Release date: 2007-12-20
China's self-developed patented product protein chip technology The incidence of autoimmune diseases in China has increased year by year. Early diagnosis and detection is particularly important. The microarray enzyme-linked immunosorbent assay, a patented protein chip technology developed by China, is available for more than one hour. The results of the detection of the traditional reagents for many hours are obtained.
How to quickly and accurately obtain six specific autoantibody indicators related to autoimmune diseases, China's self-developed protein chip product "autoimmune disease antibody spectrum diagnostic kit (microarray enzyme-linked immunosorbent assay)" in clinical A loud answer was made! Dr. Feng Feng, deputy general manager of Beijing Huada Jibi Biotechnology Co., Ltd. told reporters in December: A few months ago, the product was sent to a hospital in Beijing for clinical verification. The hospital was not interested in it and thought that the protein chip was highly sophisticated. Technology, only used in scientific research, has not been used in clinical practice. After a few days of hospital comparison test, I eagerly called: "If you take the article, you can quickly send the product, it can save our hearts." They used to test dozens of patient samples every day, one indicator Do routine inspections, from morning to night, and use protein chip technology in less than half a day.
Recently, the product has obtained the market access approval from the State Food and Drug Administration. "In China, about 500,000 people have systemic autoimmune diseases every year. The demand for early detection and diagnosis is increasing, and the dosage of reagents is increasing at a rate of 10%-15% per year. The domestic antibody-related autoantibody test kits are all imported reagents, and Lack of standardization and uniform standards, and sensitivity and specificity are not conducive to the early diagnosis of the disease.†Talking about the research and development of protein chips, Dr. Feng Feng has a lot of emotions. “The SARS fever clinic also gave us inspiration. The body temperature of the examiner is more than 38 °C, but the common respiratory diseases, such as influenza, respiratory syncytium, adenovirus and other infections can cause fever symptoms; if the differential diagnosis can quickly and one-time reaction results, it can be greatly avoided Waste of resources and cross-infection, such testing technology is urgently needed in clinical practice." In this regard, Huada Jibi has set up a special R&D department to jointly tackle the problem with Beijing Huada Gene Research Center. They borrowed the concept of DNA chips widely used in the field of genomics; combined with clinically commonly used enzyme-linked immunosorbent technology, they successfully developed the crystallization of chip technology and ELISA technology - microarray enzyme-linked immunosorbent technology.
The technology has the characteristics of high throughput, low cost, high parallelism and miniaturization of chip technology on the basis of maintaining the mature, convenient and high degree of automation of ELISA methodology. In clinical diagnosis, a single sample can be tested for multiple disease indicators at the same time; the sample amount is small; the sensitivity and reliability are higher; the detection cost is low, and the degree of automation is high; After three years of research, based on the enzyme-linked immunosorbent assay technology and microarray technology, the subject finally formed a new generation of detection technology system--microarray enzyme-linked immunosorbent technology, and established a protein chip technology platform.
In September 2006, the ENA antibody profiling kit for autoimmune diseases (microarray enzyme-linked immunosorbent assay) was successfully developed and qualified by the National Institute for the Control of Pharmaceutical and Biological Products. Recently, it obtained market access from the State Food and Drug Administration. Approval. According to the introduction, it is necessary to obtain 6 routine detection indexes of the human body. The traditional ELISA has a 1-2 hour experiment, and only one result per hole is needed, which takes more than 10 hours. The protein chip technology can obtain up to 24 results per hole in one test. In other words, it only takes 1 hour for more than 1 time. The advent of protein chips has been recognized by domestic experts and called it a "good assistant for clinical diagnosis." Clinically, it can simultaneously detect six specific autoantibodies related to autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease, Sjogren's syndrome, systemic sclerosis, polymyositis/dermatomyositis.
Experts said that the early diagnosis rate of autoimmune diseases can improve the patient's disease control rate, reduce the occurrence of serious complications, and improve the quality of life of patients. After identification, protein chip technology is in the international leading position, with good social benefits and broad application prospects. A foreign media reported that protein chip detection technology has unparalleled advantages in rapid detection and multi-project joint detection, and it will lead the technological revolution in the in vitro diagnostic reagent industry. The reporter learned that Huada Jibi has been committed to the research and development, production and sales of diagnostic reagents for more than 10 years, and provides various services in the fields of molecular biology and medicine. The main products have occupied 10%-20% market share. . The company undertakes major scientific research projects such as the National “Ninth Five-Year Plan†and the National 863; in 1995, 1999, 2003, and 2006, it successfully developed related diagnostic technologies and products such as AIDS, syphilis, SARS, and protein chips, and was recognized by the national leaders. Highly praised by the leaders of relevant state ministries! The breakthrough in protein chip technology is another leap in clinical diagnostic technology based on their exploration of genomics.
At present, they use the protein chip technology platform to target diseases such as tuberculosis, tumor markers, HPV and other disease-related detection products, so that protein chips can quickly enter clinical applications.
——Shanghai Medical Device Industry Association
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