Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP)




Medical, IoT


At the start of the Coronavirus Pandemic, we responded to a press release from Brunel University, London, stating that they, along with the University of Surrey and Lancaster University, had a proof-of-concept diagnostic prototype which could be re-purposed to detect Covid-19. The device was small, portable and took less than 30 minutes to run an antigen test for up to six samples. They were after an experienced design-to-manufacturing company to help with the productionisation stages.

Given the huge level of uncertainty on the announcement of the first Covid lock-down in the UK, GBE and many like-minded British companies wanted to use their skills and experience to help in any way they could. With our experience in product design through to manufacturing, especially in the healthcare and medical markets, we thought this was our ideal opportunity. So, we threw ourselves into the challenge.


The Brief

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Although a proof-of-concept prototype had already been made, this project required GBE’s team to learn the science behind the LAMP testing methodology. Then, retrospectively, produce a product design specification with the essential functionality, key user interface requirements and product compliance with MHRA. These aspects had not been considered when the initial prototype was developed as the initial focus had been on testing poultry for viruses on a research basis; rather than a diagnostic device for mass-testing humans.

Key Points:

  • Establishing key design aspects from all stakeholders.
  • Preparation of PDS and all interface documentation.
  • All work co-ordinated with university consortium partners.
  • Winning UKRI Innovation funding to help part-finance the project.
  • Design CAD of external enclosure - this had to manufactured rapidly to a limited budget, meaning injection moulding could not be considered.
  • Sourcing components with a very restricted, pandemic constrained, supply-chain.
  • Productionising an innovative and still, somewhat, experimental scientific methodology.
  • Corelating the engineering solution with chemical assay, which was still being developed.
  • Developing user application and back-end software solution to run the VH-6.
  • Design product to a set end build cost.
  • Ensure the product met all relevant compliance and legislative requirements, CE IVD Mark and MHRA approval.
  • Implement Design for Manufacture ‘best practice’ principles to enable a smooth transition to volume manufacturing.

Our Approach

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One of the more challenging aspects of the project was working under the pressure of a pandemic whilst extracting key technical application information from scientific and engineering academics, across three Universities, to develop a fully functioning product in a short space of time, to a constricted budget.

Our process included learning the biochemistry of the chemical assay and the mechanism of a Loop-mediated Isothermal Amplification (LAMP) test. This had to be deployed in a small, portable device with large-scale deployment in potentially hazardous testing environments.

This was a truly cross-department, multi-disciplinary, integrated research and development project leveraging GBE’s experience in rapid product development, compliance, and manufacturing. The work involved all members of our engineering team – hardware, mechanical, firmware, software along with our procurement and manufacturing departments to produce an innovative and workable solution. The collaboration included extensive work with Brunel’s engineering department and the department of Virology at Surrey to refine and optimise the chemical assay.

Firmware and software developed in Python on a Raspberry Pi-4, with a GBE custom front-end microcontroller for real-time control, plus mobile app, and back-end software in conjunction with the SW development team at Vidiia Ltd; this included development of the AI detection module.

Several of GBE’s supply-chain were vital in achieving the successful outcome, including:

  • David Edwards Precision Engineering Ltd - Rapid, high-precision CNC machining for heating and encapsulation components. Including milling multiple materials until the correct type and dimensions were established.
  • CamdenBoss - Part-customised, rapid enclosure supply and design assistance.

Electronic component and modules supplied by:
  • Anglia Components – Kitted passive components.
  • RS Components - Raspberry Pi-4 and associated components.
  • Premier Farnell - Memory storage and logic components.
  • FiDUS Power – Medical grade power supply.
  • Membrane Keypad Company – Customised keypad.
  • NEL Technologies – Customised heater.
  • Beta Layout – First batch fast turnaround PCBs.

In many cases, lead times were significantly reduced and margins cut to support GBE’s effort with this project.

The Solution

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The VH6 was successfully launched and commercialised under the newly spun-out company, Vidiia Ltd. This new company includes GBE, the University Consortium and product innovation specialist, David Rimer, as the CEO.

Not only did this help the Covid-19 testing landscape, but it also provided a technology platform to further develop technology in the diagnostic Biotech space with strong ties to the University of Surrey and Brunel. Optimising engineering technology with biochemical assays and a strong commercial focus.

Features Include:

  • A fast, accurate, secure, low-cost, and easy-to-use testing solution for Covid-19.
  • 99.4% sensitivity and 99.2% specificity.
  • Fully integrated, end-to-end application control, with results logged on a secure website.
  • Cutting edge AI application to enable rapid and accurate determination of results.
  • Supply chain for testing assay enabled.