Immunoassay Manufacturing and Lot Management R1

Immunoassay Manufacturing and Lot Management at Rules-Based Medicine, a Q² Solutions Company (formerly Myriad RBM)

The key to RBM’s success as the world’s leading multiplexed biomarker testing laboratory, is our ability to internally develop and manufacture our own immunoassays.  Building our own assays minimizes lot to lot variation as compared to the commercially available kits on the market.  A complete immunoassay kit manufactured at RBM includes conjugated antibodies, blocking buffer, three levels of controls, and a prepared standard solution that provides an eight-point standard curve.  Our multiplexed Luminex xMAP^® and ultrasensitive Quanterix Simoa^™ assays are used exclusively in our service business and are validated according to CLSI guidelines.

Quality raw materials, extensive kit qualification, and a tightly controlled manufacturing process allow us to deliver consistent results over time.  These aspects make our immunoassays and testing services the best choice for protein biomarker quantification to accompany for long term studies.