COVID-19 test kits

Genevieve Leveille, CEO of UK firm 08 Group and Co-Chair of the TechUK DLT Working Group, collaborates with digital health tech companies to deliver verified-safe China-sourced Covid-19 test kits at scale

Multiple layers of uncertainty and anxiety within society has many governments working overtime to find safe ways to release the stringent lockdowns. While economic activity across most labour-intensive industries has nose-dived and society is on pause, virologists race for a coronavirus vaccine. The reaction of most governments to the pandemic has been to take every possible action to aid in the Covid-19 response.

Meeting the requirement for widespread antibody testing to check for past infection of the virus and have as many people as possible return to their workplaces in vital industries much faster has brought into sharp focus stark deficiencies in current systems of test-kit delivery and reliability, worldwide. In Italy—one of the first countries hit hard by the pandemic—regions began their own testing campaigns on essential workers, without waiting on a national directive. Because of the variance in serological test-kits, regional governments took on the regulatory burden themselves to publish lists of tests certified for use in their own regions. Deploying digital health technology solutions and managing the spread of the virus has a high burden of production of evidence as mistakes can mean both budget losses and loss of life.

The 08 Group, a UK-led collaboration of digital health and technology companies with evidenced success in delivery of smart applications for compliance and verification monitoring in even the most infrastructure-starved operating environments, have customised a solution. Partnered with seasoned tactical technologists, IOTT, and joined by Medidee, a TÜV Italy-certified quality, regulatory and clinical affairs services consultancy, 08 Group’s response includes tactical intelligence and the regulatory guidance missing from many of the innovations thus far put forward, to ease the regulatory burden that is placed on regional government task teams.

SmartChain solution

Their SmartChain solution, implemented on a private Corda blockchain, delivers an innovative packaging compliance and verification system via distributed ledger technologies (DLT). It affords efficiencies end-to-end through the supply chain, from the Covid-19 test-kit manufacturers through to people being tested for the coronavirus at home and in workplaces. Implementation includes activation of a secured value chain. Manufacturers are equipped with product and box code printing for crypto sealing, encrypted near-field communication (NFC) code per test kit, and standard and low-cost radio frequency identification (RFID) tags for each box.

For additional shipping insight, pallet and package tracking is implemented using multiple performance sensors to read temperature, humidity, and C02 levels. The distribution state additionally requires augmented and certified automatic inventory on compliant boxes integrated with standard procedures. Various manufacturers in China will undergo certification processes to create the trusted list of suppliers. The SmartChain solution keeps the world economy moving as it allows labour to return to work with confidence that they have been tested with reliable, high-end testing kits.

Yuelin Liu, Chairman of the Tinjoy Health Group, Executive Director of the China Overseas Chinese Merchants Association and Chairman of Shenzhen One Belt and One Road Investment Development Group who has made many advances in the life sciences industry since his business began in 2007, is 08 Group’s member in China.

08 Group’s existing work in the creation of an electronic, interoperable system to identify and trace prescription drugs means that implementation of a customised solution for Covid-19 response can be both rapid and regulated. As government task teams across the globe wrestle with the impact of this crisis and the realities of living through the pandemic, a spark of certainty can be provided through a solution that ascertains the origins of Covid-19 rapid screening test kits and ensures their compliance through regulatory insight.

The results-oriented working group have focused their attention on solving supply chain deficiencies for delivery of Covid-19 test-kits at scale, such as not being able to distinguish between Chinese Government-approved factories and scam fly-by-night operations, a lack of provision of reliable product information to accompany the product to prevent goods from being rerouted and repackaged by exploitative middlemen, a lack of product movement and traceability data end-to-end that leads to trust issues, and test-kit failure from improper care and transportation procedures not being followed that should include stable temperature monitoring.

The 08 platform’s designers and engineers are active in the wider work to define interoperability and establish standards to support the Drug Supply Chain Security Act (DSCSA) regulation. Initial interest in the 08 Group’s SmartChain solution has been shown at government level by Italy, New Zealand, Australia, Switzerland, Mexico, India, and countries in Africa including Kenya. One of the challenges in developing digital health solutions is the inherent sensitivity of health data.

By making use of SmartChain features such as its capacity for data access management and exploring the application of the most recent innovations in machine learning—such as federated learning, so that data can inform decisions without having to be shared —the 08 development team plan to ensure requirements are met in rapid deployments that solve traceability and big data concerns.

Since the start of the pandemic, the global response to coronavirus and Covid-19 have been uppermost in the minds of most people. The 08 Group, while mindful that this is vital for a rapid response in this crisis, has a view to wider application of their compliance verification package.

Industries plagued with tampering, counterfeit products and pay inequity include high-end art, prescription drugs, and agriculture. With little disturbance to current practices and using available market standards, intelligence systems, and advanced IoT technology, the 08 Group have begun to disrupt the status quo by building neutral platforms in healthcare and reliable compliance ecosystems.


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