Development of in vitro diagnostic reagents in China

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The global spread of the new crown virus has caused tremendous changes in each of our lives, causing the original concern for infectious diseases and testing and diagnosis to continue to rise rapidly. For example, virus nucleic acid testing, antibody testing, clinical testing, and vaccine research and development have all become issues of urgent concern to people, but the development of in vitro diagnosis in China is relatively late.

In Vitro diagnosis (IVD) technology usually refers to products and products that, outside of the human body, obtain relevant clinical diagnostic information by testing samples of the body including blood, body fluids and tissues, thereby helping to determine diseases or body functions. service. China's IVD development started late, but benefiting from the improvement of medical consumption levels, the promotion of the national medical system reform, the support of industrial policies, and the characteristics of its one-time consumption, the IVD industry has achieved rapid growth in recent years. In 2016, China's IVD market has reached approximately RMB 43 billion.

In vitro diagnostic reagents

During the new crown epidemic, the method of sampling with a virus sampling tube and then nucleic acid detection and antibody detection are all in vitro diagnostic techniques, which together with clinical chest dialysis to observe the lungs and other methods are used as the new crown diagnostic method. It can be said that IVD is playing an increasingly important role in modern society. At present, more than 80% of clinical diagnosis of diseases are related to it. Therefore, it plays an extremely important role in the whole process of disease prevention, diagnosis, monitoring, and guidance of treatment. It is an indispensable tool for modern disease and health management.

With the rapid development of clinical medicine diagnosis and treatment technology, many traditional and conventional in vitro diagnostic technologies can no longer meet the needs of clinical medicine development. People have higher and higher requirements for the sensitivity, accuracy and specificity of clinical diagnostic analysis. Diagnostic reagents are also constantly upgraded.

From radioimmunoassay to enzyme-linked immunoassay, diagnostic reagents have also changed from radioactive isotope markers to chromogenic reagents, from phenol aniline to Trinder’s reagents (ADPS, TOOS, MAOS), and from benzidine to TMB. After enzyme-linked immunity, chemiluminescence immunity was developed. Chemiluminescence reagents such as luminol, acridinium ester and AMPPD, as well as electrochemiluminescence ruthenium terpyridine.

At present, domestic in vitro diagnostic reagents are gradually realizing domestic production, such as Trider's reagent for enzyme-linked immunoassay and Desheng's acridinium ester chemiluminescence reagent have reached the level of imported high-quality reagents, and have been widely recognized by domestic reagent companies. The self-supply of reagents is just around the corner.