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IVD industry-new situation and new problems in the "big inspection" era

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IVD industry-new situation and new problems in the "big inspection" era

  • Categories:Industry News
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  • Time of issue:2020-03-29 19:02
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(Summary description)Medical Network News, May 7th  The increase in national health awareness, the continuous expansion of the medical market and the rapid development of laboratory medicine have brought a golden opportunity for the development of the in vitro diagnostic (IVD) industry....

IVD industry-new situation and new problems in the "big inspection" era

(Summary description)Medical Network News, May 7th  The increase in national health awareness, the continuous expansion of the medical market and the rapid development of laboratory medicine have brought a golden opportunity for the development of the in vitro diagnostic (IVD) industry....

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2020-03-29 19:02
  • Views:
Information

Medical Network News, May 7th  The increase in national health awareness, the continuous expansion of the medical market and the rapid development of laboratory medicine have brought a golden opportunity for the development of the in vitro diagnostic (IVD) industry. Through the efforts of a group of IVD entrepreneurs, my country's IVD equipment level has made a qualitative leap. Domestic IVD equipment and reagents have sprung up, and some products have entered medical laboratories in developed countries in Europe and the United States. Faced with the rapid development of the industry, the organic combination of R&D, production, laboratory medicine, and clinical needs becomes more and more critical. In order to deeply discuss the hot issues of the IVD industry, reflect new developments, exchange new ideas, and build a communication platform for R&D and production, clinical testing, industry supervision and other fields, this edition has specially planned the "IVD industry hotspot observation series". I hope everyone will pass this The open window and publicity stage provide advice and suggestions for the development of the industry.

On April 27th, the "First National Conference on Clinical Laboratory Equipment and Application and National Clinical Laboratory Equipment Exhibition" was held at Ningbo International Convention and Exhibition Center. Professor Cong Yulong, Chairman of the Clinical Laboratory Equipment Technical Committee of China Medical Equipment Association, pointed out At present, life sciences are showing a trend of multi-point breakthroughs and cross-convergence. The standardization, standardization, and international management concepts of medical laboratories are increasingly recognized by the industry. All these are gestating the arrival of the "big inspection" era.

   Focusing on the concept of "big test", the new changes in my country's clinical test equipment, especially the IVD industry, and the importance of promoting suitable test equipment technology, Professor Cong Yulong elaborated in an interview with this newspaper.

  Reporter: What is the "big test" model, and what areas does it involve?

   Cong Yulong: "Big Test" is a new development concept of science, system, and integration based on the interdependence and mutual promotion of IVD industry, laboratory diagnosis, and clinical treatment. Its elements can be divided into the detection system R&D and production unit in the upstream, the hospital laboratory or medical laboratory unit in the midstream, and the clinical treatment department unit in the downstream. Without advanced equipment and testing methods, it is difficult for laboratories to develop; without laboratories actively promoting the use of new technologies, there will be no market for IVD products; without the needs of clinical departments for laboratory departments, no matter how good medical laboratories are, there is no use. Therefore, only by setting up a platform for industry-university-research and application, making them closely integrated and mutually promoting, can we achieve coordinated development. In the past 10 years, academic and exhibition activities in the field of laboratory medicine in my country have been extremely active, with new theories, new technologies, new methods, and new equipment constantly emerging, which can be described as a concrete manifestation of the "big inspection". I believe that as the "big test" model is recognized by more and more people in the industry, it will definitely promote the faster development of translational medicine.

  Reporter: What are the current mainstream development trends of laboratory medical equipment?

