In vitro diagnostic immune kits, especially innovative products, have the long process of development with highly exploratory and many influencing factors, involve many key technologies and require high research capabilities, such as determination of antibody target molecules. The preparation of antigens, screening of high-affinity and high-specific antibodies, the construction of diagnostic kits and clinical evaluation are all key aspects of the development of diagnostic kits. Our company has complete protein expression systems and antibody development platform to carry out the assay kit development in the form of project entrustment.
1. Development of diagnostic reagents and antibody raw materials
The use of innovative target protein gene immunization combined with natural protein screening strategies to prepare high-affinity, high-specificity, monoclonal antibody pairs that can be used in diagnostic kits.
2. Construction of detection method and kit process design and optimization
On the basis of obtaining the antibody raw materials, the target antigen immunoassay system was constructed. Then, according to the different characteristics of chemiluminescence, colloidal gold immunochromatography and enzyme-linked immunosorbent assay, the production process of the corresponding kits was designed and the parameters were optimized. Determine the kit's detection sensitivity, linear range, intra-batch / stability and other important indicators.
3. Small-scale pre-clinical evaluation of the kit
Small-scale pre-clinical evaluation is carried out for the kit, and its sensitivity, specificity, accuracy and other indicators are tested to determine its clinical test for the target protein.
Leading time and Quotation：
For different projects, the leading time is different. Please inquiry!
1. Complete protein expression systems and antibody discoveryt
2. Years of protein and antibody development experience
3. Comprehensive technical services, AtaGenix can provide technical services from gene synthesis, vector construction, protein expression and purification, antibody preparation, antibody screening, antibody pairing, kit production process optimization.
Diagnostic reagents and assay kit development
Tel: 0086-27-8743 3958