Study on Clinical Application and Supervision of LC-MS in in Vitro Diagnosis Test / 中国医疗器械杂志

From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.

Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

From the perspective of technical review, this paper made statistics on the supplement contents of

Study of the Application of Mobile Medical Technology in Construction of Grading Diagnosis and Treatment System / 中国医疗器械杂志

The combination of mobile medical technology and the grading diagnosis and treatment system (GDTS) can stimulate the allocation of medical resources, reduce medical cost and improve public health significantly. Firstly we summarize development features of mobile medical technology in foreign and domestic market, then we study the application model of mobile medical application in GDTS with field research data and analyzes its advantage and shortage. Finally, we propose four measures for further developing mobile medical application in the GDTS:the government departments should formulate policies and industry standards of products as soon as possible to meet requirement of market; service providers should take the hospitals as core role to achieve mutual benefit and win-win situation; take the daily monitoring of chronic diseases as an entry point to build profitable business model; enhance publicity to promote public health awareness.

Common Problems and Suggestions on Full Life-cycle Supervision and Administration of Diagnostics / 中国医疗器械杂志

This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of diagnostics, including premarket technical evaluations, pre-market QMS on-site inspections, postmarket adverse event surveillance, unannounced inspections and re-evaluation, from regulators' perspectives. It aims to provide technical reference for revisions on regulations, and help government administrators to figure out major points in daily regulatory practice.

Study of rapid endotoxin detection based on interdigital gold electrode and SAW / 国际生物医学工程杂志

ObjectiveTo establish a method of rapid detection of bacteria endotoxin based on interdigital gold electrode and surface acoustic wave (SAW).MethodsWith the carriers of 3-APTES and glutaral pentanedial,Polymyxin B (PMB) was immobilized on interdigital gold electrode,and then reacted with the bacteria endotoxin' s biological active material (lipopolysacchride,LPS) selectively.Double differential circuit based on SAW was employed to complete the detection.Two output oscillation signals were differentiated through mixer and the endotoxin content was described by frequency shift.ResultsThe experimental results indicated that there was a liner relationship between the frequency shift and endotoxin content within the content range of 75-130 EU/ml.ConclusionComparing with traditional method,the detection time is shortened to 10 minutes,the sensitivity is 13.8 KHz/(EU·mL-1),and repeatability is above 90％.

Progress in research on liquichip technology in biomedical / 国际生物医学工程杂志

Liquichip technology utilizes different fluorescent coding microbead as carriers of bio-probes and flow cytometry as optical detection method,to accomplish bio-molecules reaction in suspension liquid system.This article introduces the application of liquidchip technology in the analysis of autoimmune disease,cytokine,contagious disease,endocrinopathy,neural disease,tumor marker detection and so on.With the advantages of high sensitivity,high speed,high flux,multi-analyte,high accuracy and excellent repeatability,liquichip technology has promising prospect to be widely used as advanced biomedical detection platform.

Advance in preparation of magnetic nanowires and its application in biosensors / 国际生物医学工程杂志

Magnetic nanowires not only have nanometer properties, but also have magnetic property of giant magnetoresistance. Recently, nanowires were applied widely in high density hard disk slider, super magnetic storage element, micro-sensors, micro-engine, biomedical engineering, etc. This artical reviews the current preparation method of nanowires, the template synthesis, including several general templates such as track-etched porous polycarbonate membrane, porous anodic aluminum oxide membrane and carbon nanotubes, as well asgrowth patterns of nanowires in the templates. The applications of nanowires in several biosensors are introduced.The applications will greatly improve current ways of sensor detection, which will open up new areas of the field of biosensor study.

Microstrip antenna design and system research of radio frequency identification temperature sensor / 生物医学工程学杂志

Radio frequency identification sensor network, which is a product of integrating radio frequency identification (RFID) with wireless sensor network (WSN), is introduced in this paper. The principle of radio frequency identification sensor is analyzed, and the importance of the antenna is emphasized. Then three kinds of common antennae, namely coil antenna, dipole antenna and microstrip antenna, are discussed. Subsequently, according to requirement, we have designed a microstrip antenna in a wireless temperature-monitoring and controlling system. The measurement of factual effect showed the requirement was fulfilled.

Advances in radio frequency identification sensor network / 国际生物医学工程杂志

Radio frequency identification sensor network, a technique integrating radio frequency identification (RFID) with wireless sensor network (WSN), is introduced. The basic structure of RFID sensor network is analyzed at first. Then components of RFID sensor and relevant supporting techniques including thin film battery, quartz crystal microbalance (QCM) and surface acoustic wave (SAW) are discussed. Research status and foregrounds of both domestic and international researches are introduced as well as applications in different fields.