Sustainable Lateral Flow Assay Development: Reducing Waste Across the Whole Test Lifecycle

Introduction

Lateral Flow Assays (LFAs) are widely used because they provide rapid, accessible and easy to interpret results close to the point of need. Their simplicity, portability and scalability have made them valuable across clinical diagnostics, veterinary testing, food safety, environmental monitoring, agriculture and industrial applications.

As the use of lateral flow tests expand, sustainability is becoming an increasingly important consideration in assay development and product design. Suppliers across the sector have made significant progress in lower impact material options, including reduced plastic, plastic free, bio-based and recyclable approaches for parts of the test format. However, the sustainability of a lateral flow test is also shaped by how it is designed, manufactured, supplied, used and disposed of.

This article looks at sustainability across the lateral flow test lifecycle, focusing on how material innovation, assay design, reagent strategy, manufacturing readiness and deployment model can reduce waste without compromising assay performance.

Why Sustainability Matters in Lateral Flow Assay Development

Visible material reduction has been an important area of innovation in lateral flow assay development. Lower impact housings, reduced plastic formats, materials selected with end of life considerations in mind, packaging improvements and more efficient kit configurations can all reduce the physical footprint of a test. These developments are particularly relevant because user facing components such as the housing, sample collection and handling components, pouches, desiccant, packaging tray and outer carton can contribute substantially to the overall kit format.

Material choice, however, is only one part of the sustainability picture. A lateral flow test is a functional analytical device, and each component must support accurate sample application, controlled flow, consistent reagent release, signal generation, stability and safe use. Some materials provide technical properties that are difficult to replace without affecting assay behaviour. In these cases, sustainability may be better addressed through careful assay design, reduced component complexity, improved process efficiency, longer shelf life and fewer invalid tests.

The overall impact of a lateral flow test is also shaped by manufacturing yield, energy use, transport, user workflow and the disposal route available in the intended setting. Two tests for similar applications can differ significantly in component count, packaging volume, user steps and disposal requirements, which means design decisions made early can affect waste at scale.

Sustainability should therefore be considered early in lateral flow assay development, rather than treated as a late-stage packaging exercise. Once an assay format has been fixed, reducing waste may require further performance testing, usability work or manufacturing re-validation. Considering sustainability earlier allows technical, regulatory and commercial requirements to be balanced before the product design becomes harder to change.

The Sustainability Value of Testing at Source

Lateral flow tests also need to be considered in terms of the waste they may help prevent. In some applications, the sustainability value of a test comes not only from reducing the footprint of the device itself, but from enabling faster decisions that avoid larger downstream losses.

This is particularly relevant where testing can be performed at source. In food safety, rapid tests for toxins, pathogens, allergens or residues can help identify affected material earlier in the supply chain, allowing specific batches to be segregated rather than larger volumes being rejected later.

Mycotoxin screening is a good example. If aflatoxin contaminated feed enters the dairy chain, aflatoxin B1 can be metabolised by cattle into aflatoxin M1 and transferred into milk. In Parmesan cheese production, aflatoxin M1 has been shown to become enriched in the final cheese, creating a downstream risk for high value hard cheeses. Early lateral flow screening at feed intake, storage or processing can therefore support faster decisions before the issue moves further through the supply chain.^{1, 2}

In agriculture, in-field lateral flow testing can help identify plant disease, crop contaminants or animal health risks earlier, before problems spread or larger quantities of material are affected. This can reduce avoidable crop loss, unnecessary treatment, movement of affected stock or produce and the need for broader remedial action. In environmental monitoring, testing closer to the sampling site can also reduce sample transport, shorten the time to containment decisions and help prevent small issues from becoming larger resource or clean-up challenges.

The same principle applies in other settings where rapid decisions can reduce unnecessary steps. In clinical pathways, point-of-care testing can support earlier triage and more targeted care, helping to reduce repeat appointments, inappropriate treatment and wider resource use. In manufacturing and quality control, rapid screening of raw materials, process samples or finished goods can reduce hold times, avoid unnecessary shipment and identify problems before they create larger batch losses.

In these contexts, the sustainability value of a lateral flow test should not be judged only by the material footprint of the device. The more relevant question is whether the test enables a decision that reduces avoidable waste, transport, delay or product loss elsewhere.

Reducing Avoidable Waste Through Format and Material Design

One of the most visible areas of progress in sustainable lateral flow development is the reduction or replacement of conventional plastic components. Suppliers have made significant advances in lower impact housings, reduced plastic formats, bio-based materials, materials selected with end of life considerations in mind and more efficient kit configurations. Examples include plant based or bio-based housings developed with attention to injection moulding and scalability, as well as cellulose based backing card materials designed as alternatives to conventional plastic backing cards.

These material innovations must still be considered alongside performance and manufacturability from an early stage. A housing, backing card or adhesive system needs to protect the strip, support consistent flow, maintain device integrity, work with automated or semi-automated assembly and remain stable across storage and transport. Alternative materials may also need to meet requirements for moulding tolerance, humidity resistance, labelling, usability and regulatory expectations. Sustainable material selection should therefore be assessed during lateral flow assay development, rather than treated as a simple substitution exercise once the assay format has already been fixed.

