FSIS Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods
Guideline ID FSIS-GD-2010-0004
Issue Date October 2010
This guidance provides information about designing pathogen testing kits so that they will be appropriate for their intended use, perform comparably to the FSIS method (if applicable), and not have introduced modifications that could compromise test performance. It applies to test kit developers, laboratories, and independent validation organizations who design test kits or test for Escherichia coli O157:H7 or non-O157 Shiga toxin producing E. coli (nonO157 STEC). Establishments may use such pathogen test kits to ensure compliance with the requirements of 9 CFR 417.
Disclaimer: The contents of this guidance document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.