Precision analysis software for method validation
Variance component analysis with flexible nested designs per EP05-A3 — repeatability, intermediate precision, and precision profiles across the measuring range.
Characterise the sources of variability in your measurement procedure
Every measurement procedure has variability — between runs, between days, between operators, between sites. The question is how much, and where it comes from. EP05-A3 provides the framework for decomposing total imprecision into its constituent variance components so you can identify and address the dominant sources. IVD manufacturers need this for product labelling and regulatory submissions; clinical laboratories need it for verification against the manufacturer’s claimed precision before putting a new system into service.
I used Analyse-It for many product development, product troubleshooting, and technology evaluation activities... your product was the easiest to use, was accurate, and produced publication ready reports.
Stanley F. Cernosek, Ph.D.
Clinical Chemistry Reagent Development
Beckman Coulter, Inc.
Analyse-it supports the full EP05-A3 protocol with flexible nested designs — up to three random factors in any arrangement, balanced or unbalanced. Variance components are separated as repeatability, between-run, between-day, and within-laboratory imprecision. Precision profiles show how SD or CV changes across the measuring range, with five variance function models to fit. Results feed directly into detection capability estimation and total analytical error calculations.
What's included
Design the precision study that matches your laboratory
Up to 3 random nested factors and 1 fixed factor in any arrangement, balanced and unbalanced. Multi-site, multi-operator, multi-lot designs for IVD development, or simpler single-lab designs for verification.
Separate the sources of variability
Repeatability, between-run, between-day, and within-laboratory imprecision reported as individual variance components with ANOVA table. Precision as variance, SD, or CV% with Exact, Satterthwaite, and MLS confidence intervals.
See how precision changes across the measuring range
Precision profiles showing SD or CV as a function of concentration. Five variance function models: constant variance, constant CV, mixed constant/proportional, Sadler 3-parameter power, and alternative power. 4-parameter function with turning point.
Test whether precision meets the requirement
χ² test against a precision goal for development or verification. Pass/fail assessment against the manufacturer’s claimed CV or your own allowable imprecision.
Identify outliers before they distort the estimate
Generalised ESD outlier identification (Grubb’s test for more than one outlier). Variability of measurements plot for visual inspection.
Example analyses
See precision study results in detail — variance components, ANOVA tables, precision profiles, and verification tests — using CLSI example datasets you can download and follow along with.
EP05-A3 — Appendix B
Glucose precision study, single-site.
20 days × 2 runs × 2 observations. Repeatability and between-run/between-day variance components, ANOVA table, and variability of measurements plot.
EP05-A3 — Appendix B
CA19-9 precision study, multi-site.
6 samples × 3 laboratories × 5 runs × 5 observations. Repeatability, within-laboratory, and reproducibility components for each sample. Precision profile with 3-parameter variance function fit.
Validated, reliable, trusted for over 30-years
Validated calculations you can defend at inspection
Every calculation by Analyse-it, no Excel formulas, and no third-party functions. Validated against CLSI reference datasets, published datasets, and thousands of internal test cases. Defensible in a 510(k), CE-IVD technical file, CAP inspection, or ISO 15189 audit. See how we
develop and validate Analyse-it →
Data stays in your facility
Analyse-it runs entirely within Excel on your PC. No cloud processing, no data transmission.
Your pre-submission and patient-adjacent data stays within your facility under your data governance controls.
Standard Excel workbooks
Analyses are ordinary Excel workbooks that you can share with colleagues, archive for audit, and open on any machine with Excel — no Analyse-it licence required.
No formulas to break
Results contain no formulas, so they can’t be accidentally edited or corrupted. The results you reported will be exactly what you find when you reopen the workbook.
Technical details
CLSI protocols
- EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures
Experiment design
- Up to 3 random nested factors new in v4.60
- 1 fixed factor (e.g. level)
- Balanced and unbalanced designs
Variance components
- Precision as variance, SD, or CV%
- Exact, Satterthwaite, and MLS confidence intervals
- Abbreviated reproducibility/repeatability and detailed intermediate precision components
- ANOVA table
- Terminology: total/within, reproducibility/repeatability, or laboratory/repeatability
Precision profiles
- SD or CV across the measuring range
- Constant variance function
- Constant CV function
- Mixed constant/proportional variance function
- Sadler 3-parameter power function new in v4.00
- 3-parameter alternative power function new in v4.00
- 4-parameter function with turning point new in v4.91
Tests & diagnostics
- χ² test against precision claim
- Generalised ESD outlier identification new in v4.95
Plots
- Variability of measurements plot
- Precision profile with variance function fit
- Scatter plot
- Difference plot
