Critical reagents are essential when testing bioanalytical study samples as it provides confidence in the consistency and comparability of the collected data. This can be performed on test articles, commercial kits and reagents, and for custom prepared lots.

This service can be tailored to the specific needs of the project, and the rigor of the evaluations can be fit for the purpose of the assay. Many variables, such as, technicians, days, lots, and various other robustness parameters can be incorporated into critical reagents to determine the impact of its change on the method.  KCAS utilizes nominal concentrations, when applicable, to compare new reagent lots or materials to an existing validated standard. When absolute concentrations are unavailable, the accuracy and precision of the method are re-evaluated with the new material, and the results verified against the original validated ranges for the assay.

KCAS places high value on providing the most accurate data possible for every assay.  Critical reagents are one of the closely monitored details that is monitored to meet this goal.

By closely monitoring critical assay components, KCAS helps ensure data integrity as assays evolve.









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