Section2:Overview

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The statistical validation requirements for an assay vary, depending upon the prior history of the assay. Stability and Process studies (Section B) should be done for all assays, prior to the commencement of the formal validation studies. If the assay is new, or has never been previously validated, then full validation is required. This consists of a 3 day Plate Uniformity study (Section C) and a Replicate-Experiment study (Section D). If the assay has been previously validated in a different laboratory, and is being transferred to a new laboratory, then a 2 day Plate Uniformity study (Section C) and a Replicate-Experiment study (Section C) are required. An assay is considered validated if it has previously been assessed by all the methods in this section, and is being transferred to a new laboratory without undergoing any substantive changes to the protocol. If the intent is to store the data with the results of the previous facility’s data then an assay comparison study (Section D) should be done as part of the Replicate-Experiment study. Otherwise only the intra-laboratory part of the Replicate-Experiment study (Section D) is recommended.

If the assay is updated from a previous version run in the same facility then the requirements vary, depending upon the extent of the change. Major changes require a validation study equivalent to a laboratory transfer. Minor changes require bridging studies that demonstrate the equivalence of the assay before and after the change. See Section E for examples of major and minor changes.

These techniques are intended to be applied to ≥ 96-well primary target binding and functional assays. You should discuss with a statistician alternatives for assays with significant time, resource or expenditure constraints to properly balance validation requirements with these constraints.