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IVD industry - the new situation "big test" of the times and new problems

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IVD industry - the new situation "big test" of the times and new problems

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[Abstract]:
National health awareness, medical market continues to widen, the rapid development of medical tests, to in vitro diagnostic (IVD) industry has brought unprecedented opportunities.

National health awareness, medical market continues to widen, the rapid development of medical tests, to in vitro diagnostic (IVD) industry has brought unprecedented opportunities. After a number of IVD entrepreneurs efforts, China IVD equipment level has been a qualitative leap, domestic IVD equipment and reagents have sprung up, some products have entered the medical laboratories in Europe, the United States and developed countries. Faced with the rapid development of the industry, R & D, laboratory medicine, the combination of clinical needs in three areas seem even more critical. To further explore the hot issues of the IVD industry, reflect the new progress, exchange new ideas for the development of production, clinical testing, and other areas of industry regulation exchange platform, planned special edition "IVD industry hot observe a series of reports," hope that through this Open the window, propaganda stage, advice and suggestions for the development of the industry.

 

April 27, "The First National Clinical Laboratory Equipment and Applications Conference and the National Clinical Laboratory Equipment Exhibition" in Ningbo International Convention and Exhibition Center, chairman of the China Association of Medical Equipment Clinical Laboratory Equipment Technical Committee, People's Liberation Army General Hospital, pointed out Professor Cong Yulong the current life sciences presents multi-point breakthrough, cross convergence trend, medical laboratory standardization, standardization and internationalization of the management concept is more and more recognized by the industry, it's all in the birth of arrival "big test" era.

 

For the concept of "big test" of our clinical laboratory equipment, especially the new changes in the IVD industry, as well as promotion of appropriate test equipment and technology is important and other industry hot issues, Professor Cong Yu Long in the newspaper interview were described in detail.

 

Reporter: What is a "big test" mode, which involves what category?

 

Cong Yu Long: "Big test" is based IVD industry, laboratory diagnosis, clinical treatment interdependent, intrinsically linked and mutually reinforcing laws, according to their scope, their role in the formation of scientific, systems, integration of the new development concept. Its elements can be divided in the upstream of the detection system development and production units, in the middle of the hospital laboratory or medical laboratory units, clinical departments, the downstream unit. No advanced equipment and testing instruments, laboratory difficult to develop; no laboratory actively promote the use of new technologies, IVD product there is no market; no clinical departments demand for inspection department, no matter how useless medical laboratories. Therefore, only set up production and research platform, making it closely, promote each other in order to achieve coordinated development. Nearly 10 years, our laboratory medicine in the field of academic and exhibition activities very active, new theories, new technologies, new methods, new equipment continue to emerge, described as "big test" of concrete manifestation. I believe that with the "big test" mode for a growing number of industry recognition, will promote faster development of translational medicine.

 

Reporter: What are the main current trends in laboratory medicine and equipment presented?

 

Cong Yulong: nearly 30 years of rapid development of laboratory medicine "golden period." Throughout these 30 years of change, laboratory medicine presents automation, bedside technology, molecular, personalized four trends. In "the new technology, multi-function, easy operation, high speed, high accuracy, the results of accurate, standardized information technology" as a symbol of the automatic mode has become one of the main trends of development of laboratory medicine. For example, in a conventional blood analysis in most applications, the fastest growing hematology analyzer, which in addition to having red (white) cells, platelet count function, red blood cell volume may also be provided for the differential diagnosis of anemia traditional manual method of operation can not be obtained distribution width (RDW), mean platelet volume for thrombocytopenia cause analysis (MPV) and other indicators of diagnostic value. In recent years, the advent of machine vision recognition technology uses machines instead of human eyes to measure and judge, we can help even replace human work, the morphological examination into a new phase. Today, medical activities have been expanded from the hospital to the community, family, health care workers need easy to carry, simple operation test equipment, and real-time detection (POCT) as a quick analysis technique can be performed at the bedside of patients, due to the rapid and easy high efficiency, low cost, short cycle, specimens with less features, great development potential. This segment appeared Immunocolloidal gold, immunochromatography, immunoblot percolation, dry chemical technologies, biological and chemical sensors, biochips and other fast detection technologies and products. In addition, the rapid development of genomics, proteomics, metabolomics, bioinformatics laboratory medicine to bring revolutionary changes, a variety of advanced equipment into the routine testing electrophoresis, polymerase chain reaction (PCR) technology from qualitative toward quantitative, various in vitro gene amplification techniques such as ligase reaction (LCR), strand displacement amplification system (SDA), transcriptional amplification system (TAS), etc. being used by the research towards clinical, and the emergence of the chip so that DNA testing and Proteome analysis has entered a new stage, mass spectrometry and gradually into the routine test to improve the level of microbiological testing, for protein analysis, progress in the early diagnosis of cancer, personalized medicine provides an effective experimental means and basis.

 

Reporter: In recent years the country to support the development of suitable medical equipment and technology. However, there are still areas of medical laboratory repetitive inspections, checks and other negative issues big combinations. What are your suggestions?

 

Cong Yu Long: In recent years, our country has made significant achievements in health, but in the face of new situation and new problems, health reform and development still face serious challenges. At present, some public hospital laboratory under the influence of the past regime, emphasis on the economic benefits of the phenomenon does exist. Some test subjects regardless of whether the condition on the patient hematology, biochemistry, immunology multi-project big combinations examination, even for diagnosis or after the patient has still repeated examination, some hospitals will not have significant diagnostic clinical validation Value of high fees as a regular item, or a combination, adding to the burden on patients. For example, many hospitals with luminescent enzyme immunoassay method instead of pathogenic examination of hepatitis B (known as "two pairs of half" method) and a separate price charged as a routine examination of hepatitis B therapy monitoring, this ill conceived. "Two pairs of half" method has been applied more than 30 years, through continuous improvement and perfection, which test the quality to meet the clinical requirements and test cost, low fees, can be used as medical, hospital examination, preoperative screening such as "appropriate technology" . For those who disregard the test results, no evidence-based medicine based on a combination of checking blind multi-project large, should be stopped. Should be concerned about is that this year the Central Leading Group comprehensively deepen reforms eleventh meeting stressed the need to build a rational layout, division of labor in the health care system, medical clinics and grading structure. 2015 Health Reform teleconference held on April 29, the Prime Minister Li Keqiang made important instructions, requiring firmly grasp the basic principles of basic security, strong grass-roots level, to build mechanisms to equitable access, benefit the masses as the starting point and foothold, adhere to health care, medicine, medical "three doctors linkage" to achieve greater effectiveness in convenient for people for medical treatment, medication to reduce the burden on the doctor. This medicine, and the development of IVD test industry made new demands. Currently, the hospital urgent need to change the one-sided pursuit of high, refined, a sharp technical equipment of practice, the rational allocation and application of test equipment, to further reduce the burden on patients, manufacturers should also pay more attention to the needs of the grassroots, the grassroots development of laboratory medicine and equipment suitable for use to protect and enhance the ability of grassroots medical treatment.

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