The strengthening of national health awareness, the continuous expansion of the medical market, and the rapid development of laboratory medicine have brought unprecedented development opportunities to the in-vitro diagnostics (IVD) industry. Through the efforts of a group of IVD entrepreneurs, the level of IVD equipment in China has made qualitative leaps, and domestic IVD equipment and reagents have emerged like bamboo shoots after a spring rain, with some products already entering medical laboratories in developed countries such as Europe and the United States. In the face of the rapid development of the industry, the organic combination of research and development and production, laboratory medicine, and clinical needs is becoming increasingly crucial. In order to further explore the hot issues in the IVD industry, reflect new progress, exchange new ideas, and build an exchange platform for research and development and production, clinical testing, and industry supervision, this special issue has planned a "series of reports on hot issues in the IVD industry". We hope that everyone can use this open window and publicity platform to offer suggestions for the development of the industry.

　　On April 27, the "First National Conference on Clinical Laboratory Equipment and Applications and the National Clinical Laboratory Equipment Exhibition" was held at the Ningbo International Convention and Exhibition Center. Professor Cong Yulong, director of the Clinical Laboratory Equipment Technology Professional Committee of the Chinese Medical Equipment Association and professor of the General Hospital of the People's Liberation Army, pointed out that the current life sciences are showing a trend of multiple breakthroughs and cross-convergence, and the standardization, standardization, and internationalization management concepts of medical laboratories are increasingly recognized by the industry. All of this is fostering the arrival of the "big testing" era.

　　Professor Cong Yulong gave a detailed explanation in this newspaper's exclusive interview regarding the concept of "big testing", the new changes in China's clinical laboratory equipment, especially the IVD industry, and the important significance of promoting appropriate testing equipment technology.

　　Reporter: What is the "big testing" model, and what categories does it involve?

　　Cong Yulong: "Big testing" is a new scientific, systematic, and integrated development concept formed based on the internal connections and laws of mutual dependence and mutual promotion among the IVD industry, laboratory diagnostics, and clinical treatment, and according to their respective scopes and roles. Its elements can be divided into the detection system research and development 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 the laboratory to develop; without the laboratory actively promoting the use of new technologies, there is no market for IVD products; without the clinical department's needs for the laboratory department, even the best medical laboratory is useless. Therefore, only by establishing a production, education, research, and application platform and making it closely integrated and mutually promoting can synergistic development be achieved. In the past 10 years, academic and exhibition activities in China's laboratory medicine field have been exceptionally active, and new theories, technologies, methods, and equipment have emerged continuously, which can be regarded as a concrete manifestation of "big testing". It is believed that as the "big testing" model is increasingly recognized by more and more industry professionals, it will surely 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 age" of rapid development of laboratory medicine in China. Looking back at the changes over these 30 years, laboratory medicine has shown four major development trends: automation, bedside, molecular, and personalization. The automated mode, characterized 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 blood cell analyzer, which is the most widely used and fastest-developing instrument in routine blood analysis, can provide diagnostic indicators such as red blood cell volume distribution width (RDW), which is used for the differential diagnosis of anemia, and mean platelet volume (MPV), which is used for the analysis of the causes of thrombocytopenia, which cannot be obtained by traditional manual methods. Machine vision recognition technology, which has been introduced in recent years, uses machines to replace human eyes for measurement and judgment, can assist or even replace human work, and has brought cell morphology testing into a new stage. Nowadays, medical activities have expanded from hospitals to communities and homes. Medical personnel urgently need convenient and easy-to-operate testing equipment. Point-of-care testing (POCT), as a rapid analytical technology that can be performed at the patient's bedside, has great development potential due to its characteristics of being fast, simple, efficient, low cost, short cycle, and small sample volume. This sub-sector has seen rapid testing technologies and products such as colloidal gold immunomarking, immunochromatography, immunospot filtration, dry chemistry technology, biological and chemical sensors, and biochips. In addition, the rapid development of genomics, proteomics, metabolomics, and bioinformatics has brought revolutionary changes to laboratory medicine. Various advanced electrophoresis equipment has been introduced into routine testing, polymerase chain reaction (PCR) technology has shifted from qualitative to quantitative, and various in-vitro gene amplification technologies, such as ligation chain reaction (LCR), strand displacement amplification system (SDA), and transcription amplification system (TAS), are moving from research to clinical applications. The emergence of chips has ushered in a new stage for DNA testing and proteomics analysis, mass spectrometry technology is gradually entering routine testing, improving the level of microbial testing, and its use in protein analysis has made progress in early tumor diagnosis, providing 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, there are still problems such as duplicate checks and large combination checks in the field of medical testing. What suggestions do you have for this?

　　Cong Yulong: In recent years, China has made significant achievements in its healthcare undertakings, but in the face of new situations and problems, health reform and development still face severe challenges. At present, some public hospital laboratories do indeed have a phenomenon of focusing on economic benefits due to the influence of the past system. Some laboratories conduct multiple-item combination tests on patients, including hematology, biochemistry, and immunology, regardless of whether the condition requires it. They may even repeatedly test patients who have been clearly diagnosed or who have undergone surgery. Some hospitals use high-cost items with unproven clinical value as routine items or combinations, increasing the burden on patients. For example, many hospitals use the chemiluminescence method to replace the enzyme immunoassay method for hepatitis B pathogen testing (commonly known as the "two pairs and a half" method) as a routine test for monitoring hepatitis B treatment and charge a separate price, which is inappropriate. The "two pairs and a half" method has been used for more than 30 years. After continuous improvement and refinement, its testing quality can meet clinical requirements, and the test cost and charges are low. It can be used as "appropriate technology" for physical examinations, admission examinations, and pre-operative screening. Blind multiple-item combination tests that ignore test results and lack evidence-based medical basis should be stopped. It should be noted that the 11th meeting of the Central Leading Group for Comprehensively Deepening Reforms this year emphasized the need to build a medical service system and tiered diagnosis and treatment medical system with reasonable layout and division of labor. In the 2015 national video and telephone conference on deepening medical and health system reform, which was held on April 29, Premier Li Keqiang made an important instruction, requiring firm adherence to the basic principles of ensuring the basic, strengthening the grassroots, and establishing the mechanism, starting from the standpoint of fairness and accessibility and benefitting the masses, adhering to the "three medical linkages" of medical insurance, pharmaceuticals, and medical treatment, and achieving greater effectiveness in facilitating the masses' medical treatment and reducing the burden of medical treatment and medication. This puts forward new requirements for laboratory medicine and the IVD industry. At present, hospitals urgently need to change the practice of pursuing high-end, sophisticated, and cutting-edge technological equipment, reasonably allocate and apply laboratory technology equipment, further reduce the burden on patients, and production enterprises should also pay more attention to the needs of grassroots level and develop laboratory medical equipment suitable for grassroots use, so as to guarantee and improve the grassroots medical diagnosis and treatment capabilities.

Source: Medical Devices Network