Scientific Associate Director for Assay Development Services. The service supports customers in their development and design of LFAs and grants a unique opportunity to access the company’s expertise in the field of IVDs; ultimately helping streamline the development process, maximize the success of LFAs, and accelerate commercialization.

Nadin, Hannigan, and the team at Merck recognize the importance of providing assay development support alongside supplying raw materials. “The main reason we developed our service was in response to customer feedback,” Nadin explains. “After the COVID-19 pandemic, we found a large increase in inquiries from customers who were using our raw materials for lateral flow assays and who were also seeking support with design and development. So, we set out to create a service that responded to this obvious need and so far, the response from customers has been very positive.”

The lateral flow service is available globally, with facilities located in Cork, Ireland, St. Louis, Missouri USA, and two laboratories in China. The Assay Development Services operate on a phase-based approach, helping customers design, develop, or optimize any part of a LFA, from initial concept right through to the final design. Every project is customized and tailored to the customer’s individual needs and includes dedicated project management to ensure projects run smoothly and are proceeding in line with customer expectations.

The benefits of working with lateral flow experts

Nadin and Hannigan state that the biggest advantage of working with a lateral flow expert like Merck is the ability to tap into the team’s vast amount of knowledge on raw materials and component interactions, which would otherwise need to be tested and developed in-house. With this valuable knowledge at the customer’s disposal, tests are much more likely to achieve commercialization, and potential roadblocks can be identified and circumnavigated earlier on in the assay development process.

“The best way to ensure LFAs are designed and developed successfully is to partner with a raw material supplier that can support test development as well,” comments Hannigan. “Our Assay Development Services give customers access to our fully equipped laboratories and provides them with an opportunity to leverage the expertise of our lateral flow assay R&D scientists. Having the ability to work with an extensive network of experts also enhances the sharing of ideas and improves problem-solving capabilities.”

Nadin adds, “The Assay Development Services at Merck allow customers to maintain competitiveness and expand R&D activities without having to add new resources, whilst significantly reducing test development time.”

The future applications of LFAs

The COVID-19 pandemic highlighted the importance of rapid diagnostic testing using lateral flow assays, which were key to successfully controlling the spread of the virus. This has driven a new wave of interest in developing other types of lateral flow tests. Looking forward, Nadin and Hannigan are excited to see the expansion of LFAs into the wider marketplace and believe this could significantly improve public health.

“The broader adoption of this technology for self-testing in the general population will give people the ability to manage their own health outcomes,” says Hannigan. “I’m eager to see increased accessibility to testing and diagnosis using LFAs because this could make a huge difference to people’s lives, especially in more remote areas.”

But the potential applications for LFAs stretch beyond public health. “It’s such an exciting time to be working with this technology because there are so many possibilities for where it could be beneficial,” Nadin explains. “There are lots of people with amazing ideas about different applications for lateral flow tests and I can’t wait to see the directions they are taken, whether it’s agricultural applications, food safety, environmental testing or clinical health.”

Nadin and Hannigan are now working with the team at Merck to develop LFAs further. Specifically, they are working on enhancing the sensitivity and performance of the product through the use of more sensitive detection particles. They hope this will enable test developers to look at targets that require a greater degree of sensitivity to expand the application of the tests. Looking even further ahead, they hope to integrate LFAs with digital solutions and technologies.

Hannigan ends with solid advice for those looking to develop a lateral flow assay: “First and foremost, you must understand how you would like the test to be used, what benefit it will bring and how it will work. From this, you can work backwards to alter the design for its intended purpose. Test developers should keep in mind end user requirements and design the test with that user experience in mind.”

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