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Use of diagnostic accuracy as a metric for evaluating laboratory proficiency with microarray assays using
P S Pine1, M Boedigheimer, B A Rosenzweig
1Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Pharmacogenomics
|November 21, 2008
Summary
A new reference system with standard metrics and samples was developed for evaluating microarray assay performance. This system enables reliable assessment of microarray technology for clinical and regulatory applications.
Area of Science:
- Biotechnology
- Molecular Biology
- Genomics
Background:
- Standardized performance assessment methods are crucial for effective microarray technology use in clinical and regulatory settings.
- Previous efforts like the MicroArray Quality Control project established groundwork but lacked diagnostic assay-like performance evaluation methods.
- Existing laboratory medicine diagnostic assays require robust performance metrics not yet fully developed for microarray assays.
Purpose of the Study:
- To develop a comprehensive reference system for evaluating microarray assay performance and facilitating process improvement.
- To establish standardized reference samples, metrics, and datasets for microarray performance evaluation.
- To enable reliable comparisons of assay specificity and sensitivity for regulatory and clinical applications.
Main Methods:
- Developed a reference system comprising reference samples (two mixes of four rat tissue RNAs) and tissue-selective analytes across the measurement dynamic range.
- Utilized receiver operating characteristic (ROC) plots to calculate the area under the curve (AUC) for assessing diagnostic accuracy of expression ratio changes.
- Evaluated the system's utility for multi-laboratory proficiency testing and single-laboratory process drift monitoring.
Main Results:
- The reference system provides a single, commutable value (AUC) for comparing assay specificity and sensitivity.
- Diagnostic accuracy for detecting a 1.5-fold change in signal level proved a sensitive metric for overall performance comparison.
- This detection limit approaches the technical capabilities for reliable sample discrimination with microarray technology.
Conclusions:
- The developed reference system offers a robust mechanism for both internal and external assessment of laboratory proficiency with microarray technology.
- This system is adaptable and translatable for performance assessments on other whole-genome expression arrays used in research.
- Standardized performance evaluation is essential for advancing the reliable application of microarray technology in clinical diagnostics and regulatory science.
