Calibration product, standard product and quality control product are all reference materials. A reference substance is a material or substance for which one or more characteristic values are only sufficiently uniform and well determined for use in calibrating a measurement system, evaluating a measurement procedure, or assigning a value to a material. But the three do not use the same concept, they have their own different applications. The following is a small edition of Bolinda to introduce you to the definition of standard products, control products, quality control products and reference products.

Definition of standard, reference, quality control and reference:

Reference substance: refers to the reference substance used for identification, inspection and content determination, the reference substance used for the determination of content or titer in biological determination, antibiotics or biochemical drugs, according to the titer unit or g, and is calibrated to the international standard.

Reference products: refers to the standard substances used for identification, inspection and content determination, unless otherwise specified, are used after calculation according to dry products (or anhydrous substances).

Calibrator: a calibrator, having a reference substance used as an independent variable value in the calibration function; It should have a fixed value and known measurement uncertainty, and its purpose should be to calibrate a measurement system and thus establish the metrological traceability of the measurement results of the system.

Quality control product: A quality control substance (fixed and non-fixed value) for in vitro diagnostics is a substance, material, article or device used in a test system intended for medical use, whose purpose is to evaluate or verify the performance characteristics of measurement precision, measurement accuracy, analytical deviations that may arise from the test system due to changes in reagents or analytical instruments. Quality control substances (both fixed and non-fixed) can be used for capability verification, laboratory quality control.

Fixed value quality control product: The fixed value quality control product has a reference value for the manufacturer to use the appropriate analytical method or process analysis, and specifies the reference range.

Non-fixed value quality control products: non-fixed value quality control products can mark the target concentration (such as: low, high, medium) on the label, but there is no specified reference range, you can not specify the analysis and test system for non-fixed value quality control products, but must meet the quality control system rules.

Reference: A material or substance having one or more sufficiently uniform and well defined properties to be used for calibrating a measuring device, grading a measurement method, or assigning a value to a material.

The above content is to introduce the definition of standard products, reference products, quality control products and reference products. There are often many wrong applications in clinical practice, such as applying calibration products from different manufacturers to detection systems; Use a given value of the quality control product evaluation and testing system; Use quality control products to calibrate inspection systems, etc. The source and setting method of calibration, standard and quality control products, and the method of correctly using three reference substances are obtained.