Measurement system analysis software per CLSI EP05, EP06, EP15, and EP17 Precision, trueness, linearity, interferences, and detection capability — five CLSI protocols in a single validated package. Flexible nested designs for multi-site studies, verification against manufacturer claims, and LoB/LoD estimation.

Characterising a measurement system requires multiple studies, each governed by its own CLSI protocol, each with its own experimental design, and each producing results that feed into a broader picture of system performance. Precision studies follow EP05-A3 with nested variance component analysis across runs, days, sites, and operators. Linearity studies follow EP06-A with polynomial regression and a nonlinearity test against a performance goal. Verification follows EP15-A3 by testing imprecision and trueness against manufacturer claims. Detection capability follows EP17-A2 with LoB and LoD estimation using blank and low-level materials. Most tools cover one or two of these protocols; Analyse-it covers all five in a single package, so the entire characterisation lives in one place.

Analyse-it's precision study design is more flexible than most implementations. EP05-A3 specifies nested variance components, but it does not mandate a fixed run-within-day-within-site structure. Analyse-it supports up to three nested factors in any arrangement — runs within days, days within sites, operators within instruments — so you can design the study that matches your actual laboratory workflow rather than forcing your workflow into a rigid template. Variance components are estimated correctly for the design you specify, with repeatability, between-run, between-day, and within-laboratory imprecision reported separately. Verification per EP15-A3 then tests these estimates against the manufacturer's claimed precision and trueness, producing a clear pass/fail against the allowable goal.

Linearity evaluation per EP06-A fits polynomial models across the measuring interval and tests for nonlinearity against a predefined performance goal. If nonlinearity exceeds the allowable deviation, the reportable range may need to be restricted — the analysis tells you where and by how much. For detection capability, EP17-A2 estimation of LoB, LoD, and LoQ uses blank and low-level sample measurements, with both classical and precision-profile-based approaches available. Interference testing per EP10-A3-AMD identifies and quantifies the effect of potentially interfering substances on measurement performance.

Scientists at Abbott, Roche, Thermo Fisher, and most of the world's leading IVD manufacturers have relied on Analyse-it for measurement system characterisation for over 30 years — as have clinical laboratories running verification studies before putting a new analyser or reagent system into clinical use.