A world-first new handheld Covid-19 test device that offers results within 10 minutes and ‘gold standard’ accuracy is in development at the University of Bath.

The LoCKamp (lab on chip amplification) test carries out genetic-based diagnosis, offering the highest level of accuracy thanks to new ‘lab on chip’ technology.

Developed by members of Bath’s Centre for Biosensors, Bioelectronics and Biodevices (C3Bio) the device, which is roughly the size of a mobile phone, completes each stage of a Covid test - taking a sample, identifying specific DNA sequences, and displaying results - within 10 minutes. The way it integrates all of the test elements in a compact and portable unit is unique globally and its genetic analysis is superior to rapid tests currently in use which are protein-based.

Members of the team have been developing the Covid-detecting ‘lab on chip’ microchips since last year, and expect the LoCKamp device to begin clinical testing by September.

Dr Despina Moschou, a lecturer in Bath’s Department of Electronic & Electrical Engineering and the Lab on Chip expert in C3Bio, is leading the test’s development. She says: ““The portable all-in-one device we’re working on would allow for the rapid identification of a virus or known variants. This will be crucial to combating Covid and future outbreaks.

“The difference the LoCKamp test offers is the standard of testing. Existing rapid LFA (lateral flow assay) tests detect a virus by looking for proteins or antibodies within a sample, whereas the genetic test we are advocating identifies a full genetic sequence specific to the virus. It’s like an enhanced, faster, miniaturised PCR test, that doesn’t need to be sent to a lab to be analysed.

“I have been working on lab on chip technology since 2010, and the pandemic has focused my team’s effort further into diagnostic testing, specifically Covid and its variants. The device would be useful in clinical settings but particularly so in remote areas, or in circumstances such as surge testing in at-risk areas where new variants have been identified and need to be confined before spreading further.”

Although the team’s focus is currently on Covid-19 detection and diagnosis, Dr Moschou highlights that the device could be adapted to detect a wide range of diseases, including cancer, strains of antimicrobial resistance, and other viruses.

Advantages over existing tests

Lab on chip technology relies on the emerging principle of microfluidics, which uses specially designed microchips to manipulate tiny amounts of liquid. Lab on chip devices can produce results quickly, as their highly miniaturised size means the reactions required have less space to happen in, and so happen more quickly as molecules bump into each other more often.

Dr Pedro Estrela, Director of C3Bio, adds: “Lab on chip devices will revolutionise the way medical diagnostics is done in the presence of patients. The work we’re doing within C3Bio is at the forefront of exploring existing industrial capabilities such as printed circuit boards to develop low-cost mass-manufacturable lab on chip devices for medical and environmental applications.

“This work on SARS-CoV-2 testing opens the way to rapid genetic testing that can be used at the community level without the need for expensive laboratory testing.”

The handheld unit is projected to cost around £100, while the replaceable credit card-sized microchips that carry out the testing cost about £2 - although this is expected to fall significantly as production begins. Work is underway to understand how many tests one of the chips can safely carry out before needing to be replaced.

The LoCKamp exploits rapid DNA amplification (known as a LAMP assay) developed by partners at the University of Glasgow.

The device, currently being prototyped with Graphic plc, a manufacturing partner based in Devon, will also be able to display quantitative results on a touchscreen display or smartphone app. The C3Bio team say that wireless connectivity capability allows for results to be transmitted, or automatically added to a test-and-trace style database.

Work is currently being carried out to finalise how to incorporate all of the on-chip sample preparation functionalities needed to ‘break open’ DNA samples and carry out ‘sample-in-answer-out’ analysis.

Hospital partnership to begin testing

The project is being carried out in partnership with researchers at the Royal United Hospitals in Bath. Once a prototype unit is completed, currently scheduled for September, it will be tested by nurses and staff at the hospital to understand how it performs in clinical settings with real patients.

Dr Kelly Spencer, RUH Head of Research Operations said: “We are very pleased to be collaborating with the University of Bath on this exciting and potentially very important project that could have massive benefits in our understanding of coronavirus infection and prevention in the future.

“The RUH is proud to be participating in this project as well as a number of ethically approved research studies to help discover more about the disease and if there are treatments to help those affected.”

The project is funded by the Research England QR GCRF and EPSRC Impact Acceleration Account.