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Recommendations for conducting the rodent erythrocyte Pig‐a assay: A report from the HESI GTTC Pig‐a Workgroup
Author(s) -
Dertinger Stephen D.,
Bhalli Javed A.,
Roberts Daniel J.,
Stankowski Leon F.,
Gollapudi B. Bhaskar,
Lovell David P.,
Recio Leslie,
Kimoto Takafumi,
Miura Daishiro,
Heflich Robert H.
Publication year - 2021
Publication title -
environmental and molecular mutagenesis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1
H-Index - 87
eISSN - 1098-2280
pISSN - 0893-6692
DOI - 10.1002/em.22427
Subject(s) - workgroup , rodent , biology , guideline , veterinary medicine , pharmacology , medicine , pathology , computer science , ecology , computer network
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.