National Academies Press: OpenBook
« Previous: 6 Conclusions and Recommendations
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

References

Anthony, S.J., J.H. Epstein, K.A. Murray, I. Navarrete-Macias, C.M. Zambrana-Torrelio, A. Solovyov, R. Ojeda-Flores, N.C. Arrigo, A. Islam, S. Ali Khan, P. Hosseini, T.L. Bogich, K.J. Olival, M.D. Sanchez-Leon, W.B. Karesh, T. Goldstein, S.P. Luby, S.S. Morse, J.A. Mazet, P. Daszak, and W.I. Lipkin. 2013. A strategy to estimate unknown viral diversity in mammals. mBio 4(5):e00598-13. Available: http://mbio.asm.org/content/4/5/e00598-13 [accessed December 2, 2014].

AOAC (AOAC International). 2011a. SMPR-2010.001, Standard method performance requirements for polymerase chain reaction (PCR) methods for detection of Francisella tularensis in aerosol collection filters and/or liquids. Journal of AOAC International 94(4):1338-1341.

AOAC. 2011b. SMPR-2010.002, Standard method performance requirements for polymerase chain reaction (PCR) methods for detection of Yersinia pestis in aerosol collection filters and/or liquids. Journal of AOAC International 94(4):1342-1346.

AOAC. 2011c. SMPR-2010.003, Standard method performance requirements for polymerase chain reaction (PCR) methods for detection of Bacillus anthracis in aerosol collection filters and/or liquids. Journal of AOAC International 94(4):1347-1351.

AOAC. 2011d. SMPR-2010.004, Standard method performance requirements for immunological-based handheld assays (HHAs) for detection of Bacillus anthracis spores in visible powders. Journal of AOAC International 94(4):1352-1355.

AOAC. 2011e. SMPR-2009.005, Standard method performance requirements for immunological-based handheld assays (HHAs) for detection of ricin in visible powders. Journal of AOAC International 94(4):1356-1358.

AOAC 2014. SMPR-2014.006, Standard method performance requirements for detection and identification of Variola virus DNA in aerosol collection filters and/or liquids. Approved by AOAC Stakeholder Panel on Agent Detection Assays (SPADA). Final Version Date: August 14, 2014. Effective Date: October 15, 2014.

AOAC. In preparation-a. SMPR-2011.xxx, Standard method performance requirements for polymerase chain reaction (PCR) methods for detection of Burkholderia mallei in aerosol collection filters and/or liquids.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

AOAC. In preparation-b. SMPR-2011.xxx, Standard method performance requirements for polymerase chain reaction (PCR) methods for detection of Burkholderia pseudomallei in aerosol collection filters and/or liquids.

AOAC Methods Committee. 2011. Methods Committee guidelines for validation of biological threat agent methods and/or procedures. Journal of AOAC International 94(4):1359-1381.

Barns, S.M., C.C. Grow, R.T. Okinaka, P. Keim, and C.R. Kuske. 2005. Detection of diverse new Francisella-like bacteria in environmental samples. Applied and Environmental Microbiology 71(9):5494-5500.

Bean, W.J. Jr., N.J. Cox, and A.P. Kendal. 1980. Recombination of human influenza A viruses in nature. Nature. 284(5757):638-640.

Briese, T., J.T. Paweska, L.K. McMullan, S.K. Hutchison, C. Street, G. Palacios, M.L. Khristova, J. Weyer, R. Swanepoel, M. Egholm, S.T. Nichol, and W.I. Lipkin. 2009. Genetic detection and characterization of Lujo virus, a new hemorrhagic fever-associated arenavirus from southern Africa. PLoS Pathogens 5(5):e1000455. Available: http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1000455 [accessed December 3, 2014].

Brown, L.D., T.T. Cai, and A. DasGupta. 2001. Interval estimation for a bionomial proportion. Statistical Science 16(2):101-133.

Budowle, B., S.E. Schutzer, S.A. Morse, K.F. Martinez, R. Chakraborty, B.L. Marrone, S.L. Messenger, R.S. Murch, P.J. Jackson, P. Williamson, R. Harmon, and S.P Velsko. 2008. Criteria for validation of methods in microbial forensics. Applied Environmental Microbiology 74(18):5599-5607.

