1. What is an in vitro diagnostic reagent
According to the Management Measures for Registration of In Vitro Diagnostic Reagents, in vitro diagnostic reagents refer to in vitro diagnostic reagents managed as medical devices, including reagents, kits, calibrators, quality control products, etc. used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation, and health status evaluation. It can be used alone or in combination with instruments, tools, equipment, or systems.
Table 2: In vitro diagnostic reagents can be classified into three categories based on the degree of product risk, from low to high.
classification | Product details |
first kind | 1. Microbial culture medium (not used for microbial identification and drug sensitivity testing); 2. Sample processing products, such as hemolytic agents, diluents, staining solutions, etc. |
The second category | 1. Reagents used for protein detection; 2. Reagents used for sugar detection; 3. Reagents used for hormone detection; 4. Reagents used for enzyme detection; 5. Reagents used for ester detection; 6. Reagents used for vitamin detection; 7. Reagents used for inorganic ion detection; 8. Reagents used for drug and drug metabolite detection; 9. Reagents used for detecting autoantibodies; 10. Reagents used for microbial identification or drug susceptibility testing; 11. Reagents used for detecting other physiological, biochemical, or immune function indicators. |
The third category | 1. Reagents related to the detection of pathogenic pathogen antigens, antibodies, and nucleic acids; 2. Reagents related to blood type and tissue typing; 3. Reagents related to human genetic testing; 4. Reagents related to genetic diseases; 5. Reagents related to the testing of narcotic drugs, psychotropic drugs, and toxic drugs for medical use; 6. Reagents related to the detection of therapeutic drug targets; 7. Reagents related to tumor marker detection; 8. Reagents related to allergic reactions (allergens). |
2. Application of Serum in In Vitro Diagnostic Reagents
(1) Sealing liquid
In the in vitro diagnostic reagent industry, commonly used solid-phase sealants are buffers composed of non target proteins in a certain proportion, including animal serum such as bovine serum, horse serum, sheep serum, non serum proteins such as casein, and commonly used unrelated proteins such as bovine serum albumin. Due to cost considerations, most mature in vitro diagnostic reagent manufacturers with a certain scale of research and development and production often use solid-phase blocking buffer solutions prepared with their own systems during the research and development and production process; The commonly used passive blockers are mostly other animal IgG, such as sheep IgG, rabbit IgG, etc; Active blockers that usually have intellectual property protection typically contain mouse IgG antibodies and other clean antibodies.
(2) Enzyme diluent
High purity bovine serum can also be used to prepare enzyme dilutions, utilizing the buffering properties of its own serum protein system to protect the spatial structure and activity of enzyme substances. It is required that serum products contain as low impurities as possible, such as oxidases, hormones, and impurities.
(3) Basic serum for quality control/calibration products
The serum has undergone special stability treatment, which has the properties of clarity, transparency, absence of impurities, no precipitation, and does not affect the detection results. At the same time, it can also protect the standard. It can be directly used as a basic dilution serum for IVD standards/quality control products. Adding antigens/antibodies directly to the serum can reduce production costs.