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Basic Knowledge about In Vitro Diagnostic Reagent

In Vitro Diagnostics (IVD) are diagnostic methods that can be used for testing in the external environment of human bodies, while IVD  products refer to reagents, instruments and systems used to diagnose diseases or other conditions, including determining health conditions so as to cure, alleviate, treat or prevent diseases or its sequelae. Among IVD products, IVD reagents are an important part. There are various types of IVD reagents, and the types of diseases that different IVD reagents are applicable to are not the same.

The following is the classification of In Vitro Diagnostic reagents according to the risk level.

Ⅰ. High risk reagent

1. Pathogenic antigen, antibody, nucleic acid testing; 2. Blood type and tissue typing; 3. Human genetic testing; 4. Genetic diseases; 5. Examination of narcotic drugs, psychotropic drugs and medical toxic drugs; 6. Drug targets testing; 7. Tumor marker testing; 8. Allergic reaction (allergen);

Ⅱ. Medium risk reagents

1. Protein; 2. Hormones; 3. Enzymes; 4. Esters; 5. Vitamins; 6. Inorganic ions; 7. Drugs and their metabolic by-products; 8. Autoantibodies; 9. Microbial identification (excluding pathogens) and drug allergy test; 10. Other physiological, biochemical and immune function indicators;

Ⅲ. Low risk reagents

1. Microbial culture medium (excluding microbial identification and drug allergy test); 2. Sample processing, such as hemolysis reagents, dilution solutions and staining solutions.

The core materials of IVD reagents/kits include antibodies, antigens, enzymes, etc., which are all important factors that determine the quality and effectiveness of the reagents/kits. Although a variety of products are available in the raw material market, it is difficult to meet all the needs of IVD reagent manufacturers. Therefore, the price of IVD reagents is generally not low.