Antigens and hapten conjugates are critical components of IVD diagnostic tests and are necessary to show that a test is both sensitive and specific. They often serve as positive controls for lateral flow tests and ELISA to ensure that a test is working correctly and that the antibodies used detect the molecules of interest. Incorporated for standard curve generation, they provide a reference for determining the concentration of targets of interest.
To be used in IVD test, all components must have exceptional purity and lot-to-lot reproducibility, and in the case of many antigens, may need to retain their function. Leinco Technologies is a leader in the development and manufacturing of antibodies and recombinant proteins for early discovery research and diagnostics. All products from Leinco are manufactured in world-class facilities including in dedicated class 10K cleanrooms. Our manufacturing processes adhere to current Good Manufacturing Practices (cGMP’s) and the ISO 9001:2015 or ISO 13485:2016 quality standards.