Innovation Drives Development, Technology Leads The Future

Shanghai Ruikang Biotechnology Center has a research and management team led by overseas PhDs, adhering to the spirit of "continuous innovation and scaling new heights". It has established a full range of biochemical reagent technology development platforms, a globally leading clinical mass spectrometry technology development platform, and a third-party quality control product technology development platform, leading the market share of its products and ranking first in the domestic clinical testing reagent field. The Technology Center has carried out exchanges and cooperation with well-known domestic and foreign enterprises and universities, worked together to develop a series of innovative and market high economic value diagnostic kits suitable for clinical use, and signed a strategic cooperation agreement with the world's top 500 company "Thermo Fisher". It has also established industry university research cooperation with Ruijin Hospital affiliated with Shanghai Jiao Tong University, and jointly established the "Clinical Mass Spectrometry Co construction Laboratory" with Xuhui District Central Hospital in Shanghai. It has undertaken multiple scientific and technological projects in Shanghai, districts, and Zhangjiang, and has been recognized as a high-tech achievement transformation project in Shanghai.

As of now, a total of 42 intellectual property rights have been obtained, including 23 authorized invention patents, 16 utility model patents, and 3 design patents.

In the future, Shanghai Ruikang Biotechnology will continue to deeply cultivate the field of precision medicine, guided by market development, further enhance its independent innovation capabilities, and research and develop products suitable for precision medicine.

A comprehensive biochemical reagent kit product development platform

We have developed over a hundred testing kit products and obtained a Class II medical device registration certificate. Our products cover glucose metabolism, blood lipids, liver function, kidney function, myocardial enzyme spectrum, pancreatic function, rheumatology, blood gas electrolytes, and more. We have established a leading domestic research platform for latex enhanced immunoturbidimetric reagents and obtained multiple invention patents in the field of "high-sensitivity latex enhanced turbidimetric technology", comprehensively breaking through and improving the nanogram level detection accuracy of reagents, making the stability, sensitivity, linear range, and anti-interference ability of detection kits better. Especially, we have developed a series of diagnostic reagents suitable for clinical applications in tumor markers, reproductive health, and other areas.

  1. Shanghai High-tech Achievement Transformation Project: “Lipoprotein A Test Kit (Latex Enhanced Immunoturbidimetric Method)”; “C-Reactive Protein Test Kit (Latex Enhanced Immunoturbidimetric Method)”; “Anti-cyclic citrullinated peptide antibody test kit (Latex Enhanced Immunoturbidimetric Method)”; “Homocysteine Test Kit (Cyclase Method)”; “Total BileAnti-Cyclic Guanosine Peptide Antibody Test Kit (Latex Enhanced Immunoturbidimetric Assay)”; ‘Homocysteine Test Kit (Circulating Enzyme Method)’; ‘Total Bile Acid Test Kit (Circulating Enzyme Method)’.
  2. Development of anti-endothelin receptor antibody diagnostic kit based on antigenic peptide”, Shanghai Science and Technology Commission, China.

Global Leading Clinical Mass Spectrometry Technology Development Platform

On the liquid chromatography tandem mass spectrometry detection platform, more than 30 products have been developed, covering clinically required lipid soluble vitamin profiles, water-soluble vitamins, steroid hormones, catecholamines and their metabolites, amino acid profiles, bile acid profiles, and TDM drug monitoring. Compared with traditional immunobiochemical methods, the liquid chromatography tandem mass spectrometry detection platform is recognized as a reference method for traditional methods in the industry due to its high accuracy, sensitivity, and simultaneous detection of multiple items with one injection.

The clinical mass spectrometer RZ-500, an ultra-high performance liquid chromatography tandem mass spectrometry detection system with a registration certificate for Class II medical device products of independent brands, and the sample automated pre-processing device AUTOMAN ELITE; Among the more than 30 products developed, 10 have Class II medical device registration certificates, while the rest are Class I registered products. They have all been produced and shipped, and have been put into use in multiple hospitals and third-party laboratories, receiving good feedback from customers.

  1. Clinical Mass Spectrometry Joint Laboratory of Xuhui District Central Hospital in Shanghai

Comprehensive Third-Party Quality Control Product Development Platform

Collaborate with renowned experts and professional laboratories at home and abroad to comprehensively carry out product research and technical services for quality control and standard traceability in the field of IVD, providing leading clinical laboratory quality control solutions and consulting services for medical laboratory quality and capability accreditation (ISO15189). At present, the developed products cover sub fields of in vitro diagnostics such as immunodiagnosis, biochemical diagnostics, and molecular diagnostics.