Many scientists performing preclinical and clinical research hit a point when they need to have an assay validated. You may have painstakingly developed and perfected a particular assay, but now you must put it through the rigors of validation for it to be considered a “validated assay.” The basic principles of assay validation were described in an earlier blog post, but how do you know you if you need an assay validated? Use these questions as a guide to help you figure out your validation situation and get a little less vexed about validation.
Are You Using This Assay For Basic Research or Preclinical/Clinical Research?
Validated assays are essential to most preclinical and clinical research protocols in order to fulfill regulatory requirements. Assays used in basic research don’t need to be validated typically, but if you are thinking about developing this assay for clinical use in the future, it’s never too early to consider validation.
Can The Assay Be Validated?
Many of the earliest assays to be validated were rooted in chemistry and pharmacology. These days almost any molecular-based assay can be validated, and some of the most common validation scripts are sample stability, intra-assay precision, interassay precision, and repeatability. Even flow cytometry-based assays like immunophenotyping and intracellular cytokine staining, which examine the highly complex cell populations of the immune system, can be validated. Validation may be more challenging and time consuming for assays using live cells due to the variability of sample types and human-to-human differences.
Do I Perform The Assay Validation Or Can I Hire An Expert?
Any research scientist with proper guidance and experience can perform an assay validation, but working with an experienced organization familiar with validation is often the most efficient and cost-effective strategy. Consider using a contract research organization (CRO), as many CROs are staffed with scientists with years of experience in assay validation and regulatory requirements, and the work can be done under GLP/GCP conditions, if necessary.
Hopefully you feel less vexed by the prospect of validation and you’re better equipped to decide what to do with your assay.