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IVD: What is chemiluminescence and the technical difficulties it faces

2019-07-15 来源:转载自第三方
Chemiluminescence is one of the most important subdivisions in the in vitro diagnostic industry. In 2016, the market capacity was about 20 billion. The chemiluminescence sub-sector maintained a compound growth rate of 33% in 2011-2015. It is expected that in the next 3-5 years, with graded diagnosis and treatment. The intensification of the promotion, the grassroots medical institutions have full wings, and the chemiluminescence can still maintain a high growth rate of 20-25% in the industry, and the total market capacity doubles every three years. The domestic brand has just emerged and has huge growth potential. The effective domestic market is about 10 billion in 2016, and the compound growth rate in the next three years is 60-80%.
What is chemiluminescence?
Chemiluminescence is widely used in clinical practice. It is a kind of immunodiagnosis. It is a diagnostic method for determining the body's physical state by using the specific reaction between antigen and antibody to determine the concentration of disease markers in the body. It is widely used in infectious diseases and heart diseases. , tumors, pregnancy testing, etc.
The Difficulty in Chemiluminescence technology
The fundamental reasons for the high barriers to chemiluminescence technology are: 1) the low concentration of the substance to be detected (μg/L-pg/L), which results in high precision requirements for the entire detection system, and the instrument and reagent system are closed; 2) the entire detection process There are many steps, and the automation is difficult; 3) A variety of cutting-edge technologies including biological, chemical, physical, optical and other disciplines are indispensable.
The mainstream reagent technology at home and abroad is similar, the mainstream has direct chemiluminescence (isoluminol (new industry), acridinium ester (Abbott)), indirect (enzymatic) chemiluminescence (Danach, Mindray, Antu), electricity Chemistry (Roche) has its own advantages and disadvantages, and there is no obvious trend of technical substitution. However, electrochemiluminescence is considered to be the third generation technology, and the technology is slightly ahead.
The performance of the reagent includes accuracy, sensitivity, linear range, anti-interference ability, storage stability, bottle opening stability, kit specifications, etc. The performance of the machine includes the detection speed, reagent position, sample position, instrument size, etc. The accuracy is The core is obtained by comparison with the certified products; other performances indirectly affect the accuracy, and need to be combined with specific project standards, manufacturer performance and customer needs.
Principle of chemiluminescence
1. Immune response
The antigen enters the body and stimulates the body's immune system to produce an immune response. This reaction is called an immune response. The immune response response includes three consecutive stages of induction, response, and effect on the antigenic material.
2. Immunoassay (immunoassay, IA)
In clinical tests, antibodies and antigenic substances in body fluids are detected by known antigens or antibodies based on the specific reaction of the antigen and its paired antibodies.
3. high specificity
Binding of an antigen-antibody occurs essentially only between the antigenic determinant of the antigen and the antigen binding site of the antibody. Since the two are complementary in chemical structure and spatial configuration, the antigen-antibody reaction is highly specific. The high specificity of antigen-antibody reactions is the basis of immunological detection.
4. High affinity
The process by which an antigen binds to an antibody to form an antigen-antibody complex is a dynamic equilibrium, and its reaction formula is: Ag+Ab→Ag·Ab. The antigen binding site of the high affinity antibody and the determinant of the antigen are very suitable in the spatial configuration, and the two are firmly combined and are not easily dissociated.
Related links: Acridinium ester
Edited by Suzhou Yacoo Science Co., Ltd.