Hyper/Hypo Coagulability Assessment Photonic Integrated Chip based Point of Care

Project Information

C-POC

Grant agreement ID: 683823

DOI 10.3030/683823

Project closed

EC signature date 8 June 2015

Start date 1 July 2015

End date 31 December 2015

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Total cost € 71 429,00

EU contribution € 50 000,00

Coordinated by

DAS PHOTONICS SL
Spain

Periodic Reporting for period 1 - C-POC (Hyper/Hypo Coagulability Assessment Photonic Integrated Chip based Point of Care)

Reporting period: 2015-07-01 to 2015-12-31

Summary of the context and overall objectives of the project

The main objective of the C-POC innovation project is to finalize the development, and validation in order to commercialize at the end of the project a new diagnostic tool based on the assessment of thrombin generation curve using a Photonic Integrated Chip sensing on whole blood and urine samples.
The main objectives of the C-POC project are:
- Provide a new approach for the thrombin detection using in this case a photonic solution.
- Reach a solution beyond the state of the art for thrombin detection.
- Reduce the cost of the thrombin detection process in order to create a POC device which be able to be used in the primary attention centers.
- The fabrication of a new sensing platform with multiples uses, being one of its uses the study of the coagulation process and the behavior of the DOACs
This new approach provides
- More specific and faster assays that are not available today, in particular it is a suitable test to check the level of anticoagulation needed in many clinical situations in patients prescribed with new anticoagulants (DOACs)
- control improvements in comparison with current methods, not only probing the initiation phase of coagulation process (which is done by commercially available methods) but also quantifying the concentration of thrombin in the propagation and termination phase of the coagulation cascade.
- cost savings. The overall cost saving is due not only to the lower costs of the C-POC system and the fungible items compared with existing systems, but also coming for the reduction of measurement time, to less than half an hour, and therefore reducing diagnostic and hospital costs.
- direct measurement of the target analytes (label – free) with sensitivities down to ng/ml and high specificity, avoiding false measurements

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

As stated in the project proposal, the final assessment of the technical viability of the proposed solution has been done. In particular, the strategies for the final implementation of the device in real environments has been deeply discussed and the key decisions about how to reach the performance and cost objectives that can make C-POC well accepted in the market have been taken.
In particular, a multi-sensor approach has been put in place for the right determination of the thrombin concentration during the coagulation process along with the fluidic conceptual design to manage the samples during that process. All these test have been conducted along the market analyses and also applied to any other application.
The operative issues have also been considered:
- Strategy for whole blood sample management during coagulation process.
- Redundancy aspects in order to assure the right measurement.
- Consumable design to avoid cross contamination.
- Readout electronics and optics to reduce manufacturing costs.
- Mechanical and electrical aspects.
- Maintenance and support strategies.
Several tests have been performed on the top of photonic structures (ring resonators), once functionalized with appropriate & specific probes. Those tests were performed with the double aim of sensing thrombin analyte and determining C-POC device performances in terms of sensitivity. As a result, thrombin detection was achieved with sensitivities within 10-1 ppb range.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In this particular case, the determination of thrombin contents in whole blood samples may be required in a frequent and repetitive way due to the chronic nature of the pathologies to assess and the need to adapt the medication prescribed to the evolution of this substance in the blood of the patient. These features make the C-POC device very interesting not only for hospital purposes, but also for ambulatory care.
The most attractive applications for the C-POC technology seems to face worldwide problems affecting an enormous percentage of the population, like atrial fibrillation (AF), deep venous thrombosis (VTE) and pulmonary embolism (PE).
• More than 7% of the population above 60 suffer from AF, and it increases with age which will become a major problem in an ageing society
• Women on oral contraceptive treatment and pregnant
• Any other pathology needing new generation anticoagulants (DOACs)
Therefore, end-users of this system may be, without excluding other possibilities: hospitals, health centers, pharmacies, nursing homes and emergency support organizations.

Photonic ring resonator surface functionalised with specific monoclonal antibodies (probes).

Thrombin (1ppm) detection curve, including reference measurement

High sensitivity transducer based on photonic ring resonators

Device Building Blocks