European and American markets POCT product features and development

1, Europe and the United States POCT market characteristics:

Europe and the United States POCT products are mainly used in clinics, pharmacies, medical emergency and patient home monitoring. Compared to the domestic market, POCT in the medical market has become one of the fastest growing branches in the medical field in Europe and the United States, with the annual growth rate of 10-12%. Its POCT test products mainly focus on blood sugar, blood gas / electrolyte, blood coagulation, infectious diseases, pregnancy indicators, cardiovascular, cancer, drugs and some other market segments. Among them, blood glucose is the largest market in POCT, and myocardial markers are the fastest growing areas. The traditional gold standard qualitative analysis techniques still occupy a place in Europe and the United States POCT, mainly in the detection of pregnancy, drugs, and pathogen antibodies. With the epidemic and outbreak of some tropical viruses, some new virus antibody detection projects such as dengue virus Zika virus.

2, Europe and the United States POCT product development:

With the development of detection technology, European and American POCT products also experienced its own development path. The first generation of POCT detection products are mainly chromatographic or diafiltration qualitative detection, for common biochemical indicators and easily detectable macromolecular antibodies. As technology advances, the second generation of POCT products have been developed for the detection of more complex biomarkers using microfluidic, microelectronic and microarray nucleic acid assays. For example: CD4 + cell count, drug-resistant TB and HIV viral load testing. After entering the third generation of POCT, up to dozens of markers can be detected simultaneously on a single protein chip, and the application fields are extended to nucleic acid sequencing and protein analysis. Its products also tend to serialization, miniaturization and home use, and even appeared without the instrument directly through the test card to complete quantitative analysis, or through the phone to complete testing, Bluetooth or wireless data transmission.

Overall, the target markets for the development of POCT products in Europe and the United States are mainly focused on clinics, medical emergencies and home use. Therefore, the single "single serving" is the main target market and the single testing time is relatively long. Taking the Abbott iSTAT and Roche Cobas h232 with high market share in Europe and the United States as examples, these hand-held devices are compact and light in weight. They cover a wide range of test items and are suitable for single-person measurement. The average test time is about 10-15 minutes. Therefore, these products have entered the Chinese POCT market with the major laboratories of large medical institutions as the main application scene, and their effects have been limited to some extent.

China POCT market, product features and development

China POCT market characteristics:

POCT products are mainly divided into two types: Home-based POCT and Hospital-based POCT. Our country is mainly based on the medical POCT model, and the medical departments at all levels are the main applications of the POCT products. In particular, Examination Kemen emergency window. China's huge population base and the characteristics of its medical system have caused overcrowding in most medical institutions. Some imported POCT products have experienced the problem of "low flux and slow speed" after they have entered China. As a result, the POCT industry in China has opened up a path of growth independent of that in Europe and the United States , And integrate the concept and technology of "Internet +" to gradually explore a new generation of intelligent POCT that suits the characteristics of China's medical scene.

2, China POCT product development stage: Throughout the development of POCT products in China, defined from the technical path, can be roughly divided into five generations. The first generation of "qualitative" products, based on membrane-based gold standard chromatography; the second generation of "manual semi-quantitative", in the first generation based on the increase of colorimetric card for rough semi-quantitative; third-generation "manual quantitative ", Equipped with a reading device, the interpretation of the reaction curve to obtain quantitative results, the main operation is still done by hand; the fourth generation of" semi-automatic quantitative ", in addition to" add samples ", other steps to achieve semi-automatic or fully automatic quantitative detection; the early 21st century, The advent of the fifth generation "iPOCT" is based on the fourth generation of automated quantitative integration of Internet technology, the use of "precision, automation, cloud-based, shared" feature, iPOCT core "Internet POCT" The traditional POCT "low degree of automation, poor accuracy, high cost, low degree of information technology," and other defects, the Chinese POCT industry to iPOCT development path.

3, iPOCT with Chinese characteristics: "Concept first, product upgrade", POCT in China "localization" process, the product has been upgraded to meet the needs of domestic users, along with the new concept of iPOCT developed fifth generation POCT products to " Accurate test, quick experience "features, quickly won the favor in the Chinese market. The concept of "fully automated POCT workstations" uses high-throughput, continuous-cycle autosampler functionality with fast cycle injection. Test samples covering the whole blood, serum, plasma, capillary blood and other types of blood cells can be used to detect the same blood tube specimens on the machine, to complete a number of indicators of primary screening tests to reduce the patient's blood volume, but also to ensure clinical Doctors can get multiple indicators simultaneously on a single report card.

At the same time, iPOCT combines the Internet and big data capabilities to deliver value innovation. Through 3G / 4G or even 5G wireless network, wireless location, near field communication (Near Field Communication, NFC), the instrument and the cloud server wireless Internet. The application of big data and cloud computing provides the foundation for big data analysis of instrument information, realizes the function of "connecting cloud terminals and connecting terminals", realizes the "housekeeping service" of the products through the app, tracks the whole process from the intelligence order to the cold chain logistics system, Reagent quality real-time monitoring, active technology to provide the housekeeper service, to achieve patients, laboratories, manufacturers, intelligent information exchange. Currently, more and more domestic POCT manufacturers are gradually using the internet and big data functions to enhance the service value of their products according to different product positioning.

Looking forward to the development of China's future iPOCT road

1. In the era of "Internet +", China's iPOCT is an inevitable product of the times. It attaches great importance to data and investment data and an endless stream of incremental value will be excavated to promote the development of "precision medicine, smart medicine and great health." At the 4th POCT Industry Development Forum in 2015, Professor Kang Xi-hsiung, Chairman of the POCT Subcommittee in China, said: "With a more appropriate quantitative, interconnected and interoperable system, a guaranteed quality system and standardized procedural management Gradually improve, iPOCT will provide an important basis for the development of precision medicine. "

In June 2017, at the IFCC EUROMEDLAB in Greece, the "artificial intelligence" direction of smart software and POCT-type testing equipment have become more and more closely integrated, and the data sharing has been cloud-based and deepened through the excavation of user needs.

At the same time, the new policy of medical reform promulgated as iPOCT new trend protection. Such as the medical body, grading diagnosis and treatment, strengthening medical assistance and effective urban and rural residents insurance convergence, formed an important part of China's medical security system. A large number of primary medical institutions that are "gatekeepers" based multi-level clinic is the core direction of the majority of "screening" patients with common disease and frequently-occurring disease checks will be achieved in the primary and secondary medical institutions and passed the test The results of mutual recognition, and higher-level medical institutions and patients to achieve information sharing. IPOCT products that are quick and easy to use in this process will find their way.

2, China's next ten years iPOCT product application scenarios:

POCT is the most recent branch of traditional test medicine from the Internet. POCT technology has a high degree of cross-border integration. The demand for interoperability between doctors and patients for test results is strong, making POCT more accessible to the Internet. In China, two different iPOCT product usage scenarios may emerge in the next ten years.

The first category is "SmartMedicine" (POCT + Internet), which is used in the Medical Institutions Laboratory and Central Laboratory Professional iPOCTs and is characterized by "high-throughput, automated, medium-sized, liquid phase" equipment;

The second category is "Mobile Healthcare" (Internet + Pico Smart POCT), a non-specialist iPOCT for home-based or home-based care to enable "instant, immediate, peripheral blood, miniaturization, and even noninvasive Wearable "equipment.

The two different POCT and Internet convergence technology path are the future direction of iPOCT development.