LACTOPOC · A Low-cost disposAble eleCTrochemical biOsensor for Point Of Care (POC) hypolactasia diagnostic testing
Horizon 2020 — Marie Skłodowska-Curie Actions
- Duration
- 2017-05-02 → 2019-05-01
- EU contribution
- €158,122
- Participants
- 1
- Scheme
- MSCA-IF-EF-SE
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Results in brief
A Low-cost disposAble eleCTrochemical biOsensor for Point Of Care (POC) hypolactasia diagnostic testing
Point of Care (PoC) systems are miniaturized portable devices containing all the functions of centralized laboratory without the need for trained staff. PoC testing is better tolerated by patients since the sample extraction is less invasive and also preferred by the clinical industry due to their cost and practicality. LACTOPOC project aimed the development of a low-cost disposable electrochemical PoC biosensor for hypolactasia diagnosis. Hypolactasia affects over half of the world population and is related to lactase deficiency, preventing digestion of ingested lactose. Common symptoms (bloating, abdominal pain, flatulence and osmotic diarrhea after ingestion of dairy products) are usually nonspecific and susceptible to false diagnosis. The reference method for diagnosis is the direct determination of lactase activity following an intestinal biopsy, but it results very invasive and it is not commonly used. Other clinical tests for hypolactasia diagnosis are based on the intake and digestion of D-xylose-related compounds. The amount of D-xylose in the body is then proportional to lactase activity and it might be used as an indicative of hypolactasia. Current methods for D-xylose determination rely on traditional analytical techniques or expensive lab-based automatic analysers, requiring trained staff in both cases. LACTOPOC project sought to develop a more accessible, inexpensive and user-friendly diagnostic tool for D-xylose determination. To fulfil the overall objective, the following technological goals were approached: design of a paper-based printed microfluidic platform for electrochemical biosensors; development of a D-xylose biosensor to assist hypolactasia diagnosis in urine and blood based on plastic and paper; testing of the robustness of the D-xylose biosensor to fulfil CE marking requirements, towards clinical validation and commercialization. The global objective of the project was achieved and an IVD product (Osaxyl) was placed in the market. Actions to properly disseminate and exploit the project results were additionally undertaken.
Data: CORDIS, © European Union
Project objective
LACTOPOC is a multidisciplinary research and training programme targeted to provide Dr. Macia-Gonzalez, an expert in electrochemical analytical platforms design, with new entrepreneurial and scientific skills on translation of innovative biosensor technology into Point of Care (POC) diagnostic devices.LACTOPOC main scientific goal is to develop a low-cost and highly reproducible biosensor manufacturing platform technology for POC hypolactasia diagnostic testing. The project is based on the combination of two-well established analytical tools, i.e. paper-based microfluidics and electrochemistry, together with mass-manufacturing technologies for innovative design such wax and screen printing. Hypolactasia is related to low levels or reduced activity of intestinal lactase, the enzyme responsible for the hydrolysis of lactose during its digestion. Undigested lactose after intake of dairy products is then accumulated in the intestine causing flatulence, abdominal pain and diarrhea in the individuals suffering from this malfunction. Despite it affects over half of the world population, its diagnosis remains challenging because associated symptoms are not specific and available methods for its diagnosis are unspecific and rely on trained staff and complex equipment. LACTOPOC will bring forward the technology developed by OSASEN for determination of D-xylose in urine and venous blood samples based on an electrochemical biosensor lab-prototype into a robust POC device with high sensitivity and reproducibility. The device will be able to detect and quantify accurately minimum D-Xylose concentration levels in a simple drop of human capillary blood sample. This novel POC biosensor device will assist LacTEST®, a non-invasive diagnostic test based on the synthetic analog gaxilose recently developed by VenterPharma, to become the first promising POC diagnostic testing for hypolactasia available in the market, leveraging their impact on patients and health care providers.
Original text from CORDIS.
Participants
- BIOLAN HEALTH SL · ZAMUDIOCoordinatorSpain
Links
Data: CORDIS, © European Union