This article reviews the development and administration of Shanghai IVDs (In Vitro Diagnostics) manufactures by analyzing the administration and history of the regulation of IVDs in ten years. It is to find out the problems in the administration of IVDs manufactures and products, and to make suggestions for improvements.
China ; Indicators and Reagents ; Public Sector ; organization & administration ; Quality Control

Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.
Clinical Trials as Topic ; Indicators and Reagents/administration & dosage* ; Reagent Kits, Diagnostic

OBJECTIVEIn order to adapt the rapid development of modern medicine, this paper is aimed to analyze the application of in vitro diagnostic reagents (IVD Reagents) in hospital management and improve the overall level of hospital management.

METHODSBy groping the management experience of IVD reagents, we discuss the internal hospital management mode of IVD reagents in reality.

RESULTSWith the continuous improvements on the information platform of IVD reagents,we can realize benefit analysis of IVD reagents within the process of management.

CONCLUSIONReasonable management on IVD reagentscan improve the working efficiency in hospitals and provide swifter and better medical service for patients.

The regulatory history and status of in vitro diagnostic reagents (IVD) at home and abroad are introduced. Suggestions are also provided on the administration of IVD.
Diagnostic Techniques and Procedures ; instrumentation ; Health Services Administration ; Indicators and Reagents ; standards ; Product Surveillance, Postmarketing

OBJECTIVETo explore the modern hospital and regional medical consumable reagents logistics system management.

METHODSThe characteristics of regional logistics, through cooperation between medical institutions within the region, and organize a wide range of special logistics activities, to make reasonable of the regional medical consumable reagents logistics. To set the regional management system, dynamic management systems, supply chain information management system, after-sales service system and assessment system. By the research of existing medical market and medical resources, to establish the regional medical supplies reagents directory and the initial data. The emphasis is centralized dispatch of medical supplies reagents, to introduce qualified logistics company for dispatching, to improve the modern hospital management efficiency, to costs down.

RESULTSRegional medical center and regional community health service centers constitute a regional logistics network, the introduction of medical consumable reagents logistics services, fully embodies integrity level, relevance, purpose, environmental adaptability of characteristics by the medical consumable reagents regional logistics distribution.

CONCLUSIONSModern logistics distribution systems can increase the area of medical consumables reagent management efficiency and reduce costs.

This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.
China ; Device Approval ; Indicators and Reagents ; classification ; standards ; Quality Control ; Reagent Kits, Diagnostic ; classification ; standards ; United States ; United States Food and Drug Administration

This article makes a pilot study on the key points of the quality management system of in-vitro diagnostic reagents by analyzing the technical characteristics and production methods of these products as well as the status in quo, and problems the in-vitro diagnostic reagent industry in China is facing nowadays. It can serve as a reference to the supervision departments and the manufacturers in this field which are establishing and running the quality management system.
China ; Equipment and Supplies ; standards ; Humans ; Indicators and Reagents ; chemistry ; standards ; Pilot Projects ; Quality Assurance, Health Care ; organization & administration ; Quality Control ; Reagent Kits, Diagnostic ; standards ; Safety Management ; Technology, Pharmaceutical ; organization & administration ; standards ; Total Quality Management

Allergen immunotherapy (AIT) and diagnostic tests are based on well qualified allergen extracts, which are derived from biologic organisms. The allergenicity of the extracts is markedly affected by the climate, soil, year of production, storage methods, and manufacturing processes. Thus, standardization is a crucial process to guarantee the clinical efficacy and safety of the treatment and diagnostic reagents in allergic diseases. There are 2 different standardization processes, one is In vivo and the other is in vitro standardization. In vivo standardization is done by skin prick or intradermal tests. For in vitro standardization, measurements of weight/volume and protein nitrogen units have been widely used since the early period of AIT. In the 1970s, immunological methods such as radial immunodiffusion, enzyme-linked immunosorbent assay (ELISA) inhibition test and basophil activation test were developed. Allergen potency measured by ELISA inhibition test reflects the potency measured by skin tests and has been widely used for quality control of batch-to-batch variation. Recently, standardizations focused on the major allergen content of extracts have developed. Standardization for major allergens requires reliable reference materials (RMs) made of recombinant allergens and 2-site ELISA kits. However, only a few reliable RM and 2-site ELISA kits are available. For the standardization process, allergen RMs are essential. The Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration provides 19 allergen RMs, and our research team also proved 9 RMs which are important in Korea. In conclusion, allergen standardization is an essential process for the development of reliable treatment and diagnostic reagents, and allergy specialist should be familiar with the concept of allergen standardization.
Allergens ; Basophils ; Biological Products ; Climate ; Desensitization, Immunologic ; Diagnostic Tests, Routine ; Enzyme-Linked Immunosorbent Assay ; Hypersensitivity ; Immunodiffusion ; In Vitro Techniques ; Indicators and Reagents ; Intradermal Tests ; Korea ; Nitrogen ; Quality Control ; Skin ; Skin Tests ; Soil ; Specialization ; Treatment Outcome ; United States Food and Drug Administration