Why do the concentrations of the highest calibrators in the certificate of analysis (COA) for validated kits vary between kit lots?

As part of the kit lot verification process, we compare the calibrator for the new kit lot to a reference calibrator lot in order to assign a concentration to the new calibrator lot. We report the measured concentration for the new calibrator lot. For example, if there is a 10% difference between the new and the reference calibrator lots, then the stock concentration for the two calibrator lots would be different by 10% and the top of the standard curves would change accordingly. This means that when you measure the same sample/control across kit lots, you get a consistent measured concentration.

Each MSD toxicology assay kit is provided with a COA that includes the calibrator concentration specific to that kit and the representative standard curves.

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