Using the App

Method Validation Simulator

Premium tool. Open from /training-dashboard → Method Validation card (the dashboard uses the short label, without the "Simulator" suffix), or directly at /method-validation.

Validating and verifying methods is one of the most commonly-tested Band 6 skills. This simulator walks you through real-world validation studies end-to-end.

What it does

• Provides simulated datasets for new-method verification (e.g. a new troponin assay)
• Asks you to design the acceptance criteria — precision, accuracy, linearity, comparability, reference range verification
• Calculates uncertainty of measurement (MU) from your inputs
• Generates limit of detection (LoD) and limit of quantitation (LoQ) from blank/low samples
• Produces a documented validation report you can attach to portfolio evidence

Studies covered

• Precision — repeatability (intra-run) and intermediate (inter-run) CV%
• Accuracy / trueness — comparison to reference method or certified reference material
• Linearity — across the analytical measurement range
• Comparability / method comparison — Bland-Altman, Deming regression
• Reference range verification — minimum 20 samples or transferring with rationale
• LoD / LoQ — blank + low-concentration replicates
• Sample stability — temperature × time matrix
• Carryover (analyser-based)
• Interference — common assay interferents (HAMA, biotin, haemolysis, lipaemia, icterus)

Verification vs validation

The simulator teaches the distinction:

• Verification — when adopting an already-validated commercial method, you only need to verify performance in your own lab. Smaller study.
• Validation — when developing a new in-house method or modifying a commercial one significantly, you need full validation against intended use. Larger study.

ISO 15189:2022 clause 7.2.2.2 mandates this distinction.

Standards alignment

• ISO 15189:2022 clause 7.2 — Examination methods
• CLSI EP05-A3 — precision
• CLSI EP06-A — linearity
• CLSI EP09-A3 — method comparison
• CLSI EP17-A2 — LoD/LoQ
• CLSI EP07-A3 — interference
• CLSI EP28-A3c — reference intervals
• JCGM 100:2008 (GUM) — uncertainty of measurement
• MHRA / IVDR for regulated devices

Bands and competency mapping

• Band 5 — execute studies under supervision, capture data
• Band 6 / 7 — design the study, set acceptance criteria, write the validation report, sign off

The simulator output is accepted as IBMS Specialist Portfolio evidence in the relevant specialty (most portfolios require multiple validation/verification cases).

Common interview question themes

• "Tell me about a method validation you led — what was the toughest acceptance criterion to meet?"
• "How do you calculate uncertainty of measurement?"
• "When is verification sufficient vs full validation?"
• "How do you handle a comparison method that fails the Bland-Altman bias test?"

Pair the Method Validation Simulator with the QC Simulator (article 38) — once a method is validated, your QC strategy is set by its Sigma performance.