Biomedical Engineering Reference
In-Depth Information
steps in-between are fully automated. This feature allows for routine use by the
doctor in his office while the patient is still present as well as during intensive care
monitoring, monitoring at emergency stations of a clinic or in external emergency
situations where the performance of laborious assays would be prohibitive or
simply impossible. Also in quite different settings such as nutrition and food
control, agriculture or environmental analysis point-of-care diagnostics, which do
not require any hands-on time, would be beneficial.
To fabricate such LoC devices several technical and technological hurdles have
to be overcome. The production of LoC devices has to be compatible with mass
production; otherwise the market will never accept the prices necessary to produce
LoC today. Therefore, standardized processes have to be implemented for the
production of POCT devices based on LoC. Another technological challenge
comes from all aspects of nano-micro integration: Nanostructuring of surfaces for
sensors, the integration of small-scale low-cost electronics, as well as the analysis
of biocompatibility of the microchannels and reaction chambers and the homo-
geneous surface coverage of the whole device.
Hence, new technologies have to fulfill many requirements to enable their use
in this new way diagnostics can be performed. To sum up, the four key challenges
for the technologies involved are (i) to deliver more data in less time (ii) to be
closer to the point-of-need (iii) to provide more complex information, and (iv) to
be mass producible.
2 ivD-Platform
2.1 Technical Design
In a joint project between seven Fraunhofer institutes a more generic Lab-on-Chip
system was developed [
9
]. The key design rules for the Lab-on-Chip system were
as follows to match the above-mentioned challenges:
(i)
High degree of integration for highest possible miniaturization of the system;
(ii)
Open and modular system to adapt many different biomedical assays;
(iii)
Possibility for serial production.
The developed system consists of a credit-card-sized cartridge which is used as
a consumable and a processing and read-out unit which enables the fully auto-
mated processing of the cartridges once inserted. Depending on the types of
analytes to be detected the read-out unit can be as small as possible to be used as a
handheld device especially for protein markers or small molecules (immunoas-
says) or it can be a bench-top device for the detection of nucleic acids including
PCR on-chip.
Within the development process a generic workflow was established. It includes
all steps necessary to describe the value chain from a biomarker to a marketable
