Technologies to Enable Autonomous Detection for BioWatch Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary (2014) / Chapter Skim
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Appendix F: White Paper 1: The BioWatch Program: What Information Is Needed to Inform Decision Making?
Appendix F: White Paper 1: The BioWatch Program: What Information Is Needed to Inform Decision Making?
Pages 145-154
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Director, Division of Molecular Diagnostics and Virology Massachusetts Department of Public Health Bureau of Laboratory Sciences A white paper prepared for the June 25–26, 2013, workshop on Strategies for Cost-Effective and Flexible Biodetection Systems That Ensure Timely and Accurate Information for Public Health Officials, hosted by the Institute of Medicine's Board on Health Sciences Policy and the National Research Council's Board on Life Sciences. The author is responsible for the content of this article, which does not necessarily represent the views of the Institute of Medicine or the National Research Council.
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is a laboratory test result indicating that multiple nucleic acid signatures specific to an individual biological agent have been detected in the environment. Prior to determining a BAR, a two-tiered testing process occurs: (1)
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Once a laboratory BAR has been determined, a number of rapid local and national notifications occur within the jurisdiction, including notification to convene a conference call within 2 hours to discuss the laboratory BAR with the local BioWatch Advisory Committee (BAC) , or a BAC subset with key representation.
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estimation of the time for the next BAC conference call. The BioWatch national conference call occurs immediately following the local jurisdictional BAC call and begins with a summary by the BAC chair of the current situation, follow-on actions, requests for federal assistance from the various agencies (DHS, CDC, FBI, EPA, or the strategic national stockpile)
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Specifically, qualified laboratory testing staff must demonstrate ongoing individual competency as well as participate in overall laboratory proficiency assessments. Each laboratory is responsible for maintaining all of the components of a comprehensive quality assurance plan (standardized methods, staff training, proficiency tests, stringent record keeping, equipment maintenance, corrective action protocols, etc.)
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At the time, the laboratory test reagents within the test panel were not specific enough to differentiate between virulent and avirulent subspecies of this organism. Since this event BioWatch has introduced an additional set of laboratory reagents to rapidly differentiate between virulent and avirulent subspecies.4 These two examples highlight the need for flexibility in the panel of agents detected -- to improve upon the performance of a reagent, remove the organism from the panel, or adjust a local threshold -- if repeated detections in the natural environment act as a "red herring." One limitation of the current system has been the length of the turnaround time -- the time between when the air sample collection begins and a laboratory test result is reported.
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To ensure the public health mission of staying abreast of modern disease diagnostics, CDC has initiated a fiscal year 2014 budget request to fund the Advanced Molecular Detection and Response to Infectious Disease Outbreaks initiative.5 While this effort focuses on next-generation sequencing methods and the application of bioinformatics to public health science and practice, other methodologies, such as mass spectrometry, are rapidly emerging on the clinical diagnostics front (van Belkum et al., 2012) and being adopted within the public health laboratory network.
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While this information is important to confirm a source, it may not add immediate value to public health response decisions unless the information improves upon the ability to discriminate between closely related species. Examples include differentiation between virulent and avirulent Francisella tularensis subspecies or the resolution of closely related species such as Burkholderia mallei and Burkholderia pseudomallei.
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Saving a portion of the test sample to verify by other test meth ods would be highly desirable. Provision for the option for some jurisdictions to perform basic autonomous detection reagent loading and quality checks is de sirable and would facilitate a familiarity with the technology and its inherent limitations.
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The public health laboratory must be provided with sufficient data to be familiar with the instrument's performance, including its limitations, in order to instill trust and confidence in the quality of the data. This is critical to ensure technical competence and expertise in interpreting the results of an autonomous detector BAR for public health officials and other key stakeholders involved in response actions.
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