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ToxSci Advance Access published online on February 2, 2005
Toxicological Sciences, doi:10.1093/toxsci/kfi099
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Toxicological Sciences © 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
Received November 30, 2004
Accepted January 28, 2005

Review

Diagnosis: toxic! - Trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations

Sebastian Hoffmann 1 and Thomas Hartung 2*

1 European Commission, JRC - Joint Research Centre, Institute for Health & Consumer Protection, ECVAM - European Centre for the Validation of Alternative Methods, 21020 Ispra (VA), Italy
2 European Commission, JRC - Joint Research Centre, Institute for Health and Consumer Protection, ECVAM - European Centre for the Validation of Alternative Methods, Via E. Fermi 1, TP 580, 21020 Ispra (VA), Italy. Tel.: +39 0332 785939; Fax: +39 0332 786297

* To whom correspondence should be addressed.
Thomas Hartung, E-mail: Thomas.HARTUNG{at}cec.eu.int


  Abstract

The assessment of relevance of toxicological testing was compared with approaches of diagnostic medicine, a discipline which 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 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.

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