China's independent development of patented product protein chip technology

China's independent development of patented product protein chip technology

Release date: 2007-12-20

China has developed a patented protein chip technology that is revolutionizing the early detection of autoimmune diseases. As the incidence of such conditions continues to rise, timely and accurate diagnosis has become increasingly critical. This innovative microarray enzyme-linked immunosorbent assay (ELISA) technology, created in China, offers results in under an hour—significantly faster than traditional methods, which can take several hours. It enables the rapid identification of six key autoantibodies associated with autoimmune diseases, providing a breakthrough in clinical diagnostics.

Dr. Feng Feng, Deputy General Manager of Beijing Huada Jibi Biotechnology Co., Ltd., shared an inspiring story about the technology’s real-world impact. A few months ago, the company sent their product to a hospital in Beijing for testing. Initially, the hospital was skeptical, believing such advanced technology was only suitable for research and not for practical use. However, after just a few days of comparison testing, the hospital became highly enthusiastic. “If you send the product, we can quickly get the results and save our time,” they said excitedly. Previously, the hospital tested dozens of samples daily, one antibody at a time, which took all day. With the protein chip, they could complete the same process in less than half a day.

This technology recently received market approval from the State Food and Drug Administration, marking a major milestone. According to Dr. Feng, more than 500,000 people in China are diagnosed with systemic autoimmune diseases each year, and the demand for early detection is growing rapidly. Traditional reagent-based tests are often imported, leading to inconsistencies in standards, sensitivity, and specificity. The new protein chip technology addresses these issues by offering higher accuracy, lower costs, and greater efficiency.

The development of this technology was inspired by the challenges faced during the SARS outbreak. Rapid and accurate differential diagnosis is essential to avoid unnecessary resource use and reduce the risk of cross-infection. By combining DNA chip concepts with ELISA techniques, Huada Jibi successfully created a powerful diagnostic tool that allows multiple disease markers to be tested simultaneously from a single sample. This high-throughput, miniaturized system improves detection speed, reduces sample volume, and enhances automation.

After three years of research, the company launched a new generation of detection technology known as microarray ELISA. This system not only maintains the reliability of traditional ELISA but also introduces the advantages of chip technology. In clinical settings, it can detect up to 24 results per test, compared to just one result per well in traditional methods. This means the entire process, which once took over 10 hours, now takes less than an hour.

Experts have praised the technology as a valuable tool in clinical diagnosis, calling it a "good assistant" for doctors. It can detect six key autoantibodies related to diseases like lupus, Sjogren’s syndrome, and scleroderma. Early diagnosis significantly improves patient outcomes, reduces complications, and enhances quality of life. Internationally, this innovation is seen as a leading-edge advancement in diagnostic technology, with potential to reshape the in vitro diagnostic industry.

Huada Jibi has been actively involved in developing diagnostic solutions for over a decade, contributing to major national projects such as the “Ninth Five-Year Plan” and the 863 Program. Their breakthroughs in AIDS, syphilis, SARS, and protein chips have earned recognition from both government officials and industry experts. This latest achievement represents another significant step forward in clinical diagnostics, building on their work in genomics and molecular biology.

Currently, the company is expanding its applications of protein chip technology to areas like tuberculosis, tumor markers, and HPV testing, ensuring broader clinical adoption. As the field of diagnostics continues to evolve, China's advancements in this area are setting new global standards.

—Shanghai Medical Device Industry Association

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