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POINT OF CARE DEVICE FOR VITAMIN D DEFICIENCY MONITORING

Periodic Reporting for period 1 - OSAvit-D (POINT OF CARE DEVICE FOR VITAMIN D DEFICIENCY MONITORING)

Reporting period: 2019-10-15 to 2020-10-14

BIOLAN HEATLH is a young technological SME focused on the development of novel biosensors for healthcare (Point of Care-PoC devices), addressing priority needs in healthcare diagnostics and/or therapies monitoring for the benefit of patients, providing affordable systems with unique features that meet specific well identified requirements in healthcare. BIOLAN HEALTH has recently identified a healthcare need in relation with prevention, treatment and monitoring of Vitamin D (VitD) deficiency. VitD (1,25-DihydroxyvitaminD) is considered a multipurpose steroid hormone that in human plays an essential role in multiple aspects, being its primary role to participate in the regulation of metabolism of calcium and phosphorous. VitD deficiency is evident throughout the European population at a prevalence of 13% (FP7-613977-ODIN project), a rate that is a matter of concern. People over 50 have an increased risk of vitamin D deficiency with consequent bone loss risk leading to osteoporosis and fractures. Emerging evidence has shown that VitD administration improves muscle performance and reduces falls in VitD deficient older adults. Other populations of higher risk for VitD deficiency are children, pregnant and lactating women and patients with digestive disorders, among others. VitD deficiency is also associated with increased risk of cancer, cardiovascular disease, infections, and autoimmune diseases. In this context, BIOLAN HEALTH has identified the opportunity to develop a novel PoC device for the quantification of VitD in blood based on lateral flow immunoassay (LFI), combined with electrochemical detection on screen printed electrodes (SPEs). As result of OSAVIT-D project, BIOLAN HEALTH has incorporated an expert in LFI that lead the development of a first prototype of a LFI device with electrochemical detection and has established the roadmap for transforming the novel idea into an innovation project.
The two overarching main aims of OSAvit-D were: 1) develop and validate a first prototype of a PoC device for VitD quantification based on LFI combined with electrochemical detection; 2) design a roadmap for transforming the novel idea into an innovation project. In order to achieve the overall aim, the following work was performed:
• Specifications and requirements of the device were defined
• The most adequate components of the device were selected and their suitability assayed.
• The geometry and layout of the LF strip in combination with the screen-printed electrodes were established and verified.
• A first prototype of an electrochemical immunosensor was developed and is ready to be applied to VitD detection based on the progress made during project execution.
• Next actions along the full development of OSAvit-D device were planned and partially undertaken.
The development of on-site analysis is conditioned by technological progress and change. Advances in electrochemistry, optics, efficiency in thermal signal transduction and, in particular, electronic miniaturisation, have contributed to the development of small portable analysers that can be used outside the laboratory and, in particular, in the unit where the clinical care of patients is carried out, Point of Care (PoC) devices. The development of a quantitative immunosensor with electrochemical detection on paper substrates using low-cost manufacturing techniques is relatively new and offers the following advantages over the state of the art:
- Greater ease of use of the devices by minimizing the number of external interventions
- Easy handling of waste generated by incineration
- Lower environmental impact by reducing plastic consumption
- Devices that can be used on site by non-specialists
Vit D analysis in blood is currently carried out in clinical analysis laboratories using tedious analytical methods (hours) with a high operational cost. A PoC device for the quantification of VitD could facilitate immediate decision making, controlled dosage of VitD avoiding oversaturation and cost reduction. The development of a PoC device for the quantification of Vit D will have a clear impact on the health sector speeding up diagnosis and treatment and reducing costs for the health system.
LF printing station