Study in Progress
PCR Standards for the BioWatch ProgramBoard on Life Sciences
Request for Community Input
A committee convened by the National Research Council and the Institute of Medicine is examining PCR standards appropriate for the BioWatch program (full statement of task below). The committee seeks your input on performance characteristics and data needed to have sufficient confidence to facilitate subsequent steps of the response to a BioWatch result. Please share your input using the link below. We hope you will consider sharing this request with your colleagues. Kindly respond by June 11, and we thank you in advance for your assistance.
What is Meant by "Actionable"?
How the term "Actionable" in a BioWatch Actionable Result (BAR) is understood has important implications for the PCR performance characteristics needed. The "Actionable" term refers to the fact that the result is a verified detection that warrants some sort of response from the affected Jurisdiction and from the Federal Government. This response usually involves a National Conference Call between the Jurisdiction and the Federal Partners to share information for situational assessment to put the BAR into context. As described to the committee, a BAR indicates that genetic material (nucleic acid) considered distinctive for a tested organism is present on a filter and provides qualitative indications of amount of material and location/time of sample pickup. A BAR "does not necessarily mean that a terrorist attack has occurred; a viable biological agent was released; the agent is infectious; [or] there is a risk to the public?s health" (Michael Walter, BioWatch Program Manager, presentation to the committee on March 13, 2014). Following declaration of a BAR, notification protocols are activated and situational assessment activities (e.g. environmental sampling) provide additional data to better understand the circumstances and to determine the potential risk to public health to better inform decision makers.
What is Meant by "PCR Standard" in this Context?
The committee is exploring what performance data and information should be gathered and shared with stakeholders in order for the performance of BioWatch PCR assays to meet BioWatch's mission and the needs of its stakeholders, including such characteristics as specificity, sensitivity, and limits of detection (LOD). Technical details of the BioWatch system may change over time (e.g. methods of collection and extraction), as may details of particular PCR assays (e.g. the DNA signatures used). The committee is particularly interested in the fundamental types of performance data, performance levels, and data analysis the community requires in order to have reasonable confidence that results of a BioWatch PCR assay are actionable.
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Statement of Task
An ad hoc committee will be convened to conduct a study and prepare a report that will evaluate and provide guidance on appropriate standards for the validation and verification of polymerase chain reaction (PCR) tests and assays in order to ensure that adequate performance data are available to public health and other key decision makers with a sufficient confidence level to facilitate the public health response to a BioWatch Actionable Response (BAR).
Specifically the ad hoc committee will:
- Determine PCR assay test and evaluation criteria that will provide a reasonable measure of confidence to federal, state, and local public health officials and key stakeholders.
- Identify and evaluate the Stakeholder Panel on Agent Detection Assays (SPADA), the Public Health Actionable Assays (PHAA) and any other existing and proposed standards applicable for use in defining the performance (validation and verification) of PCR assays for the BioWatch and other programs to ensure confidence as identified in Sub-Task 1 above. Standards are to be evaluated in terms of performance, cost, and public health applicability.
- Examine current PCR protocols used by the BioWatch program and other relevant biosurveillance programs and determine if the processes used to assess the performance of these protocols and assays is adequate to meet the standards identified in Sub-Task 2 above.
- Determine whether improvements could be made by adopting changes based on the evaluation in Sub-Tasks 2 and 3 above.
- Determine if any existing standards approach is conducive, taking into consideration cost, schedule, and data requirements, to measuring performance of a PCR assay in multiplexed format.
- In the event that no approach currently in existence is judged to be appropriate in Sub-Task 5 above, provide recommendations for aspects that a standard must include to measure performance of multiplex PCR technology.
In the course of this task, the ad hoc committee will require access to classified national security information up to and including the SECRET level. Access is also required to controlled-restricted unclassified information that is exempt from public disclosure as described in title 5 U.S.C. section 552(b) (i.e., exemptions under the Freedom of Information Act (FOIA)). All products generated during this task will be subject to DHS security review, relevant classification guides, and institutional policies.