The Point of Care IVD market is in a strong need of portable Tests with Lab-quality that can be widely spread to guarantee access at the right place, at the right time, to the right people, and minimising the impact to the environment.
The use of the right reagent chemistry is key for the obtention of a Lab-quality rapid test. However, in many occasions it is not sufficient, as it requires of complex energy-demanding engineering solutions within the device to ensure the desired performance, robustness and reproducibility of the Reagent Chemistry.
At Fuelium we are focused on solving this engineering challenges through Minimalist and Universal solutions, with the aim of boosting the decentralization of the Medical Care system both in developing and developed countries.
Point of Care In Vitro DiagnosticsIVD
1.Self-Powered Temperature Control Module (i.e. Molecular Isothermal amplification)
Key features of the Temperature Module:
- It can hold any Isothermal Amplification reaction, by incubating the reaction at the adequate temperature and during the required duration.
- The module can also work as a heat bacterial lysis platform, as shown during the grant from the Bill & Melinda Gates Foundation.
- It can be designed to be single-use or re-usable.
- Other Smart functions requiring energy, such as connectivity or readout, could also be enabled with the proprietary battery included in the Temperature Control module.
- It can be adapted to Immunoassay to ensure Reproducibility of the results independently on the variable Ambient Temperature.
- It can also be adapted to Enzymatic tests that require specific temperatures to run the Assay chemistry.
Example of a Colorimetric LAMP reaction hold by the Fuelium Self-Powered Temperature Control Module (COVID test):
Please, watch the video about the example of a Fuelium powered cassette that can enable incubation at 37C to hold biochemistry reactions (i.e. Immunoassays):
2.Stand-Alone Smart Cassette
A Fuelium battery can be readily integrated within a IVD test and encapsulated in a traditional rapid test cassette. In this way, a plethora of functionalities can be implemented without having to develop dedicated complex instrumentation. The time that a certain functionality is enabled can be adjusted by simply adapting the capacity of the Fuelium battery being used, so the Fuelium battery works as a pre-programed timer by itself.
Fuelium battery enables functions like lighting components such as LEDs, powering displays, heating elements for isothermal amplification or assay temperature control, induced magnetic fields that can be used to trap magnetic particles for sample pre-concentration, stir mixing, operating valves, powering connectivity units, sensors and electronics.
3.Plug-And-Power IVD assay
In the Plug-and-Power configuration, the reader unit contains all the required electronic systems to run the test but does not include any battery or power source. Instead, the disposable part – containing both the test strip and the paper power source – is plugged into the reader, which uses the energy stored in the test strip to read the assay and communicate the result. Once the readout is performed and communicated, the disposable part is discarded, and the reader can be reused. The electronic reader could be based on any type of measurement principle, such as electrochemical, optical, magnetic, etc.
Figure below shows a diagram that illustrates this concept with an electrochemical sensor (glucose sensor). The disposable part contains a Fuelium battery (power source), an amperometric sensor and a connector to interface and power a battery-less handheld reader.