IN THIS SECTION
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2. Controls, calibrators, normal and disease-state sera are used in virtually all assays to ensure the reproducibility, accuracy, and specificity of results.
3. General chemicals, buffers, detergents, cross-linking reagents, stabilizers are components of all diagnostic reagents. Buffers control pH; detergents and other proprietary stabilizers prevent loss of biochemical activity and reduce or eliminate unwanted adsorption to containers and solid matrices; cross-linking agents create hybrid biochemical reagents such as antibody-biotin complexes.
4. Growth media, cell and virus culture reagents are employed in the production of biochemicals (e.g., proteins and enzymes by recombinant technologies) and in growing bacteria and viruses for use in assays or as sources of biochemicals.
5. Immunologicals (antigens, adjuvants, antibodies, antisera) are the specific components of immunoassays. Antigens and adjuvants are used to stimulate animals to produce the desired antibodies, which in turn provide the high specificity of immunoassay procedures.
6. Lipids, hormones (nonpeptide) are products of biological origin, or of chemical synthesis, and are usually the analytes being assayed. Such components can be added to sera to produce calibrators and control materials.
7. Proteins, enzymes, peptides are biological materials that may be components of diagnostic reagents; analytes being measured; or components of controls, calibrators, or immunoassay reagents. Antibodies are a particular type of protein, as are enzymes.
8. Contract manufacturers produce many of the materials in this category. Antibody production, special-chemical synthesis, and production of bulk media are common examples of contract manufacturing in this field (see also Section 8: Contract manufacturing).
9. Stock items suppliers provide most of the general chemicals in this category, as well as the common biochemicals and chemical reagents.
