TABLE 5.

Parameters to consider in the analytic component of a validation plan

Parameter(s) of a validation plan	Description
Sensitivity	Minimum amount or concentration of an analyte required to generate a reliable result (“analyte” is used here generically and may refer to an entire microorganism or to an ion)
Specificity	Ability to measure the intended target, analyte, or signature
Reproducibility	Closeness of agreement between the results of successive measurements of the same analyte under similar but not necessarily identical conditions
Precision	Degree to which individual measurements of the same sample are similar
Accuracy	Degree to which the measured material or analyte is similar to its true value
Robustness	Stability of analytical performance under variable conditions
Reference samples	Samples for testing the performance of the assay (e.g., reference panels of the target and mock or nonprobative materials) corresponding to the intended application of the assay. Assays should be evaluated for performance in the presence of potential interfering substances that may mimic some conditions encountered with forensic samples.
Input values	Range of quantities of an analyte that can be analyzed reliably
Quantitation	Amount or concentration of an analyte
Dynamic range	Range of values or limits within which precision is held
Limit of detection	Minimum level at which all replicates are consistently positive
Controls	Test materials of known value for the measured analyte (includes blind samples, negative controls, and positive controls)
Selectivity	Ability to measure and to differentiate the analyte in the presence of other materials that may be present
Window of performance for operational steps of assay	Parameters that define analytical condition variations that will not substantially affect performance or reliability
Critical equipment calibration	Equipment requiring calibration prior to its initial use and on a regular basis thereafter
Critical reagents	Reagents determined by empirical studies or routine practice to require testing on known samples prior to use with evidentiary materials in order to prevent an unnecessary consumption of forensic samples
Databases	Collection of data to be used to support an interpretation of results
Personnel training, proficiency, and safety	Qualifications and education of the personnel to conduct the analysis safely
Interpretation criteria for results	Analysis (statistical or qualitative) used and confidence level of a match or result