scope:

This document is intended to serve two purposes:

1) to assist manufactures and other developers of laboratory measurement procedures in characterizing the susceptibility of measurement procedures to interfering substances, by offering scientifically valid experimental designs, by specifying the relevant substances and concentrations to be tested, and by clarifying appropriate data analysis and interpretation, so that potential hazards can be evaluated and meaningful interference claims may be provided to users; and

2) to assist clinical laboratories in investigating discrepant results due to interfering substances, by defining a systematic investigation strategy, by specifying data collection and analysis requirements, and by promoting greater cooperation between laboratory users and manufacturers, so that new interferences can be identified, disclosed, and ultimately eliminated.

This guideline is intended for manufacturers of in vitro diagnostic medical devices and clinical laboratories.

Manufacturers and other developers of laboratory measurement procedures are responsible for characterizing the analytical performance of their procedures and analyzing hazards to patients caused by errors due to interfering substances.

Manufacturers are required to provide information about interference susceptibility to those who use their systems. NOTE: The term "manufacturer," for the purpose of this document, is used to mean anyone that develops a measurement procedure for use in a clinical laboratory.

Clinical laboratories are responsible for ensuring that measurement procedures are specific enough to meet the needs of their physician clients. Laboratories should also investigate discrepant results, identify interfering substances, and provide objective feedback to the manufacturers who supply their analysis systems.