Kit architecture and pack format are also practical routes to reducing waste. Components such as buffer bottles, extraction tubes, transfer pipettes, swabs, lancets, and interpretation cards may be necessary in some applications, but each adds material, cost and user complexity. Where appropriate, integrating sample or buffer handling steps, reducing loose accessories and simplifying the workflow can reduce component count. Supplementary digital support, such as QR code linked instructions, video guidance or phone apps, may also help users follow the correct procedure and reduce invalid tests, provided these approaches are suitable for the intended user setting and regulatory requirements.

Packaging should also reflect how the test will actually be used. Bulk formats may reduce material per test in high-throughput settings such as centralised screening, manufacturing QC or routine laboratory use. Smaller kits may reduce expiry related waste for intermittent users, such as field testers, veterinary practices, small food producers or distributed point-of-care settings. However, smaller kits can also increase the number of cartons, instructions and accessories required. The most sustainable pack format is therefore the one that best matches storage conditions, expected throughput, distribution model and user behaviour.

Practical waste reduction comes from designing a lateral flow test that is appropriate for the user, setting and decision it is intended to support. Lower impact materials and plastic reduction are important parts of this, but they need to be combined with a format that is simple to perform, robust in use, efficient to manufacture and packaged in a way that reflects real world demand.

Improving Sustainability Through Reagent Design

Reagent design is a less visible, but still important, part of sustainable lateral flow assay development. While housing, packaging and kit components are easier to quantify, reagent performance often determines whether a test can be manufactured consistently, stored reliably and used with a low invalid test rate.

Sustainability in this context does not simply mean using the lowest possible amount of antibody, detector particle or buffer. Reducing reagent loading without maintaining assay sensitivity, specificity and reproducibility can create more waste if it leads to repeat testing. A more useful aim is to develop a reagent system that delivers the required performance with an appropriate margin for manufacture, storage and real world use.

Lateral flow assay conjugation is a key example. The detector conjugate must release consistently from the conjugate pad, migrate through the strip and generate a clear signal at the test line. Poorly controlled conjugation can lead to weak or variable signal, higher background, repeated optimisation, increased reagent loading or failed QC. A robust conjugate supports consistent assay performance, efficient reagent use and smoother transfer into manufacture, reducing the avoidable material, reagent and packaging waste associated with failed batches or repeated tests.

Stability is equally important. A test that loses performance during storage or transport may generate waste through expired stock, failed QC or repeated testing. Reagent formulation, pad treatment, drying conditions, packaging selection and storage requirements all influence whether the assay remains fit for purpose throughout its intended shelf life.

Drying and lyophilisation strategies can play an important role in improving assay robustness and reducing waste. Drying reagents onto pads, stabilising conjugates or lyophilising key reagents can help maintain performance during storage and transport, support longer shelf life, reduce reliance on temperature controlled logistics and simplify the user workflow.

The most sustainable reagent strategy is therefore one that is technically robust, efficient, manufacturable and suitable for the intended user setting. It should use reagents effectively, maintain performance across expected conditions, support shelf life, avoid unnecessary user complexity, reduce repeat testing and minimise avoidable failure during development, scale-up and routine use.

Designing for Sustainable Manufacture

For lateral flow manufacture, consistency and yield are critical. Variation in dispensing, drying, strip cutting, assembly, pouching or housing dimensions can affect final assay performance and increase scrap or QC rejection. Development work that improves process control therefore contributes to sustainability as well as cost control, particularly during scale-up where small inefficiencies become significant across large batch sizes.

Sustainability is also influenced by how materials are supplied, converted and assembled. Supplier process improvements, such as improved material consistency, lower energy use, reduced scrap, better solvent or adhesive management and more efficient roll formats, can reduce waste before the test reaches final assembly.

Development should therefore consider not only whether an assay works at feasibility stage, but whether it can be transferred and manufactured reproducibly with acceptable yield, cost and material efficiency. Early optimisation, performance testing, stability assessment, documentation and transfer planning can help identify risks before they lead to failed batches, repeat work or avoidable waste.

Transport and supply model should also be considered. Manufacturing close to the intended market may reduce shipping burden, improve supply resilience and support market specific packaging or labelling requirements. However, regional manufacture is not automatically the lowest impact route. The best model depends on batch size, regulatory requirements, supply chain capability, cost, quality systems and market demand.

Transfer readiness is therefore part of the sustainability conversation. An assay that can be controlled and transferred into a suitable manufacturing environment is more likely to achieve consistent yield, lower waste and reliable supply.

Practical Considerations for Sustainable LFA Development

Sustainability claims need to be treated carefully in regulated diagnostics. Terms such as recyclable, biodegradable, compostable, degradable, bio-based and lower-carbon are not interchangeable, and each depends on the material, use conditions and disposal route. Where specific claims are made, developers should consider the relevant standards, certification schemes and disposal conditions. Compostability standards such as EN 13432 for packaging, and EN 14995 for non-packaging plastics, assess compostability under defined conditions; they do not guarantee that a used lateral flow or diagnostic test will be collected, accepted or processed through a composting route after use.

