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ToxSci Advance Access originally published online on February 2, 2005
Toxicological Sciences 2005 85(1):422-428; doi:10.1093/toxsci/kfi099
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Toxicological Sciences vol. 85 no. 1 © The Author 2005. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org

REVIEW

Diagnosis: Toxic! – Trying to Apply Approaches of Clinical Diagnostics and Prevalence in Toxicology Considerations

Sebastian Hoffmann and Thomas Hartung1

European Commission, JRC–Joint Research Centre, Institute for Health & Consumer Protection, ECVAM–European Centre for the Validation of Alternative Methods, 21020 Ispra (VA), Italy

Received November 30, 2004; accepted January 28, 2005

The assessment of relevance of toxicological testing was compared with approaches of diagnostic medicine, a discipline that faces a comparable situation. Considering the work of a toxicologist as setting a diagnosis for compounds, assessment tools for diagnostic tests were transferred to toxicological tests. In clinical diagnostics, test uncertainty is well accepted and incorporated in this assessment. Furthermore, prevalence information is considered to evaluate the gain in information resulting from the application of a test. Several common toxicological scenarios, in which test uncertainty and prevalence are combined, are discussed including the interdependence of test accuracy, prevalence and predictive values or the sequential application of a screening and a confirmatory test. In addition, real prevalences derived from prevalences determined by an imperfect test are presented. We conclude that information on prevalences of toxic health effects is required to allow a complete assessment of the relevance of toxicological test. In this process, lessons can be learned from evidence-based approaches in clinical diagnostics.

Key Words: prevalence; validation; evidence-based medicine; biometry; reference standard; risk assessment.


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