Criteria for validation of methods in microbial forensics.
Budowle-B; Schutzer-SE; Morse-SA; Martinez-KF; Chakraborty-R; Marrone-BL; Messenger-SL; Murch-RS; Jackson-PJ; Williamson-P; Harmon-R; Velsko-SP
Appl Environ Microbiol 2008 Sep; 74(18):5599-5607
Validation is an essential process for any scientific discipline, including the evolving field of microbial forensics. It is important to define, or at the very least describe, what one means by the term validation and what parameters were tested in the development of a method. The description of validation should encompass the context and purpose of that which is being validated. As a field still developing, microbial forensics has a motivation and an unencumbered opportunity to define validation more explicitly. Therefore, a minimum set of criteria that should be considered in developing a validation plan for microbial forensic methods have been presented herein. These criteria apply to global goals, the collection process, transport and storage under a chain of custody, laboratory procedures, and interpretation. It is not possible to be all inclusive because of the wide diversity of samples and sample types for which microbial forensic methods may be applied. Therefore, this outline serves as a guiding document, rather than an exhaustive prescriptive one. Careful consideration of the criteria presented here will be useful for transitioning research efforts into operational microbial forensic settings. Application of these criteria also will be useful for generally improving the quality of microbial forensic research efforts and laying a solid foundation for developing the field of microbial forensic science.
Microbiology; Microorganisms; Sample-preparation; Sampling-methods; Analytical-processes; Quality-standards; Quality-control
Steven E. Schutzer, UMDNJ-New Jersey Medical School, Newark, NJ 07103
Applied and Environmental Microbiology
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