Proceedings of the International Cyanide Detection Testing Workshop

Vocabulary, 1994
4.5 Foundations of Clinical Research, Applications to Practice, Leslie Gross Portney, Mary
Watkins, Appleton & Lange, 1993
4.6 Validation and Peer Review of U.S. Environmental Protection Agency Chemical Methods
of Analysis”, Forum on Environmental Measurements, October 14, 2005
4.7 Protocol for the Design, Conduct, and Interpretation of Method-Performance Studies,
Pure and Applied Chemistry, 67, No. 2, 1995, 331-343.
4.8 Harmonized Guidelines for Single-laboratory Validation of Methods of Analysis, Pure
and Applied Chemistry, 2002, 74, 835 - 855.”
5. Specifi c Procedure(s):
5.1 Prior to submitting methods to the network:
5.1.1 The intended use of the method should be defi ned
5.1.2 The intended use should be aligned with network capabilities
5.1.3 A study plan for method validation should be submitted to and approved by the
involved network for review before starting the validation.
5.1.4 A written procedure which includes all the following elements must be prepared:
• Intended use and criteria for use
• Assay principle and safety precautions
• Acceptable sample types, sample collection method, preparation, preservation,
storage and transportation conditions
• Description of reagents supplied or directions for preparation and QC
• Description of quality controls to be used.
• Detailed instructions on how to perform the method.
• Detailed instructions on how to interpret and report the result. ,
• Any limitations of the method that are known or suspected
• A summary of the performance characteristics of the method
5.1.5 Written directions (specifi cations) for the production and QC of the reagents, if
provided for the method
5.2 Methods should be validated whenever any of the following occur:
5.2.1 Submission of a new method to the network for inclusion as an offi cial method.
5.2.2 Expansion of the scope of an existing network method to include additional analytes
66