Graded diagnosis and treatment, the next golden age to open in vitro diagnosis!



At present, China's medical reform has entered a new era of comprehensive implementation and deepening of various measures. In order to break through the deep-water period of medical reform and solve the current situation of difficult medical treatment for the people, the establishment of a graded diagnosis and treatment system has been placed in the first place in the medical reform by the state. On February 11th, News Network introduced the progress of the reform of graded diagnosis and treatment with the theme of “Thirteen Five-Years” medical reform planning and drawing a healthy Chinese blueprint. With the establishment of a grading diagnosis and treatment system, the in vitro diagnostic industry will also usher in the next golden age.

Graded diagnosis and treatment means that according to the priority of the disease, different diseases are treated in different levels of hospitals, and the pattern of “primary diagnosis, two-way referral, rapid division and treatment, and up and down linkage” is formed between large and small hospitals. This year (2017) will conduct pilot medical treatment trials in more than 85% of cities and towns to promote the sinking of medical resources and rationally divert patients. During the “Thirteenth Five-Year Plan” period, 11 provinces including Jiangsu, Anhui, Fujian and Qinghai carried out comprehensive medical reform pilots.

With the establishment of grading medical treatment, it will bring new investment prospects to related fields such as POCT and third-party testing.


From the perspective of global development, POCT is undoubtedly one of the hot developments in the in vitro diagnostic industry. According to data released by the China Investment Consultant, the global POCT market is large and growing steadily. The global POCT market has grown from $9.38 billion in 2011 to $15.87 billion in 2018, doubling in 10 years, with a compound annual growth rate of 7.5%. In the global POCT market, developed countries in Europe and America account for 80% of the market share, and Asia accounts for about 15% of the POCT market.

China's POCT market is in the early stage of development. Due to the huge population base and the change of health concept, coupled with the support of policies, the growth rate of China's POCT market is much higher than the global level. In 2008, the size of China's POCT market was about 330 million US dollars. By 2018, China's POCT market will reach 860 million US dollars, a year-on-year increase of 2.5 times, and an average annual compound growth rate of 13.5%.

With the continuous advancement of grading diagnosis and treatment, the development of POCT industry in China has also undergone some changes. In recent years, POCT detection technology has been gradually carried out in community health institutions, in public health services such as disease prevention and control, physical examination screening, and common diseases. And the role of primary and secondary care services, chronic disease management and follow-up grading assessment management. The detection service under the grading diagnosis and treatment mode sinks to the grassroots level, which can promote the development of various POCT segments and greatly increase the demand space for POCT products. At the same time, some of the routine testing items that are cumbersome and time-consuming in large hospitals will be replaced by POCT.

In the future, POCT will show the characteristics of diversification, wide-ranging demand and networking, and PTCT technology will gradually change from qualitative to quantitative.

The graded diagnosis and treatment will bring greater development opportunities to POCT, mainly in four aspects:

First, the development opportunities of POCT in tertiary hospitals: the implementation of the graded diagnosis and treatment system, the third-level hospitals will have patients diverted downwards, the quality of disease types will increase, the number of diseases will decrease, and the number of test specimens will be greatly reduced. The existing fully automated assembly line and workstation-style large inspection platform will gradually disappear. The POCT and the regional inspection and inspection center came into being. Specimens in the hospital: POCT is very useful in emergency department, anesthesiology department, ICU, cardiac interventional catheter room, nerve interventional catheter room, internal medicine ward, surgical ward, etc. The rest of the specimens can be undertaken by regional inspection centers.

Second, the development opportunities of POCT in hospitals below the second level: POCT plus conventional domestic testing equipment can meet the needs, and the rest are basically the same as tertiary hospitals.

Third, the development opportunities of POCT in community health service stations or centers: the number of POCTs from cold to hot, common diseases, frequently-occurring diseases, and chronic diseases has increased significantly.

Fourth, the development opportunities of POCT in family and individualized diagnosis and treatment: Internet + - POCT + mobile medical in the family and individualized health management, disease prevention and control, chronic disease management and other aspects of the development opportunities.

Third party medical examination

The purpose of grading medical treatment is to solve the problem of difficult medical treatment. However, due to the lack of medical resources such as funds and talents, primary medical institutions cannot meet the needs at this stage. This third-party medical test will be a powerful complement to medical institutions. The State Council also clearly stated in the 'Guiding Opinions on Promoting the Construction of Graded Diagnosis and Treatment System': 'Exploring and setting up independent regional medical inspection institutions and pathological diagnosis institutions to achieve regional resource sharing. Strengthen medical quality control and promote mutual recognition of inspection results between medical institutions at the same level and between medical institutions and independent inspection and inspection agencies.'

At present, in China's clinical testing projects, only about 5% of the inspection projects are undertaken by third-party inspection agencies, and 95% of the inspection business is still completed in the hospital inspection department. In developed countries such as Europe, America and Japan, independent laboratories have occupied one-third of the clinical testing market.

It can be determined that with the continuous expansion of clinical testing service needs of medical institutions at all levels in the future, and the sinking of medical institutions, the development of third-party medical testing services will enter the fast lane. The expansion of new markets will greatly promote the development of the in vitro diagnostic industry. In addition, it is understood that there are more than 1,000 projects in vitro diagnosis in China. There are almost 4,000 items in the United States, and there are 3,000 medical items that have not been landed. It may also be realized through third-party inspection agencies.

For the grassroots community, the model of third-party medical testing, including the regional inspection center, has been very successful abroad. The hospital only needs to keep the emergency part of the testing project, and other non-emergency projects are entrusted to the third-party service organization. This mode has several advantages:

First, reduce hospital costs, improve service levels, do not need to repeatedly purchase and manage medical equipment in each hospital, and the people do not have to queue up for inspections in large hospitals;

Second, regional resource sharing, reducing duplication of inspections, an inspection report of ordinary people can be shared in all hospitals in the same city, mutual recognition of inspection results, the same indicators to avoid repeated inspections, saving medical insurance expenditures, convenient for the public to seek medical treatment;

Third, shorten the inspection cycle and reduce the inspection cost. Many inspection projects in hospitals, especially in primary hospitals, take more than a week to produce results. The reason is that there are too few samples, and it is necessary to accumulate enough sample quantities to perform the test, otherwise it will cause reagents and Waste of supplies. Concentrating samples from a certain area into regional inspection centers will reduce the cycle and cost;

Fourth, the county hospitals have greatly improved their professionalism through the centralized examination of the medical association model;

Fifth, the inspection center has independent accounting, the economic benefits have increased, and the income of the laboratory doctors has increased substantially.