LGC Gene Measurement activity and the UK MfB programme

1
LGC Gene Measurement activity and the UK MfB
programme

• Carole Foy, LGC
• IMCLGS
• Paris, 3-5 May 2005

2
LGC and the UK Measurements for Biotechnology
(MfB) programme

• Analytical Services include
• Forensics
• National DNA Database
• Scene of crime analysis
• Paternity/relationship testing
• Genetic screening
• Pharmacogenetics
• Clinical genotyping
• HT genotyping
• Pharmaceutical services
• Contract RD

• LGC is designated UK Measurement Institute for
  Chemical and Biochemical measurements
• Validation of Reference Methods
• Proficiency testing
• Reference Materials
• International metrology activities (CCQM, JCTLM,
  ISO)
• Role underpinned by funding from DTI MfB
  Programme aimed at
• Improving the accuracy and reliability of
  biomeasurements
• Strengthening the measurement science
  underpinning the regulation of biotechnology
• Ensuring that the UK biomeasurement system is
  co-ordinated and developed in harmony with those
  of other countries

3
Complex Genetic Analyses Challenges

• Little technology standardisation - comparability
  difficult
• Standards and control materials to enable
  performance evaluation of reproducibility,
  sensitivity and robustness across competitive
  platforms, labs and technologies
• Process definition analytical guidelines to use
  tools appropriately to enable an assessment of
  data, irrespective of platform
• Measurable repeatability/reproducibility and
  Quality Metrics
• Many assumptions made - validity?
• Volume of information - format, analysis,
  interpretation, storage transfer
• Performance compromised over single-analyte
  assays (accuracy, sensitivity, specificity)

4
MfB projects (mfbprog.org.uk)

• Performance Indicators and Quality Metrics to
  improve confidence in array based measurements
• spike-in controls
• platform comparability
• guidelines QMs to reduce variability increase
  confidence in measurements
• Standardisation Requirements For
  Genotyping/Haplotyping
• reference materials
• Standardisation of Gene Expression Measurements
• reference methods and materials
• standard unit of measure for gene expression
• Primary Method to Produce Standards for DNA
  Quantitation
• High level standards quantified by Mass Spec
  approaches
• Critical Data Analysis for Low Level DNA
  Measurements
• trace DNA detection using real-time PCR