Clinical Performance: According to ISO 20916:2019, the purpose of the clinical performance studies is to assess the ability of an in vitro diagnostic medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population.
Clinical Utility: Clinical utility is an indicator of whether the use of a test leads to improved patient outcomes and the risks posed by the test; it is an essential factor influencing the decision of clinicians to use the test. Clinical utility studies include potential benefits and harms in terms of the patient perspective, recognition of the beneficial and/or harmful outcomes that are results of decisions guided by test results, and that may occur at different time points.
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