Term | Definition |
Analyte | A substance that is being identified or measured in a laboratory test. |
Calibration | A mechanism to check the precision and accuracy of a test system, such as an automated analyzer, to determine if the system is providing accurate results. Calibration is typically performed using a calibration device, often called a standard. |
Clinical diagnosis | A tentative diagnosis of a patient's condition obtained through evaluation of the health history and the physical examination, without the benefit of laboratory or diagnostic tests. |
Control | A solution that is used to monitor a test system to ensure the reliability and accuracy of test results. |
Fasting | Abstaining from food or fluids (except water)for a specified amount of time before the collection of a specimen. |
Homeostasis | The state in which body systems are functioning normally, and the internal environment of the body is in equilibrium; the body is in a healthy state. |
In vivo | Occurring in the living body or organism. |
Laboratory test | The clinical analysis and study of materials, fluids, or tissue obtained from patients to assist in diagnosis and treatment of disease. |
Nonwaived test | A complex laboratory test that does not meet the CLIA criteria for waiver and is subject to the CLIA regulations. |
Plasma | The liquid part of the blood, consisting of a clear, yellowish fluid that comprises approximately 55% of the total blood volume. |
Product insert | A printed document supplied by the manufacturer with a laboratory test product that contains information on the proper storage and use of the product. |
Profile | An array of laboratory tests for identifying a disease of state or evaluating a particular organ or organ systems. |
Qualitative test | A test that indicates whether or not a substance is present in the specimen being tested and also provides an approximate indication of the amount of the substance present. |
Quality control | The application of methods to ensure that results are reliable and valid and that errors are detected and eliminated. |
Quantitative test | A test that indicates the exact amount of a chemical substance that is present in the body, with the results being reported in measurable units. |
Reagent | A substance that produces a reaction with a patient specimen that allows detection or measurement of the substance by the test system. |
Reference range | A certain established and acceptable parameter or reference range within which the laboratory test results of a healthy individual are expected to fall. |
Routine test | A laboratory test performed routinely on apparently healthy patients to assist in the early detection of disease. |
Serum | The clear, straw-colored part of the blood (plasma) that remains after the solid elements and the clotting factor fibrinogen have been seperated out of it. |
Specimen | A small sample of something taken to show the nature of the whole. |
Test system | A setup that includes all of the test components required to perform a laboratory test such as testing devices, controls, and testing reagents. |
Waived test | A laboratory test that meets the CLIA criteria for being a simple procedure that is easy to perform and has a low risk of erroneous test results. Waived tests include tests that have been FDA-approved for use by patients at home. |