STUDIES ON VARIABILITY OF THE MICROMASS TERATOGEN TEST

The micromass assay is an in vitro test that can be used to predict the teratogenic potential of compounds being developed in the pharmaceutical and chemical industries. The assay is currently undergoing validation by an interlaboratory blind trial at several national and international institutions. The present paper investigates some areas of the assay system where variability in technique may influence the reproducibility of the test results. The main areas identified are possible variations in the micromass preparation procedure (for example in terms of the precise source of tissue and the time taken), degrees of subjectivity in the endpoint measurement and possible variations in the experiment design. Control of these sources of variability increases the reproducibility of the results. © 1990.