Explore the resources in DAVN validation tools harboring a framework for assay validation by tiers in a step-by-step process diagram, DAVN validation statistical calculators and an outline on how to develop positive controls by technique or assay.View Our Statistical Calculators
Framework of Assay Development and Validation
The validation of diagnostic tests is crucial and must consider the end use throughout the process. This includes accounting for the biology and diversity of the pathosystem, the test's intended environments, and its application in a broader diagnostic context. Here, we present the
DAVN framework for assay develpment and validation, based on
Groth-Helms et al. 2023
Key attributes such as
specificity, sensitivity, precision, and robustness are consistently assessed, ensuring that positives are reliably identified as positive and negatives as negative for every end user. Validation schemes can vary significantly based on test targets, technologies, and applications, but certain performance characteristics are consistently evaluated regardless of these differences.
Validation is tiered as shown in the workflow below, with Tier 1 focusing on analytical sensitivity and specificity, Tier 2 broadening inclusivity and exclusivity panels for pathogen surveillance, Tier 3 emphasizing reproducibility in various laboratory settings, and Tier 4 evaluating fitness for use in international diagnostics.
Consistent use of validation terminology is essential for developers and stakeholders to understand a test's fitness for a specific purpose. Descriptors of test performance can be found in the Diagnostic Assay Terminology glossary at the end of this page, and authors are encouraged to mention the validation tier level in their publications to facilitate appropriate adoption by end users.
If your assay development follows this framework, please cite
Groth-Helms, D., Rivera, Y., Martin, F.N., Arif, M., Sharma, P. and Castlebury, L.A., 2023. Terminology and guidelines for diagnostic assay development and validation: Best practices for molecular tests. PhytoFrontiers™, 3(1), pp.23-35.
1. Workflow for assay design based on DAVN terminology
2. Key terms for validation assays and validation tier assignments
