Project: Automatic Point-Of-Care-Testing Service
Automatic Point-Of-Care-Testing project (AutoPOCT) has a goal of automatically providing patient blood test results at healthcare locations in real time. The testing capacity is provided in the form of sealed testing servers with preloaded liquid chemistries for thousands of tests with a working time up to six months. A complete automation allows networking via internet and a remote monitoring ensuring of testing quality. AutoPOCT users only need patient samples and make test requests from test selection of 40 most frequently needed tests covering 75% of all test requests. Network monitoring ensures the quality to meet and even exceed medical laboratory, because degrading and time consuming sample transport to the laboratory is avoided. _x000D_Long working time of on-board laboratory chemistry is enabled by hermetic preservation and by special circumstances of AutoPOCT platform requiring a specific chemistry development program by the DiaSys participant. AutoPOCT platform improves quality control and accuracy traceability with remote monitoring._x000D__x000D_Whenever exact evidence from medical science is required to support diagnosis and care decisions in healthcare - called as Evidence-Based-Medicine (EBM), medical laboratory testing provides most EBM. When the laboratory is located separately, even in separate cities, the laboratory distance slows down the care process and increases costs by delays of hours or days besides the inconvenience for the patient. Delays in quality laboratory testing is caused by the sample (or patient) transport, by the laboratory staff of organizing the testing process itself and returning results. Laboratory analyzers are using old, originally manual testing steps between open reagent vessels and open “In-Vitro-Diagnostics” IVD test tubes. IVD is now mechanized using indirect single goods automation methods to manipulate vessels containing test liquid materials. The control of liquid process itself is left for the professional laboratory staff to ensure quality and to fill automation gaps. Mechanized analyzers have greatly increased the productivity of medical laboratories. One central laboratory can serve large geographic populations, but samples tend to deteriorate in transportation. The present IVD technology as too costly is available only to 1/6 wealthiest of global population. Healthcare needs themselves are global and uniform._x000D_An alternate solution, Point-Of-Care-Testing, (POCT) has emerged and is increasing. POCT requires local work and provides less quality and higher cost than laboratory tests. Without professional skills accurate laboratory liquid methods cannot be used. _x000D__x000D_General goals of AutoPOCT are not new since these goals have been repeatedly stated but without a working solution. Goals are high quality tests, failsafe execution by care personnel, a sufficiently large selection of tests, test results to be automatically recorded in digital infrastructure and delivered to healthcare personnel in real time. AutoPOCT is aiming at these goals using best liquid IVD methods. Initially few tests are used to verify the integrated solution. Later tens of frequently requested tests are used to cover 70 % of all test requests. This project aims at a globally functional IVD platform suitable for locally available infrastructures. _x000D_AutoPOCT automation eliminates facilities and staff costs and simultaneously increases quality by networked quality control. AutoPOCT will have a potential for ubiquitous, high quality, low cost IVD diagnostics at the patient location. That would reduce the need of hospitalization and costly interventions. A citizen access of AutoPOCT testing services would facilitate preventive health monitoring and chronic disease management_x000D__x000D_Following two SMEs are representing the technical specialties integrated in AutoPOCT testing platform and will form the consortium:_x000D_1. TeleChemistry OY start-up company is formed for development and exploitation of AutoPOCT, first from development and production skills of key persons in said patented ICT technologies replacing mechanical IVD technologies and secondly from key persons having experience and skills in development, production and marketing of biomedical instruments and thirdly from key persons in management of IVD testing. Narrow sectors of the patented technology are market leaders for tens of years._x000D_2. DiaSys Diagnostics GmbH has made breakthroughs in long preserving liquid reagents and other liquid species needed in AutoPOCT and solid experience in end user IVD applications, where present technical solutions can not exploit long preservation of DiaSys reagents. AutoPOCT needs well proven standard liquid chemistries but modified to fit AutoPOCT preservation and operating system to mutually benefit from long working life of DiaSys present IVD chemistries. _x000D_
| Acronym | AutoPOCT (Reference Number: 4294) |
| Duration | 30/08/2008 - 22/05/2012 |
| Project Topic | Medical laboratory supports diagnosis and care decisions with hours to days delays. AutoPOCT testing service plans to provide immediate test results at care site. The service will be remote monitored turn-key investment-free operation with time and cost saving for patients and for care organization |
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Project Results (after finalisation) |
The project achieved proof-of-principle of our key technology and enabled moving towards proof-of-concept. Details below:_x000D__x000D_The technology concept was evaluated by Dr. Drese from IMM, Germany in 2011. The report (IMM Final Report P11162.pdf) found that:_x000D_- The overall impression of the system concept and the components was fine. _x000D_- The LMP system concept has a high potential of being a disruptive innovation, because it follows a different concept compared to most microfluidic developments in the field and because it addresses a need of new approaches in clinical chemistry. _x000D_- All the single components seem to be at hand and there was also a good understanding of the performance especially of the key components. This means the developments has been fine on the component level._x000D_- The weak spot in the whole development appeared to be the system level. System level effects show up whenever different element/components are combined._x000D__x000D_The proof-of-principle for the LMP (liquid microprocessor) system was achieved using Prototype 0 in late 2011. _x000D_The report for the proof of principle tests found that:_x000D_- Proof of principle, the functionality for the clinical chemistry analyser application of the LMP technology concept has been demonstrated successfully with cholesterol measurements using a plasma specimen. _x000D_- This chemistry testing was performed with the Proto 0 system, the comparison tests with a manual spectrophotometric test in the laboratory of Telechemistry Oy and with a Konelab clinical chemistry analyser in an external laboratory. The cholesterol concentration of the analysed plasma specimen was equivalent to the result obtained with two comparison methods._x000D__x000D_The project continued even after the Eurostars-funding ended. At the time of ending the Eurostars-funding, the design work for Prototype 1 was done and the construction of Prototype 1 analyzers was on-going. Presently (Feb 2013) we are using the prototype series 1 to do proof-of-concept tests with five different analytes in random access manner. |
| Network | Eurostars |
| Call | Eurostars Cut-Off 1 |
Project partner
| Number | Name | Role | Country |
|---|---|---|---|
| 2 | DiaSys Diagnostic Systems GmbH | Partner | Germany |
| 2 | TeleChemistry OY | Coordinator | Finland |