Table 2.

Method validation parameters and their definitions as ipplied to the quantitation of soluble aggregates by SV-AUC.

Method validation parameter	Definition
Specificity	Ability to resolve aggregates as a population of c(s) species with s-values greater than that of the monomer
Accuracy	Agreement of the measured value with the accepted true or reference value
Precision	Closeness between multiple aggregate measurements
Limit of Detection (LOD)	Lowest amount of aggregate which can be reliably detected
Limit of Quantitation (LOQ)	Lowest amount of aggregate which can be reliably quantified
Linearity	Ability of SV-AUC to detect and quantify soluble aggregates directly proportional to their concentration in the sample
Range	Interval between the highest and lowest amount of soluble aggregates where the method has the appropriate degree of precision, accuracy, and linearity
Robustness	Ability of the SV-AUC method to provide reliable quantitation with respect to small variations in method parameters