From: Considerations in the development of circulating tumor cell technology for clinical use
Assay Validation | |
---|---|
Pre-Analytic | How is specimen collected (venous route, body position, draw order, tourniquet time, needle bore, tube type)? |
When is specimen collected (time of day, relative to treatment, relative to infusates)? | |
How is specimen stored (time and temperature)? | |
How is specimen handled (shipping, transfers)? | |
Analytic | Sensitivity (lower limit of quantitation)? |
Reportable range? | |
Specificity? | |
Reproducibility? | |
Robustness? | |
Post-Analytic | How is data reported? |
How is data analyzed? | |
What are the reference intervals? | |
Clinical Feasibility | |
• Are there analytically valid results when tested in appropriate preclinical models? | |
â—‹ with use of clinically relevant/feasible specimen acquisition? | |
â—‹ with use of clinically relevant specimen handling procedures (both at the point of acquisition and in the receiving laboratory)? These processes should be tracked and recorded. | |
â—‹ with use of clinically relevant collection scheduling? | |
Therapeutic Relevance | |
• For predictive biomarkers, is there a relationship between dose/exposure, quantifiable target modulation, and disease outcome? | |
• For prognostic biomarkers, is there a relationship between baseline levels and survival? |