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Abstract:
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Establishing adequate success criteria to evaluate the performance of diagnostic devices depends on several factors. These include the intended use of the medical test, how results provided by the diagnostic will be interpreted by the user, and clinical claims. Different types of success criteria to evaluate the performance of diagnostics will be discussed taking into consideration, for example, whether the device is intended to be used as an adjunct or as a replacement to other established diagnostics, benefits and risks from increased adherence to testing, and implicit or explicit tradeoff between false positive and false negative test errors.
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