In-Vitro Diagnostics (IVD) refers to taking blood, body fluids, tissues and other samples from the human body, and using in vitro detection reagents, kits, calibrators, quality control substances, etc. to test and verify the samples. The process of disease prevention, diagnosis, treatment detection, post-observation, health evaluation, genetic disease prediction, etc.
From this, we can see that in vitro diagnostic products cover a wide range of applications, such as disease prevention, diagnostic testing, and prognosis evaluation, and are an important part of the medical and health industry.
In vitro diagnosis includes two parts: diagnostic instruments and diagnostic reagents. Among them, in vitro diagnostic instruments belong to the clinical testing and analysis instruments under the secondary classification of medical devices, while diagnostic reagents belong to the category of biological products in biological pharmaceutical products.
According to the degree of product risk from low to high, in vitro diagnostic reagents are divided into first, second and third categories of products.
IVD reagents definition: according to the detection principles and methods, in vitro diagnostic reagents are divided into four categories: biochemical reagents, immunodiagnosis, molecular diagnosis, and microbial diagnosis.
1. Biochemical diagnosis
Biochemical detection started early in China. At the same time, due to the advantages of low cost and fast speed of biochemical diagnosis, while diagnostic technologies such as immunodiagnosis and molecular diagnosis are booming, they still maintain a large market share, biochemical diagnosis will remain an important in vitro diagnostic reagent.
Immunoassay is one of the fields with the largest scale, the most new varieties and the fastest growth rate in the field of in vitro diagnostics in China. The development of immunodiagnostic technology has gone through several technical stages, including the evolution of isotope radioimmunity, colloidal gold, enzyme-linked immunosorbent assay, time-resolved fluorescence, and chemiluminescence.
Chemiluminescence products have the advantages of high sensitivity, wide linear range, long validity period of in vitro diagnostic reagents, wide clinical application range, simplicity and speed, etc. The technology development has been relatively mature and has become the mainstream direction of immunodiagnosis.
3. Molecular diagnosis
Molecular diagnosis mainly includes nucleic acid amplification technology, in situ hybridization technology, gene chip, and genetic testing. After years of research and development, Chinese IVD products list have made good progress in the field of PCR and gene chips, and the technology has reached or approached the international level.
China's molecular in vitro diagnostic reagent technology started late, but due to its high technical starting point and small market base, it has become the fastest growing segment of diagnostic field in recent years.
4. Blood and body fluids, microbial diagnosis
The blood and urine market is the most important in China's hematology and humoral field. China's technology is not mature enough, and the high-end market is mainly occupied by foreign brands.
The field of microbiology diagnosis started relatively late, and is limited by the application of biomedicine and mechatronics, which lags behind the international level.
In the future, the development of blood and body fluids and microbial diagnosis in China will be combined with the introduction of digestion and independent research and development to improve the concentration of the industry.