Patent ID: 8187826

Claim:
A method of assessing mutagenic DNA-damaging potential of an agent comprising: subjecting a peripheral blood sample, obtained from a mammal exposed to an agent that may induce mutagenic DNA damage, to conditions effective to substantially separate erythrocytes from platelets and leukocytes, thereby forming an enriched erythrocyte sample; first contacting the enriched erythrocyte sample with a first reagent that binds GPI anchor-expressing erythrocytes, but not GPI anchor-deficient erythrocytes, wherein the first reagent comprises a first fluorochrome; second contacting the enriched erythrocyte sample with a second reagent that differentially labels normochromatic erythrocytes from reticulocytes and leukocytes, the second reagent comprising a second fluorochrome having a fluorescent emission spectrum that does not substantially overlap with the fluorescent emission spectra of the first fluorochrome; exciting the first and second fluorochromes with light having a wavelength suitable to induce fluorescence thereof; and detecting the fluorescent emission and light scatter produced by erythrocytes labeled with the first fluorochrome, while excluding nucleated cells but not reticulocytes labeled by the second fluorochrome, and counting the number of GPI anchor-deficient erythrocytes and/or reticulocytes relative to the number of total erythrocytes and/or reticulocytes, respectively, wherein a statistically significant deviation in the frequency of GPI-anchor-deficient erythrocytes and/or reticulocytes from a baseline frequency of GPI-anchor-deficient erythrocytes and/or reticulocytes in unexposed or vehicle control mammals indicates the mutagenic DNA-damaging potential of the agent.