In a NIHR i4i Next Generation project, we have developed a prototype handheld mobile phone-connected device based on SAW technology to rapidly diagnose HIV. The device has the capability to detect HIV antibodies and antigen from a small finger prick of blood within minutes. The device has bluetooth connectivity allowing results to be displayed on a user-friendly app interface, and with the connectivity to help patients link to follow up care and healthcare systems.
Key Aims and Achievements
The project aimed to address the need for more widely available, accurate and fast HIV testing outside of a hospital setting and focused on developing an innovative HIV diagnostic tool. In particular, we aimed to develop a prototype mobile-phone connected device to rapidly diagnose HIV, based on multiplexed antibody-antigen detection, with inbuilt wireless connectivity, which works similarly to a pregnancy test (testing a drop of blood with a chip).
Its key achievements were:
- Development of an initial proof of concept (during the proposal phase).
- Development of a pre-market prototype of a portable device.
- Development of associated microchips and the coatings for the detection of HIV antibodies.
- Testing of the device in a small-scale clinical pilot.
- Development of an exploitation plan and a roadmap for the next stages of the work.
- Achievement of all milestones and overall objectives of the i4i-funded project.
Benefits of this technology
- High sensitivity
- High specificity
- Quantitation of marker levels
- Low cost
- Ease of use
- Electronic POC diagnostics
Benefits to Patients, Public and NHS
Widening access to HIV tests has the potential to bring major health economic benefits. People who are unaware of their HIV infection face a poorer prognosis, and are more likely to transmit the virus. Diagnosis offers patients the opportunity to improve their quality of life, and benefits the NHS and wider public by reducing the risk of transmission. Public Health England (PHE) and NICE showed that testing in community settings is feasible, acceptable and has major economic benefits – for every diagnosis made the NHS saves more than £200,000 associated with a lifetime of treatment costs.
Benchmarking and Testing
The analytical and clinical performance of the device has been benchmarked to gold-standard technologies in partnership with UCLH diagnostic lab and to leading rapid point-of-care (PoC) HIV tests showing notable advantages in terms of the volume of sample required, time to result, simplicity of the readout and data linkage capabilities.
Our research results have been presented at major national and international meetings. Our PhD student Val Turbe was awarded a poster prize at Biosensors 2014, and Professor Rachel Mckendry of UCL was awarded the Royal Society Rosalind Franklin Award 2014.
Partners and Funding
This project was conducted in cooperation with UCL Partners (who care for 15% of the total UK HIV-positive population), HIV-patients through the “Bloomsbury User Group” and the i-base HIV activist group.
Orla Protein Technologies, one of OJ-Bio’s parent companies, engineered novel proteins.
Japan Radio Company, one of OJ-Bio’s parent companies, provided the Surface Acoustic Wave (SAW) biochips and were closely involved for the chip development for the HIV application.
i4i was the sole funder of the project and thus, a key enabler of this innovative project.
Further Developments and Future Prospects
OJ-Bio and UCL have continued collaboration and are continuing the development of its pre-commercial prototype into a product which would be fit for being approved through regulatory approval processes. Additonally, OJ-Bio works closely with i-sense that is led by UCL and aims to engineer a new generation of early-warning sensing systems to identify disease outbreaks.
OJ-Bio is open for partnerships and co-development agreements with partners seeking to expand their product range with an innovative portable HIV testing device.
Read more about the project here: Rapid, early warning HIV test in development thanks to £1 million funding