It starts with the right tube
Design your assay for scale from day one
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The free Assay Development Handbook shows how collection, stabilization and validation choices made early can affect how your assay holds up through multi-site collection, shipping and regulatory review.
SIX CHAPTERS. ONE SYSTEM.
- Designing from scale from day one
- Sample collection, stabilization and pre-analytical control
- Validation and regulatory planning
- Data analysis and interpretation
- Workflow optimization and future-proofing
- Support and practical tools
50+ years
in pre-analytics innovations
46% – 68.2%
of errors in the total testing process traced to the pre-analytical phase in a 2006 review (Plebani, Clin Chem Lab Med)
BLOODPAC
member shaping pre-analytical standards
What’s inside the handbook
Six chapters built to take your assay from first tube to full-scale deployment, with practical tools, real-world lessons and decision frameworks in every chapter.
Chapter 1
Designing for Scale from Day One
Why tube selection, sample type and stabilization strategy set the ceiling on what your assay can achieve and the roadmap from pilot to multi-site deployment
Chapter 2
Sample collection, stabilization and pre-analytical control
What happens after the draw, where standard EDTA tubes may fall short, and a failure-mode to root-cause matrix across five analyte classes.
Chapter 3
Validation and regulatory planning
What to document to demonstrate sample integrity, how to build pre-analytical variable into stability studies and fixes to lock before decision-grade data.
Chapter 4
Data analysis and interpretation
How pre-analytical instability show up in cfDNA, RNA, protein and EV data and how to separate true biological signal from handling artifacts
Chapter 5
Workflow optimization and future-proofing
What works at 20 samples a week can break at 2,000. Shipping design, ambient vs. cold chain and planning headroom for modalities you haven’t added yet
Chapter 6
Support and practical tools
Checklists for early-stage design, pre-validation and scale-up plus how Streck supports feasibility, stability studies and regulatory framing.
Take a look inside
Frameworks, real data and ready-to-use tools you can bring straight into your next protocol review.
A roadmap to scalable assay
From biomarker and collection through validation, analysis and scale.
Failure mode – root cause matrix
Link what you see in your data to its pre-analytical cause.
Instability signatures in real data
How unstabilized storage distorts cfDNA, RNA, protein and EV results.
What you’ll be able to do
Start with the right tube. Protect the biology. Build for scale.
Identify the sample type and stabilization approach that help reduce pre-analytical variability for your analyte.
Build workflows that help withstand shipping, batching, multi-site collection and platform transitions.
Develop validation strategies that help support regulatory planning and reduce the likelihood of avoidable rework or bridging.
Written for teams building biomarker assays
Whether your work centers on oncology, infectious disease, neurodegenerative disease, transplant monitoring, genetic testing or exploratory biomarker discovery, the principles are the same.
Get the Assay Development Handbook
18-page PDF. We’ll email you a copy.