The company has successfully developed an anti-nuclear antibody (ANA) test kit.
Release time：2015.09.11
The research team, composed of personnel from the company's New Technology Department, Drug Department, and the subsidiary Zhongshan Ruifu, after more than two years of dedicated research and scientific breakthroughs, has finally developed the anti-nuclear antibody spectrum (IgG) detection kit (immunoblotting method), which has obtained the registration certificate approval from the Guangdong Provincial Food and Drug Administration. The launch of this product effectively enriches the company's product line.
The successfully developed anti-nuclear antibody spectrum (IgG) detection kit can be used for in vitro qualitative detection of 15 different antigen IgG antibodies in human serum or plasma, including anti-nRNP/Sm, Sm, SSA, Ro52, SSB, Scl-70, PM-Scl, Jo-1, CENPB, PCNA, dsDNA, nucleosome, histone, ribosomal P protein, and AMAM2. By segmentally coating and assembling different antigens, each immunoblot membrane strip is fixed with 15 ANA antigens and 1 quality control antigen, allowing parallel detection of 15 ANA antibodies. This enables one-step screening and typing of ANA, with rapid and convenient detection, high sensitivity, and simultaneous screening for diseases such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome (SS), neonatal lupus erythematosus (NLE), systemic sclerosis (SSc), polymyositis/dermatomyositis, overlap syndrome, and primary biliary cirrhosis.
To further subdivide and meet different customer needs, the company's R&D team, based on the ANA 15-item immunoblotting kit, optimized and combined indicators according to different screening focuses, and also developed ANA 12-item and ANA 7-item kits respectively.
Currently, the company's R&D team is working closely with production and quality personnel from Zhongshan Ruifu and has successfully completed the production transfer of the kit. With the active cooperation of the company's marketing department, high-standard internal testing and evaluation have been conducted: by synchronously comparing this product with several mainstream market brand kits, good test results have been achieved. Especially encouraging is that the product has already begun trial use in more than ten hospitals nationwide, showing significant clinical effects and positive customer feedback. This undoubtedly lays a solid foundation for the product to enter the market more quickly and comprehensively, bringing benefits to a wide range of autoimmune disease patients.
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