Manual of Commercial Methods in Clinical Microbiology 1st Edition by AL Truant ISBN 1118131126 9781118131121

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ISBN 10: 1118131126 
ISBN 13: 9781118131121
Author: AL Truant

Manual of Commercial Methods in Clinical Microbiology 1st Table of contents:

CHAPTER 1: Role of the US Food and Drug Administration in the Regulation of Clinical Microbiology Devices
1.1 Historical overview of in vitro diagnostics
1.2 Current microbiology device review regulatory pathways: practical considerations
1.3 Assay performance characteristics: “Statistics 101” for diagnostic device developers[1]1.4 Common issues with new FDA submissions
Appendix: web sites
References
CHAPTER 2: Commercial Blood Culture Systems and Methods
2.1 Manual blood cultures
2.2 Automated blood culture systems
2.3 Molecular and other methods
2.4 Future directions
References
CHAPTER 3: Rapid Devices and Instruments for the Identification of Aerobic Bacteria
3.1 Introduction
3.2 Major methods currently available
3.3 Commercial systems for identification of Gram-positive organisms
3.4 Commercial systems for identification of Gram-negative organisms
3.5 Commercial methods for identification of microorganisms directly in blood culture bottles
3.6 Commercial molecular methods for identification of bacteria isolated in culture
3.7 Emerging technologies for the identification of organisms: mass spectrometry
References
CHAPTER 4: Rapid Devices and Instruments for the Identification of Anaerobic Bacteria
4.1 Introduction and clinical considerations
4.2 Steps in the diagnosis of anaerobic bacterial infections
4.3 Commercial kit requiring 24 h of anaerobic incubation
4.4 Commercial enzyme kits for identification after four hours ofaerobic incubation
4.5 Identification by gene sequencing
4.6 Identification by chemical methods
4.7 Immunodiagnostic and molecular methods for diagnosis of Clostridium difficile infection
References
CHAPTER 5: Rapid Antigen Devices and Instruments for the Detection and Identification of Viruses
5.1 Influenza viruses
5.2 Respiratory syncytial virus
5.3 Immunofluorescence staining of respiratory viruses
5.4 Herpes simplex virus, varicella zoster virus, cytomegalovirus
5.5 Gastrointestinal viruses
References
CHAPTER 6: Molecular Tests for the Identification of Viruses
6.1 Introduction
6.2 Respiratory viral infections
6.3 Enteric viruses
6.4 Enterovirus and parechovirus
6.5 Herpesviruses
6.6 Viral infections associated with transplantation
6.7 Implementation and additional considerations
References
CHAPTER 7: Viral Hepatitis
7.1 Introduction/background
7.2 Clinical manifestations, epidemiology, and diagnostic considerations by virus
7.3 Commercial methods
7.4 Summary
References
CHAPTER 8: Human Papillomaviruses
8.1 Background
8.2 Commercial assays
8.3 Current challenges and future directions
References
CHAPTER 9: Human Immunodeficiency Virus
9.1 Introduction
9.2 Markers of HIV infection
9.3 HIV screening
9.4 Laboratory-based immunoassays
9.5 Rapid, less-sophisticated immunoassays
9.6 Specimen matrices for HIV screening
9.7 Confirmatory and supplemental tests
9.8 Serological testing of neonates
9.9 p24 Antigen detection
9.10 Qualitative molecular detection
9.11 Quantification of HIV RNA
9.12 Phenotypic and genotypic assays for drug resistance
References
CHAPTER 10: Chlamydia
10.1 Introduction
10.2 Epidemiology
10.3 Biology
10.4 Natural history
10.5 Clinical symptoms and sequelae
10.6 Treatment
10.7 Laboratory testing for C. trachomatis
References
CHAPTER 11: Rickettsiae and Tick-borne Diseases
11.1 Introduction
11.2 Overview of tick-borne diseases
11.3 Newly emerging tick-borne disease
References
CHAPTER 12: Mycoplasma
12.1 Introduction and clinical considerations
12.2 Culture-based diagnosis
12.3 Serological diagnosis
12.4 Molecular detection systems
12.5 Antimicrobial susceptibility testing
12.6 Future directions
References
CHAPTER 13: Commercial Methods for Identification and Susceptibility Testing of Fungi
13.1 Direct examination and detection methods
13.2 Culture and detection
13.3 Identification systems
13.4 Molecular testing
13.5 Susceptibility testing
References
CHAPTER 14: Mycobacteria
14.1 Introduction
14.2 Specimen processing
14.3 Acid-fast staining reagents
14.4 Direct detection of mycobacteria from clinical specimens
14.5 Blood-culture recovery of mycobacteria
14.6 Mycobacteria-culturing methods and systems
14.7 Identification of mycobacteria
14.8 Susceptibility tests for mycobacteria
14.9 Immunodiagnosis of tuberculosis
14.10 Conclusion
References
CHAPTER 15: Diagnostic Medical Parasitology
15.1 Diagnostic parasitology testing
15.2 Solicitation of product information
15.3 Specimen collection systems
15.4 Fresh stool specimen collection
15.5 Preservation of stool specimens
15.6 Intestinal tract specimens (stool)
15.7 Ova and parasite examination
15.8 Molecular methods
15.9 Other diagnostic methods
15.10 Collection of specimens from other body sites
15.11 Blood collection
15.12 Malaria rapid diagnostic tests
References
CHAPTER 16: Molecular Microbiology
16.1 Introduction
16.2 Specimen processing and nucleic acid extraction platforms
16.3 Amplification methods and platforms
16.4 Amplicon detection and identification platforms
16.5 Future directions
16.6 Summary
References
CHAPTER 17: Automated Immunoassay Analyzers
