"Normal values" for the lymphocyte cytokinesis-block micronucleus cytome parameters: Repeatability and reproducibility in a healthy reference population.

The micronucleus test in peripheral blood lymphocytes is the most widely validated technique to evaluate the DNA damage and chromosomal instability in human populations. The test is largely applied in monitoring environmental and occupational exposure to genotoxic agents. It was also proposed as a biomarker of risk/susceptibility for cancer and other degenerative diseases. The availability of "normal values" in healthy populations is a main requisite for the assay application in human biomonitoring. Age and gender-related ranges of micronucleated binucleated cells (MNBN) baseline values were established in a group of 103 healthy platelet donors (50 males and 53 females) not recently exposed to genotoxic agents and characterized for demographic, lifestyle and dietary factors. Repeatability of the test by the same scorer was evaluated. Reproducibility was estimated through analysis of repeated blood samples. High correlation between the results of the three blood samplings in two separate scoring sessions of MNBN/1000BN (R values were 0.83, 0.74 and 0.68; P < 0.0001) and PI values (R values were 0.69, 0.62 and 0.65; P < 0.0001) was detected. High consistency among the values obtained in three different samplings in the same individual was observed (Intraclass Correlation Coefficient (ICC) = 0.905, (95% CI = 0.868-0.933, P < 0.0001) The range of "normal" values predicted on the basis of the results of the present study appears to be sufficiently narrow to warrant application of the assay in the comparison of data obtained from groups of exposed or susceptible subjects, supporting its use in preventive programs. The large inter-individual variability predicted by the model used in the present study hampers a clinical application of the assay at individual level. The method applied in the present study represents a generally applicable model to derive "normal values" in any population, as an essential step before starting a biomonitoring study.