Generate a structured, CLSI EP-aligned validation plan for a biological aging assay. Adjust assay characteristics on the left; the right pane shows your study matrix, sample-size targets, and reporting checklist.
For educational use. Always confirm against current CLSI EP05-A3, EP06, EP07, EP09, EP17, EP25, EP28 documents and your local regulatory body.
Epigenetic Age (DNAmAge)
LDT · whole-blood
DNA methylation age (years) — reportable range 20 – 100 years. Decision point: Δage > 5 years.
Plan steps
8
Working days
155 d (~31 wk)
Approx. samples
2,323
Precision (repeatability & within-lab)
CLSI EP05-A3
Quantify random error at ≥2 concentrations spanning the reportable range (20 – 100 years).
Design
2 levels (low, high) — add a 3rd at the clinical decision point
2 runs/day × 2 replicates × ≥20 days
Same instrument, ≥2 operators, ≥2 reagent lots
Sample size
16 days × 2 runs × 2 replicates × 2 levels = 128 measurements per level pair
Acceptance
Total CV ≤ 4% at each level (95% CI upper bound).
~16 working days
Trueness via reference materials
CLSI EP15-A3
No comparator method: assess recovery using certified reference materials / proficiency samples.
Design
≥3 certified reference materials or interlaboratory comparison panels
5 replicates per material, single run
Sample size
3 materials × 5 replicates
Acceptance
Mean bias ≤ 5% at the decision point (Δage > 5 years).
~5 working days
Linearity / reportable range
CLSI EP06-Ed2
Verify linear response across the claimed reportable range (20 – 100 years).
Design
5–11 equally spaced levels from low to high anchor
4 replicates per level
Polynomial regression: prefer linear unless higher-order term is significant AND clinically meaningful
Sample size
9 levels × 4 replicates = 36 measurements
Acceptance
Deviation from linearity ≤ 5% across the range.
~2 working days
Limit of blank / detection / quantitation
CLSI EP17-A2
Define analytical sensitivity for low-concentration reporting.
Design
LoB: ≥60 blank measurements across 4 reagent lots / 3 days