KRONO’s COVID-19 test technology will make the world more prepared for new threats to human, animal and even plant health
The KRONO project is working to deliver an ultra-fast COVID-19 diagnostic test that will provide results within 40 minutes. It will be used to detect pre-symptomatic and asymptomatic cases, when and where it is needed, without the need for a lab or trained technicians. Rapid testing carried out while the disease is in the early stages allows for quick triaging of subjects. Testing can be carried out in doctors’ surgeries, schools, care homes, transit points of entry (airports, ship ports), and even in people’s own homes.
The technology is adaptable to a large number of pathogens; the aim is to be able to detect not only human pathogens, but also those that threaten animal and plant health. The project’s aim is to build up a generic platform technology pipeline that can be operational within weeks of the appearance of a new disease-causing agent in the population.
The KRONO Project is on schedule and the project partners expect to have the system validated for emergency use and ready for production scale-up in under 16 months. The core technology, developed by British SME BG Research, detects viruses without the need for nucleic acid extraction or laboratory equipment. It is an ultra-rapid PCR-based molecular test (‘RT-QPCR’) that deploys a novel type of custom reagent that breaks open the virus, with a single enzyme system that is resistant to being inhibited by compounds that can be found in crude samples of blood, saliva and nose or throat swabs.
How it will work
The sample is placed into a tube that contains the buffer agent, and then a fixed amount of the sample is transferred into another tube that contains the freeze-dried reagent. The test is run and the result is displayed in the form of a traffic light, which simplifies the interpretation of results. This whole operation can be carried out by a trained non-expert user or by a trained technician in care-homes, doctors’ offices, schools, as well as dental clinics and hospitals. The entire process will take about 40 minutes, which will be critical in places like airport testing centres or at other points of entry, where people will only be permitted to transit if they can be shown not to pose an infection risk to others.
As for how innovative it is, KRONO project coordinator Nelson Nazareth, CEO of BG Research says, “RT-QPCR-based systems already exist but the reagent system is unique in that it allows processing direct from raw samples. The instrument is innovative in that it is an ultra-rapid, compact, off-grid-powered, field-portable device that is designed to work in resource and economically poor regions. The software will allow for easy interpretation of complex results through algorithms based on actual clinical data, correlated with current gold standard tests to calibrate the results. Higher throughput systems are also being designed.”
The fast-changing landscape of the pandemic poses risks that are beyond anyone’s ability to predict, but Mr. Nazareth is optimistic that the system will deliver KRONO’s objectives in the required timeframe. “Time is an issue for scale-up, as our supply chain and manufacturing partners may be affected by the pandemic. At each step of the project we might experience delays and potential roadblocks, as some of this work is fundamental research, but we have worked to mitigate these risks by preparing alternative options and look to have tight control of key resources and services.”
This is the first time that BG Research has been involved in an IMI project. “The requirements for the project and our core technology was a good fit,’ says Mr. Nazareth. “The partners, with their own extensive experience and knowledge in communicable diseases, were very receptive once they were introduced to the unique benefits of the platform technology.”