TABLE 1.

Elements of validation guidelines for methods and procedures for analyses

Element(s) of validation guidelines or procedure
Developmental validation should be appropriately documented and should address specificity, sensitivity, reproducibility, bias, precision, false positives, and false negatives. Appropriate controls should be determined. Any reference database used should be documented.
Preliminary validation is the acquisition of limited test data to enable an evaluation of a method used to provide investigative support to investigate a biocrime or bioterrorism event. If the results are to be used for other than investigative support, then a panel of peer experts, external to the laboratory, should be convened to assess the utility of the method and to define the limits of interpretation and conclusions drawn.
Internal validation should be performed and documented by the laboratory.
The procedure should be tested using known samples. The laboratory should monitor and document its reproducibility and precision and define reportable ranges of the procedure using a control(s).
Before the introduction of a new procedure into sample analysis, the analyst or examination team should successfully complete a qualifying test for that procedure.
Material modifications made to analytical procedures should be documented and subjected to validation testing commensurate with the modification and have documented approval.