NEWS INFORMATION
IVD Industry - New Situation and Problems in the Era of "Big Testing"
Release Time：
2020-03-29 19:02
Pharmaceutical Network on May 5 The enhancement of 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. After the efforts of a group of IVD entrepreneurs, China's IVD equipment level has produced a qualitative leap, domestic IVD equipment and reagents have sprung up, and some products have entered the medical laboratories of developed countries in Europe and the United States. In the face of the rapid development of the industry, the organic combination of R&D and production, laboratory medicine, and clinical needs is becoming more and more critical. In order to deeply discuss the hot issues of the IVD industry, reflect new progress, 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 Hot Spot Observation Series Report", hoping that everyone will provide suggestions for the development of the industry through this open window and publicity stage.
On April 4, the "First National Conference on Clinical Laboratory Equipment and Application and National Clinical Laboratory Equipment Exhibition" was held in Ningbo International Convention and Exhibition Center, Professor Cong Yulong, chairman of the Clinical Laboratory Equipment Technical Committee of China Medical Equipment Association and PLA General Hospital, pointed out that the current life science presents a trend of multi-point breakthrough and cross-convergence, and the standardization, standardization and international management concept of medical laboratories are increasingly recognized by the industry, all of which are giving birth to the era of "big testing".
In view of the concept of "big test", the new changes in China's clinical testing equipment, especially the IVD industry, and the importance of promoting appropriate testing equipment technology, Professor Cong Yulong elaborated in an exclusive interview with this newspaper.
Reporter: What is the "big test" model and what are its categories?
Cong Yulong: "Big test" is a new development concept of science, system and integration formed according to the interdependence and mutual promotion of IVD industry, laboratory diagnosis and clinical treatment, and according to their respective scope and respective roles. Its elements can be divided into upstream testing system R & D and production units, hospital laboratory departments or medical laboratory units in the midstream, and clinical treatment departments 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 is no market for IVD products; Without the need for clinical departments for laboratory departments, even the best medical laboratories are useless. Therefore, only by building a platform for production, education and research, so that it is closely combined and mutually promoted, can we achieve coordinated development. In the past 10 years, China's academic and exhibition activities in the field of laboratory medicine have been extremely active, and new theories, new technologies, new methods and new equipment have continued to emerge, which can be described as the concrete embodiment of "big test". It is believed that as the "big test" model is recognized by more and more people in the industry, it will surely promote the faster development of translational medicine.
Reporter: What are the mainstream development trends of current laboratory medical equipment?
Cong Yulong: The past 30 years have been the "golden period" of the rapid development of laboratory medicine in China. Throughout the 30 years of changes, laboratory medicine has presented four major development trends: automation, bedside, molecularization and personalization. The automation mode marked by "new technology, multiple functions, easy operation, fast speed, high precision, accurate results, standardization and informatization" has become one of the main trends in the development of laboratory medicine. For example, the most widely used and fastest growing blood cell analyzer in routine blood analysis, in addition to red (white) blood cell and platelet count functions, can also provide red blood cell volume distribution width (RDW) for anemia differential diagnosis (RDW), platelet mean volume (MPV) for thrombocytopenia etiology analysis and other diagnostic indicators. The machine vision recognition technology that has emerged in recent years uses machines instead of human eyes for measurement and judgment, which can assist or even replace human work, bringing cell morphological examination to a new stage. Nowadays, medical activities have expanded from hospitals to communities and families, and medical staff urgently need to carry easy-to-carry and easy-to-operate testing equipment, and point-of-care testing (POCT), as a rapid analysis technology that can be carried out at the patient's bedside, has great development potential due to its fast, simple, high efficiency, low cost, short cycle and small amount of specimens. Colloidal gold immunolabeling, immunochromatography, immunospot diafiltration, dry chemical technology, biological and chemical sensors, biochips and other rapid detection technologies and products have emerged in this segment. 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, polymerase chain reaction (PCR) technology has moved from qualitative to quantitative, various in vitro gene amplification technologies, such as ligase reaction (LCR), strand replacement amplification system (SDA), transcriptional amplification system (TAS), etc. are moving from scientific research to clinic, and the emergence of chips has made DNA detection and proteome analysis enter a new stage. Mass spectrometry technology has gradually entered routine testing, improved the level of microbiological detection, and its use in protein analysis has made progress in early diagnosis of tumors, providing an effective experimental means and basis for personalized medicine.
Reporter: In recent years, the state has vigorously supported the development of appropriate medical equipment technology. However, at present, there are still undesirable problems in the field of medical testing, such as repeated examinations and large combination examinations. What advice do you have for this?
Cong Yulong: In recent years, China's health industry has made great achievements, but in the face of the new situation and new problems, health reform and development still face severe challenges. At present, under the influence of the past system, the laboratory departments of some public hospitals do have a phenomenon of emphasizing economic benefits. Some laboratory departments require a combination of hematology, biochemistry, and immunology on patients regardless of whether their condition requires a large combination of hematology, biochemistry, and immunology, and even repeat examinations for patients who have been clearly diagnosed or postoperatively, and some hospitals take high-fee items that have not been clinically verified and have obvious diagnostic value as routine items or combinations, which increases the burden on patients. For example, many hospitals use the luminescence method instead of enzyme-free hepatitis B etiology test (commonly known as the "two-to-half" method) as a routine test for hepatitis B treatment monitoring and set a separate price, which is inappropriate. The "two-to-half" method has been applied for more than 30 years, and after continuous improvement and improvement, its inspection quality can meet clinical requirements, and the test cost and low fee can be used as a "suitable technology" for physical examination, admission examination, preoperative screening, etc. Blind multi-item large-panel examinations that ignore the results of the test and have no basis in evidence-based medicine should be stopped. It should be noted that the 4th meeting of the Central Leading Group for Comprehensively Deepening Reform this year emphasized the need to build a medical service system with reasonable layout and division of labor and coordination, and a hierarchical diagnosis and treatment pattern. At the 29 teleconference on deepening the reform of the medical and health system held on April 2015, Premier Li Keqiang made important instructions, calling for firmly grasping the basic principles of ensuring the basics, strengthening the grassroots and building mechanisms, taking fairness and accessibility and benefiting the masses as the starting point and foothold, adhering to the "three-doctor linkage" of medical insurance, medicine and medical treatment, and achieving greater practical results in facilitating the masses to seek 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 technical equipment, rationally allocate and apply testing technology equipment, further reduce the burden of patients, manufacturers should also pay more attention to the needs of the grassroots level, research and development of laboratory medicine equipment suitable for grassroots use, in order to ensure and improve the ability of primary medical diagnosis and treatment.