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Replication index in cultured human lymphocytes: Methods for statistical analysis and possible role in genetic toxicology

The replication index (RI) is an index of cytokinetics in cultured cells. This paper presents statistical methods for the analysis of RI data. It also proposes formulas for the calculation of RI and its standard error. The proposed statistical analysis may be applied only in cases when replicate cultures are used. If duplicate or repeated cultures are used, the interculture variation may provide a more suitable error term for RI. Determining the RI in human blood cultures may be useful in genotoxicity testing, because inhibition of DNA synthesis will result in a decrease of the RI. Monte Carlo methods are used to show that the sensivity of the proposed method is roughly equivalent to that of a χ2 test. Power studies indicate that for the study sample, no less than 200 cells should be analyzed when assessing the RI.