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Produktbild: Manual of Commercial Methods in Clinical Microbiology International Edition

Manual of Commercial Methods in Clinical Microbiology International Edition Editio

Fr. 263.00

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

13.06.2016

Herausgeber

Allan L. Truant

Verlag

John Wiley & Sons

Seitenzahl

616

Maße (L/B/H)

28.2/21.8/3.3 cm

Gewicht

1837 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-1-118-13112-1

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

13.06.2016

Herausgeber

Allan L. Truant

Verlag

John Wiley & Sons

Seitenzahl

616

Maße (L/B/H)

28.2/21.8/3.3 cm

Gewicht

1837 g

Auflage

2. Auflage

Sprache

Englisch

ISBN

978-1-118-13112-1

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  • Produktbild: Manual of Commercial Methods in Clinical Microbiology International Edition
  • 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
    1.3 Assay performance characteristics: "Statistics 101" for diagnostic device developers, 7
    1.4 Common issues with new FDA submissions, 8
    References, 10
    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
    5.4 Herpes simplex virus, varicella zoster virus, cytomegalovirus, 93
    5.5 Gastrointestinal viruses, 94
    References, 95
    6 Molecular Tests for the Identification of Viruses, 97
    Scott Duong and Christine C. Ginocchio
    6.1 Introduction, 97
    6.2 Respiratory viral infections, 97
    6.3 Enteric viruses, 105
    6.4 Enterovirus and parechovirus, 107
    6.5 Herpesviruses, 108
    6.6 Viral infections associated with transplantation, 109
    6.7 Implementation and additional considerations, 112
    References, 113
    7 Viral Hepatitis, 121
    Emily Jeanne Cartwright and Yun F. (Wayne) Wang
    7.1 Introduction/background, 121
    7.2 Clinical manifestations, epidemiology, and diagnostic considerations by virus, 121
    7.3 Commercial methods, 127
    7.4 Summary, 131
    References, 132
    8 Human Papillomaviruses, 135
    N. Esther Babady
    8.1 Background, 135
    8.2 Commercial assays, 136
    8.3 Current challenges and future directions, 143
    References, 144
    9 Human Immunodeficiency Virus, 149
    Richard L. Hodinka
    9.1 Introduction, 149
    9.2 Markers of HIV infection, 150
    9.3 HIV screening, 151
    9.4 Laboratory-based immunoassays, 152
    9.5 Rapid, less-sophisticated immunoassays, 154
    9.6 Specimen matrices for HIV screening, 157
    9.7 Confirmatory and supplemental tests, 157
    9.8 Serological testing of neonates, 159
    9.9 p24 Antigen detection, 160
    9.10 Qualitative molecular detection, 161
    9.11 Quantification of HIV RNA, 162
    9.12 Phenotypic and genotypic assays for drug resistance, 165
    References, 167
    10 Chlamydia, 175
    Claudiu I. Bandea, Robert C. Jerris, and Carolyn M. Black
    10.1 Introduction, 175
    10.2 Epidemiology, 176
    10.3 Biology, 177
    10.4 Natural history, 178
    10.5 Clinical symptoms and sequelae, 178
    10.6 Treatment, 179
    10.7 Laboratory testing for C. trachomatis, 179
    References, 183
    11 Rickettsiae and Tick-Borne Diseases, 184
    Natalie Williams-Bouyer, Donald H. Bouyer, and Michael J. Loeffelholz
    11.1 Introduction, 184
    11.2 Overview of tick-borne diseases, 184
    11.3 Newly emerging tick-borne disease, 191
    References, 191
    12 Mycoplasma, 195
    Ken B. Waites and Cécile Bébéar
    12.1 Introduction and clinical considerations, 195
    12.2 Culture-based diagnosis, 197
    12.3 Serological diagnosis, 202
    12.4 Molecular detection systems, 206
    12.5 Antimicrobial susceptibility testing, 209
    12.6 Future directions, 210
    References, 211
    13 Commercial Methods for Identification and Susceptibility Testing of Fungi, 214
    Stephen A. Moser and Jason Wicker
    13.1 Direct examination and detection methods, 214
    13.2 Culture and detection, 220
    13.3 Identification systems, 224
    13.4 Molecular testing, 236
    13.5 Susceptibility testing, 248
    References, 261
    14 Mycobacteria, 273
    Xiang Yang Han
    14.1 Introduction, 273
    14.2 Specimen processing, 273
    14.3 Acid-fast staining reagents, 273
