Recently, a Chief Medical Officer reported, "There is currently not (an antibody) test available that (our regulator) has enough confidence in." Indeed, current commercialised COVID19 IgM/IgG tests aren't reliable in terms of detecting true immunity and infection in parallel. Further, there is a global need to improve the measurement accuracy and reporting of immunity and infection by COVID19.
An individual with an early immune response may display typical antibody patterning, with weak signs of immunity, while being replication-active and a COVID19 reservoir. Silenced asymptomatic cases (which represent 85% of the infected community) are the biggest viral reservoir. They live with the disease unaffected, their immune system combats the condition correctly, preventing progression to more severe outcomes. Viral replication and viral shed can also be interpreted from PCR measurements or a set of physiological biomarkers that arise in the COVID19 infection. It is the later biomarker patterning that will profile an individual's disease progression from asymptomatic, through mild or occasionally severe, possibly fatal, otherwise moving on to recovery and immunity. In combination with the accurate measurement of antibody titers, which are “alive” or have neutralising properties against the virus, a novel path to avoid false positives is provided. The complete picture of a COVID19 patient measures both the immune system status and the physiological biomarkers. Patient responses vary, requiring individualised diagnosis and treatment.
What it does
By refining a novel, multiplexed point-of-care (xPOCT) device built using integrated microfluidic ELISA, we will be able to identify a combination of immunological and physiological biomarkers that can accurately indicate infection, prognosis and immunity of every COVID19 patient. xPOCT can translate the biochemical signal into a digitalised protein quantity, and we will be able to transfer these measurements via secure blockchain (IMMUPASS) to the health authorities, governments and the public domain. This will facilitate the detection and interpretation of COVID19 cases around the globe with the comfort that the measurements go directly from the device to a secure public domain. Hence, we can tackle the issues of misleading or poorly-collected data by the governments; leading to much-improved epidemiological statistics worldwide. Finally, we achieve not only a European, globally-recognised immunisation passport but also an infection passport. Traditional vaccination cards imply the acquisition of immunity, having received one or two doses of vaccines. Nevertheless, they do not provide a specific measure of immunity strength. Therefore our project will deliver, for the very first time, Digital European Vaccination Cards (DiVEC) for public use. Our devices will directly provide, via the blockchain, a public domain Immunity Strength Indicator (ISI), based on the neutralising titer of anti-COVID19 antibodies. Besides, a quantified approach will significantly reduce false positives. This project is needed to ascertain infection and immunity to confirm the success of future COVID19 vaccination programmes.
For a comparatively small cost, the pandemic's economic impact can be reduced, and recovery will accelerate with detection of COVID19 in near-real-time because governments and citizens will be able to re-establish safe proximity and access reliable reporting statistics.
How we built it
We are a multidisciplinary team from 5 countries, rapidly building a Business Strategy on top of Medicine, Biochemistry, Diagnostics and Blockchain. Researching pre-press papers provided knowledge for the multi-marker perspective of xPOCT. Collaboration between hackers, businesses, EU institutions and investors delivered the community solution - quantification of immunity and infection - with a design for testing, validation and delivery of prototype and full solution.
Challenges we ran into
Single biomarkers (e.g. IgG) aren't the answer. Cheaper, binary tests may nor deliver accurate, consistent results. A lack of high quality, quantified, consistent, longitudinal data for protein biomarkers with clinical outcomes to test AI/ML solutions.
Accomplishments that we are proud of
We teamed up in an agile and collaborative manner within a MedTech environment. We have been able to capture divergent thoughts to align quantitative detection of infection, treatment and immunity for COVID19. We discussed policy, pricing, regulation, use of epidemic statistics, data security and confidentiality. Therefore, we delivered a new integrated vision to address current diagnosis problems in COVID19, government transparency and economy recovery.
What I learned
The benefits of working with a mixed-discipline team to drive thinking and identify new solutions. Respecting every team member as part of the group in their expertise and building together from every viewpoint, an integrated, blockchain-based xPOCT design in a short amount of time.
What's next for CRT C-19 MultiMarkers
We need to validate the biomarker search in a laboratory and validate the prototype with serum samples. We need to plan, build support and secure financial backing. Phased delivery can help validate the approach and accuracy. Afterwards, a scale-up can be performed to deliver a test and certificate for each citizen.