Calibration verification and linearity testing are laboratory processes used to confirm that analytical systems continue to produce accurate and reliable results across an assay's reportable range. Calibration verification assesses whether an existing calibration remains acceptable using materials with assigned concentrations at multiple levels, while linearity testing evaluates performance across the analytical measurement range (AMR). Together, these activities help laboratories verify assay performance, identify potential analytical variation, support regulatory compliance, maintain inspection readiness, and ensure confidence in reported patient results as part of an ongoing quality management programme.
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What is calibration verification and linearity testing?
Confirming accuracy across the reportable range
How LGC supports calibration verification and linearity studies
Laboratories often need to balance compliance requirements, increasing workloads and limited resources. We provide calibration verification and linearity materials designed to help simplify verification studies, reduce preparation requirements and improve documentation workflows.
Who we support
Clinical laboratory scientists and managers, laboratory directors, quality assurance and quality control (QA/QC) professionals, pathologists, and in vitro diagnostic (IVD) developers and manufacturers.
What they need
Multi-level calibration verification materials, reportable range assessments, AMR verification, linearity studies, compliance documentation, inspection readiness support and reliable analytical performance monitoring.
How calibration verification supports laboratory workflows
Applications
Support analytical accuracy, reportable range assessment and inspection readiness through calibration verification and linearity testing.
Technologies
Calibration verification materials supporting quantitative and molecular testing workflows.
Featured Resources
Featured Resources
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Why laboratories choose LGC for calibration verification and linearity materials
Trusted calibration verification and linearity solutions helping laboratories maintain analytical performance and compliance confidence.
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Global impact
37,000+
Customers supported worldwide
Portfolio
11,000
Products supporting diagnostics and genomics
Frequently asked questions
How do you verify calibration?
Calibration verification is performed by analysing materials with assigned concentrations across the reportable range in the same manner as patient samples and comparing the measured results against established acceptance criteria.
Is linearity the same as calibration verification?
No. Calibration verification confirms acceptable assay performance at representative concentrations across the reportable range, while linearity testing evaluates performance across multiple concentration levels throughout the analytical measurement range. In many laboratories, appropriately designed linearity studies may be used to support calibration verification requirements.
What is the difference between calibration and verification?
Calibration is the act of setting or adjusting the instrument's measurement parameters. Verification is an independent quality check performed after calibration or at defined intervals to confirm calibration remains acceptable.
What is the difference between calibration verification and qualification?
Calibration verification confirms the ongoing analytical accuracy of a specific assay's reportable range. Instrument qualification (IQ/OQ/PQ) is a broader engineering process that checks whether the physical hardware of the instrument meets its operational design specifications.
How often should calibration verification be performed?
Calibration verification is typically performed at least every six months and may also be required following events that could affect assay performance, such as major maintenance or method changes.
What materials should be used for calibration verification?
Laboratories should use calibration verification materials with assigned values that span the analytical measurement range, provide suitable analyte coverage and support the generation of documented performance data for compliance and quality management purposes.
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Need support with calibration verification and linearity testing?
Whether you are preparing for routine calibration verification, supporting AMR studies, validating assay performance or improving inspection readiness, our specialists can help identify the right VALIDATE® and AccuTrak™ solutions for your laboratory.