On the importance of the upstream core raw materials of in vitro diagnostic reagents

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In recent years, my country's in vitro diagnostic industry has developed rapidly and has become one of the fastest growing markets for IVD in the world. At present, my country has a relatively complete in vitro diagnostic industry chain, including upstream raw material supply links, midstream instrument and reagent R&D, production and sales links, and downstream demand markets. 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 biological buffers, various amino acids and organic acids, etc.

Among them, enzymes are the most widely used core biological materials, including enzymes, coenzymes, and enzyme substrates, such as horseradish peroxidase, ascorbate oxidase, proteinase K, etc., and 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 Detection platforms such as immunoassay, colloidal gold lateral chromatography, fluorescent immunolateral chromatography, biological buffers and other fine chemicals are mainly used in the buffer solution system for preparing reagents. The most used biological buffer is TRIS, which can not only As a buffer, it can also be used in pharmaceutical intermediates and pharmaceutical excipients.

In vitro diagnostic reagents with different colors

The development and supply of these upstream core raw materials deeply restricts the development of the industry and restricts the development and use of in vitro diagnostic reagent products. The new crown epidemic has fully highlighted the importance of in vitro diagnostic reagents and their raw materials. In the main detection methods of the new coronavirus, 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 the new coronavirus nucleic acid detection as an example. The process includes sample collection and reception, inactivation, nuclear collection registration, reagent preparation, nucleic acid extraction, computer amplification, and result analysis. Virus sampling tubes and RNA extraction are used. Reagents and instruments such as kits, fluorescent quantitative PCR machines, vortex mixers, centrifuges and PCR reaction tubes. The new coronavirus nucleic acid detection kit includes 2X qPCR main premix, reverse transcription premix, PCR primer and probe set, buffer, new coronavirus positive control, negative control and other components. Many core materials are used in the whole process, such as guanidine isothiocyanate, a component of the virus preservation solution in the virus sampling tube, and 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 new coronavirus detection products can be guaranteed and they have played an important role in the prevention and control of the epidemic. Therefore, the core raw materials play a very important role in the entire in vitro diagnostic field. It is precisely because Desheng always adheres to the service tenet of quality first and leading technology to ensure all links from raw material procurement to production, so that R&D and production are trusted by customers. The main products currently produced are: biological buffers, chemiluminescence reagents, virus transport medium, carbomers, blood collection tube additives and other products. For more information about in vitro diagnostic reagents, please pay attention to Desheng Chemical.