A-Patch Project – 1 svetlana

A-Patch aims to research, develop, and validate a novel non-invasive wearable sensing patch for detection of infectious disease at point-of-care, such as Tuberculosis (TB), from the skin, with an ability to serve as a monitoring and epidemic control tool.


The device will be a wearable autonomous sensing patch incorporating newly printed sensors and thin-film oxide based flexible electronics, self-repairing components, self-powered components, and a communication layer, for wireless transfer of sensor readout. The patches will be produced in a pilot-line setting for validation trials, and at the same time aligned for subsequent volume manufacturing. A supply-chain and roadmap for large-scale production, regulatory approvals, and go-to-market strategy, will be prepared to enable full post-project commercialization and exploitation of the A-Patch platform.


Things to know about A-PATCH
The concept

The concept of A-Patch is to design and demonstrate a patch that sense TB-specific volatile organic compounds (VOCs), which are compounds that are released into the bloodstream by or as a result of infected cells and can be detected from air trapped above the skin (the “skin headspace”). Deviation from the healthy VOC range may indicate either infection or high infection risk, in which cases the autonomous wearable device can warn the user and recommend either follow-up testing or treatment. The patches can also be worn continuously for monitoring disease treatment and to ensure effective treatment. To enable extended usage periods, we will design the sensor array to be self-repairing if scratched or cut, and the device to be self-powered by harvesting energy from skin movement. We will also incorporate a secure transmission component to enable privacy-ensured diagnosis monitoring by physicians, national health systems and worldwide health organizations. A-Patch will thus enable not only adequate patient diagnosis, treatment, and follow-up, but also a continual screening of at-risk populations and real-time monitoring of epidemics, providing population-wide and location-based data for statistical analysis and data mining, and thereby facilitating in-depth epidemiological study. The success of A-Patch will be a launch pad for similar approaches to be used in the diagnosis and/or follow-up of other infectious as well as non-infectious diseases.

For detection purposes, only one measurement will be required. For monitoring over time (such as in the case of medical treatments) once/day is sufficient. The communication features of the A-Patch system will enable data transfer in local, regional, national, and international levels, expected to be a major epidemiological change in TB control. Eventually, within a few years of usage, a great amount of information (clinical information, lifestyle and other relevant data) will be collected and stored in a secure manner. This secure database will serve as an enormous in-silico potential for making new medical discoveries based on statistical analyses and data mining, allowing comparison of changes during a person’s life, and comparison of large groups of people with similar conditions. These abilities should provide additional insights into the general studies of disease initiation, progress, treatment efficacy enabling future medical breakthroughs. Data from initial positive detection and throughout the treatment period will be communicated to physicians, national health systems and worldwide health organizations mapping disease spread. Considering the complex legal, ethical, and regulatory issues, the A-Patch platform will be designed with expert guidance so that great care is taken to direct information flow in a way that protects the privacy of individuals, while at the same time protecting the health of all citizens.

Obj. 2: Patch System Design Low-cost, disposable electronics platform for the patch using flexible thin-film oxide transistors

  • Design and test of multi-functional thin-film ASICs for self-powered wireless sensors (simultaneous readout of several VOC sensors, data fusion, RFID/NFC power harvesting, and data transfer)
  • Develop and demonstrate thin-film ASICs technology and manufacturing in a pilot-line environment, aligned with an external foundry process for volume manufacturing
Obj. 3: Wearable Patch Integration Technology Develop a multi-component wearable patch integration technology

  • Develop a scalable interconnect technology  combining various blocks of the TB detection patch (thin-film ASIC, printed sensor, RFID antenna, stretchable patch textile, and adhesive to the skin)
  • Ensure bio-compatibility for subsequent validation trials
  • Identify the industrial supply chain for integration in volume
Obj. 4: Prototyping and connectivity Prototypes for validation trials

  • Create sufficient infrastructure for validation trials in relevant (200 or more disposable patches, re-usable reader devices)
  • Bluetooth and WiFi connectivity to app and server platform to report the results back to the physician, and ultimately to the patient. Also, to potentially leverage the data for monitoring purposes at the national level.
  • A machine learning algorithm for increased diagnostics accuracy (correlation and data fusion from  VOC sensors)
Obj. 5: Verification and product Validate and drive the developed devices and technologies toward exploitation

  • Validate new technology in a relevant environment – a hospital lab simulating an infectious disease control point
  • Benchmark in a standard triage test (specificity >70%, sensitivity >90%, as defined by the WHO)
Obj. 1: Printed Sensor Technology Chemiresistor-based VOC printed sensors for TB detection patch

  • Select and verify VOC-based biomarker materials for accurate TB diagnostics from skin
  • Develop self-repair and self-power functionality
  • Select device architecture and scalable print processes for sensor printing and test


Work plan
WP1 -Requirements, Architecture & Specifications

Requirements, Architecture & Specifications will analyze and define the requirements, application scenarios and use-cases for the A-Patch work, and then define the architecture and specifications. Lead partner: Bio-Rad.

WP2 - Self-Healing, Self-Powered Printed Sensor Array for TB

Self-Healing, Self-Powered Printed Sensor Array for TB will optimise methods for off-line non-invasive collection of skin VOCs, collect skin VOCs from TB patients and control groups, determine the skin-related VOC profile characteristic of TB, design self-repairing hybrid sensors that exhibit a chemiresistive transduction mechanism for (semi)selective detection of VOCs emitted from skin of TB patients, and achieve sensing signals with high signal-to-noise ratio and selective measurement of VOCs of TB from skin. Lead partner: Technion.

