PMID- 25953398 OWN - NLM STAT- MEDLINE DCOM- 20150710 LR - 20150508 IS - 1879-3592 (Electronic) IS - 1383-5718 (Linking) VI - 783 DP - 2015 May 1 TI - The in vivo Pig-a assay: A report of the International Workshop On Genotoxicity Testing (IWGT) Workgroup. PG - 23-35 LID - S1383-5718(14)00247-2 [pii] LID - 10.1016/j.mrgentox.2014.09.007 [doi] AB - The in vivo Pig-a assay uses flow cytometry to measure phenotypic variants for antibody binding to cell surface glycosylphosphatidylinositol (GPI)-anchored proteins. There is good evidence suggesting that the absence of antibody binding is the result of a mutation in the endogenous X-linked Pig-a gene, which forms the rationale for the assay. Although the assay has been performed with several types of hematopoietic cells and in a variety of mammalian species, including humans, currently it is optimized only for measuring CD59-deficient (presumed Pig-a mutant) erythrocytes in the peripheral blood of rats. An expert workgroup formed by the International Workshop on Genotoxicity Testing considered the state of assay development and the potential of the assay for regulatory use. Consensus was reached on what is known about the Pig-a assay and how it should be conducted, and recommendations were made on additional data and refinements that would help to further enhance the assay for use in hazard identification and risk assessment. CI - Published by Elsevier B.V. FAU - Gollapudi, B Bhaskar AU - Gollapudi BB AD - E(x)ponent , Midland, MI, USA. FAU - Lynch, Anthony M AU - Lynch AM AD - GlaxoSmithKline, Hertfordshire, UK. FAU - Heflich, Robert H AU - Heflich RH AD - US Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA. Electronic address: robert.heflich@fda.hhs.gov. FAU - Dertinger, Stephen D AU - Dertinger SD AD - Litron Laboratories, Rochester, NY, USA. FAU - Dobrovolsky, Vasily N AU - Dobrovolsky VN AD - US Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA. FAU - Froetschl, Roland AU - Froetschl R AD - Federal Institute for Drugs and Medical Devices, Bonn, Germany. FAU - Horibata, Katsuyoshi AU - Horibata K AD - National Institute of Health Sciences, Tokyo, Japan. FAU - Kenyon, Michelle O AU - Kenyon MO AD - Pfizer Global Research and Development, Groton, CT, USA. FAU - Kimoto, Takafumi AU - Kimoto T AD - Teijin Pharma, Tokyo, Japan. FAU - Lovell, David P AU - Lovell DP AD - St. George's, University of London, UK. FAU - Stankowski, Leon F Jr AU - Stankowski LF Jr AD - BioReliance, Rockville, MD, USA. FAU - White, Paul A AU - White PA AD - Environmental Health Science and Research Bureau, Health Canada, Ottawa, ON, Canada. FAU - Witt, Kristine L AU - Witt KL AD - National Institutes of Health, National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Research Triangle Park, NC, USA. FAU - Tanir, Jennifer Y AU - Tanir JY AD - Health and Environmental Sciences Institute, Washington, DC, USA. LA - eng PT - Journal Article DEP - 20140926 PL - Netherlands TA - Mutat Res Genet Toxicol Environ Mutagen JT - Mutation research. Genetic toxicology and environmental mutagenesis JID - 101632149 RN - 0 (Antibodies) RN - 0 (Membrane Proteins) RN - 0 (phosphatidylinositol glycan-class A protein) RN - CD59 Deficiency SB - IM MH - *Anemia, Hemolytic/metabolism/pathology MH - Animals MH - Antibodies/chemistry MH - Education MH - *Erythrocytes/metabolism/pathology MH - *Flow Cytometry/methods/standards MH - *Hemoglobinuria/metabolism/pathology MH - Humans MH - *Membrane Proteins/genetics/metabolism MH - *Mutation MH - Rats OTO - NOTNLM OT - CD59 OT - Flow cytometry OT - Glycosylphosphatidylinositol OT - Mutation OT - Red blood cells OT - Reticulocytes EDAT- 2015/05/09 06:00 MHDA- 2015/07/15 06:00 CRDT- 2015/05/09 06:00 PHST- 2014/09/13 00:00 [received] PHST- 2014/09/15 00:00 [accepted] PHST- 2015/05/09 06:00 [entrez] PHST- 2015/05/09 06:00 [pubmed] PHST- 2015/07/15 06:00 [medline] AID - S1383-5718(14)00247-2 [pii] AID - 10.1016/j.mrgentox.2014.09.007 [doi] PST - ppublish SO - Mutat Res Genet Toxicol Environ Mutagen. 2015 May 1;783:23-35. doi: 10.1016/j.mrgentox.2014.09.007. Epub 2014 Sep 26.