Scientists from the University of Oxford’s Department of Engineering Science and Oxford Suzhou Centre for Advanced Research (OSCAR) based near Shanghai in China, have developed a rapid test which detects the presence of COVID-19.
Oxford University Innovation (OUI), the research commercialisation company of the University, has supported the formation of spinout social enterprise, Oxsed Limited, which is registered in the UK, to commercialise and deploy the test.
The test Oxsed RaViD Direct will soon be certified with CE-mark and ahead of its commercial launch. The test will cost £20 per kit, making it more cost-effective than similar products currently on market, and could be adapted for use in settings ranging from community care, schools, airports or home self-testing.
Oxsed RaViD Direct produces results within 30-45 minutes. It detects SARS-CoV-19 with accuracy and specificity using throat/nasal swabs. Clinical trials gave comparable results with laboratory tests, demonstrating reliability.
It is a simplified one-step version of a viral RNA test and can be used in the field without specialist equipment or training. The simple colorimetric result is read by eye or fluorescent display, meaning there is no need for additional tools to analyse results. A bluetooth-linked fluorescent detection instrument can link the test result into a laboratory information system, so that test results can be tracked.
Across the world, countries face the combined challenges of controlling the spread of SARS-CoV-2 while maintaining an economically productive workforce. Current testing relies on complex lab tests with supply chain issues arising from unprecedented demand; challenges of sample collection and turnaround time for results. Developing countries also suffer from a lack of testing labs and the financing of mass testing. Yet effective testing strategies are key for releasing countries from lockdown in a safe and sustainable way.
Professor Zhanfeng Cui, Director of OSCAR, said: “Our test is ideal for use in community or field settings by lay persons and allows immediate decisions to be made. Immediate applications are: returning to work/education (i.e. schools, universities, companies) and making quarantine decision (e.g. care homes, hospitals, temporary migrants, tourists). Use of such a test could be crucial to economic recovery globally.”
Dr Jane Jin, Senior Licensing and Venture Manager at Oxford University Innovation, said: “Speed of response is crucial in the current pandemic, and we are very pleased to have supported our researchers through the commercialisation process in just three months. Now that the social venture has been incorporated we look forward to seeing the technology deployed globally at scale, in particular in resource-poor developing countries.”
Professor Wei Huang, Associate Professor at University of Oxford, added: “By designing the specific primers and controlling the biochemical reaction, we are able to eliminate the non-specific reactions that cause false positives and make our RT-LAMP test robust. And the Oxford test can be transported and stored at ambient temperature without need for cold chain, which makes shipping and distribution much easier.”
Dr Monique Andersson, Director of Microbiology at Oxford University Hospitals NHS Foundation Trust, added:
“An advantage of using LAMP technology is that it uses different reagents to most laboratory based PCR tests. Implementation of this test for screening would ease the pressure on the PCR reagent supply chain in the NHS. In terms of its wider application, the assay requires little infrastructure and is relatively low cost making it a viable option for widespread testing in LMIC’.
The project was initiated by OSCAR, a University of Oxford centre in Suzhou Industrial Park. Development was supported by the Department of Engineering Science at the University of Oxford. Clinical validation on direct use of swab solution was performed in Oxford University Hospitals NHS Foundation Trust, Peter Medawar Institute of Virology, and the Sir William Dunn School of Pathology.