Assay validation
Demonstrating analytical sensitivity, analytical specificity, accuracy, precision and limit of detection (LoD) for molecular assays and laboratory-developed tests.
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How LGC supports molecular laboratories
Supporting molecular laboratories with assay validation, quality control, proficiency testing and accreditation readiness activities.
Who we support
Molecular laboratory directors, technical supervisors, molecular pathologists, quality managers and senior technologists responsible for assay validation, quality control, external quality assessment and accreditation readiness.
How we help
We provide independent quality controls, clinical genomics reference materials, proficiency testing solutions and informatics tools that support assay validation, verification, quality monitoring and regulatory compliance.
Related applications
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Clinical Diagnostics
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Clinical Diagnostics
Why molecular laboratories choose LGC
Supporting molecular laboratories through validation, quality control and accreditation readiness
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Employees
1,500+
Experts supporting global science
Products
11,000
Products supporting research, development and manufacturing workflows
Featured Resources
Featured Resources
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Frequently asked questions
What is molecular diagnostics in a hospital laboratory setting?
Molecular diagnostics uses DNA, RNA and other molecular biomarkers to detect, characterise and monitor disease using technologies such as qPCR, digital PCR and next-generation sequencing (NGS).
What quality control does a molecular assay need?
Most molecular assays require positive controls, negative controls, no-template controls and assay-specific quality control materials that demonstrate performance remains within established acceptance criteria.
What is the difference between a run control and a reference material?
Run controls monitor routine assay performance, whereas reference materials are used to establish or verify analytical performance characteristics such as accuracy, precision and LoD.
What material do you need to validate a laboratory-developed test?
Validation studies commonly use characterised reference materials, contrived samples and clinical specimens to demonstrate assay performance claims.
How do you establish limit of detection for a molecular assay?
LoD studies establish the lowest concentration at which an assay can reliably detect the target with predefined confidence.
What is external quality assessment and how does it differ from proficiency testing?
Both assess laboratory performance using external samples. Proficiency testing is typically a formal assessment programme, while external quality assessment (EQA) may encompass broader inter-laboratory performance comparisons.
How do you monitor assay performance between lots?
Independent quality controls, reference materials and lot comparison studies help identify changes in analytical performance following reagent or consumable changes.
What documentation do CAP and CLIA inspections expect for molecular assays?
Inspections typically review validation records, QC data, proficiency testing results, corrective actions, lot verification studies and quality management documentation.
How do control requirements differ between oncology and infectious disease panels?
Oncology assays frequently require low-frequency variant controls and sensitivity monitoring, while infectious disease assays place greater emphasis on extraction controls, amplification controls and contamination monitoring.
Can controls be supplied for a laboratory-developed test?
Yes. Independent controls and reference materials can support both validation and ongoing quality monitoring of laboratory-developed tests.
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Discuss your molecular laboratory programme
Whether you are validating a laboratory-developed test, implementing a new NGS panel, monitoring analytical performance or preparing for CAP accreditation, our specialists can help identify appropriate quality controls, reference materials and proficiency testing solutions for your molecular laboratory.