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Micronucleus (MN) assay in buccal exfoliated cells is a minimally invasive method for monitoring genetic damage in human populations. Statistical and epidemiological issues related to the design and analysis of studies based on this biomarker are addressed.

A systematic review of recent literature on the buccal MN assay has been carried out to provide a state-of-the-art evaluation of how critical topics such as control for confounding, sample size and statistical power, number of cells scored, endpoint selection, and statistical modelling, are considered. In addition, a meta-analysis has been performed to estimate the impact of most common confounders on MN frequency, and to provide a baseline value of MN frequency in the control population.

A total number of 63 eligible studies were included in the analysis. Age (98.4%), gender (85.7%), and smoking habit (90.5%) were the …