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IVD industry -- new situation and new problem in the era of big test

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[Abstract]:
Net of medicine of the May 7 hearing, national health consciousness enhancement and the medical market will continue to expand, the rapid development of laboratory medicine, to the in vitro diagnostic

Net of medicine of the May 7 hearing, national health consciousness enhancement and the medical market will continue to expand, the rapid development of laboratory medicine, to the in vitro diagnostics (IVD) industry brought rare opportunities for development. Through the efforts of a group of IVD entrepreneurs, IVD equipment level of our country has produced a qualitative leap, domestic IVD devices and reagents have mushroomed like, some of the products has entered the European and American developed countries in the medical laboratory. In the face of rapid development of industry, the organic combination of research and development, inspection and clinical need is becoming more and more important. For an in-depth discussion of the IVD industry hot issues, reflecting the new progress, the exchange of new thinking, for the field of R & D and production, clinical examination, the industry regulator to build communication platform, version of the planned a special IVD industry hot series of reports of observation, hope everyone through the open window, publicity of the stage, as to provide suggestions for the industry development and suggestions.

On April 27, "the first session of the national clinical laboratory equipment and Applications Conference and national clinical laboratory equipment exhibition" held in Ningbo International Convention and Exhibition Center, China Association of medical equipment clinical laboratory equipment and technology professional committee chairman, liberation army general hospital research professor pointed out that the life sciences has more breakthrough and cross the convergence trend, medical laboratory standardization, standardization, internationalization management idea is more and more recognized by the industry, all this in the birth of the arrival of the era of "big test".

According to the concept of "test", Chinese clinical and laboratory equipment, especially the new changes of the IVD industry and promotion of appropriate test equipment technology is of great significance to industry hot issues, Professor Cong g in an exclusive interview with this newspaper were detailed.

Reporter: what is the "big test" mode, which involved in what areas?

Research: "big test" is according to the IVD industry, laboratory diagnosis, clinical treatment of interdependence, mutual promotion relations and rules, formed according to their scope, the respective roles of scientific, systematic and fusion as a new concept of development. Its elements can be divided into the upstream detection system research and development and production units, in the middle reaches of the hospital laboratory or medical laboratory unit, in the downstream clinical treatment unit. Without advanced equipment and testing instruments, laboratory is very difficult to development; no laboratory and actively promote the use of new technologies, IVD products there is no market; no clinical departments of inspection department needs, again good medical laboratory is also useless. Therefore, only put up the platform for industry, research, and make it closely integrated and promote each other, to realize the cooperative development. In the last 10 years, the academic and exhibition activity of our country's inspection medicine field is unusually active, and the new theory, new technology, new method and new equipment are emerging, it is the concrete embodiment of "big test".. I believe that with the big test mode for more and more industry insiders agree, will promote the transformation of medicine faster development.

Reporter: what mainstream development trend of current inspection medical equipment presents?

Cong Yulong: nearly 30 years is the rapid development of China's medical testing, the golden period ". Throughout the 30 years of the change, the medical examination showed automation, bedside, molecular, personalized four trends. The automatic mode of the technology, function, easy operation, fast speed, high accuracy, accuracy, accuracy, standardization and informationization is the main trend of the inspection medical development.. For example, in the routine blood analysis application is the most, the fastest growing blood cell analyzer, it besides with red (white) cell and platelet function, provide to the traditional manual method cannot be obtained for differential diagnosis of anemia of red blood cell volume distribution width (RDW) and for thrombocytopenia etiology analysis of mean platelet volume (MPV), a diagnostic value of the indicators. In the last few years, the machine vision recognition technology uses the machine to replace the human eye to measure and judge, and can help even to replace human's work, and bring the cell morphology test into a new stage.. Today, the medical activities has from the hospital expanded to community, family, medical personnel need to carry convenient, simple operation and equipment inspection, and real-time detection (POCT) as a can be performed at the patient's bedside in the fast analysis technique, because of the characteristics of rapid, simple, high efficiency, low cost, short cycle, specimen amount less, so it has great development potential. This niche has the colloidal gold immune labeling, immune chromatography, immune dot filtration, dry chemical technology, biological and chemical sensors, bio chip and other fast inspection technology and products. In addition, genomics, proteomics, metabolomics, the rapid development of bioinformatics to laboratory medicine has brought revolutionary changes, into a variety of advanced equipment routine inspection of electrophoresis, polymerase chain reaction (PCR) technique from qualitative to quantitative, various in vitro gene amplification technology, such as the ligase reaction (LCR), strand displacement amplification system (SDA), transcription amplification system (TAS) is from research to clinical, and the emergence of DNA chip detection and proteomic analysis has entered a new stage, mass spectrometry technology gradually into the regular inspection, improve the microbiological examination level, which is used for protein analysis, the progress made in the early diagnosis of tumor, to provide effective the experimental means and basis for personalized medicine.

Reporter: in recent years, the country strongly supports the development of appropriate medical equipment technology. However, there are still bad questions such as repeated examination and combination inspection in the field of medical inspection.. What's your suggestion?

Cong Yulong: in recent years, China's health cause major achievements, but in the new situation and new problems, health reform and development are still facing severe challenges. At present, some public hospitals in the past system, the impact of the past, there is indeed a phenomenon of economic benefits. Some inspection, no matter whether the illness needs is the patients blood, biochemistry, immunology multi project combination check, even to has been clear about the diagnosis and postoperative patients still repeated examination, some hospitals will not clinically proven to have significant diagnostic value of high fees for general project or in combination, adding to the burden of the patients. For example, many hospitals by luminescence method instead of enzyme immunoassay for hepatitis B pathogen examination (commonly known as "two half and half") as the hepatitis B therapeutic monitoring of routine examination and other fees, which is inappropriate. "Two half and half" method has been used for more than 30 years, through continuous improvement and perfection, the inspection quality can meet the clinical requirements, and test cost, low fees, can as a physical examination, admission examination, preoperative screening of "appropriate technology". For those who have no evidence of the results of the trial, the blind multi - item combination of the medical foundation should be stopped. It should be concerned that the central comprehensive deepening reform of the Central Committee this year, the eleventh meeting stressed the need to build a reasonable layout, the division of medical service system and medical service system classification and medical treatment pattern. On April 29, held in 2015, deepening the reform of the medical and health work in television and telephone conference, Premier Li Keqiang made important instructions, firmly grasp the basic principle of insurance basic, strong basic level, building mechanism, and fair, benefit for people as the starting point and the foothold, adhere to the health care, pharmaceutical, medical "tripartite linkage, medical care at the convenience of the masses, reduce the medical burden has greater effectiveness. This is a new requirement for the development of medical and IVD industry.. At present, the hospital of the urgent need to change the one-sided pursuit of high, refined, sharp technical equipment, reasonable configuration and application testing equipment, to further reduce the burden on patients, production enterprises should also pay more attention to the needs of the grassroots, R & D suitable use of primary equipment of laboratory medicine, to safeguard and improve grassroots medical diagnosis and treatment.