    14.4 Direct detection of mycobacteria from clinical specimens, 274
    14.5 Blood-culture recovery of mycobacteria, 275
    14.6 Mycobacteria-culturing methods and systems, 276
    14.7 Identification of mycobacteria, 278
    14.8 Susceptibility tests for mycobacteria, 280
    14.9 Immunodiagnosis of tuberculosis, 281
    14.10 Conclusion, 281
    References, 281
    15 Diagnostic Medical Parasitology, 284
    Lynne S. Garcia and Gary W. Procop
    15.1 Diagnostic parasitology testing, 284
    15.2 Solicitation of product information, 287
    15.3 Specimen collection systems, 287
    15.4 Fresh stool specimen collection, 287
    15.5 Preservation of stool specimens, 289
    15.6 Intestinal tract specimens (stool), 294
    15.7 Ova and parasite examination, 297
    15.8 Molecular methods, 297
    15.9 Other diagnostic methods, 303
    15.10 Collection of specimens from other body sites, 303
    15.11 Blood collection, 303
    15.12 Malaria rapid diagnostic tests, 305
    References, 307
    16 Molecular Microbiology, 309
    Raghava Potula and Yi-Wei Tang
    16.1 Introduction, 309
    16.2 Specimen processing and nucleic acid extraction platforms, 309
    16.3 Amplification methods and platforms, 310
    16.4 Amplicon detection and identification platforms, 313
    16.5 Future directions, 316
    16.6 Summary, 316
    References, 316
    17 Automated Immunoassay Analyzers, 319
    Richard L. Hodinka and Matthew J. Binnicker
    References, 333
    18 Molecular Typing Instruments and Methods, 336
    Ruth Ann Luna
    18.1 Introduction, 336
    18.2 Background, 336
    18.3 Current molecular typing methodologies, 337
    18.4 Comparison of typing techniques, 340
    18.5 Summary, 343
    References, 343
    19 Commercial Methods in Clinical Veterinary Microbiology, 346
    Thomas J. Inzana, Xiang-Jin Meng, Tanja Opriessnig, and Lora Ballweber
    19.1 Collection and transportation of clinical samples, 347
    19.2 Selection of diagnostic laboratories and tests, 348
    19.3 Pathology and histopathology, 349
    19.4 Quality control of veterinary diagnostic assays: sensitivity and specitivity, 349
    19.5 Veterinary virology, 350
    19.6 Veterinary bacteriology, 359
    19.7 Veterinary mycology, 365
    19.8 Veterinary parasitology, 366
    Acknowledgements, 371
    References, 371
    20 Microbiology Laboratory Information Systems, 377
    Raymond D. Aller and Vincent Salazar
    20.1 In general, microbiology laboratory information systems fit one of three categories, 377
    20.2 What are the key features of software to support management of microbiology?, 378
    20.3 Microbiology information systems have evolved over several decades, 380
    20.4 Criteria for comparison of current systems, 382
    20.5 Specialized software, 382
    20.6 Selecting an information system for your laboratory, 383
    20.7 Cases, 383
    20.8 Management of the laboratory information system, 384
    20.9 Personnel management, 384
    References, 385
    21 Emerging Infectious Diseases, 386
    Brett Laurence, Julie Collins, Carolyn Fernandes, Rafik Samuel, and Byungse Suh
    21.1 Introduction, 386
    21.2 Plasmodium knowlesi, 386
    21.3 Clostridium difficile, 389
    21.4 Pandemic H1N1 influenza, 391
    21.5 Escherichia coli O104:H4, 393
    21.6 Cryptococcus gattii, 394
    21.7 Borrelia miyamotoi, 396
    21.8 Rickettsia parkeri, 397
    21.9 Mycobacterium lepromatosis, 398
    21.10 Bocavirus, 400
    21.11 Human metapneumovirus, 400
    21.12 Severe fever with thrombocytopenia syndrome virus, 402
    21.13 Zika virus, 403
    References, 404
    22 Automated and Manual Systems for Antimicrobial Susceptibility Testing of Bacteria, 414
    Alan T. Evangelista and James A. Karlowsky
    22.1 Introduction, 414
    22.2 Evaluation of commercial AST performance, 415
    22.3 Automated broth microdilution AST systems, 415
    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, Cécile Bébéar, 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
    32.3 Marketing of IVD reagents in Japan, 526
    32.4 Clinical efficiency study/correlation study, 527
    32.5 Marketing approval, 530
    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