1. Recommendations for conducting the rodent erythrocyte Pig-a assay: A report from the HESI GTTC Pig-a Workgroup
- Author
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Robert H. Heflich, Takafumi Kimoto, David P. Lovell, Daniel J Roberts, Stephen D. Dertinger, Leon F. Stankowski, Daishiro Miura, B. Bhaskar Gollapudi, Javed A. Bhalli, and Leslie Recio
- Subjects
Male ,Pig‐a gene ,Reticulocytes ,Epidemiology ,Health, Toxicology and Mutagenesis ,Rat model ,Pig a gene ,Rodentia ,Review ,010501 environmental sciences ,Bioinformatics ,01 natural sciences ,03 medical and health sciences ,mutation assay ,Dose group ,Medicine ,Animals ,Statistical analysis ,Workgroup ,Genetics (clinical) ,030304 developmental biology ,0105 earth and related environmental sciences ,0303 health sciences ,mutagen ,business.industry ,Mutagenicity Tests ,flow cytometry ,genotoxicity ,Guideline ,Rats ,Mutation ,Biological Assay ,business ,Blood sampling ,Mutagens - Abstract
The rodent Pig‐a assay is a flow cytometric, phenotype‐based method used to measure in vivo somatic cell mutation. An Organization for Economic Co‐operation and Development (OECD) test guideline is currently being developed to support routine use of the assay for regulatory purposes (OECD project number 4.93). This article provides advice on best practices for designing and conducting rodent Pig‐a studies in support of evaluating test substance safety, with a focus on the rat model. Various aspects of assay conduct, including laboratory proficiency, minimum number of animals per dose group, preferred treatment and blood sampling schedule, and statistical analysis are described.
- Published
- 2021