We hope that when new assays are published, reference will be made to this scale as a standardised way to communicate to end users the extent to which it has been validated. It will help end users to decide whether or not an assay is suitable for their needs in terms of its level of validation and the remaining uncertainty around positive or negative results, and will also help guide any next steps for the further development of particular assays in order to move them further along the scale.
Please note that this is version 1 of the scale, and we expect to make updates to it. We are currently carrying out a meta-analysis of published assays to understand the historic level of validation applied to published assays, and this process involves a review of the original scale as presented here. The final version will be published along with the meta-analysis.
The scale was developed at a workshop of DNAqua-net (Working Group 3: field and laboratory methods) in Innsbruck, Austria in March 2018