References
CHAPTER 18: Molecular Typing Instruments and Methods
18.1 Introduction
18.2 Background
18.3 Current molecular typing methodologies
18.4 Comparison of typing techniques
18.5 Summary
References
CHAPTER 19: Commercial Methods in Clinical Veterinary Microbiology
19.1 Collection and transportation of clinical samples
19.2 Selection of diagnostic laboratories and tests
19.3 Pathology and histopathology
19.4 Quality control of veterinary diagnostic assays: sensitivity and specitivity
19.5 Veterinary virology
19.6 Veterinary bacteriology
19.7 Veterinary mycology
19.8 Veterinary parasitology
Acknowledgements
References
CHAPTER 20: Microbiology Laboratory Information Systems
20.1 In general, microbiology laboratory information systems fit one of three categories
20.2 What are the key features of software to support management of microbiology?
20.3 Microbiology information systems have evolved over several decades
20.4 Criteria for comparison of current systems
20.5 Specialized software
20.6 Selecting an information system for your laboratory
20.7 Cases
20.8 Management of the laboratory information system
20.9 Personnel management
References
CHAPTER 21: Emerging Infectious Diseases
21.1 Introduction
21.2 Plasmodium knowlesi
21.3 Clostridium difficile
21.4 Pandemic H1N1 influenza
21.5 Escherichia coliO104:H4
21.6 Cryptococcus gattii
21.7 Borrelia miyamotoi
21.8 Rickettsia parkeri
21.9 Mycobacterium lepromatosis
21.10 Bocavirus
21.11 Human metapneumovirus
21.12 Severe fever with thrombocytopenia syndrome virus
21.13 Zika virus
References
CHAPTER 22: Automated and Manual Systems for Antimicrobial Susceptibility Testing of Bacteria
22.1 Introduction
22.2 Evaluation of commercial AST performance
22.3 Automated broth microdilution AST systems
22.4 Semiautomated and manual broth microdilution AST systems
22.5 Manual and semiautomated agar antimicrobial gradient diffusion and disk diffusion susceptibility tests
22.6 Phenotypic detection of antimicrobial resistance using chromogenic media
22.7 Genotypic detection of antimicrobial resistance determinants in positive blood cultures
22.8 Next generation methods for antimicrobial susceptibility testing
References
CHAPTER 23: Bioterrorism
23.1 Introduction
23.2 History of bioterrorism
23.3 Bioterrorism in the future
23.4 Laboratory Response Network
23.5 Rapid methods
23.6 Conclusion
References
CHAPTER 24: Clinical Microbiology
24.1 Introduction
24.2 Connectivity between extraction and amplification platforms
24.3 Polymerase chain reaction and RT-PCR: detection and characterization
24.4 Other amplification methods
24.5 Probe technology
24.6 Mass spectrometry
24.7 DNA sequencing
24.8 Emerging technology
24.9 Other strategies and concepts that will impact clinical microbiology
24.10 Some new responsibilities for the coming years
24.11 Summary
References
CHAPTER 25: Clinical Microbiology In Vitro Diagnostic Medical Devices in Argentina
25.1 History
25.2 Regulation of clinical microbiology in vitro diagnostic medical devices in Argentina
References
CHAPTER 26: Clinical Microbiology In Vitro Diagnostics in Australia
26.1 The Therapeutic Goods Administration
26.2 National Pathology Accreditation Advisory Council
26.3 National Association of Testing Authorities
26.4 RCPA quality assurance programs
26.5 Manufacturers and suppliers of IVDs
References
CHAPTER 27: Clinical Microbiology In Vitro Diagnostic Devices in Canada
References
CHAPTER 28: Clinical Microbiology In Vitro Diagnostics in China
28.1 The regulatory requirements for clinical microbiology in vitro diagnostics products in China
28.2 IVD product review: devices and instruments
References
CHAPTER 29: Clinical Microbiology In Vitro Diagnostic Medical Devices in France
29.1 Regulatory requirements
29.2 European Directive 98/79/EC
29.3 Directive 98/79/EC in France
29.4 The implications of the regulatory level authorities
29.5 Assessment procedures
Reference
CHAPTER 30: Clinical Microbiology In Vitro Diagnostic Medical Devices in India
References
Websites for reference
CHAPTER 31: Clinical Microbiology In Vitro Diagnostics in Italy
31.1 Introduction
31.2 National classification of medical devices
31.3 Assessment procedures for IVD medical devices
31.4 Registration for manufacturers of IVD medical devices
Bibliography
CHAPTER 32: Clinical Microbiology In Vitro Diagnostics in Japan
32.1 The regulatory structure of pharmaceuticals and clinical trials in Japan
32.2 The regulatory structure of in vitro diagnostic testing in Japan
32.3 Marketing of IVD reagents in Japan
32.4 Clinical efficiency study/correlation study
32.5 Marketing approval
32.6 National Health Insurance coverage of IVD reagents
Bibliography
CHAPTER 33: Clinical Microbiology In Vitro Diagnostic Medical Devices in the Republic of Korea: Regulatory Requirements and Product Information
Bibliography
CHAPTER 34: Clinical Microbiology In Vitro Diagnostic Medical Devices in South Africa: Regulatory Requirements and Product information
34.1 Regulatory requirements
34.2 Product information
Reference
CHAPTER 35: Clinical Microbiology In Vitro Diagnostic Medical Devices in the UK: Regulatory Requirements and Product Information
35.1 Background
35.2 Definitions
35.3 Conformity assessment
35.4 Other considerations

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