Budowle, B., N.D. Connell, A. Bielecka-Oder, R.R. Colwell, C.R. Corbett, J. Fletcher, M. Forsman, D.R. Kadavy, A. Markotic, S.A. Morse, R.S. Murch, A. Sajantila, S.E. Schmedes, K.L. Ternus, S.D. Turner, and S. Minot. 2014. Validation of high throughput sequencing and microbial forensics applications. Investigative Genetics 5:9 [online]. Available: http://www.investigativegenetics.com/content/5/1/9 [accessed November 18, 2014].

Burd, E.M. 2010. Validation of laboratory-developed molecular assays for infectious diseases. Clinical Microbiology Reviews 23(3):550-576.

Bush, G.W. 2003. State of the Union Address. Washington Post, January 28 [online]. Available: http://www.washingtonpost.com/wp-srv/onpolitics/transcripts/bushtext_012803.html [accessed November 17, 2014].

Bustin, S.A., V. Benes, J.A. Garson, J. Hellemans, J. Huggett, M. Kubista, R. Mueller, T. Nolan, M.W. Pfaffl, G.L. Shipley, J. Vandesompele, and C.T. Wittwer. 2009. The MIQE guidelines: Minimum information for publication of quantitative real-time PCR experiments. Clinical Chemistry 55:611-622.

Case, R.J., Y. Boucher, I. Dahllöf, C. Holmström, W.F. Doolittle, and S. Kjelleberg. 2007. Use of 16S rRNA and rpoB genes as molecular markers for microbial ecology studies. Applied and Environmental Microbiology 73(1):278-288.

Chain, P.S.G., D.V. Grafham, R.S. Fulton, M.G. FitzGerald, J. Hostetler, D. Muzny, J. Ali, B. Birren, D.C. Bruce, C. Buhay, J.R. Cole, Y. Ding, S. Dugan, D. Field, G.M. Garrity, R. Gibbs, T. Graves, C.S. Han, S.H. Harrison, S. Highlander, P. Hugenholtz, H.M. Khouri, C.D. Kodira, E. Kolker, N.C. Kyrpides, D. Lang, A. Lapidus, S.A. Malfatti, V. Markowitz, T. Metha, K.E. Nelson, J. Parkhill, S. Pitluck, X. Qin, T.D. Read, J. Schmutz, S. Sozhamannan, P. Sterk, R.L. Strausberg, G. Sutton, N.R. Thomson, J.M. Tiedje, G. Weinstock, A. Wollam, Genomic Standards Consortium Human Microbiome Project Jumpstart Consortium, and J.C. Detter. 2009. Genome project standards in a new era of sequencing. Science 326(5950):236-237.

Chiu, C.Y. 2013. Viral pathogen discovery. Current Opinion in Microbiology 16(4):468-478.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

CLSI (Clinical and Laboratory Standards Institute; formerly National Committee on Clinical Laboratory Standards). 2004. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. NCCLS Document EP17-A. Wayne, PA: NCCLS.

CLSI. 2012. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline, 2nd ed. CLSI document EP17-A2. Wayne, PA: Clinical and Laboratory Standards Institute.

Coates, S.G., S.L. Brunelle, and M.G. Davenport. 2011. Development of standard method performance requirements for biological threat agent detection methods. Journal of AOAC International 94(4):1328-1337.

CRP (Critical Reagents Program). 2015. Critical Reagents Program FY15 Product Catalog, Version 1. Available: www.jpeocbd.osd.mil/packs/DocHandler.ashx?DocID=14895 [accessed January 15, 2015].

Davenport, M.G. 2014. Stakeholder Panel on Agent Detection Assays. Presentation to the Committee on PCR Standards for the BioWatch Program, March 13, Washington, DC.

DOD (Department of Defense). 2005. Department of Defense Chemical and Biological Defense Program Annual Report to Congress. March.

Domingo, E., J. Sheldon, and C. Perales. 2012. Viral quasispecies evolution. Microbiology and Molecular Biology Reviews 76(2):159-216.

Dorai-Raj, S. 2014. Binomial confidence intervals for several parameterizations. Version 1.1-1. Package “binom” for R. Available: http://cran.r-project.org/web/packages/binom/binom.pdf [accessed January 9, 2015].

DHS (Department of Homeland Security). 2011. Implementation Plan for Federal Standards for Evaluating Assay Performance and Equivalency in Support of National Biomonitoring Architecture—Nucleic Acid Based Detection Assays. August 26..

