How Reliable is Laboratory Testing?
Introduction For many people, clinical laboratory testing is an invisible side of medical care. Yet many of the decisions your health care provider makes 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. Your provider trusts the results coming from the lab. That trust is well placed. Clinical laboratory testing is held to very high standards. • A test method must meet scientifically rigorous criteria before it can be used in clinical practice. In the U.S., the Food and Drug Administration (FDA) reviews the scientific evidence that: • the test is able to detect or measure the substance it claims to detect or measure, and • 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. • A laboratory must demonstrate that it is able to perform
For many people, clinical laboratory testing is an invisible side of medical care. Yet many of the decisions your health care provider makes 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. Your provider trusts the results coming from the laboratory and that trust is well placed. Clinical laboratory testing is held to very high state and federal regulatory standards. • All laboratory test methods must meet scientifically rigorous criteria before they can be used in clinical practice. For commercial tests in the U.S., the Food and Drug Administration (FDA) reviews the scientific evidence to ensure that: • the test is able to detect or measure the substance it claims to detect or measure, and • 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
