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What are the core raw materials for in vitro diagnostic reagents?
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 products such as reagents, kits, calibrators, and quality control products for in vitro testing of human samples. The upstream core raw materials include enzymes, serum primers, antigens, antibodies and other biological products, as well as 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., 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 in vitro diagnostic reagent materials. 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 development 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 SARS-CoV-2, 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.
Suzhou Yacoo Science Co., LTD was founded in 2003. Via the innovation and development of more than 10 years, it has been a national high-tech enterprise specializing in "IVD Reagents Raw Materials", "New Electronic and Chemical Materials", "Biobuffers" and "Pharmaceutical Intermediates". Yacoo Science is committed to the research and development, production and service of in vitro diagnostic reagents. Its products cover molecular diagnostics, clinical biochemical testing, immunodiagnosis and other fields. It contributes to the development of the in vitro diagnostic industry and guarantees the development of excellent in vitro diagnostic reagents that meet the needs of human health.