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Project Title:

PCR Standards for the BioWatch Program
PIN: DELS-BLS-13-06        

Major Unit:

Division on Earth and Life Studies
Institute of Medicine

Sub Unit: Board on Life Sciences
Board on Health Sciences Policy

RSO: Bowman, Katherine

Subject/Focus Area: Biology and Life Sciences; National Security and Defense

Project Scope
An ad hoc committee will 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 used by the BioWatch Program - such that adequate performance data is 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 committee will:

1. 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. 

2. 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 indentified in Task 1 above.  Standards are to be evaluated in terms of performance, cost, and public health applicability. 

3. 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 Task 2 above.

4. Determine whether improvements could be made by adopting changes based on the evaluation in Tasks 2 and 3 above.

5. 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. 

6. In the event that no approach currently in existence is judged to be appropriate in Task 5 above, provide recommendations for aspects that a standard must include to measure performance of multiplex PCR technology.

Project Duration: 16 months    

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Contact the Public Access Records Office to make an inquiry, request a list of the public access file materials, or obtain a copy of the materials found in the file.

Committee Membership
Committee Membership

 Meeting 1 - 01/31/2014
 Meeting 2 - 02/10/2014
 Meeting 3 - 03/13/2014
 Meeting 4 - 04/23/2014
 Meeting 5 - 06/12/2014
 Meeting 6 - 09/03/2014
 Meeting 7 - 09/10/2014
 Meeting 8 - 09/24/2014
 Meeting 9 - 10/01/2014
 Meeting 10 - 10/09/2014
 Meeting 11 - 10/23/2014
 Meeting 12 - 11/06/2014
 Meeting 13 - 11/20/2014
 Meeting 14 - 12/03/2014
 Meeting 15 - 12/31/2014
 Meeting 16 - 01/08/2015
 Meeting 17 - 01/15/2015


Reports having no URL can be seen
at the Public Access Records Office
BioWatch PCR Assays: Building Confidence, Ensuring Reliability (Abbreviated Version)