ANTHRAX : Agency Approaches to Validation and Statistical Analyses Could Be Improved

Abstract

In 2001, the FBI investigated an intentional release of B. anthracis, a bacterium that causes anthrax, which was identified as the Ames strain. Subsequently, FBI contractors developed and validated several genetic tests to analyze B. anthracis samples for the presence of certain genetic mutations. The FBI had previously collected and maintained these samples in a repository. GAO was asked to review the FBIs genetic test development process and statistical analyses. This report addresses (1) the extent to which these genetic tests were scientifically verified and validated; (2) the characteristics of an adequate statistical approach for analyzing samples, whether the approach used was adequate, and how it could be improved for future efforts; and (3) whether any remaining scientific concerns regarding the validation of genetic tests and statistical approaches need to be addressed for future analyses. GAO reviewed agency and contractor documentation, conducted literature reviews, and conducted statistical analyses of the repository data. GAOs review focused solely on two aspects of the FBIs scientific evidence: the validation of the genetic tests and the statistical approach for the analyses of the results. GAO did not review and is not taking a position on the conclusions the FBI reached when it closed its investigation in 2010. GAO recommends that the FBI develop a framework for validation and statistical approaches for future investigations. The FBI agreed with our recommendations.

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Document Details

Document Type
Technical Report
Publication Date
Dec 01, 2014
Accession Number
AD1177571

Entities

People

  • Amy Bowser
  • Elaine Vaurio
  • Hazel Bailey
  • James Ashley
  • Jan Montgomery
  • Mae Liles
  • Penny Pickett
  • Pille Anvelt
  • Sushil Sharma
  • Timothy M. Persons

Organizations

  • United States Government Accountability Office

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Accuracy
  • Chemical Reactions
  • Computational Science
  • Congress
  • Databases
  • Department Of Homeland Security
  • Detection
  • Genetic Markers
  • Genetic Testing
  • Genetic Variation
  • Genetics
  • Governments
  • Literature Surveys
  • Microbial Genetics
  • Microbiology
  • Microorganisms
  • Public Health
  • Standards
  • Statistical Analysis
  • Test And Evaluation
  • Test Methods
  • United States
  • United States Government

Readers

  • Molecular and genetic basis of cancer.
  • Regression Analysis.
  • Systems Analysis and Design

Technology Areas

  • Biotechnology