BioWatch PCR Assays Building Confidence, Ensuring Reliability: Abbreviated Version (2015) / Chapter Skim
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2 Performance Standards Provide Confidence in Results
2 Performance Standards Provide Confidence in Results
Pages 37-52
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From page 37... ...
Therefore, the jurisdiction must know how to interpret the assay results it obtained and what risks are involved with that interpretation. ESTABLISHING APPROPRIATE PERFORMANCE STANDARDS HELPS RESULTS BE ACTIONABLE The BioWatch system is substantially more complex than described in the simple scenario above.
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From page 38... ...
Chapter 4 returns to the validation framework and explores how performance standards fit into the overall picture. ASSUMPTIONS AND DEFINITIONS FOR "PCR ASSAY" AND RELEVANT STANDARDS Many terms related to PCR performance characterization and validation have ambiguous definitions in common use.
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From page 39... ...
• PCR reference collection standards: PCR assays are tested against inclusivity and exclusivity strain panels (targets, near neighbors, and more distant nontarget organisms) and diverse backgrounds (soils, aerosols, pollens, dust, and other potentially problematic environmental backgrounds)
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From page 40... ...
These different forms of PCR standards are interrelated. The committee's task with regard to the BioWatch program focused primarily on the real-time PCR assays used by the program for biological agent detection.
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From page 41... ...
Circular A-119 on Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities (OMB 19983)
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From page 42... ...
Two performance standards, in particular, also have since been developed that may be applicable for use or adaptation by the BioWatch program to validate the performance of the real-time PCR assays it employs. These are the performance requirements developed under the Public Health Actionable Assays (PHAA)
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From page 43... ...
. Stakeholder Panel on Agent Detection Assays SPADA operates under the auspices of AOAC International, an association of analytical communities, as a voluntary consensus standards body and is supported by funding from DHS.
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From page 44... ...
. 5 For real-time PCR assays, the information contained in the DTO molecular assay transition packages is similar to guidance that has been described by the Minimum Information for Publication of Quantitative Real-Time PCR Experiments (Bustin et al.
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From page 45... ...
Within DOD, the Critical Reagents Program (CRP) serves as a consolidation point for quality control programs, standard operating procedures, conformance test plans, and assay reference materials.
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From page 46... ...
. The agreement discussed development of a basis to demonstrate performance equivalency among the PCR assays used by federally owned biomonitoring activities to confirm the presence of biothreat agents.
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From page 47... ...
recommendations on T&E strategies and established standards 2005 MOU on Coordinated Calls for effort on test performance Monitoring of Biological equivalency for confirmation of a biothreat Threat Agents by DHS, agent, to be coordinated by DHS HHS, DOD, USPS, and DOJ. 2005 BioNet PCR Equivalency Goal of demonstrating assay performance Study equivalency between deployed DOD assays and CDC LRN assays for environmental monitoring programs 2005 DTO CB.56 Molecular Provide a harmonized set of descriptive Assay Transition package information and performance details begins to be used across about assays developed for use by DOD; DOD subsequently agreed-upon as assay development information by international partners under Chemical, Biological, and Radiological (CBR)
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From page 48... ...
transitions to using CRP provided materials for its agent screening assays 2013 SPADA working group on SMPR released in late 2014 performance requirements for Variola PCR assay established 2014 DHS cancels the BioWatch "Gen-3" acquisition program Ongoing Assembly of PHAA strain panels being undertaken Ongoing CDC submitting LRN PCR assays for FDA approval (for clinical use)
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From page 49... ...
A "BioNet" study was undertaken between PCR assays deployed by DOD and those used by the CDC LRN. The multiyear, multi-milliondollar effort involved developing an agreed-upon test plan and comparing the performance of real-time PCR assays then in use by the CDC LRN, DOD Joint Program Executive Office for Chemical and Biological Defense, and DOD Naval Medical Research Center.
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From page 50... ...
FSAPE appears to be an ongoing effort, and it is not clear to the committee whether all of the relevant federal agencies have formally signed on to this approach. ASSAY PERFORMANCE CHARACTERIZATION CONDUCTED BY LOS ALAMOS NATIONAL LABORATORY On behalf of the BioWatch program, Los Alamos National Laboratory (LANL)
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From page 51... ...
performance standards is presented in Chapter 3. The committee returns in Chapter 4 to the broader validation framework, the important role of monitoring and feedback, and the operational context of assay use.
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