In vitro diagnostics (IVD) procedures mainly include clinical chemistry, immunoassays for protein detection, and nucleic acid testing for molecular detection. These IVD procedures involve complex biological assays that usually require a sequence of steps, including sample preparation, incubation, washing, etc. All of these steps can be integrated onto a single disc in a centrifugal Microfluidic device. Centrifugal Microfluidic technology, which combines the benefits of both Microfluidics and centrifugal forces in a single device, has been used in various biological applications for many years, even today in clinical laboratories.
IVD can be broadly classified into three areas: 1) clinical chemistry which identifies electrolytes, minerals, and protein concentrations in a given biological fluid; 2) nucleic acid tests with very high precision and sensitivity; and 3) immunoassays which use antibodies to detect disease or disorders.
Fig.1 Examples of the fully integrated lab-on-a-chip for biomedical, food, environmental, and energy applications. (Gorkin, 2010)
In developing countries, the primary clinical chemistry needs focus on the fields of non-communicable diseases among adults, malnutrition among children, and deficiency of vital nutrients during prenatal and maternal care. A representative centrifugal Microfluidic product that can perform blood chemistry applications had developed to address these needs. Clinical chemistry involves relatively simpler assays than other IVD tests, and Microfluidic operations can be fully automated for the entire assay simply by manipulating the inherent micro-geometry of the disc. This technique has enabled full automation in several commercially available centrifugal Microfluidic devices, rendering them the most appropriate devices currently available for point-of-care testing (POCT).
The user can select a specific disc for a particular diagnosis, and the operating system recognizes the disc type by reading barcodes on the disc; the disc is then operated with a spinning profile appropriate for the disc type. This system facilitates a fully automated assay to test more than 10 chemicals in a blood sample, performing plasma separation, pre-loading, mixing and detection within 12 minutes.
Nucleic acid tests facilitate the detection of a target molecule at the molecular level and have thus become an important method for the detection of many diseases. It requires a robust and precise Microfluidic network because the detection of nucleic acids often requires a large sample volume and the assay consists of a complex series of steps, including sample concentration, nucleic acid extraction, target purification, amplification, and detection.
Many advantages can be obtained by moving the fluidics of a DNA microarray hybridization assay into the micro-domain, and further speed-of hybridization advantages are gained when the flow is involved. Centrifugal Microfluidic platforms have been utilized in various ways for microarray applications.
Fig.2 Centrifugal Microfluidic systems for DNA microarray applications. (Gorkin, 2010)
Immunoassays have become standard tools in proteomics used to quantify proteins, evaluate drug targets, identify biomarkers, aid in clinical diagnostics, and give insights into disease biology. Microfabrication has been utilized to create new detection means for immunoassays, improving target capture rates and incorporating multiple tests in a single device. Microfabrication greatly improves the efficiency of detecting.
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