In recent years, the rise and integration of various new technologies and methods have promoted the development, application and replacement of in vitro diagnostic (IVD) instruments and reagents. According to the research of the Werney Institute, the in vitro diagnostic market in China is developing rapidly and is expected to surpass the United States in the next 10-15 years to become the world's largest in vitro diagnostic market.
According to the Blue Book data of the 2015 domestic in vitro diagnostic (IVD) industry released by the Ministry of Industry and Information Technology, the IVD market accounted for 16% (44 billion yuan) of the domestic medical device market in 2014. The IVD industry has become an important growth pole for the entire medical device market. The Industrial Information Center also predicts that the size of the IVD market will reach 72.3 billion yuan in 2019.
So, in such a huge market, how does microfluidic chip technology stand out to lead a new trend?
In fact, in the nanotechnology revolution of the 1980s, microfluidic chips were only one of the small branches. In the late 1990s, after studying the material science of microchip substrates and the fluid mobility technology of microchannels, microfluidics were developed. The technology has also made great progress, and finally found a breakthrough in the in vitro diagnostic application, re-emerged in the public vision, and finally successfully commercialized.
The microfluidic chip can integrate a series of basic operation units such as sample preparation, reaction, separation and detection involved in the fields of chemistry and biology into a micron-sized chip. At the same time, the network formed by the microchannel can penetrate the whole system. It has the advantages of being portable, low energy consumption, easy to manufacture, easy to master, etc. It is easy to meet the needs of life science for low dose, more efficient, sensitive and rapid separation analysis of biological samples.
Professor Lin Jinming, Department of Chemistry, Tsinghua University, director of the Beijing Key Laboratory of Microanalytical Testing and Instrumentation, also believes that microfluidic chips can be used to construct a simple and portable device for biomarker detection, which is expected to be ready for outdoor diagnostics in the future. Family medicine offers new ways. It should be noted that the rapid and sensitive detection of biomarkers, especially protein markers, is an important basis for clinical medical diagnosis and drug treatment, and the microfluidic chip requires very small sample volume (<10 μL) due to miniaturization.
The rolling circle amplification technique (immuno-RCA) of immunoassay studied by Professor Lin Jinming is a highly sensitive nucleic acid amplification technology based on immunoassay. RCA can perform DNA amplification at room temperature and at a constant temperature without the need for special equipment. By immunoreaction, the target protein is combined with a functional nucleic acid ligand to obtain a catalytic G-quadruplex. Then, a repeating sequence of G-quadruplex is obtained by RCA. G quadruplex can self-assemble with heme, produce different colors under the action of ABTS and hydrogen peroxide, and can be directly observed by the naked eye. More importantly, the RCA reaction based on the linear kinetic model enables direct semi-quantitative analysis without the need for excessive standards. Therefore, RCA is a new technology suitable for signal amplification on a chip, which can greatly improve the sensitivity and specificity of analysis. It is used for the detection and research of trace biomolecules and biomarkers, and is the future development of biochips. And popular use of indispensable testing methods.
Taking the detection of thrombin as an example, the combination of microfluidic chip technology and immunoassay technology of functional nucleic acid aptamers has developed a fast, simple, highly sensitive and easy to carry device for the analysis of biomarkers. The method arranges a plurality of microchannels in parallel on the microfluidic chip, and modifies the high-throughput, specific capture and analysis of the specific nucleic acid aptamer target protein on the channel, thereby reducing matrix interference. The use of rolling circle amplification and the action of G-quadruplex DNAzymes achieve signal amplification, improve sensitivity and reduce detection limits. At the same time, preliminary judgments can be made by the naked eye through changes in color.
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