Glossary of terms (terminology and key principles).
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Ability of an in vitro medical assay to conform to predefined quality specifications (e.g. as defined by the Stockholm Conference hierarchy or in clinical guidelines)
Consequences of testing beyond clinical effectiveness and cost-effectiveness (e.g. acceptability, social, psychological, legal, ethical, societal, organizational consequences and other aspects).
Ability of a test to improve health outcomes that are relevant to the individual patient.
A description of typical processes of care in managing a specific condition in a specific group of patients.
Ability of a biomarker to conform to predefined clinical specifications in detecting patients with a particular clinical condition or in a physiological state.
A cost-effectiveness analysis compares the changes in costs and in health effects of introducing a test, to assess the extent to which the test can be regarded as providing value for money.
A characteristic or event that can be measured to assess the impact of clinical care on an individual’s health. It describes or reflects how an individual feels, functions or survives.
In vitro medical assay
A measurement procedure undertaken on a biological specimen which measures the quantity of the biomarker (see below) intended to be measured; i.e. the measurand.
In vitro medical test
In vitro medical tests or testing strategies utilize laboratory assays of biomarkers in a specific clinical context and for a specific clinical purpose (see below), in a specific patient population.