ToxSci Advance Access originally published online on December 22, 2003
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Toxicological Sciences 78, 107-115 (2004)
Society of Toxicology
Extended Histopathology in Immunotoxicity Testing: Interlaboratory Validation Studies
* Laboratory of Molecular Toxicology/National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina (RTP, NC); Laboratory of Experimental Pathology, National Institute of Environmental Health Sciences, RTP, NC; Biostatistics Branch, National Institute for Occupational Safety and Health, Morgantown, West Virginia; TNO Nutrition and Food Research, Zeist, The Netherlands; ¶ Laboratory of Computational Biology and Risk Assessment, National Institute of Environmental Health Sciences, RTP, NC; || Pathology and Physiology Research Branch, National Institute for Occupational Safety and Health, Morgantown, West Virginia; ||| Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan; and |||| Toxicology and Molecular Biology Branch, National Institute for Occupational Safety and Health, Morgantown, West Virginia
Received September 22, 2003; accepted November 28, 2003
There has been considerable interest in the use of expanded histopathology as a primary screen for immunotoxicity assessment. To determine the utility of a semiquantitative histopathology approach for examining specific structural and architectural changes in lymphoid tissues, a validation effort was initiated. This study addresses the interlaboratory reproducibility of extended histopathology, using tissues from studies of ten test chemicals and both negative and positive controls from the National Toxicology Program's immunotoxicology testing program. We examined the consistency between experienced toxicologic pathologists, who had varied expertise in immunohistopathology in identifying lesions in immune tissues, and in the sensitivity of the individual and combined histopathological endpoints to detect chemical effects and dose response. Factor analysis was used to estimate the association of each pathologist with a so-called "common factor" and analysis-of-variance methods were used to evaluate biases. Agreement between pathologists was highest in the thymus, in particular, when evaluating cortical cellularity of the thymus; good in spleen follicular cellularity and in spleen and lymph node-germinal center development; and poorest in spleen red-pulp changes. In addition, the ability to identify histopathological change in lymphoid tissues was dependent upon the experience/training that the individual pathologist possessed in examining lymphoid tissue and the apparent severity of the specific lesion.
Key Words: immunology; pathology; spleen; thymus; lymph node; histopathology; immunopathology; risk assessment.
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