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In Vitro Diagnostic (IVD) Product Classification and Desheng Advantage Products

Release time:

2020-10-19

In vitro diagnostic (IVD) products can be divided into biochemical diagnostic products, immunological diagnostic products and molecular diagnostic products according to methods. Biochemical diagnosis, immunodiagnosis, and molecular diagnosis are the three main methods of in vitro diagnosis in my country, representing the three detection levels of metabolites and enzymes, proteins, and DNA.

Various colors of in vitro diagnostic reagents

Biochemical diagnosis

Biochemical diagnosis is generally used for indicators such as enzymes, carbohydrates, lipids, protein and non-protein nitrogen, trace elements, etc. It is mainly used for basic examination items such as blood sugar, blood lipids, cholesterol, liver function, kidney function, etc. The representative technology is dry chemistry Technology, immunoturbidimetric technology, equipped with biochemical analyzer and supporting reagents.

The biochemical diagnostic reagents are basically domestic brands, occupying more than 70% of the market share. The new technology enterprise Desheng takes "in vitro diagnostic reagent raw materials", "chemiluminescence reagents", "biological retardants", "blood collection tube additives", and "pharmaceutical intermediates" as its leading products, and can provide customers with high-quality gram-level products. To ton-level research products commissioned and customized business and mass production services. The raw materials of Desheng clinical biochemical detection reagents include blood collection tube additives heparin lithium/sodium, separation gel, coagulant, EDTA dipotassium/tripotassium, etc.

Immunodiagnosis:

Immunodiagnosis is based on the reaction of antigen and antibody. It is generally used for infectious diseases, tumors, venereal diseases, virus and blood source screening, drug testing, blood type identification, pregnancy test, cardiovascular and cerebrovascular diseases, etc. The representative method is immunity Fluorescence method, enzyme-linked immunoassay, radioimmunoassay, chemiluminescence method, colloidal gold method, etc.

Among them, enzyme-linked immunoassay and chemiluminescence immunoassay are the current mainstream techniques of immunodiagnosis. Desheng can provide high-quality chemiluminescence immunoassay materials such as luminol, isoluminol, acridine esters, etc.

Molecular diagnosis:

Molecular diagnosis is the use of molecular biology techniques to detect genetic material (such as pathogens, viruses, etc.) contained in patient samples, and to prevent, treat, monitor, and evaluate the patient’s disease by detecting changes in its content or structure. Common applications include the detection of hepatitis, venereal diseases, prenatal and postnatal care, genetic disease genes, tumors and other diseases.

Molecular diagnostic technology can be divided into two categories: nucleic acid detection and biochip. Among them, nucleic acid detection is subdivided into nucleic acid molecular hybridization, polymerase chain reaction (PCR) and gene sequencing. In this epidemic, nucleic acid testing played an important role as a "contributor". Desheng can provide the core material of nucleic acid detection virus transprot medium, oral and nasopharyngeal swabs, and disposable sampling tubes.