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Point-of-Care Testing

CLSI POCT15

Point-of-Care Testing for Infectious Diseases

CLSI POCT15 offers a simplified, yet detailed summary of current knowledge and global best practices for rapid and point-of-care testing to aid in the treatment of patients with infectious diseases.

January 21, 2020
Sheldon M. Campbell, MD, PhD, FCAP

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Abstract

Clinical and Laboratory Standards Institute report POCT15—Point-of-Care Testing for Infectious Diseases is intended for use in assessing, implementing, and managing programs for the detection, control, and/or management of infectious diseases using point-of-care testing (POCT) methodologies. Clinicians rely heavily on laboratory tests for the etiological diagnosis of infectious diseases, which guides both prognostication and management. The clinical importance of these results means that testing must be performed in an optimal manner, and the results must be interpreted with clear knowledge of the methodologies’ abilities and limitations. This report summarizes current methods and practice in POCT for infectious diseases.

Scope

This report provides recommendations for clinicians, laboratories, public health agencies, and policymakers who are responsible for assessing, implementing, performing, and using point-of-care (POC) tests to improve management of infectious diseases. It also provides recommendations for indications, limitations, appropriate use, and reporting and interpretation for the major POC tests available. In addition, this report summarizes potential uses of POC tests in community outreach and public health testing and in resource-limited settings. 

The intended users of this report are point-of-care testing (POCT) professionals, including but not limited to POC coordinators, medical directors and laboratory directors of POCT programs, and microbiology laboratory directors. Users may also include public health agencies and public health policymakers. 

This report is not intended to provide an overview of quality control (QC), quality assurance (QA), or other good laboratory practices as related to these types of POC tests. Nor is it intended to provide a comprehensive review of the emerging technologies in POCT for infectious diseases. For the most part, discussions in this report are confined to commercialized or soon-to-be-commercialized technologies.

Product Details
POCT15Ed1E
978-1-68440-069-0
84
Authors
Sheldon M. Campbell, MD, PhD, FCAP
Robert L. Sautter, PhD, HCLD/CC (ABB), MT(ASCP)SM
Ellen Jo Baron, PhD, D(ABMM)
Suzanne E. Dale, PhD, D(ABMM)
Charlotte A. Gaydos, BS, MS, MPH, DrPH
Mitch Gonzales
Barbara Haller, MD, PhD
Ralf Labugger, MSc, PhD
Cindy B. McCloskey, MD
Norman Moore, PhD
Heather Stang, MS, MT
Abstract

Clinical and Laboratory Standards Institute report POCT15—Point-of-Care Testing for Infectious Diseases is intended for use in assessing, implementing, and managing programs for the detection, control, and/or management of infectious diseases using point-of-care testing (POCT) methodologies. Clinicians rely heavily on laboratory tests for the etiological diagnosis of infectious diseases, which guides both prognostication and management. The clinical importance of these results means that testing must be performed in an optimal manner, and the results must be interpreted with clear knowledge of the methodologies’ abilities and limitations. This report summarizes current methods and practice in POCT for infectious diseases.

Scope

This report provides recommendations for clinicians, laboratories, public health agencies, and policymakers who are responsible for assessing, implementing, performing, and using point-of-care (POC) tests to improve management of infectious diseases. It also provides recommendations for indications, limitations, appropriate use, and reporting and interpretation for the major POC tests available. In addition, this report summarizes potential uses of POC tests in community outreach and public health testing and in resource-limited settings. 

The intended users of this report are point-of-care testing (POCT) professionals, including but not limited to POC coordinators, medical directors and laboratory directors of POCT programs, and microbiology laboratory directors. Users may also include public health agencies and public health policymakers. 

This report is not intended to provide an overview of quality control (QC), quality assurance (QA), or other good laboratory practices as related to these types of POC tests. Nor is it intended to provide a comprehensive review of the emerging technologies in POCT for infectious diseases. For the most part, discussions in this report are confined to commercialized or soon-to-be-commercialized technologies.

POCT15Ed1E
978-1-68440-069-0
84
Authors
Sheldon M. Campbell, MD, PhD, FCAP
Robert L. Sautter, PhD, HCLD/CC (ABB), MT(ASCP)SM
Ellen Jo Baron, PhD, D(ABMM)
Suzanne E. Dale, PhD, D(ABMM)
Charlotte A. Gaydos, BS, MS, MPH, DrPH
Mitch Gonzales
Barbara Haller, MD, PhD
Ralf Labugger, MSc, PhD
Cindy B. McCloskey, MD
Norman Moore, PhD
Heather Stang, MS, MT