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Critical Factors Impacting Interlaboratory Transferrability of the Mouse Embryonic Stem Cell Test

Published: October 5th, 2009
by Hans A. Raabe, Angela M. Sizemore, Erica L. Dahl and Daniel M. Bagley

SUMMARY
The EST has been formally validated by the European Centre for the Validation of Alternative Methods (ECVAM) as an acceptable in vitro embryotoxicity assay. During the prevalidation trials, the technology was easily transferred between laboratories in the European Union. However, transferring the assay to the Institute for In Vitro Sciences (IIVS) was problematic. Though we were able to provide good quality data, we experienced significant difficulty consistently running assays that passed our quality control criteria, which specify that at least 87.5% of the negative control cultures in the differentiation assay must contain well differentiated, beating myocytes. We began a research program to examine the parameters and technical factors which may have impacted our ability to consistently run this assay.

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