Chapter 1 · Method verification

Method verification confirms that an established method performs as the manufacturer claims in your specific laboratory setting. Verification parameters include: precision (repeatability and intermediate precision), trueness (bias), linearity, and reference interval confirmation. A minimum of 20 samples across the measuring range is typically used. Verification must be completed and documented before the method is used for patient results.

Practical example

A laboratory installs a new automated immunoassay for TSH. Good practice: The section head runs a 20-sample verification comparing the new system to the existing method, calculates bias and imprecision, confirms the manufacturer’s reference interval is appropriate, and documents the results. The QM signs off the report before TSH is reported from the new system. Poor practice: TSH is reported from the new system the day after installation because ‘the kit inserts says it’s accurate’.

What this means for your practice: A kit insert is the manufacturer’s claim. Verification is your confirmation that the claim is true in your laboratory.