A review of laboratory testing errors found that up to 68.2 percent occurred in the pre-analytical phase. To reduce this number, labs need to pay close attention to sample type, collection method, transportation and storage conditions, and processing parameters. The collection tube and stabilization strategy, for example, need to protect the intended analyte through handling while remaining compatible with the downstream assay.
Once a pre-analytical process is designed, teams should validate its performance and then continually monitor for variation. Identifying deviations early can limit their effect on assay results and show where workflows need improvement.
The Assay Development Handbook details the pre-analytical factors that influence the risk of error and offers a framework for designing assays with the full workflow in mind. Teams can use its comparisons and checklists to make informed decisions and refine practices as workflows scale.
Download the handbook to learn how to:
- Match sample type and stabilization approach to the intended analyte and downstream assay
- Build workflows that can withstand shipping, batching, multi-site collections, and platform transitions
- Develop validation strategies that support regulatory planning and reduce the risk of avoidable rework
- Recognize patterns in assay data that point to pre-analytical instability