What performance characteristics are usually validated?
These almost always include the reportable range, precision (or imprecision), accuracy (or inaccuracy, bias), and the reference interval. Sometimes the studies include detection limit (or sensitivity), interference, and recovery. In US laboratories, the CLIA regulations define which characteristics need to be validated for methods with difference classifications of complexity. Fewer studies are required with less complex methods. More extensive testing is necessary for methods developed by the laboratory or modified by the laboratory.
