BioWatch PCR assays building confidence, ensuring reliability

BioWatch PCR Assays evaluates and provides guidance on appropriate standards for the validation and verification of 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...

Full description

Bibliographic Details
Corporate Authors: National Research Council (U.S.) Committee on PCR Standards for the BioWatch Program, Institute of Medicine (U.S.) Board on Health Sciences Policy, United States Department of Homeland Security
Format: eBook
Language:English
Published: Washington, D.C. National Academies Press [2015]©2015, 2015
Edition:Abbreviated version
Subjects:
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
LEADER 04673nam a2200433 u 4500
001 EB001839773
003 EBX01000000000000001003762
005 00000000000000.0
007 tu|||||||||||||||||||||
008 180702 r ||| eng
020 |a 0309367239 
020 |a 9780309367233 
020 |a 9780309367226 
050 4 |a HV6433.35 
245 0 0 |a BioWatch PCR assays  |h Elektronische Ressource  |b building confidence, ensuring reliability  |c Committee on PCR Standards for the BioWatch Program, Board of Life Sciences, Division on Earth and Life Studies, Board on Health Sciences Policy, Institute of Medicine, National Research Council and Institute of Medicine of the National Academies 
246 3 1 |a Polymerase chain reaction assays 
250 |a Abbreviated version 
260 |a Washington, D.C.  |b National Academies Press  |c [2015]©2015, 2015 
300 |a 1 PDF file (xxiv, 175 pages)  |b illustrations 
505 0 |a Performance Standards Provide Confidence in Results -- Key Components of a Performance Standard for BioWatch -- The Framework that Surrounds the PCR Reaction Affects Performance -- Looking to the Future: Multiplex PCR and Next Generation Sequencing -- Conclusions and Recommendations -- Appendix A: BioWatch Program and Operational Details -- Appendix B: Study Activities -- Appendix C: Glossary -- Appendix D: Biographies of Committee Members 
505 0 |a Includes bibliographical references 
653 |a Biohazard Release / prevention & control 
653 |a United States 
653 |a Polymerase Chain Reaction 
653 |a Bioterrorism / prevention & control 
653 |a Biological Warfare Agents 
653 |a Microbiological Phenomena 
710 2 |a National Research Council (U.S.)  |b Committee on PCR Standards for the BioWatch Program 
710 2 |a Institute of Medicine (U.S.)  |b Board on Health Sciences Policy 
710 2 |a United States  |b Department of Homeland Security 
041 0 7 |a eng  |2 ISO 639-2 
989 |b NCBI  |a National Center for Biotechnology Information 
500 |a Title from PDF title page 
856 4 0 |u https://www.ncbi.nlm.nih.gov/books/NBK305486  |3 Volltext  |n NLM Bookshelf Books  |3 Volltext 
082 0 |a 363.32530973 
082 0 |a 700 
520 |a BioWatch PCR Assays evaluates and provides guidance on appropriate standards for the validation and verification of 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. This report discusses principles of performance standards, reviews information from several existing guidance documents and standards that might be applicable to BioWatch, and discusses assay testing efforts that have occurred or are ongoing. BioWatch PCR Assays provides recommendations on general principles and approaches for a performance standard and validation framework to meet BioWatch's mission. The report also considers how developments in technology, particularly in multiplex PCR and next-generation sequencing, can contribute to the ability of the BioWatch program to meet current and future challenges.  
520 |a This report has been determined to contain information exempt from disclosure under 5 U.S.C. 552(b). Section 15 of the Federal Advisory Committee Act provides that the National Academies shall make its final report available to the public unless the National Academies determines that the report would disclose matters described in one or more of the exemption provisions under the Freedom of Information Act (FOIA). In such case, the National Academies "shall make public an abbreviated version of the report that does not disclose those matters." This unrestricted, abbreviated version of the report represents, in so far as possible, the committee's findings, recommendations, and other substantive material without disclosing materials described in 5 U.S.C. 552(b)."--Publisher's description 
520 |a "BioWatch is an air monitoring system deployed in jurisdictions around the country with the goal of detecting the presence of certain high risk pathogenic microorganisms. It relies on a network of federal and nonfederal collaborative relationships to be successful, and is one part of a larger array of disease surveillance, intelligence-gathering, and biomonitoring activities in support of public safety and health. The assays used in the BioWatch system to detect the presence of pathogens in collected samples rely on the technique of polymerase chain reaction (PCR) to sensitively and specifically amplify target nucleic acid sequences.