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Recommended protocols based on a survey of current practice in genotoxicity testing laboratories: study design
S H Swierenga1, J P Gilman, R L Brillinger
1Bureau of Drug Research, Health Protection Branch, Health and Welfare Canada, Ottawa, Ont.
Mutation Research
|February 1, 1991
Summary
This study surveyed genotoxicity assays in mammalian cells, revealing significant interlaboratory variations in protocols. Standardized methods are needed to improve the reliability of these crucial toxicology tests.
Area of Science:
- Toxicology
- Cell Biology
- Genetics
Background:
- Mammalian cell mutagenesis, chromosome aberrations, hepatocyte UDS, and cell transformation are key genotoxicity assays.
- Protocol modifications in these assays often remain unpublished, impacting reproducibility.
- A comprehensive survey was conducted to assess the current 'state of the art' for these tests.
Discussion:
- Analysis of 425 questionnaires highlighted substantial interlaboratory variability in assay protocols.
- Minor, unpublished modifications contribute to inconsistencies in genotoxicity testing.
- The study aimed to consolidate current practices and identify areas for standardization.
Key Insights:
- Significant variations exist in culture conditions and testing protocols across laboratories.
- Commonly used approaches and modifications for each procedural step were identified.
- The findings underscore the need for harmonized genotoxicity testing methodologies.
Outlook:
- Detailed protocols, including step-by-step instructions and interpretation guidelines, have been prepared.
- The developed protocols aim to enhance consistency and reliability in genotoxicity assessments.
- Future work should focus on implementing and validating these standardized protocols.