Development Status of global IVD industry analysis

2021-11-08 17:34:05

First, in vitro diagnostic reagents concept and principle

IVD in the prevention, diagnosis, treatment monitoring, prognosis of, health status evaluation and forecasting process hereditary diseases, for human samples in vitro detection reagents, its mechanism is as follows: diagnostic reagents and substances in the body In vitro biochemical reactions occur in strength, due to the nature and quantity of the reaction strength / speed and substances in the body, and therefore by measuring the in vivo diagnostic reagents and substances in vitro biochemical reactions take place, you can infer the nature and quantity indicators substances in the body, and then the The index and normal physiological conditions were compared to determine the relative range, then determine the physiological state of the human body.

Second, in vitro diagnostic reagents classification

Press the detection principle or detection methods, major biochemical diagnostic reagents, immunodiagnostics, molecular diagnostics, microbiology diagnostic reagents, urine diagnostic reagents, clotting diagnostic reagents, diagnostic reagents hematology and flow cytometry.

Biochemical diagnostic reagents biochemical indices measured in vivo by various biochemical reactions or immunological reagents, mainly used in conjunction with manual, semi-automatic biochemical analyzer and other equipment for testing, measuring enzymes, carbohydrates, lipids, proteins, and non-protein nitrogen, inorganic element classes, and other indicators of liver function.

Immunodiagnostics is a specific reaction by the combination of antigen and antibody measurement reagent is determined from the results of the method can be divided into radioimmunoassay (RIA) on science, colloidal gold, enzyme immunoassay (ELISA), time-resolved fluorescence ( TRFIA), chemiluminescent (CLIA) and other reagents, mainly used in infectious disease, endocrinology, oncology, drug testing, blood type identification.

Molecular diagnostic reagents is mainly protein and a variety of immune active molecules and genes encoding these molecules associated with the disease agent is measured, mainly for hepatitis, sexually transmitted diseases, lung infections, prenatal and postnatal care, genetic disease genes, tumor and other testing . Molecular diagnostic reagents have been used clinically mainly nucleic acid amplification technique (PCR) products and research and development at home and abroad is vigorously gene chip and protein chip products.