WP3 - TOLAE RFID/NFC Sensing Patch Platform

TOLAE RFID/NFC Sensing Patch Platform will design and realize sensor readout circuitry for wearable patch, design RFID/NFC sensor platform development, perform sensor platform prototyping, design self-repairing porous polymer films, for medical use, and develop and characterize a power source unit based on a triboelectric nanogenerator (TENG) and a supercapacitor to drive a flexible, bio-compatible platform without a battery. Lead partner: IMEC.

WP4 - Wireless Connectivity and Data Analysis

Wireless Connectivity and Data Analysis will integrate wireless sensing features for detection, and the future possibility of monitoring, of TB infection, apply methods of data analysis, for both internal rapid-response, and remote cloud-oriented deep analysis, and develop machine learning for pattern recognition of VOCs characteristic of TB. Lead partner: Riviera waves.

WP5 - Autonomous Wearable Patch Integration

Autonomous Wearable Patch Integration will assemble all components designed in WP3 and WP4 together as a patch, integrate test performance of the mid-period integrated patch in lab conditions, develop secure connectivity for collecting, analyzing and presenting data in a secure and ethical manner, and integrate and manufacture the final-prototype patches for end-user validation in WP6. Lead partner: TNO, Holst Centre.

WP6 - Validation and Evaluation

Validation and Evaluation will examine and assimilate all relevant responsible research practices, perform preclinical testing with the mid-term prototype and final integrated patches, analyse and validate the performance of the patches in discriminating between patients with and without TB or with high-risk TB conditions, and validate impact of real-world confounding factors and environment upon the results obtained by the complete patch. Lead partner: University of Latvia.

WP7 - Dissemination, Communications and Exploitation Planning

Dissemination, Communications and Exploitation Planning will plan and implement dissemination and communication to a wide range of relevant stakeholders and to the public at large, manage knowledge contributed and generated, and plan the post-project exploitation of the project’s results. Lead partner: VTT.

WP8 - Management, Collaboration and Social Responsibility

Management, Collaboration and Social Responsibility will set up the management infrastructure, provide financial and contractual management of the consortium, provide technical and scientific management of all research, technology and knowledge management activities of the project, and perform Management of data acquisition, data protection and privacy and ethics procedures. Lead partner: Technion.

List of Deliverables
# Deliverable name WP # Lead
Type Diss. level Month
D1.1 Requirements Definition 1 BRL R CO 3
D1.2 Architecture & Specifications Definitions 1 BRL R CO 5
D2.1 Mid-Period Report on Self-Healing, Self-Powered Printed Sensor Array for TB 2 TECH R PU 13
D2.2 Final Report on Self-Healing, Self-Powered Printed Sensor Array for TB 2 TECH R CO 24
D3.1 Verification report of threshold sensor readout circuitry 3 IMEC DEM + R CO 9
D3.2 Low Power GEN1 Pilot Line Compatible Dual-Gate a-IGZO TFT Technology for Sensor Read-out and RFID Communication 3 TNO  R CO 24
D3.3 Mid-Period Demo + Verification report of 8-bit threshold sensor RFID 3 IMEC DEM + R CO 24
D3.4 Verification report of upscaled 8-bit threshold sensor RFIDs 3 TNO DEM + R CO 27
D3.5 Final Demo + Verification report of 8-bit threshold sensor NFC 3 IMEC DEM + R CO 27
D4.1 Mid-Period Report on Wireless Connectivity and Data Analysis 4 RW DEM + R CO 18
D4.2 Final Report on Wireless Connectivity and Data Analysis 4 RW DEM + R CO 30
D5.1 Mid-Period Prototype & on A-Patch Autonomous Wearable Patch Integration 5 TNO DEM + R PU 24
D5.2 Final Prototype & on A-Patch Autonomous Wearable Patch Integration 5 TNO DEM + R PU 30
D6.1 Mid-Period Report on A-Patch Validation and Evaluation 6 TECH R PU 20
D6.2 Final Report on A-Patch Validation and Evaluation 6 UoL R PU 36
D7.1 Dissemination & Communications Plan 7 VTT R PU 6
D7.2 Project Web Portal 7 VTT DEC PU 6
D7.3 Dissemination, Communications, IP Protection and Standardisation Activities Report 7 VTT R PU 36
D7.4 Exploitation Plan and Business Plan 7 BRL R CO 36
D8.1 Project Management and Quality Assurance Manual 8 TECH R PU 3
D8.2 Data Management Plan 8 UoL R PU 6
D8.3 Data Management Report 8 UoL R PU 36
List of Milestones
Number Milestone name WP(s) Month Means of verification
ML 1 Requirements Identified 1 3 D1.1 published
ML 2 Architecture & Specifications Defined 1 5 D1.2 published
ML 3 Web Portal, Dissemination Plan and DMP Ready 7, 8 6 Web portal up and running; Dissemination plan and DMP documents published
ML 4 TB VOCs Collected and Identified 2 18 Collection of VOCs from TB patients and control group completed
ML 4 Mid-Period Prototype Ready 2 to 5 24 Mid-period patch prototype ready
ML 5 Self-Healing, Self-Powered Printed Sensor Array for TB & TOLAE RFID/NFC Sensing Patch Platform Ready 3 27 R&D work on Self-Healing, Self-Powered Printed Sensor Array for TB and on TOLAE RFID/NFC Sensing Patch Platform successfully completed
ML 5 Final Prototype Ready and Manufactured; Wireless Connectivity and Data Analysis Ready 4, 5 30 Patch final prototype, as well as wireless connectivity and data analysis, ready for validation trials and production completed;
ML 6 Project Completion 6, 7, 8 M36 All deliverables delivered and validated
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