Manual of Commercial Methods in Clinical Microbiology, 2nd Edition
By Allan L. Truant
Manual of Commercial Methods in Clinical Microbiology, 2nd Edition PDF reviews in detail the current state of the art in each of the disciplines of clinical microbiology, and reviews the sensitivities, specificities and predictive values, and subsequently the effectiveness, of commercially available methods โ both manual and automated. This text allows the user to easily summarize the available methods in any particular field, or for a specific pathogen โ for example, what to use for an Influenza test, a Legionella test, or what instrument to use for identification or for an antibiotic susceptibility test.
The Manual of Commercial Methods in Clinical Microbiology, 2ndย Edition, International Editionย presents a wealth of relevant information to clinical pathologists, directors and supervisors of clinical microbiology, infectious disease physicians, point-of-care laboratories, professionals using industrial applications of diagnostic microbiology and other healthcare providers. The content will allow professionals to analyze all commercially available methods to determine which works best in their particular laboratory, hospital, clinic, or setting.
Updated to appeal to an international audience, The Manual ofย Commercial Methods in Clinical Microbiology,ย 2ndย Edition, International Editionย is an invaluable reference to those in the health science and medical fields.
Table of Contents
Important Notice, xiii
Preface to the Second Edition, xiv
Foreword, xvi
Acknowledgments, xvii
Rising Sun Chair, xviii
Contributors, xix
1 Role of the US Food and Drug Administration in the Regulation of Clinical Microbiology Devices, 1 Kathleen B. Whitaker, Sally A. Hojvat, and Estelle Russek-Cohen
1.1 Historical overview of in vitro diagnostics, 1
1.2 Current microbiology device review regulatory pathways: practical considerations, 2
2 Commercial Blood Culture Systems and Methods, 11 Michael L. Wilson, Melvin P. Weinstein, and L. Barth Reller
2.2 Automated blood culture systems, 12
2.3 Molecular and other methods, 18
2.4 Future directions, 19
References, 19
3 Rapid Devices and Instruments for the Identification of Aerobic Bacteria, 21 Laura J. Chandler, P. Rocco LaSala, and Susan Whittier
3.1 Introduction, 21
3.2 Major methods currently available, 21
3.3 Commercial systems for identification of Gram-positive organisms, 29
3.4 Commercial systems for identification of Gram-negative organisms, 38
3.5 Commercial methods for identification of microorganisms directly in blood culture bottles, 46
3.6 Commercial molecular methods for identification of bacteria isolated in culture, 48
3.7 Emerging technologies for the identification of organisms: mass spectrometry, 49
References, 49
4 Rapid Devices and Instruments for the Identification of Anaerobic Bacteria, 56 Christopher L. Emery, Maria D. Appleman, Jean A. Siders, and Thomas E. Davis
4.1 Introduction and clinical considerations, 56
4.2 Steps in the diagnosis of anaerobic bacterial infections, 57
4.3 Commercial kit requiring 24 h of anaerobic incubation, 64
4.4 Commercial enzyme kits for identification after four hours of aerobic incubation, 64
4.5 Identification by gene sequencing, 71
4.6 Identification by chemical methods, 71
4.7 Immunodiagnostic and molecular methods for diagnosis of Clostridium difficile infection, 74
References, 82
5 Rapid Antigen Devices and Instruments for the Detection and Identification of Viruses, 87 Wallace H. Greene, Marilyn A. Menegus, and Allan L. Truant
5.1 Influenza viruses, 88
5.2 Respiratory syncytial virus, 91
5.3 Immunofluorescence staining of respiratory viruses, 92
22.4 Semiautomated and manual broth microdilution AST systems, 422
22.5 Manual and semiautomated agar antimicrobial gradient diffusion and disk diffusion susceptibility tests, 423
22.6 Phenotypic detection of antimicrobial resistance using chromogenic media, 425
22.7 Genotypic detection of antimicrobial resistance determinants in positive blood cultures, 427
22.8 Next generation methods for antimicrobial susceptibility testing, 428
References, 430
23 Bioterrorism, 433 James W. Snyder and Michael A. Pentella
23.1 Introduction, 433
23.2 History of bioterrorism, 433
