Manual of Commercial Methods in Clinical Microbiology International Edition

The Manual of Commercial Methods in Clinical Microbiology 2nd Edition, International Edition 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 - both manual and automated. This text allows the user to easily summarize the available methods in any particular field, or for a specific pathogen - 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, 2nd Edition, International Edition 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 of Commercial Methods in Clinical Microbiology, 2nd Edition, International Edition is an invaluable reference to those in the health science and medical fields.

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 d