DHS. 2013a. Public Health Actionable Assays (PHAA) Standards of Implementation Independent Statistical Assessment. BioWatch Quality Assurance Program. October 2.

DHS. 2013b. SPADA Standard Method Performance Requirements Independent Statistical Assessment. BioWatch Quality Assurance Program, October 2.

DHS. 2014. Government Unique Standards for Implementation of Public Health Actionable Assays—Nucleic Acid Based Diagnostic/Detection Assays (Clinical and Non-Clinical Samples). May 27.

Emanuel, P. 2014. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

EPA (Environmental Protection Agency). 2009. Method Validation of U.S. Environmental Protection Agency Microbiological Methods of Analysis. Prepared by the FEM Microbiology Action Team for the EPA Forum on Environmental Measurements (FEM). FEM Document Number 2009-01. October 7.

FDA (Food and Drug Administration). 2008. FDA clears first test designed to detect and identify 12 respiratory viruses from single sample. FDA News Release. January 3 Available: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116829.htm [accessed November 11, 2014].

FDA. 2011. Guidelines for the Validation of Analytical Methods for the Detection of Microbial Pathogens in Foods. FDA Methods Validation Guidelines for Microbial Pathogens, Office of Foods. Available: http://www.fda.gov/ScienceResearch/FieldScience/ucm273423. htm [accessed November 18, 2014].

FDA. 2014a. Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic DevicesGuidance for Industry and Food and Drug Administration Staff. Document. August 27. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm327293.htm [accessed November 11, 2014].

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

FDA. 2014b. Letter to Robert E. Miller, U.S. Department of Defense, from Margaret E. Hamburg, Commissioner of Food and Drugs, October 10, 2014. Available: http://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM418799.pdf [accessed November 11, 2014].

FDA. 2014c. Quality system regulation. Code of Federal Regulations, Title 21, Volume 8, Part 820, Section 3. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.3 [accessed October 31, 2014].

GAO (Government Accountability Office). 2009. Biosurveillance: Developing a Collaboration Strategy Is Essential to Fostering Interagency Data and Resource Sharing. GAO-10-171. Washington, DC: GAO. Available: http://www.gao.gov/assets/300/299667.pdf [accessed October 28, 2014].

GAO. 2010. Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a National Strategy and a Designated Leader. GAO-10-645. Washington, DC: GAO. Available: http://www.gao.gov/assets/310/306362.pdf [accessed October 28, 2014].

GAO. 2011. Biosurveillance: Nonfederal Capabilities Should Be Considered in Creating a National Biosurveillance Strategy. GAO-12-55. Washington, DC: GAO. Available: http://www.gao.gov/assets/590/586047.pdf [accessed October 28, 2014].

GAO. 2012a. Biosurveillance: DHS Should Reevaluate Mission Need and Alternatives Before Proceeding with BioWatch Generation-3 Acquisition. GAO-12-810. Washington, DC: GAO. Available: http://www.gao.gov/assets/650/648026.pdf [accessed October 28, 2014].

GAO. 2012b. Chemical, Biological, Radiological, and Nuclear Risk Assessments: DHS Should Establish More Specific Guidance for Their Use. GAO-12-272. Washington, DC: GAO. Available: http://www.gao.gov/assets/590/587674.pdf [accessed January 6, 2015].

Garza, A. 2012. The truth about BioWatch: The importance of early detection of a potential biological attack. June 12, 2012. Washington, DC. Available: http://www.dhs.gov/blog/2012/07/12/truth-about-biowatch [accessed October 29, 2014].

Gire, S.K., A. Goba, K.G. Andersen, R.S. Sealfon, D.J. Park, L. Kanneh, S. Jalloh, M. Momoh, M. Fullah, G. Dudas, S. Wohl, L.M. Moses, N.L. Yozwiak, S. Winnicki, C.B. Matranga, C.M. Malboeuf, J. Qu, A.D. Gladden, S.F. Schaffner, X. Yang, P.P. Jiang, M. Nekoui, A. Colubri, M.R. Coomber, M. Fonnie, A. Moigboi, M. Gbakie, F.K. Kamara, V. Tucker, E. Konuwa, S. Saffa, J. Sellu, A.A. Jalloh, A. Kovoma, J. Koninga, I. Mustapha, K. Kargbo, M. Foday, M. Yillah, F. Kanneh, W. Robert, J.L. Massally, S.B. Chapman, J. Bochicchio, C. Murphy, C. Nusbaum, S. Young, B.W. Birren, D.S. Grant, J.S. Scheiffelin, E.S. Lander, C. Happi, S.M. Gevao, A. Gnirke, A. Rambaut, R.F. Garry, S.H. Khan, and P.C. Sabeti. 2014. Genomic surveillance elucidates Ebola virus origin and transmission during the 2014 outbreak. Science 345(6202):1369-1372.

