Are these data accepted by regulatory agencies?
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Yes. Data obtained using the MicroFlow method have been evaluated and accepted by the regulatory authorities in the US and EU. These results meet OECD test guideline 474 and comply with the new ICH S2(R1) guideline. See at right.
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Does this method meet OECD test guideline 474 for micronucleus assays?
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Yes. The guideline states “Systems for automated analysis (image analysis and cell suspensions flow cytometry) are acceptable alternatives to manual evaluation if appropriately justified and validated.”
Assays are considered validated if they meet the criteria as determined by the International Workshop on Genotoxicity Testing (IWGT) in this article. To meet these criteria, a method must:
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- Provide % MN-RET, % MN-NCE and % RET.
- Identify fragments and whole chromosomes.
- Score consistently within and between experiments.
- Understand how known artifacts behave in the system.
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MicroFlow kits meet all of these criteria. |
Are MicroFlow BASIC analyses, performed at Litron, GLP-compliant?
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Yes. Litron routinely performs these analyses and complies with FDA GLP regulations and the OECD Principles of GLP. For more information, please contact us.
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Does this method comply with the new ICH S2(R1) guideline?
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Yes. The guideline states “Systems for automated analysis (image analysis and flow cytometry) can be used if appropriately validated…” Assays are considered validated if they meet the criteria as determined by the International Workshop on Genotoxicity Testing (IWGT) in this article. See the criteria, at left, under "Does this method meet OECD test guideline 474 for micronucleus assay?"
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The guideline states “…each laboratory should determine the appropriate minimum sample size to ensure that scoring error is maintained below the level of animal-to-animal variation." and
“Rat blood can be used for micronucleus analysis provided: |
- Methods are used to ensure analysis of the newly formed reticulocytes…
- And the sample size is sufficiently large to provide appropriate statistical sensitivity…”
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MicroFlow kits meet all the criteria of IWGT. They restrict analysis to the newest red blood cells (newly formed reticulocytes). In addition, 20,000 cells can be routinely analyzed per sample that is sufficiently large to be below the level of animal-to-animal variation, as well as providing the appropriate statistical sensitivity. |
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