Application value of recombinant proteins in in vitro diagnostic reagents and supply chain management points

With the development of in vitro diagnostic technology towards high sensitivity, quantification and automation, recombinant proteins have become an important part of the diagnostic raw material system.Compared with naturally extracted proteins, the source is clear, the sequence is clear, the process can be replicated, and it is easier to establish a standardized quality system.Reagent companies introduce suitable recombinant proteins in the methodological development stage, which helps to improve the controllability of raw materials and the efficiency of product iteration.

Primary use in IVD methodology

In immunodiagnostic platforms such as ELISA, chemiluminescence, and lateral chromatography, recombinant proteins can be used as coated antigens, detection antigens, calibrators, or quality controls, and can also be used to prepare monoclonal or polyclonal antibodies to immunogens.For items such as pathogen detection, myocardial markers, inflammatory factors, hormones, and tumor-related markers, recombinant antigens can help identify specific epitopes and reduce the risk of cross-reactivity.Some recombinases, recombinant antibodies, and binding proteins are also used in sample processing, signal amplification, and homogeneous detection systems.In molecular diagnostics, recombinant polymerases, reverse transcriptases, and nucleic acid modifying enzymes are the core raw materials of the reaction system.

How raw material performance affects reagent performance

The sensitivity, specificity and stability of the diagnostic reagent are closely related to the spatial conformation, purity, aggregation ratio and buffer system of the recombinant protein.Incorrect protein folding or masking of key epitopes by tags may result in decreased antibody recognition efficiency; high levels of host protein residues and endotoxins may also increase nonspecific binding.Therefore, raw material development is not only to obtain the target band, but also to control