   Cong Yulong: The past 30 years have been the "golden period" of rapid development of laboratory medicine in my country. Throughout these 30 years of changes, laboratory medicine has presented four major development trends: automation, bedsideization, molecularization, and individualization. The automation model marked by "new technology, multiple functions, easy operation, fast speed, high precision, accurate results, standardization, and informationization" has become one of the main trends in the development of laboratory medicine. For example, the most used and fastest-growing blood cell analyzer in routine blood analysis, in addition to red (white) blood cell and platelet counting functions, it can also provide red blood cell volume for differential diagnosis of anemia that cannot be obtained by traditional manual methods. The distribution width (RDW), mean platelet volume (MPV) used for the analysis of the cause of thrombocytopenia and other indicators of diagnostic value. The machine vision recognition technology that has come out in recent years uses machines to replace human eyes for measurement and judgment, which can assist or even replace human work and bring cell morphology inspection into a new stage. Nowadays, medical activities have expanded from hospitals to communities and families. Medical staff urgently need convenient and easy-to-operate inspection equipment. As a rapid analysis technology that can be performed at the patient's bedside, POCT is fast and simple. , High efficiency, low cost, short cycle, and small amount of specimens. It has great development potential. In this subdivision, rapid detection technologies and products such as colloidal gold immunolabeling, immunochromatography, immunospot percolation, dry chemical technology, biological and chemical sensors, and biochips have emerged. In addition, the rapid development of genomics, proteomics, metabolomics, and bioinformatics has brought revolutionary changes to laboratory medicine. Various advanced electrophoresis equipment has entered routine testing, and polymerase chain reaction (PCR) technology has been qualitatively Moving towards quantification, various in vitro gene amplification technologies, such as ligase reaction (LCR), strand displacement amplification system (SDA), and transcription amplification system (TAS), are moving from scientific research to clinical practice. The emergence of chips makes DNA detection and Proteomics analysis has entered a new stage. Mass spectrometry technology has gradually entered routine testing and improved the level of microbiological testing. It is used for protein analysis and has made progress in the early diagnosis of tumors, providing effective experimental methods and basis for personalized medicine.

  Reporter: In recent years, the state has strongly supported the development of appropriate medical equipment and technology. However, there are still undesirable problems in the field of medical testing, such as repeated inspections and combined inspections. Do you have any suggestions for this?

   Cong Yulong: In recent years, my country's health industry has made major achievements, but in the face of new situations and new problems, health reform and development still face severe challenges. At present, under the influence of the past system in some public hospitals, clinical examination departments do have a phenomenon of emphasizing economic benefits. Some laboratories conduct comprehensive examinations of hematology, biochemistry, and immunology on patients regardless of whether the condition is necessary or not, and even perform repeated examinations on patients who have been diagnosed or after surgery. Some hospitals will have an obvious diagnosis without clinical verification. High-value, high-charge items are routine items or combinations, which increase the burden on patients. For example, many hospitals use the luminescence method instead of the enzyme immunoassay method for hepatitis B pathogenic examination (commonly known as the "two-and-a-half" method) as a routine examination for hepatitis B treatment monitoring and set a separate fee, which is inappropriate. The "two-and-a-half" method has been used for more than 30 years. After continuous improvement and perfection, its test quality can meet clinical requirements, and the test cost and fees are low. It can be used as "appropriate technology" for physical examination, hospital admission, preoperative screening, etc. . Those blind multi-item combined inspections that disregard test results and have no evidence-based medicine should be stopped. It should be noted that the eleventh meeting of the Central Leading Group for Comprehensively Deepening Reforms this year emphasized the need to build a medical service system with a reasonable layout, division of labor and coordination, and a hierarchical diagnosis and treatment pattern. In the 2015 teleconference on deepening the reform of the medical and health system held on April 29, Premier Li Keqiang made important instructions, demanding to firmly grasp the basic principles of preserving the basics, strengthening the grassroots, and building mechanisms, with fairness and accessibility and the benefit of the people as the starting point Based on its foothold, adhere to the "three-medicine linkage" of medical insurance, medicine, and medical treatment, and achieve greater results in facilitating medical treatment and reducing the burden of medical treatment. This puts forward new requirements for the development of laboratory medicine and IVD industry. At present, hospitals urgently need to change the one-sided pursuit of high, precise, and cutting-edge technology and equipment, and rationally configure and apply testing technology and equipment to further reduce the burden on patients. Manufacturers should also pay more attention to the needs of the grassroots and develop laboratory medical equipment suitable for grassroots use. , In order to protect and enhance the diagnosis and treatment capabilities of primary care.

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