Technical validity and clinical validity

The distinction needs to be made between the technical validity and the clinical validity of a test. One may demonstrate the analytical specificity of a test, detection of IgE that will react with particular antigens reliably and reproducibly in vitro. This does not necessarily mean that the person whose serum was the source of the specific IgE will have a clinical problem with that food, the clinical specificity of the test. For this the clinician needs information about the test's diagnostic performance when compared against the DBPCFC. This information is often not available. The manufacturer should demonstrate the technical validity of the test by ensuring its analytical sensitivity, analytical specificity, accuracy and precision. The performance of the test when measured against the clinical problems of the patient from whom the serum was extracted has been discussed earlier.

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