LEADER 05086nam 2200541 450 001 9910797368203321 005 20200520144314.0 010 $a0-309-36725-5 010 $a0-309-36723-9 035 $a(CKB)3710000000450901 035 $a(EBL)3439887 035 $a(MiAaPQ)EBC3439887 035 $a(Au-PeEL)EBL3439887 035 $a(CaPaEBR)ebr11091796 035 $a(OCoLC)914165948 035 $a(EXLCZ)993710000000450901 100 $a20150904h20152015 uy| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aBioWatch PCR assays $ebuilding confidence, ensuring reliability /$fCommittee on PCR Standards for the BioWatch Program, Board on 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 205 $aAbbreviated version. 210 1$aWashington, District of Columbia :$cThe National Academies Press,$d[2015] 210 4$dİ2015 215 $a1 online resource (186 p.) 300 $aDescription based upon print version of record. 311 $a0-309-36722-0 320 $aIncludes bibliographical references. 327 $aFront Matter; Acknowledgments; Preface; Contents; Boxes, Figures, and Tables; Acronyms and Abbreviations; Executive Summary; Summary; 1 Introduction; 2 Performance Standards Provide Confidence in Results; 3 Key Components of a Performance Standard for BioWatch; 4 The Framework that Surrounds the PCR Reaction Affects Performance; 5 Looking to the Future: Multiplex PCR and Next Generation Sequencing; 6 Conclusions and Recommendations; References; Appendix A: BioWatch Program and Operational Details; Appendix B: Study Activities; Appendix C: Glossary; Appendix D: Biographies of Committee Members 330 $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. 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)"--Publisher's description. 606 $aBioterrorism$zUnited States$xPrevention 606 $aPolymerase chain reaction 606 $aPathogenic microorganisms$xDetection$zUnited States 607 $aUnited States$2fast 615 0$aBioterrorism$xPrevention. 615 0$aPolymerase chain reaction. 615 0$aPathogenic microorganisms$xDetection 712 02$aNational Research Council (U.S.).$bBoard on Life Sciences.$bCommittee on PCR Standards for the BioWatch Program, 712 02$aInstitute of Medicine (U.S.).$bBoard on Health Sciences Policy.$bCommittee on PCR Standards for the BioWatch Program, 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910797368203321 996 $aBioWatch PCR assays$93725570 997 $aUNINA