Historical
EP07-A
Interference Testing in Clinical Chemistry; Proposed Guideline
Intended to promote uniformity in the evaluation of interference characteristics of clinical laboratory methods. EP7 describes procedures for manufacturers to screen potentially interfering substances, to quantify interference effects, and to confirm interference in patient samples. This document also describes procedures for clinical laboratories to verify interference claims, and to investigate discrepant results caused by unsuspected interfering substances. Detailed examples are given. EP7 also contains background information on interference testing concepts, tables of recommended test concentrations for analytes and potential interference, and data collection and analysis worksheets. FDA
Clinical And Laboratory Standards Institute [clsi]