Focusing on the common qualitative and semi-quantitative test procedures performed in clinical microbiology labs, this Cumitech helps readers understand and comply with the criteria and decision-making process for verifying tests considered for clinical use. Moreover, it enables readers to confidently validate tests already in use in order to assess their continued clinical relevance. The Cumitech begins with a review of federal regulations on test verification and validation, including the Clinical and Laboratory Improvement Amendments (CLIA). Next, the authors set forth the criteria for selecting a laboratory method and then verifying and validating a test, explaining all the key components of the process. Examples using both FDA-approved and laboratory-developed tests are provided, helping with the design of test verification studies that fully meet regulatory requirements.

In response to the ever-changing needs and responsibilities of the clinical microbiology field, Clinical Microbiology Procedures Handbook, Fourth Edition has been extensively reviewed and updated to present the most prominent procedures in use today. The Clinical Microbiology Procedures Handbook provides step-by-step protocols and descriptions that allow clinical microbiologists and laboratory staff personnel to confidently and accurately perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation. If you are looking for online access to the latest from this reference or site access for your lab, please visit www.wiley.com/learn/clinmicronow.

Gold Standard consensus-based procedures from the experts. The Clinical Microbiology Procedures Handbook, 5th edition, provides those engaged in microbial analysis of clinical specimens with procedures for the detection, identification, and characterization of microorganisms involved in human infections. This unique and valuable collection of step-by-step descriptions of the numerous testing modalities used in the clinical microbiology laboratory was written and edited by highly knowledgeable laboratorians. The 5th edition features two new sections, one on blood cultures and one on MALDI-TOF MS, and the sections on molecular diagnostics, virology, and serology were extensively revised and updated. Presented over multiple volumes, this handbook enables laboratory staff to perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation. If you are looking for online access to the latest from this reference or site access for your lab, please visit www.wiley.com/learn/clinmicronow.

The definitive clinical virology resource for physicians and clinical laboratory virologists The clinical virology field is rapidly evolving and, as a result, physicians and clinical laboratory virologists must have a reliable reference tool to aid in their ability to identify and diagnose viral infections to prevent future outbreaks. In this completely revised edition of the Clinical Virology Manual, Editor in Chief, Michael Loeffelholz, along with Section Editors, Richard Hodinka, Benjamin Pinsky, and Stephen Young, have complied expert perspectives of a renowned team of clinical virology experts and divided these contributions into three sections to provide the latest information on the diagnosis of viral infections, including ebola, HIV and Human papillomavirus state of the art diagnostic technologies, including next-generation sequencing and nucleic acid amplification methods taxonomy of clinically important viruses such as polyomaviruses and zoonotic viruses This comprehensive reference also includes three appendices with vital information on reference virology laboratories at the Centers for Disease Control and Prevention, state and local public health laboratories, and international reference laboratories and laboratory systems. Additionally, a new section "Diagnostic Best Practices," which summarizes recommendations for diagnostic testing, and cites evidence-based guidelines, is included in each viral pathogens chapter. Clinical Virology Manual, Fifth Edition serves as a reference source to healthcare professionals and laboratorians in providing clinical and technical information regarding viral diseases and the diagnosis of viral infections.

Presenting the latest molecular diagnostic techniques in one comprehensive volume The molecular diagnostics landscape has changed dramatically since the last edition of Molecular Microbiology: Diagnostic Principles and Practice in 2011. With the spread of molecular testing and the development of new technologies and their opportunities, laboratory professionals and physicians more than ever need a resource to help them navigate this rapidly evolving field. Editors David Persing and Fred Tenover have brought together a team of experienced researchers and diagnosticians to update this third edition comprehensively, to present the latest developments in molecular diagnostics in the support of clinical care and of basic and clinical research, including next-generation sequencing and whole-genome analysis. These updates are provided in an easy-to-read format and supported by a broad range of practical advice, such as determining the appropriate type and quantity of a specimen, releasing and concentrating the targets, and eliminating inhibitors. Molecular Microbiology: Diagnostic Principles and Practice Presents the latest basic scientific theory underlying molecular diagnostics Offers tested and proven applications of molecular diagnostics for the diagnosis of infectious diseases, including point-of-care testing Illustrates and summarizes key concepts and techniques with detailed figures and tables Discusses emerging technologies, including the use of molecular typing methods for real-time tracking of infectious outbreaks and antibiotic resistance Advises on the latest quality control and quality assurance measures Explores the increasing opportunities and capabilities of information technology Molecular Microbiology: Diagnostic Principles and Practice is a textbook for molecular diagnostics courses that can also be used by anyone involved with diagnostic test selection and interpretation. It is also a useful reference for laboratories and as a continuing education resource for physicians. If you are looking for online access to the latest clinical microbiology content, please visit www.wiley.com/learn/clinmicronow.

Accompanying CD-ROM contains ... "a companion eBook version of Molecular diagnostics : for the clinical laboratorian, Second edition ... for downloading and use in the reader's PC or PDA."--Page 4 of cover.

A comprehensive and updated volume for the clinical virologist. • Details laboratory procedures for detecting and handling viruses, from specimen requirements and quality assurance to virus detection and identification, from the fundamentals through the latest molecular methods. • Presents the most current knowledge on the wide range of specific viral pathogens. • Includes information on services provided by federal and state public health virology laboratories. • Provides essential information for clinicians and laboratory virologists.