Grard, G., J.N. Fair, D. Lee, E. Slikas, I. Steffen, J.J. Muyembe, T. Sittler, N. Veeraraghavan, J.G. Ruby, C. Wang, M. Makuwa, P. Mulembakani, R.B. Tesh, J. Mazet, A.W. Rimoin, T. Taylor, B.S. Schneider, G. Simmons, E. Delwart, N.D. Wolfe, C.Y. Chiu, and E.M. Leroy. 2012. A novel rhabdovirus associated with acute hemorrhagic fever in central Africa. PLoS Pathogens 8(9):e1002924. Available: http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1002924

Goodwin, B. 2014. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

Hobson, J.P. 2014. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

Hospodsky, D., N. Yamamoto, and J. Peccia. 2010. Accuracy, precision, and method detection limits of quantitative PCR for airborne bacteria and fungi. Applied and Environmental Microbiology 76(21):7004-7012.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

IOM and NRC (Institute of Medicine and National Research Council). 2011. BioWatch and Public Health Surveillance: Evaluating Systems for the Early Detection of Biological Threats. Abbreviated Version. Washington, DC: The National Academies Press.

IOM and NRC. 2014. Technologies to Enable Autonomous Detection for BioWatch: Ensuring Timely and Accurate Information for Public Health Officials: Workshop Summary. Washington, DC: The National Academies Press.

Isbell, M. 2014. PCR standards for the BioWatch Program: BioWatch and statistical assessment of implementation. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

Jennings, L., V.M. Van Deerlin, M.L. Gulley, and College of American Pathologists Molecular Pathology Committee. 2009. Recommended principles and practices for validating clinical molecular pathology tests. Archives of Pathology and Laboratory Medicine 133:743-755.

Keim, P. 2014. SPADA’s Burkholderia Working Group Report. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

Kuske, C.R., S.M. Barns, C.C. Grow, L. Merrill, and J. Dunbar. 2006. Environmental survey for four pathogenic bacteria and closely related species using phylogenetic and functional genes. Journal of Forensic Sciences 51(3):548-558.

Lindler, L. 2014. Selection of Yersinia pestis assay validation panels. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

LANL (Los Alamos National Laboratory). 2010. Test Plan for the Evaluation of Generation 3 Vendor Assays. April 8. Department of Homeland Security (DHS) BioWatch Project. Los Alamos, NM: Los Alamos National Laboratory.

LANL. 2011a. Assembly of Stakeholders’ Panel on Agent Detection Assays (SPADA) Test Panels. September 13. Final Report. LA-CP 11-01070. Department of Homeland Security (DHS) BioWatch Project. Los Alamos, NM: Los Alamos National Laboratory.

LANL. 2011b. Evaluation of the Critical Reagents Program PCR-Based Assay for Agent 7. November 9. Final Report. Department of Homeland Security (DHS) BioWatch Project. Los Alamos, NM: Los Alamos National Laboratory.

LANL. 2012a. Evaluation of the Critical Reagents Program PCR-Based Assay for Agent 8. November 28. Final Report. Department of Homeland Security (DHS) BioWatch Project. Los Alamos, NM: Los Alamos National Laboratory.

LANL. 2012b. Evaluation of the Critical Reagents Program PCR-Based Assay for Agent 9. November 28. Final Report. Department of Homeland Security (DHS) BioWatch Project. Los Alamos, NM: Los Alamos National Laboratory.

Merlin, T.L. 2014. BioWatch PCR standards—a CDC LRN perspective. Presentation to the Committee on PCR Standards for the BioWatch Program, March 13, Washington, DC.

Merrill, L., J. Dunbar, J. Richardson, and C.R. Kuske. 2006. Composition of Bacillus species in aerosols from 11 U.S. cities. Journal of Forensic Sciences 51(3):559-565.

