Abstract
Ancillary tests, including histochemical analyses, immunohistochemistry (IHC), in situ hybridization, and a panoply of established and emerging molecular techniques, are designed with the hope that results generated by these tests will improve diagnostic accuracy, provide for better prediction of response to targeted therapies, and lead to overall better patient management. Using IHC as an example, the attendant risks to better practice through ancillary testing can be discussed. While understanding how the specificity of a reagent for its analyte forms a solid foundation for the development and implementation of clinically useful ancillary tests, mitigation of potential error in these testing systems can only be achieved through careful development of appropriate controls on which optimization/calibration and validation of the method can be based. However, even within the framework of a validated assay, errors in diagnosis and clinical management may emerge. Proper use of evidence may diminish the likelihood of error in the use and interpretation of ancillary tests, but some level of error is implicit in the system, and the risk of error may increase with the use of ancillary tests if not properly mitigated.
Published Version
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