Cologuard 2.0 Ready-to-Use Calibrators and Controls

The goal of this project was to develop, manufacture, and determine the feasibility of producing ready-to-use calibrators and controls for the Cologuard 2.0 assay. The calibrator is used to create a standard curve which is then used to quantify specific levels in the patient samples and controls. The controls are processed in the assay alongside the patient samples to confirm the validity of the run. These components arrive to the laboratory in a lyophilized manner and then laboratory personnel reconstitute the material to then be run on the assay. With the improvement of Cologuard 2.0 is coming many improvements, one of which being providing ready-to-use calibrators and controls, not requiring any special procedures before being used.