Method Validation Edition

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.

Separate the sources of variability in your measurement procedure

Knowing the total imprecision isn’t enough. A method with high overall CV might have excellent within-run repeatability but large between-day drift — a different problem from one that’s noisy within every run. Without separating the variance components, you can’t identify the dominant source, you can’t take targeted corrective action, and you can’t produce the precision data that regulatory submissions and accreditation inspections require.

Analyse-it supports the full EP05-A3 protocol with flexible nested designs that match the way your laboratory actually operates. Variance components are separated at every level, precision profiles show how imprecision behaves across the measuring range, and the results feed directly into detection capability estimation and total analytical error calculations.

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.

What's included

Flexible experiment design

Up to three random nested factors (days, runs, operators, sites, lots) plus one fixed factor (concentration level) in any arrangement, balanced or unbalanced — such as 3 sites × 5 days × 2 runs × 3 replicates for an IVD development study, or a simpler 20 × 2 × 2 single-lab verification design.

Variance components separated at every level

Repeatability, between-run, between-day, between-operator, between-site, within-laboratory, and reproducibility — each reported as an individual variance component with ANOVA table. Precision as variance, SD, or CV% with exact, Satterthwaite, and modified large-sample (MLS) confidence intervals.

Precision profiles across the measuring range

Precision profile plots SD or CV as a function of concentration with a fitted variance function. Six models: constant variance, constant CV, mixed constant/proportional, Sadler 3-parameter power, 3-parameter alternative power, and 4-parameter function with turning point. The fitted variance function feeds directly into detection capability estimation (LoB, LoD, LoQ) via EP17-A2.

Chi-squared test against precision claim

Test observed precision against a precision goal — such as the manufacturer’s claimed CV of 3.5% — for a formal pass/fail assessment per EP05-A3.

Generalised ESD outlier identification

Grubbs’s test extended for multiple outliers. Variability of measurements plot for visual inspection of drift, shifts, or individual aberrations across the dataset.

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.

Part of measurement system analysis

Precision is one part of measurement system analysis, alongside linearity (EP06-A), bias/trueness verification (EP15-A3), interference evaluation (EP10-A3-AMD), and detection capability (EP17-A2). Precision profiles from EP05-A3 feed directly into detection capability estimation.

See the full MSA workflow on the measurement system analysis page →

Software you can trust

Validated calculations you can defend at inspection Every calculation is performed by Analyse-it — no Excel formulas, no third-party functions. Results are validated against CLSI reference datasets, published datasets, and thousands of internal test cases before every release. See how we develop and validate Analyse-it →

Data stays in your facility Analyse-it runs entirely within Microsoft Excel on your PC. No cloud processing, no data transmission. Pre-submission data, patient-adjacent data, and in-process results stay within your facility under your own data governance controls.

Standard Excel workbooks anyone can open Every analysis is an ordinary .xlsx workbook. Share with colleagues, submit to regulatory affairs, archive for audit, open on any PC with Excel. No proprietary format, no licence required to view results. Colleagues and auditors see exactly what you see.

Results that can’t be accidentally broken Analysis output contains computed values, not formulas. Nothing to accidentally overwrite, no cell references to break, no formula errors to introduce. The results you reported are exactly what you’ll find when you reopen the workbook months or years later for an audit.

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

Method Validation Edition 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.