Standards, Reference Substances, Quality Control Substances, and
Standard: refers to the reference material used for identification, inspection, content determination, for biological determination, antibiotics or biochemical drugs in the content or titer determination of the reference material, according to the titer unit or in g, to international standards for calibration.
Reference substance: refers to the reference substance used for identification, inspection, and content determination. Unless otherwise specified, it is calculated as a dry product (or anhydrous substance) and used.
Calibrator: a calibrator, having a reference material used as the value of an independent variable in the calibration function; it should have a fixed value and a known measurement uncertainty, and its purpose should be to calibrate a measurement system so as to establish the metrological traceability of the measurement results of this system.
Quality Control Substances: Quality control substances (fixed and non-fixed values) used in in vitro diagnostics. They are substances, materials, articles or equipment used in detection systems intended for medical use. Their purpose is to evaluate or verify performance characteristics such as measurement precision, measurement accuracy, analytical bias that may occur in detection systems due to changes in reagents or analytical instruments. Quality control substances (fixed and non-fixed values), which can be used for capability verification, quality control in laboratories.
Fixed value quality control product: fixed valueQuality ControlThe manufacturer uses the appropriate analytical method or process to analyze the reference value and specifies the reference range.
Non-fixed-value quality control products: Non-fixed-value quality control products can be labeled with the target concentration (e.g. low, high, medium), but there is no specified reference range, and the analysis and testing system for the application of non-fixed-value quality control products cannot be specified, but the system rules for quality control must be met.
Reference: A material or substance having one or more sufficiently uniform and well-defined properties to calibrate a measuring device, grade a measurement method, or assign a value to a material
