In vitro diagnosis is abbreviated as IVD, which is an important part of the prevention and treatment of diseases. Internationally, IVD, as an independent branch of medical devices, has its own unique definition and regulatory system, especially the United States (FDA) and the European Union (EC). Internationally common IVD concepts mainly include medical devices, in vitro diagnostic reagents and medicines. However, the situation in China is different. IVD is not independently differentiated and defined, that is, there is no concept of IVD. Except for blood source screening and the use of radionuclide markers to be defined in vitro TA detection reagents for drug management, all other IVDs The products are all under the medical device (MD).
Since 2015, the compound annual growth rate of the domestic in vitro diagnostic market has been maintained at more than 15%, and successfully exceeded 90 billion yuan in 2019. Since 2020, affected by the epidemic, the market has grown rapidly and has reached 1,000 yuan. With a scale of 100 million yuan, the development space is very broad.
It is worth mentioning that because IVD belongs to a high-tech industry, it has the characteristics of intensive high-tech application, extensive interdisciplinary, and technological integration. The early domestic technology and product quality are far behind foreign products, and they are mainly based on learning and imitating foreign products. Mainly, this also makes China's IVD industry not have a high share of the global market. In recent years, with the development and growth of the domestic IVD industry and technological innovation, the industry is in a critical period of rapid development, and the pace of domestic substitution has accelerated. According to statistics, in 2019, the State Food and Drug Administration approved and registered a total of 524 domestic IVD products and imported IVD products, including 352 domestic IVD products and 172 imported IVD products. Import substitution has increased significantly.
At present, although most domestic IVD products are still in the low-end market in the field of immunodiagnosis and molecular diagnosis, some high-end products such as high-throughput automatic biochemical analyzer, automatic chemiluminescence, real-time PCR, smart POCT, etc. have also started domestic production. The road of transformation will further meet the new domestic medical needs.
automatic biochemical analyzer is one of the most popular products in the field of in vitro diagnostics in recent years. It is an instrument that measures a specific chemical composition in body fluids based on the principle of photoelectric colorimetry. Because of its fast measurement speed, high accuracy, and small consumption of reagents, it has now been widely used in hospitals, epidemic prevention stations, and family planning service stations at all levels, and its combined use can greatly improve the efficiency and benefits of routine biochemical inspections.
In order to help the localization of fully automatic biochemical analyzer products, the related companies behind it are also silently making efforts and contributions. For example, the centrifuge belongs to a module in the automatic biochemical analyzer, and through the matching combination, it becomes an in vitro diagnostic automatic biochemical analyzer. In recent years, domestic centrifuge companies are also speeding up their research to help the development of domestic fully automatic biochemical analyzers.
Recently, Shanghai Lu Xiangyi Centrifuge Instrument Co., Ltd. (hereinafter referred to as Shanghai Lu Xiangyi) has shipped a batch of automatic positioning centrifuges, which will cooperate with customers to complete third-party testing and be used for IVD-related medical device license review. At present, Shanghai Lu Xiangyi has customized a number of domestic leading companies in the industry to provide reliable automatic positioning centrifuges for the overall solution of in vitro diagnostics.
According to the data, Shanghai Lu Xiangyi is a Chinese centrifuge company that has been certified by the US FDA. It has a history of more than 40 years. The company adheres to the "customer first" loyal service tenet and pursues "continuous innovation and facing the future". The goal is that its centrifuges have won the recognition and praise of the majority of users with reliable quality and service. At present, it has established a stable technical cooperation relationship with many domestic universities, hospitals, petrochemicals, pharmaceutical companies, food companies, high-tech companies and scientific research units. At the same time, Shanghai Lu Xiangyi's products are also continuously going to overseas markets, and continue to contribute to the high-quality development of the instrument industry!