Morelli, G., Y. Song, C.J. Mazzoni, M. Eppinger, P. Roumagnac, D.M. Wagner, M. Feldkamp, B. Kusecek, A.J. Vogler, Y. Li, Y. Cui, N.R. Thomson, T. Jombart, R. Leblois, P. Lichtner, L. Rahalison, J.M. Petersen, F. Balloux, P. Keim, T. Wirth, J. Ravel, R. Yang, E. Carniel, and M. Achtman. 2010. Yersinia pestis genome sequencing identifies patterns of global phylogenetic diversity. Nature Genetics 42(12):1140-1143.

Morse, S.A. 2014. Perspectives on the standards development process. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

Murphy et al. 2012. Strategies for detection of Plasmodium species gametocytes. American Journal of Tropical Medicine and Hygiene 86(3):383-394.

Naraghi-Arani, P. 2014. Presentation to the Committee on PCR Standards for the BioWatch Program, June 12, Washington, DC.

NRC (National Research Council). 2010. Sequence-Based Classification of Select Agents: A Brighter Line. Washington, DC: The National Academies Press.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

NRC. 2011. Review of the Scientific Approaches Used During the FBI’s Investigation of the 2001 Anthrax Letters. Washington, DC: The National Academies Press.

NSC (National Security Council). 2009. National Strategy for Countering Biological Threats. Washington, DC: Executive Office of the President. Available: http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Countering_BioThreats.pdf.

NSTC (National Science and Technology Council). 2011. A National Strategy for CBRNE Standards. Washington, DC: Executive Office of the President Available. http://www.whitehouse.gov/sites/default/files/microsites/ostp/chns_cbrne_standards_final_24_aug_11.pdf.

NSTC. 2013. National Biosurveillance Science and Technology Roadmap. Washington, DC: Office of Science and Technology Policy, Executive Office of the President.

O’Neill, W. 2014. USPS BDS briefing. Presentation to the Committee on PCR Standards for the BioWatch Program, March 13, Washington, DC.

OIE (World Organisation for Animal Health). 2013. Chapter 1.1.5. Principles and methods of validation of diagnostic assays for infectious diseases. In Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2014. Available: http://www.oie.int/internationalstandard-setting/terrestrial-manual/access-online/ [accessed November 18, 2014].

OMB (Office of Management and Budget). 1998. Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. OMB Circular A-119.

Omberg K. 2014. BioWatch gen-3 assay evaluation. Presentation to the Committee on PCR Standards for the BioWatch Program, October 1, Washington, DC.

Opel, K.L., D. Chung, and B.R. McCord. 2010. A study of PCR inhibition mechanisms using real time PCR. Journal of Forensic Science 55(1):25-33.

Peccia, J., and M. Hernandez. 2006. Incorporating polymerase chain reaction-based identification, population characterization, and quantification of microorganisms into aerosol science: A review. Atmospheric Environment 40:3941-3961.

Pillai, S. 2014. PSAA vs FSAPE vs PHAA nucleic acid based detection. Presentation to the Committee on PCR Standards for the BioWatch Program, April 23, Washington, DC.

Quick, J., A.R. Quinlan, and N.J. Loman. 2014. A reference bacterial genome dataset generated on the MinION™ portable single-molecule nanopore sequencer. Gigascience 3:22.

Rasko, D.A., P.L. Worsham, T.G. Abshire, S.T. Stanley, J.D. Bannan, M.R. Wilson, R.J. Lang-ham, R.S. Decker, L. Jiang, T.D. Read, A.M. Phillippy, S.L. Salzberg, M. Pop, M.N. Van Ert, L.J. Kenefic, P.S. Keim, C.M. Fraser-Liggett, and J. Ravel. 2011. Bacillus anthracis comparative genome analysis in support of the Amerithrax investigation. Proceedings of the National Academy of Sciences of the United States of America 108(12):5027-5032.

Schrader, C., A. Schielke, L. Ellerbroek, and R. Johne. 2012. PCR inhibitors—occurrence, properties and removal. Journal of Applied Microbiology 113:1014-1026.

Smidansky, E. D., Arnold, J. J., and C. E. Cameron. 2008. Nucleic acid polymerase fidelity and viral population fitness. pp 135-160. In Origin and Evolution of Viruses (Domingo, E., Parrish, C. R., and Holland, J. J. eds.), Academic Press, London.