23.3 Bioterrorism in the future, 434
23.4 Laboratory Response Network, 435
23.5 Rapid methods, 436
23.6 Conclusion, 436
References, 436
24 Clinical Microbiology: Looking Ahead, 438 Natalie N. Whitfield, Raquel M. Martinez, and Donna M. Wolk
24.1 Introduction, 438
24.2 Connectivity between extraction and amplification platforms, 439
24.3 Polymerase chain reaction and RT-PCR: detection and characterization, 441
24.4 Other amplification methods, 447
24.5 Probe technology, 448
24.6 Mass spectrometry, 449
24.7 DNA sequencing, 451
24.8 Emerging technology, 452
24.9 Other strategies and concepts that will impact clinical microbiology, 459
24.10 Some new responsibilities for the coming years, 460
24.11 Summary, 462
References, 463
International Section, 473
Introduction, 473 Allan L. Truant, Yi-Wei Tang, Ken B. Waites, Cรฉcile Bรฉbรฉar, and Robert Rennie
25 Clinical Microbiology In Vitro Diagnostic Medical Devices in Argentina: Regulatory Requirements And Product Information, 475 Marcela Echavarria and Mariela Aranda
25.1 History, 475
25.2 Regulation of clinical microbiology in vitro diagnostic medical devices in Argentina, 477
References, 481
26 Clinical Microbiology In Vitro Diagnostics in Australia: Regulatory Requirements and Product Information, 483 Carola Venturini, Vitali Sintchenko, and Jonathan R. Iredell
26.1 The Therapeutic Goods Administration, 483
26.2 National Pathology Accreditation Advisory Council, 486
26.3 National Association of Testing Authorities, 486
26.4 RCPA quality assurance programs, 487
26.5 Manufacturers and suppliers of IVDs, 487
References, 489
27 Clinical Microbiology In Vitro Diagnostic Devices in Canada: Regulatory Requirements and Product Information, 491 James A. Karlowsky
References, 493
28 Clinical Microbiology In Vitro Diagnostics in China: Regulatory Requirements and Product Information, 494 Shangwei Wu, Weiwei Zhao, Hongbo Li, and Dongfeng Tan
28.1 The regulatory requirements for clinical microbiology in vitro diagnostics products in China, 494
28.2 IVD product review: devices and instruments, 495
References, 506
29 Clinical Microbiology In Vitro Diagnostic Medical Devices in France: Regulatory Requirements and Product Information, 507 Frederique Gouriet
29.1 Regulatory requirements, 507
29.2 European Directive 98/79/EC, 507
29.3 Directive 98/79/EC in France, 514
29.4 The implications of the regulatory level authorities, 514
29.5 Assessment procedures, 514
Reference, 514
30 Clinical Microbiology In Vitro Diagnostic Medical Devices in India: Regulatory Requirements and Product Information, 515 Abhijit Chaudhury
References, 519
Websites for reference, 519
31 Clinical Microbiology In Vitro Diagnostics in Italy: Regulatory Requirements and Product Information, 520 Simone Ambretti, Mariapaola Landini, Davide Gibellini, and Tiziana Lazzarotto
31.1 Introduction, 520
31.2 National classification of medical devices, 520
31.3 Assessment procedures for IVD medical devices, 521
31.4 Registration for manufacturers of IVD medical devices, 524
Bibliography, 524
32 Clinical Microbiology In Vitro Diagnostics in Japan: Regulatory Requirements and Product Information, 525 Koji Kawakami and Yukie Yamauchi
32.1 The regulatory structure of pharmaceuticals and clinical trials in Japan, 525
32.2 The regulatory structure of in vitro diagnostic testing in Japan, 525
32.6 National Health Insurance coverage of IVD reagents, 530
Bibliography, 530
33 Clinical Microbiology In Vitro Diagnostic Medical Devices in the Republic of Korea: Regulatory Requirements and Product Information, 531 Jeong Hwan Shin
Bibliography, 534
34 Clinical Microbiology In Vitro Diagnostic Medical Devices in South Africa: Regulatory Requirements and Product Information, 535 Abdool Kader Peer
34.1 Regulatory requirements, 535
34.2 Product information, 536
Reference, 536
35 Clinical Microbiology In Vitro Diagnostic Medical Devices in the UK: Regulatory Requirements and Product Information, 537 Timothy D. McHugh, Jim F. Huggett, and Simon Rattenbury
35.1 Background, 537
35.2 Definitions, 537
35.3 Conformity assessment, 545
35.4 Other considerations, 545
Bibliography, 545
Appendix: Manufacturers, Distributors and Vendors, 546 Raquel DeLeon-Gonsalves and Allan L. Truant
Index, 581
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