Table 1

Elements to be considered when non–fully validated assays are employed.

1.Review the assay techniques with an independent panel of experts and seek their input and advice about the proposed assay processes, measurements, and limitations.
2.Identify the parameters that can affect results.
3.Identify potential factors that can contribute to uncertainty and quantify these contributions where possible. If not possible within the constraints of the exigent conditions, these factors should be characterized and efforts made to minimize their impact on the analyses.
4.Consider the possibility of false positives and false negatives, and at least appreciate the possibility of such results.
5.Identify test panels and other appropriate controls.
6.Test the assays before using them on a case-relevant sample.
7.Document in detail the manner in which the actual assays were performed.
8.Maintain the integrity of samples (in forensic cases, also maintain chain of custody).