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However, comparability studies are not always an option, especially for the introduction of a method to a new laboratory. Access to original validation data and suitable reference sample panels then becomes essential to provide evidence that the assay remains 'fit for the intended purpose'.Any modification to a validated assay must be evaluated in terms of the impact on the assay's performance characteristics and whether the assay remains fit for the intended purpose. The comparison is referred to as a 'method comparison', 'method compa
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