The practical disposal route, contamination risk and local waste infrastructure still need to be considered. A recyclable material only provides benefit if it can realistically enter an appropriate recycling stream after use. Similarly, compostable or biodegradable materials depend on defined conditions, time and the nature of the breakdown products. In some settings, incineration or controlled waste handling may remain the most realistic route, particularly where tests are used with clinical samples, infectious material, toxins or hazardous environmental matrices.

Sustainability is also becoming more relevant to procurement and supplier qualification. In the UK, NHS England’s Net Zero Supplier Roadmap links procurement to net zero and social value requirements, including a minimum 10% net zero and social value weighting in NHS procurements.³ For diagnostic developers, sustainability evidence, supply chain transparency, credible waste reduction strategies and, where appropriate, lifecycle assessment or product carbon footprinting may increasingly support tender readiness as well as environmental performance.

Regulatory expectations remain centred on safety, performance and evidence. Sustainability improvements do not remove these obligations. Any material or format change that could affect performance, stability, usability, safety or manufacturing consistency needs to be assessed through appropriate verification and change control. This is why lateral flow assay performance testing and lateral flow assay performance verification are critical when sustainability led changes are introduced.

Cost is equally important. Lateral flow tests are often used in high volume and price sensitive markets. A lower impact format that is too expensive to manufacture, difficult to scale or incompatible with established assembly processes may not be adopted. Equally, a material change that increases scrap rate or QC burden can increase both cost and waste. The most practical route is to balance sustainability with affordability, manufacturability and robust assay performance.

Conclusion

Sustainable lateral flow assay development requires a lifecycle view that considers how the test is designed, manufactured, supplied, used and disposed of. The lowest impact format is not necessarily the one with the most obvious material substitution, but the one that delivers the required result reliably while using materials responsibly, avoiding unnecessary components and supporting efficient manufacture.

For some applications, lateral flow testing can also contribute to sustainability by enabling earlier decisions closer to the point of need. By helping users identify problems earlier and intervene sooner, lateral flow tests may reduce unnecessary transport, material loss and wider resource use.

In practice, sustainability should be built into lateral flow development from the outset. Assay format, reagent strategy, material selection, packaging, manufacturing route and disposal assumptions all influence the final impact of the product. When these factors are considered together, developers are better placed to produce lateral flow assays that are robust, scalable, commercially viable and lower in avoidable waste.

Fleet Bioprocessing supports this process at the start of a project by working with clients to understand and capture key design inputs, including the intended market, user setting, assay requirements and transfer pathway. Considering these factors early helps align practical design decisions with sustainability, manufacturability, regulatory expectations and assay performance objectives.

Contact us to discuss how sustainability aware design can be built into your Lateral Flow Assay Development and transfer strategy.

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FAQs

What is sustainable Lateral Flow Assay Development?

Sustainable lateral flow assay development means considering waste, usability, manufacturability and disposal routes during assay and product design, rather than treating sustainability as a late stage packaging decision. It includes material choices, reagent strategy, kit format, manufacturing yield, stability, transport and how the test is used in the intended setting.

Can Lateral Flow tests be made without plastic?

Some components can be reduced, replaced or redesigned using lower impact materials, including reduced plastic, plastic free or bio-based options. However, each change must still support assay performance, stability, usability and manufacture. A lifecycle approach is usually more practical than focusing only on plastic removal.

How can at source Lateral Flow testing support sustainability?

At source testing can help users make earlier decisions in areas such as food safety, agriculture, animal health, environmental monitoring, clinical pathways and manufacturing quality control. Earlier screening may reduce unnecessary transport, product loss, repeat testing, inappropriate treatment or wider downstream waste.

How can reagent design and performance testing reduce avoidable waste?

Reagent design affects how reliably a lateral flow test performs during manufacture, storage and use. Consistent conjugation and stable reagents can reduce weak signal, high background, failed QC, short shelf life and repeat testing. Performance testing then helps confirm that material, reagent, packaging or format changes maintain sensitivity, specificity, usability and reproducibility.

Can Fleet support sustainable Lateral Flow Test Development?

Fleet Bioprocessing supports lateral flow assay development by working with clients to understand the intended market, user setting, assay requirements and transfer pathway. Where appropriate, we can also help clients consider supplier options for lower impact materials and sustainable kit components, ensuring sustainability, manufacturability and robust assay performance are assessed together from an early stage

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References

¹ Canestrari et al. Aflatoxin B1 Risk Management in Parmigiano Reggiano Dairy Cow Feed. Italian Journal of Food Safety, 2016.https://pmc.ncbi.nlm.nih.gov/articles/PMC5076703/

²  Pietri et al. Fate of aflatoxin M1 during production and storage of Parmesan cheese. Food Control, 2016.https://www.sciencedirect.com/science/article/abs/pii/S0956713515301675

³ NHS England. NHS Net Zero Supplier Roadmap. Published November 2023.https://www.england.nhs.uk/greenernhs/wp-content/uploads/sites/51/2024/04/NHS-Net-Zero-Supplier-Roadmap-2024.pdf