The expected reaction or concentration of analytes is within known limits to cause either positive or negative results when used in place of a human sample. They are materials that contain assay-specific analyte in an assay-compatitive matrix are tested with patient samples to ascertain the reliability of the assay. The purpose in running an assay using QC material is to assure users that the device is functioning according to its labeling within the limit of what the material is designed to control for.
Quality Control
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