Biomedical Engineering Reference
In-Depth Information
2.4
Read-Out and Processing Unit ...................................................................................
82
2.5
Development and Performing an Assay ....................................................................
84
2.6
Production ...................................................................................................................
6
3
Summary and Further Developments .................................................................................
86
References..................................................................................................................................
87
1 Introduction
The huge research activities of the last two decades relating to genome and pro-
teome research led to a deeper understanding of the molecular basis of diseases,
their occurrence, development, and cure [
1
-
3
]. In consequence of this knowledge,
more suitable therapies are on the horizon and are discussed widely as ''person-
alized medicine'' [
4
]. Molecular diagnostics will be an integrated part of this
concept, since medication, success of treatment but also early occurrence of
specific biomarkers for early detection or even presymptomatic diagnosis will
move into the focus of medical treatments. Also genetic markers for risk screening
and all aspects of companion diagnostics which defines medication according to
the genetic constitution of a patient will help to serve for an improved therapy [
5
].
Therefore, the market for molecular in vitro diagnostics can forecasted asvery
attractive.this to a producible and cost Especially combined with point-of-care
testing (POCT)—sometimes better described as point-of-need—in vitro diagnos-
tics might help in gaining great benefit from molecular knowledge [
6
]. Biochip-
and Lab-on-Chip (LoC) technologies designed for routine application present the
opportunity of performing complex and multiparameter analysis on a small scale.
Lab-on-Chip systems have the potential to transfer molecular diagnostics to the
point-of-need [
7
,
8
].
Despite the fact that several POCT products are already available on the
market, widespread use in routine or day-to-day diagnostics has not been achieved.
There are several reasons for this related to the present need for investment in
POCT: Besides well-trained personnel several machines for sample preparation
(e.g., centrifuges), microarray spotting and readout, washing, and also incubation
stations (with well controlled temperature) have to be made available.
Miniaturization and integration of electronic, microfluidic, mechanical, and
optical components will help to overcome these limitations. For this reason Lab-
on-Chip systems have to be built that have been especially designed for POCT
applications in medical care and in vitro diagnosis.
The Lab-on-Chip concept is based on microfluidic structures, which should
integrate all necessary steps of a biochemical assay including sample preparation,
isolation or separation, and finally quantitative analysis of the components of
interest. All this should be done in a device as small as a credit card. Ideally the
use of the LoC does not need more than the application of the sample, for example
a drop of blood from the finger tip, and readout of the signal as the given result, all
