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Interstitial cell adenoma of the rat testis: why is it such a problem in toxicology studies using Sprague-Dawley
1Schering-Plough Research Institute, Lafayette, New Jersey 07848, USA.
Abstract:
Arbitrary criteria can give unreliable diagnoses. Conditions that occupy the same marginal diagnostic space, such as interstitial cell hyperplasia and interstitial cell adenoma, sometimes will be mistaken for one another. When the true prevalence is low, the risk of false positives, as a percentage of all positives, is high. The preceding analysis predicts that, with currently recommended diagnostic criteria, any compound that causes nonneoplastic interstitial cell hyperplasia will be interpreted to cause interstitial cell neoplasia if SD rats are used and only microscopic diagnoses are considered. Conversely, the analysis predicts that no compound that actually causes neoplasia in interstitial cells will be identified as an interstitial cell tumorigen if F-344 rats are used and only microscopic diagnoses are considered. These predictions are consistent with experience.