With the development of knowledge economy, people's living standards have greatly improved, for health, led to the emergence of medical and health services and more strong, in vitro diagnostic reagents as an important part of medical supplies, has its enormous market potential, each production enterprises have mushroomed in all around the country, new products constantly, the domestic and international market, and the impact of this phase is associated with the lack of intellectual property. Using relevant legal economics, economics theory, is to study the legal theory and method of legal issues, it is not only related to relevant legal value has philosophical sense of legal theory, but also involves specific legal problems and almost all sectors, including intellectual property. Domestic law in introducing law of intellectual property economy class, but not involved in vitro diagnostic reagents, especially in the field of intellectual property law analysis is almost zero. This paper explains economic growth and intellectual property rights of economic relations between in vitro diagnostic reagents, intellectual property, the existing social cost and benefit the necessity and restrictive in three aspects for intellectual property protection and the use of in vitro diagnostic reagents and urgency of the problem, and reveals the in vitro diagnostic reagents fields of intellectual property law system, and puts forward the practical requirements for future improvement suggestion, the rationality of in vitro diagnostic reagents in intellectual property related legal system, and provides the reference for future : HBeAg quantitative detection in chronic hepatitis b antiviral treatment has important scientific significance and economic value, the graduation topic selection, guangzhou was antibody engineering technology Co., LTD. Is developed "hepatitis b virus e antigen (HBeAg) quantitatively kit (time-resolved immunofluorescence)", through the representative for a certain amount of research, clinical samples to assess the clinical application of test, and its effectiveness and safety to provide important basis. Methods: according to the clinical diagnostic reagents clinical research technique guiding principles for design, according to the design of clinical epidemiology, randomized controlled "three principles" and the blind, the design of the test results and diagnostic kits and re-checked results compared to assess the clinical application of kit. Results: the testing results and comparison of diagnostic kits and review kit, sensitivity achieved respectively, specificity of reco-very and , for 100% on index of and greatly, and + LR, consistent - LR less rate , kappa value and per cent for (P < ), and the correlation coefficient r = (P = ). Conclusion: the kit, accurate, reliable and stable, safe, convenient with high value of clinical applications.
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