Criteria for validation of methods in microbial forensics.

摘要: A process for validation is essential in the development of methods that microbial forensics uses to generate reliable and defensible results. Law enforcement investigators need respond quickly best leads counter ever-increasing threats will rely upon results generated from analyses any forensic evidence attempt attribute attack a person(s) or group. Readily available technology knowledge are making it easier an individual group carry out biocrimes bioterrorism using microorganisms toxins as weapons. The potential biological weapon be used serious concern safety security people critical infrastructure. If biocrime committed, sought, collected, characterized help identify perpetrator(s) exclude innocent suspects. Analyses collected material often challenging because identification signatures most useful attribution requires substantial effort (3). In addition, some specimens can limited quantity and/or quality. Despite these demands, accurate credible needed interpretation such might seriously impact course focus investigation, thus affecting liberties individuals, even justification government’s military response attack. Therefore, collection, extraction, analysis could key scientifically robust possible so they legal community (12, 21) and, perhaps, international government, law enforcement, scientific communities. Proper relies substantially on understanding performance limitations collection analytical processes, assays, involved. Failing properly validate method misinterpreting may have severe consequences. DEFINING VALIDATION Validation frequently connote confidence test process. However, frequently, not well defined described context. Not being explicit about what meant by result misinterpretation misapplication performed test. It also lead false sense poor method. nascent field (5), there better describe constitutes validation. strict delineation steps too restrictive; myriad methods, targets, platforms, applications. Yet basic requirements transcend differences reinforced contextual description illustrated with examples. reliability dire This paper provides framework developing plan application other fields where “validation” colloquially.