Lateral flow
R&D
Large-scale production of infectious disease test kits.
Developing point-of-care lateral flow tests to support faster triage, early intervention and reduced lab burden
Contract manufacturing for diagnostic devices
Accurate, scalable, and fully compliant UK manufacturing; from first production run to high-volume supply.
Your UK contract manufacturing partner for lateral flow and rapid diagnostics
Bringing a diagnostic product to market takes more than a validated design. You need a manufacturing partner with the capacity, quality systems and regulatory expertise to deliver consistent performance at any scale.
SureScreen Diagnostics is a UK based contract manufacturer specialising in lateral flow tests, rapid diagnostic devices and custom diagnostic kits. We support organisations at every stage, from start-ups moving into their first production run to global companies requiring overflow capacity or CE/UKCA/IVDR compliant supply at scale.
Our Derby facility brings together automated and manual assembly lines, ISO‑certified quality processes, and complete packaging and logistics. That means a single, accountable partner from component sourcing through to finished‑product dispatch.
30 years of diagnostic manufacturing experience
ISO 13485 certified quality management
CE, UKCA & IVDR regulatory framework expertise
OEM, private label & white label supply
Products – what we manufacture
We provide contract manufacturing across the full range of lateral flow and rapid diagnostic formats including OEM manufacturing, private label diagnostics, sub components, full devices and completed kits.
Lateral flow cassettes
Fully assembled cassette-format devices manufactured to your specification and validated against agreed performance criteria
Strips & membranes
Custom nitrocellulose strips and lateral flow components with tailored test lines, control lines and pre-treatments
Device housing & format
Custom and standard cassette housings, mid-stream devices and dipstick configurations; sourced, assembled and quality-checked in-house
Reader-compatible test systems
Manufacture of assays designed for integration with digital or electronic readers, including quantitative and semi-quantitative outputs
Custom-packaged test kits
Complete kit assembly - device, buffer, collection components, instructions for use and ancillaries - packed and labelled to your specification
Labelling & barcoding
Regulatory-compliant labelling, lot coding, barcoding and IFU insertion managed within our ISO 13485 framework
OEM & private label manufacture
White-label and OEM production for brands, distributors and resellers; your product, your branding, manufactured to our quality standards
UK manufacturing facilities & quality assurance
Our purpose built UK medical device manufacturing facility in Derby is designed to support every stage of diagnostic manufacturing, from early prototype builds through to large-scale commercial production. By combining automated assembly with flexible manual manufacturing processes, we can adapt to changing project requirements while maintaining consistent quality and efficiency.
All manufacturing is carried out within our ISO 13485 certified quality management system, giving customers confidence that every product is manufactured to recognised medical device quality standards. From incoming materials and in-process inspections to final product release, quality assurance is embedded throughout the manufacturing process.
Our contract manufacturing facilities are designed to support projects as they grow, allowing a seamless transition from pilot production to full-scale manufacturing without changing manufacturing partners. This helps reduce risk, maintain consistency and accelerate time to market.
Who we work with – suitable for a wide range of clients
Our contract manufacturing service is designed to flex around your business stage, market and growth plans.
Start-ups moving from prototype to production
University spin-outs
Large corporates requiring additional capacity
Government bodies & NGOs
Export & distribution partners
Veterinary & agricultural companies
OEM and private label brands
Healthcare & pharma organisations
If you're unsure whether your project is a fit, we're happy to discuss requirements, realistic MOQs, timelines and indicative costs – no obligation.
In practice - example contract manufacturing
Our team supports a broad range of diagnostic development projects. These are some of the areas our R&D capability covers:
Lateral flow
R&D
Veterinary disease diagnostics for national distributors.
Designing rapid diagnostic assays for companion animal and livestock pathogens, suitable for large-scale field deployment where laboratory access is limited
Lateral flow
R&D
OEM drug testing strips for workplace screening providers.
Creating sensitive, specific LFTs capable of detecting adulterants, pathogens or common allergens at production sites or within the supply chain
Why choose SureScreen Diagnostics for contract manufacturing?
Proven at national scale
UK-based quality assurance
Flexible manufacturing solutions
End-to-end development and manufacture
Global regulatory expertise
A single, accountable partner
Ready to discuss your manufacturing project?
Whether you're placing your first order or exploring options, our team can provide realistic timelines, indicative costings and an honest assessment of feasibility.
FAQ's
How long does an R&D project typically take?
Timelines vary by target analyte complexity, sample matrix and regulatory pathway. As a guide:
- Feasibility studies: 4-8 weeks
- Prototype development: 3-6 months
- Full assay development to validated prototype: 6-18 months
For biomarker discovery, complex matrices or reader integration, timelines trend longer. Every project receives a detailed plan with milestones and influencing factors.
What sample types can you work with?
Your test can be developed to work with a wide range of sample matrices, including nasal swabs, saliva, oral fluid, blood, serum, plasma, urine, faecal samples, milk, soil extracts, water and food homogenates.
If your matrix is unusual, our team can develop extraction or pre-treatment strategies to ensure reliable performance.
What are your minimum order quantities (MOQs) for manufacture?
MOQs vary by product type and packaging format. Where specific requirements fall outside standard thresholds, we are happy to discuss options. As a guide:
- Pilot/initial runs: 50-10,000 units
- Volume pricing available as quantities increase
We advise early discussions so capacity planning can align with your timelines and funding milestones.
What applications can lateral flow tests be used for?
LFTs are widely used across:
- Human health: infectious disease, fertility, cardiac markers, allergies, toxicology
- Veterinary: livestock and companion animal diseases
- Food safety: allergens, mycotoxins, residues
- Agriculture/environment: soil pathogens, plant viruses, water contaminants
- Workplace drug testing: single and multi-panel formats
If your analyte isn’t listed, we can still assess feasibility.
Why choose a lateral flow test?
Key advantages include:
- Speed: results in 5-30 minutes
- Ease of use: no laboratory infrastructure needed
- Cost‑effective: highly economical at scale
- Scalable: same format can be manufactured in the millions
- Versatile: detects proteins, nucleic acids, small molecules, toxins and more
