BEIJING APIS BIOTECHNOLOGY CO., LTD
The development of POCT industry in the world
POCT is an emerging segment of IVD, which consists of point (location, time), care (health care), and testing (test). The definition of POCT abroad has a "test for any medical treatment at the patient's medical site". Therefore, its core element is to meet the rapid diagnosis needs of clinical treatment or home care, and to get reliable diagnosis results quickly and instantly is the ultimate goal.
"2014-2018 years Chinese in vitro diagnostic reagent industry market research and investment trends analysis report" pointed out: as a dynamic category development test, POCT currently can detect a number of indicators, including blood glucose, blood gas, blood coagulation, heart / electrolyte / tumor markers, drug / alcohol detection etc..
For applications, POCT can be divided into two parts: hospital, hospital, including ICU, emergency laboratory, outpatient department, etc. With the continuous expansion of the scope of POCT applications, such as natural disaster relief, military field, anti terrorist attacks, and so on will also be applied to POCT.
POCT can effectively reduce the diagnosis turnover time (TAT) and obtain reliable diagnostic results by reducing a large number of operations. Relying on its advantages such as portability and quick response, POCT has only retained the core of the diagnostic "sampling analysis quality control output" step, so as to provide a time guarantee for patients to get reasonable treatment in the best time window.
Taking heart failure or myocardial infarction diagnosis as an example, POCT detection can get BNP, Myo, cTn-I and other cardiac markers within 15 minutes, while the traditional laboratory test takes 1 to 2 hours. The confirmation of the key clinical indicators in the early stage of the disease is crucial to the effective treatment of the patients, and the advantage of POCT can satisfy this need.
Characteristics of POCT detection
At the same time, POCT has great advantages in the amount of sample, the type of sample, the convenience of the reagent, the operator's request and so on. The Abbott classic i-STAT as an example, only need to complete the blood gas, electrolyte, cardiac marker detection, blood biochemical indexes of 65-95 microliters of blood can be important in 2 minutes; very low sample amount so that the POCT has a huge advantage in the pediatric field, and no need to use blood anticoagulant treatment, avoid the influence of the detection results.
Therefore, based on the performance advantages of POCT, which is different from traditional inspection methods, it can meet the fast and real-time inspection needs and become one of the booming sub industries in the IVD industry.
With the advantages of fast and convenient and emerging technologies, POCT has become a fast growing blue ocean in the IVD field. Even in the mature markets of Europe and America, it has maintained steady growth. The origin of POCT since 1995, held in California, AACC is the clinical chemistry annual meeting exhibition, opened a special exhibition of POCT; the same year the National Committee for clinical laboratory standards: AST2-P file, the guide for inspection of bedside in vitro diagnostics, puts forward the concept of POCT, POCT standard.
The development of POCT
After nearly 20 years of development, the US supervision of POCT is relatively mature, which is jointly organized by the certification authority, the POCT Committee and the POCT coordinator, and is supervised by FDA. Now POCT has been accepted and applied by many other countries, such as Britain and Germany, and so on.
POCT national regulation and regulation
At present, the POCT market accounts for about 30% of the market capacity of the whole in vitro diagnosis industry, of which about 19% of the blood glucose detection OTC, and the other POCT test other than blood sugar accounting for about 12%. This is mainly due to the high technical maturity and patient basis of blood glucose testing, which has become the largest POCT test project.
At present, the global POCT market is dominated by transnational giants. Among them, Johnson and Roche are leading in the field of blood glucose. Alere, Abbott and others are leading in the areas of blood gas and cardiac markers. With the growth of downstream demand and the maturity of technology development, POCT has also differentiated in every subdivision area. The proportion of blood glucose has been decreasing gradually, and the proportion of cardiac markers, infectious diseases and hemagglutination has increased gradually, which indicates that its growth rate is higher than that of POCT.
EastCoast Bio China officially became a dealer of blood