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Industry Definition and Classification of the Diagnostic Reagent

With the development of the global economy, people's awareness of health care is constantly improving, and the medical security policies of most countries are constantly improving. The rapid development of global health care has led to the development and growth of the diagnostic industry. The diagnostic reagent industry has become one of the most active and fastest growing industries in the world today. So what is the definition of the diagnostic reagent industry? The following is the definition and classification information of the diagnostic reagent industry.


Ⅰ. Definition of the diagnostic reagent industry


Based on general purposes, diagnostic reagents can be divided into two categories: the in vivo diagnostic reagent and in vitro diagnostic reagent. Except for intradermal in vivo diagnostic reagents such as old tuberculin, brucellin, and sekkertoxin used for diagnosis, most of them are in vitro diagnostic products.


Ⅱ. Classification of the diagnostic reagent industry


A. Registration classification


1. The third category


(1) Diagnostic reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids;


(2) Reagents related to blood type and tissue matching;


(3) Reagents related to human genetic testing;


(4) Reagents related to genetic diseases;


(5) Reagents related to the testing of narcotic drugs, psychotropic drugs, and medical toxic drugs;


(6) Reagents related to the detection of target points of therapeutic drugs;


(7) Reagents related to tumor marker detection, like gastric cancer diagnostic tests.


(8) Reagents related to allergies (allergens).


2. The second category


The second category of products: Except for the products that have been clearly defined as the third and the first category, the others are the second category of products, mainly including:


(1) Diagnostic reagents for protein detection;


(2) Reagents for sugar detection;


(3) Reagents for hormone detection;


(4) Reagents for enzyme detection;


(5) Reagents for ester detection;


(6) Reagents for vitamin detection;


(7) Reagents for inorganic ion detection;


(8) Reagents for the detection of drugs and drug metabolites;


(9) Reagents for autoantibody detection;


(10) Reagents used for microbial identification or drug sensitivity test;


(11) Reagents used for the detection of other physiological, biochemical or immune function indicators.


3. The first category


(1) Microbial culture medium (not used for microbial identification and drug sensitivity test);


(2) Products for sample processing, such as hemolytic agents, diluents, staining solutions, etc.


B. Methodological classification


1. Clinical biochemical reagents


Clinical biochemical reagents mainly include several categories of products such as enzymes, sugars, lipids, protein, and non-protein nitrogen, inorganic elements, liver function, clinical chemistry control serum, etc., which are mainly used for manual, semi-automatic, and general complete automatic biochemical analyzer and other instrument tests. There are single reagents, liquid double reagents, dry powder double reagents, chemical reagents, standard products, and other specifications. At the same time, each manufacturer provides quality control serum series suitable for inter-testing room and indoor quality control, which is the same for the IVD manufacturer.


2. Immunodiagnostic reagents


Immunodiagnostic reagents have the largest variety of diagnostic kits. According to the diagnostic category, they can be divided into infectious diseases, endocrine, tumors, drug testing, blood group identification, etc.


Judging methods from the results can be divided into EIA, colloidal gold, chemiluminescence, isotope and other different types of reagents. Among them, the isotope radioimmunoassay reagents have been eliminated in the international market due to relatively large environmental pollution.


3. Molecular diagnostic reagents


Molecular diagnostic reagents mainly include nucleic acid amplification technology (PCR) products that have been used clinically and gene chip products that are currently being vigorously researched and developed at home and abroad. PCR products have high sensitivity, strong specificity, short diagnostic window, and can be used for qualitative and quantitative detection. They have been widely used in the detection of hepatitis, venereal diseases, pulmonary infectious diseases, prenatal and postnatal care, genetic disease genes, tumors, etc. However, due to market confusion and cross-contamination, the Ministry of Health strictly prohibited the clinical application of fluorescent electrophoresis qualitative PCR reagents. At present, the State Food and Drug Administration has approved a small number of hybrid semi-quantitative and quantitative kits that have solved cross-contamination.


Gene chip is the crystallization of the combination of molecular biology, microelectronics, computer and other disciplines. It integrates a variety of modern high-precision technologies and is praised by experts as the ultimate product in the diagnostic industry. However, it is expensive and difficult to develop. At present, there are few types of products, which are only used for scientific research and drug screening.

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