In vitro diagnostic (IVD) reagents refer to products such as reagents, kits, and standards for in vitro testing of human samples. In the development and production of in vitro diagnostic products with different methodologies, the main reaction components that can be selected and prepared usually include chemical raw materials, biological raw materials, biological excipients and other materials.
Chemical Raw Materials
Classification
- Inorganic chemical raw materials mainly include disodium hydrogen phosphate, sodium dichloride phosphate, sodium chloride, sodium hydroxide, etc.
- Organic chemical raw materials mainly include trihydroxyaminomethane, citric acid, disodium edetate, aminopyridine, Tween 20, etc.
- Special chemical raw materials mainly include luminol, polyethylene glycol, acrylamide, N,N,N’,N’-tetramethyldiethylamine (TEMED), ethidium bromide (EB), etc.
Selection and preparation
In the development of in vitro diagnostic products, chemical raw materials are mainly used in the production of buffers, activators, stabilizers, chemiluminescent agents, etc. The raw materials are generally purchased from outside. Different companies can choose to outsource products provided by different suppliers according to the technical requirements of the products developed and produced.
- In the development and production of in vitro diagnostic reagents with different methods such as enzyme-linked immunoassay, nucleic acid amplification, and luminescence immunoassay, the quality standards of the quality standards of the chemical raw materials selected by the enterprise should meet the requirements of relevant regulations. The quality standards of chemical raw materials should include appearance, general salt testing, solution pH, heavy metal testing, dissolution, loss on drying, residue on ignition, etc.
- When purchasing raw materials, the supplier shall be able to provide quality assurance materials and quality inspection reports for the relevant batch of raw materials. The quality standards provided by the raw material suppliers should be able to meet the requirements of the quality standards of the products developed and produced.
- The supplier of chemical raw materials selected by the enterprise should be relatively fixed.
Biological Raw Materials
Classification
- The biological raw materials most closely related to the quality of in vitro diagnostic products mainly include various antigens, antibodies, enzymes, hormones, etc.
- Antigens and antibodies are one of the most important in vitro diagnostic materials, which are mainly used in detection platforms such as enzyme-linked immunoassay, chemiluminescence immunoassay, colloidal gold lateral chromatography, and fluorescence immune lateral chromatography. Antigens include proteins, polysaccharides, polypeptides, lipids, and small molecule compounds. Antibodies mainly include monoclonal antibodies and polyclonal antibodies.
- Enzymes/coenzymes/enzyme substrates are the most widely used core biological materials, such as horseradish peroxidase, ascorbate oxidase, proteinase K and so on. Enzymes/coenzymes/enzyme substrates are widely used in almost all in vitro diagnostic sub-fields such as biochemical diagnosis, immunodiagnosis, molecular diagnosis, POCT, coagulation diagnosis, and blood glucose diagnosis.
Selection and preparation
In the development and production of in vitro diagnostic products, biological raw materials are mainly used for the preparation of ELISA Plates, marker enzymes, antigens or antibodies for neutralization, reaction solutions, and calibrators (standards). Different enterprises can choose to produce or purchase the biological raw materials required for development and production by themselves based on their technical capabilities.
Regulatory requirements
- The process of the biological raw materials produced by the enterprise must be relatively stable.
- The biological source and supplier of the purchased biological raw materials must be clarified. The supplier shall issue the performance index and inspection certificate of the purchased biological raw material. The enterprise shall provide the products of the selected supplier as the basis for the main raw materials;
- The quality standards of the biological raw materials selected by the enterprise shall meet the requirements of relevant regulations. The quality standards of biological raw materials generally include appearance, purity and molecular weight, protein concentration, potency, functional experiments, etc.
- The preparation process of biological raw materials and the selected supplier should be relatively fixed.
Biological Excipients
Classification
Biological excipients mainly include bovine serum, goat serum, bovine serum albumin, etc.
Selection and preparation
Biological excipients refer to a type of biological raw materials used as protein protective agents in the production process. These materials are usually purchased from outside. Different companies can choose to outsource products provided by different suppliers according to the technical requirements of the products developed and produced.
Regulatory requirements
- The material supplier shall provide the performance index and inspection certificate of the selected materials.
- The quality standards of the biological excipients selected by the enterprise meet the requirements of relevant laws and regulations. After reaching the corresponding quality standards, the biological excipients can be used for production.
- The supplier of biological excipients selected by the enterprise should be relatively fixed.
Other Materials
Classification
Other materials mainly include microporous strips, glass slides, and nitrocellulose membranes.
Selection and preparation
Such materials can be used for solid phase carriers, and are generally purchased from outside. Different companies can choose to outsource products provided by different suppliers according to the technical requirements of the products developed and produced.
Regulatory requirements
- The material supplier shall provide the performance index and inspection certificate of the selected materials.
- The quality standards of the raw materials and excipients selected by the enterprise meet the requirements of relevant laws and regulations. After reaching the corresponding quality standards, the materials can be used for production.
- The supplier of materials selected by the enterprise should be relatively fixed.