![]() Laboratories must perform routine quality control tests, usually every day, and in many cases, several times a day.State and federal regulatory agencies monitor the laboratory and set standards that a laboratory must meet in order to be allowed to perform the test. the measurement or detection of this substance provides important information about an illness or about health status that assists in the diagnosis, treatment, or monitoring of a patient.įor more on the regulation and evaluation of test development, see the article Putting New Laboratory Tests into Practice.Ī laboratory must demonstrate that it is able to perform that test in a clinically acceptable way.the test is accurately able to detect or measure the substance it claims to detect or measure, and.For commercial tests in the U.S., the Food and Drug Administration (FDA) reviews the scientific evidence to ensure that: Clinical laboratory testing is held to very high state and federal regulatory standards.Īll laboratory test methods must meet scientifically rigorous criteria before they can be used in clinical practice. Your provider trusts the results coming from the laboratory and that trust is well-placed. Yet many of the decisions you and your healthcare provider make about your health status – obtaining a diagnosis, developing a course of action for treatment, or monitoring your body’s response to therapy – are based on laboratory data. For many people, clinical laboratory testing is an unfamiliar side of medical care. ![]()
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