Tettelin, H., V. Masignani, M.J. Cieslewicz, C. Donati, D. Medini, N.L. Ward, S.V. Angiuoli, J. Crabtree, A.L. Jones, A.. S. Durkin, R.T. DeBoy, T.M. Davidsen, M. Mora, M. Scarselli, I. Margarit y Ros, J.D. Peterson, C.R. Hauser, J.P. Sundaram, W.C. Nelson, R. Madupu, L.M. Brinkac, R.J. Dodson, M.J. Rosovitz, S.A. Sullivan, S.C. Daugherty, D.H. Haft, J..Selengut, M.L. Gwinn, L..Zhou, N. Zafar, H. Khouri, D. Radune, G. Dimitrov, K. Watkins, K.J..B. O’Connor, S. Smith, T.R. Utterback, O. White, C.E. Rubens, G. Grandi, L.C. Madoff, D.L. Kasper, J.L. Telford, M.R. Wessels, R. Rappuoli, and C.M. Fraser. 2005. Genome analysis of multiple pathogenic isolates of Streptococcus agalactiae: Implications for the microbial “pan-genome.” Proceedings of the National Academy of Sciences of the United States of America 102(39):13950-13955.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

U.S. House of Representatives. 2012a. BioWatch Present and Future: Meeting Mission Needs for Effective Biosurveillance? Serial No. 112-117. Joint Hearing Before the Subcommittee on Emergency Preparedness, Response, and Communications and the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies of the Committee on Homeland Security, House of Representatives, 112th Congress, 2nd Session, September 13. Available: https://www.hsdl.org/?view&did=743066 [accessed October 29, 2014].

U.S. House of Representatives. 2012b. Letter from the Honorable Red Uptan, Chair, Committee on Energy and Commerce, and the Honorable Cliff Stearns, Chair, Subcommittee on Oversight and Investigations, to Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention, November 13.

U.S. House of Representatives. 2012c. Letter from the Honorable Red Uptan, Chair, Committee on Energy and Commerce, and the Honorable Cliff Stearns, Chair, Subcommittee on Oversight and Investigations, to the Honorable Janet Napolitano, Secretary, Department of Homeland Security, November 13.

Walter, M.V. 2014a. BioWatch program overview: Briefing on PCR standards. Presentation to the Committee on PCR Standards for the BioWatch Program, March 13, Washington, DC.

Walter, M.V. 2014b. PCR standards for the BioWatch program. Presentation to the Committee on PCR Standards for the BioWatch Program, June 13, Washington, DC.

White House. 2004. Homeland Security Presidential Directive 10. Biodefense for the 21st Century. Washington, DC: Executive Office of the President.

White House. 2007. Homeland Security Presidential Directive 21. Public Health and Medical Preparedness. Washington, DC: Executive Office of the President.

White House. 2012. National Strategy for Biosurveillance. July 31. Washington, DC: Executive Office of the President.

Wilson, I.G. 1997. Inhibition and facilitation of nucleic acid amplification. Applied and Environmental Microbiology 63(10):3741-3751.

Wilson, M.R., S.N. Naccache, E. Samayoa, M. Biagtan, H. Bashir, G. Yu, S.W. Salamat, S. Somasekar, S. Federman, S. Miller, R. Sokolic, E. Garabedian, F. Candotti, R.H. Buckley, K.D. Reed, T.L Meyer, C.M. Seroogy, R. Galloway, S.L. Henderson, J.E. Gern, J.L DeRisi, and C.Y. Chiu. 2014. Actionable diagnosis of neuroleptospirosis by next-generation sequencing. New England Journal of Medicine 370(25):2408-2417.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×

This page intentionally left blank.

Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 153
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 154
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 155
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 156
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 157
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 158
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 159
Suggested Citation:"References." Institute of Medicine and National Research Council. 2015. BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version. Washington, DC: The National Academies Press. doi: 10.17226/21658.
×
Page 160
Next: Appendix A: BioWatch Program and Operational Details »
BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version Get This Book
×
 BioWatch PCR Assays: Building Confidence, Ensuring Reliability: Abbreviated Version
Buy Paperback | $52.00 Buy Ebook | $41.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

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.

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).

READ FREE ONLINE

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!