Another stick of the father of hepatitis B vaccine: high quality POCT

One of the founders of the modern biotechnology industry, Dr. William J. Rutter, the founder of American Relais Biotechnology and a member of the American Academy of Sciences, was invited to visit China many times and cooperated with the Chinese Academy of Sciences to speak out in the exchange of China's POCT industry construction process: As a bedside rapid inspection system, the high accuracy and accuracy of POCT directly determines the accuracy and reliability of the test results, and is crucial for the timely and effective diagnosis and treatment of patients.

Another stick of the father of hepatitis B vaccine: high quality POCT

High quality products are an important guarantee for the sustainable development of the industry

Dr. William J. Rutter has led his research and development team for many years, with a strong commitment to science and rigor, focusing on research and development. Chiron, founded in 1981, eventually became one of the top five international vaccine companies and was incorporated into Novartis in 2005 with a valuation of $5.1 billion. Dr. William J. Rutter first developed the hepatitis B vaccine using DNA recombination technology. In 1987, he first discovered and cloned the hepatitis C virus HCV, which laid a good foundation for the development of highly sensitive virus detection reagents, vaccines and therapeutic drugs. .

For the development of the POCT industry in China, Dr. William J. Rutter pointed out that high precision and accuracy are important performances of POCT quality. The smaller the coefficient of variation in the test, the higher the accuracy of the product. The accuracy and accuracy of POCT not only affect the correct diagnosis and judgment of the disease, but may even affect the life of the patient. For example, patients with acute myocardial infarction have only a few hours of treatment window. If the accuracy and accuracy of the POT test item cTnI is high, false negative results can be avoided, thus ensuring timely disease intervention and saving the patient's life. Therefore, the high accuracy and accuracy of POCT are very important in practical applications. It can improve the immediate detection efficiency of POCT and verify the accuracy. It is an important basis for accurate diagnosis of patients' condition. At present, the world attaches great importance to the high precision and accuracy of POCT quality. High-quality products and services are the driving force behind the sustainable development of the industry. Whether the POCT industry is to continue to develop in China or the world, it is necessary to pay attention to the accuracy and accuracy of POCT products.

Professional focus on improving POCT real-time detection stable and effective

ReLIA Diagnostics, headquartered in Silicon Valley, Calif., and its wholly-owned company in China, Rayleigh Bio, share the world's leading technology resources and have an advanced management team. Under the leadership of the founder Dr. William J. Rutter, the professional management team gathers high-tech talents from all over the world, covering medical and bioengineering technology research and development, high-tech industrialization and intellectual property. More importantly, Dr. Rutter has implemented the high quality requirements and concepts of Chiron's R&D and product manufacturing in his medical diagnostics industry, and has been well implemented and practiced in the development of Relais Bio. .

As one of the earliest American companies to enter the Chinese POCT industry, Rayleigh Bio's research and development of POCT products combined with China's national conditions, according to the characteristics of China's high cardiovascular disease and kidney damage. It has been devoted to the development of POCT for immediate detection technology and products in heart and kidney disease for several years. The self-developed ReLIA inspection system is in sync with the important development trend of the 21st century world medical laboratory. It is the first POCT technology system with many international independent intellectual property rights in China. Its core patented technology two-way lateral flow immunity technology and far-infrared fluorescence immuno-immunization technology have the advantages of “fast, simple, whole blood, quantitative detection”, etc. The inspection system greatly improves the accuracy and accuracy of POCT product detection, which can be short. Complete the test within the time, analyze the data and give a quantitative report, which provides a great guarantee for the patient to find the disease in time and obtain effective treatment. Taking heart failure or myocardial infarction as an example, Rayleigh Bio POCT can obtain results of multiple cardiac markers such as NT-proBNP, Myo, cTn-I within 8-15 minutes, while traditional laboratory tests require 0.5 to 2 Hours. Ruilai Bio's POCT products have been widely used in the domestic market for nearly ten years and have been highly evaluated and recognized by the market.

Scientific rigorously achieves the ultimate in accuracy and accuracy of POCT

Ruilai Bio has technical design and stable and reliable quality assurance system in line with international standards. Implement Q+ quality certification for suppliers and optimize supplier quality management system. For example, in the selection of raw materials, efforts have been made to compare the products of many internationally renowned antibody suppliers in terms of product specificity, sensitivity, and repeatability, so as to screen out the highest quality antibodies and other core materials in the world. Using the rigorous technical means to create the world's top POCT products.

In the research and development of new products, Ruilai Bio has mature and perfect product development certification process and expert team. It has been committed to the research and development of high quality POCT products for many years. After repeated experiments and clinical practice, we have selected the best and ensured the quality control of the products at the design source.

Reliance Bio uses production equipment components that meet US standards and has a complete component certification process, from component introduction, reliability test testing to problem improvement, ensuring component quality throughout the process.

The Ruilai team has a professional quality control center. After the development of POCT, there will be professionals who have been working on the product for a few months, and for several years, repeated verification, exploration and comparison to adjust the product to achieve the best stability.

In production, Ruilai Bio has a world-class R&D and production base. Its 100,000-class cGMP standard clean plant and production and quality management system are fully implemented in accordance with cGMP, ISO13485 and EU CE-MARK standards.

It is worth mentioning that Ruilai Bio's three myocardial detection indicators (cTnI, Myoglobin, CK-MB) and heart failure marker reagent NT-proBNP participated in the inter-room quality assessment of the Ministry of Health for three consecutive years and obtained 100 % passed the score.

Dr. William J. Rutter said: "The development of POCT has become more global. Compared with the various POCT products that are generated by the current marketization effects, we are more focused on the improvement of product quality and the stability of real-time detection. We are committed to truly medical care at all levels. Institutions and the general public provide instant, accurate and accurate inspection services."

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