In recent years, China's IVD industry has developed rapidly and has become one of the fastest growing markets for IVD in the world. At present, China has a relatively complete in vitro diagnostic industry chain, including upstream raw materials, midstream instrument and reagent research and development, and downstream demand markets. Among them, the quality of raw materials, especially core raw materials, directly determines the quality of in vitro diagnostic reagents. This article will introduce the core raw materials of in vitro diagnostic reagents and their importance.
In vitro diagnostic reagents refer to reagents, kits, calibrators, quality control products and other products used for in vitro testing of human samples. The upstream core raw materials include enzymes, serum primers, antigens, antibodies and other biological products, in addition to various fine chemicals Raw materials, such as buffers, various amino acids and organic acids, etc.
Among them, enzymes are the most widely used core biological materials, including enzymes, coenzymes, enzyme substrates, such as horseradish peroxidase, ascorbate oxidase, proteinase K, etc., which are widely used in biochemistry, immunity, molecules, POCT, coagulation, and blood sugar Almost all in vitro diagnostic sub-fields. Antigens and antibodies are one of the most important raw materials for in vitro diagnostic reagents. Antigens include proteins, polysaccharides, polypeptides, lipids, small molecule compounds, etc. The antibodies mainly include monoclonal antibodies and polyclonal antibodies, which are mainly used for enzyme-linked immunoassay and chemiluminescence Immunoassay, colloidal gold lateral chromatography, fluorescence immunological lateral chromatography and other detection platforms. Fine chemicals such as buffers are mainly used in the buffer solution system for preparing reagents.
The R&D and supply of these upstream core raw materials deeply restrict the development of the industry and restrict the development and use of in vitro diagnostic reagent products. The COVID-19 epidemic has fully highlighted the importance of in vitro diagnostic reagents and their raw materials. In the main detection methods of COVID-19, nucleic acid detection relies on raw materials such as enzymes and serum primers, while antibody detection mainly relies on raw materials such as antigens and antibodies.
Take COVID-19 nucleic acid detection as an example. The process includes sample collection and reception, inactivation, nuclear collection registration, reagent preparation, nucleic acid extraction, computer amplification, result analysis and other links. Virus sampling tubes and RNA are used. Reagents and instruments such as extraction kit, fluorescent quantitative PCR instrument, vortex mixer, centrifuge and PCR reaction tube. The COVID-19 nucleic acid detection kit includes 2X qPCR main premix, reverse transcription premix, PCR primer and probe set, buffer, COVID-19 positive control, negative control and other components. Many core materials are used in the whole process, such as the guanidine thiocyanate component of the virus preservation solution in the virus sampling tube, and the Tris or Tris-HCl, EDTA, proteinase K, etc. contained in the lysate of the nucleic acid extraction kit. It is precisely because of the support of these excellent raw materials that the quality of COVID-19 testing products is guaranteed and they play an important role in the prevention and control of the epidemic.