Clinical Validation

Clinical validations are intended to show that the results produced by an assay correlate with clinical disease. Neither CLIA '88 nor CAP requires the clinical validation of an assay prior to implementation of its use in a testing laboratory. Although clinical validations are not required before testing, these types of validation study are still needed before the assay can be used for clinical diagnosis. In many instances, clinical studies for a given analyte have been performed and published and the results of these studies can be extended to similar assays developed or introduced elsewhere. However, care must be taken in interpreting these findings. Because of lack of standardization among most molecular assays (especially home-brew assays), the results from one assay are not necessarily equivalent to a similar assay performed in a different laboratory.

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