Laboratory Detection and Identification of Mycobacteria
This CLSI guideline offers comprehensive guidance on the laboratory diagnosis of mycobacterial infections. It covers specimen collection, processing, microscopy, culture methods, molecular detection, and identification techniques. The guideline addresses safety, risk assessment, contamination issues, and quality control, providing recommendations for handling both Mycobacterium tuberculosis and nontuberculous mycobacteria.
Clinical and Laboratory Standards Institute guideline M48—Laboratory Detection and Identification of Mycobacteria covers topics related to laboratory diagnosis of mycobacterial infections, including safety and risk assessment, referrals, clinical significance, acceptable specimen types, specimen collection, transport, and storage, specimen processing methods, microscopy for direct detection, molecular methods for directly detecting mycobacteria in patient specimens, culture methods, contamination issues, reporting, quality control, and conventional identification methods as they relate to mass spectrometry and genotypic procedures. Recommendations for managing the unique challenges associated with the increasing incidence of Mycobacterium tuberculosis and nontuberculous mycobacteria infections are included.
Overview of Changes
This guideline replaces the previous edition of the approved guideline, M48-A, published in 2008. Several changes were made in this edition, including: • Reorganized to fit the CLSI quality management system and path of workflow format • Removed information on service levels for mycobacteriology laboratory services • Revised the safety and risk assessment chapter • Expanded the review of the clinically significant NTM isolates from various patient specimens to reflect the significant increase in the number of different species and emerging roles in various clinical settings • Expanded the discussion and review of the role of nucleic acid amplification tests for detecting Mycobacterium tuberculosis complex directly in patient specimens • Described the method for determining contamination rates for mycobacterial culture • Removed information on conventional biochemical tests and high-performance liquid chromatography, because these methods are no longer recommended for mycobacterial identification – Other conventional phenotypic tests such as growth rate on subculture to solid mycobacterial media, pigment production, and colony morphology were retained, because these tests remain essential for accurate identification of some mycobacterial species. • Added guidance for using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for mycobacterial identification • Expanded the discussion of molecular sequencing methods for mycobacterial identification • Developed an algorithm for mycobacterial identification using different methods • Added a subchapter discussing the collection of performance parameters for monitoring internal QC indicators
Scope
This guideline provides recommendations for laboratories on the total testing process for patients with suspected mycobacterial infections. Recommendations are provided for patient specimen collection, preservation, and transport. Procedures for detecting mycobacteria directly in specimens using microscopy and amplification techniques, optimal recovery of mycobacteria from patient specimens, and identification of mycobacterial species by traditional (phenotypic) and alternative (phenotypic and genotypic) laboratory methods are discussed. Mycobacterial susceptibility testing is not included in this guideline and is covered in CLSI document M24.3 This guideline is intended for medical and public health laboratories performing procedures for identifying mycobacteria from patient specimens. However, many chapters of this guideline, especially those related to identification methods, are intended for full-service mycobacteriology laboratories in industrialized countries. It is recognized that providing various laboratory services depends on existing local conditions and resources. For many laboratories in tuberculosis (TB)-endemic countries, implementing quality-assured, direct sputum smear microscopy may be a higher priority than the more equipment- and reagent-dependent methods described. Additional information for such laboratories is publicly available from the World Health Organization (WHO) and other scientific and public health organizations. However, these guidelines should provide useful information for international laboratories providing or planning to provide services beyond microscopy, such as solid media culture or rapid methods for Mycobacterium tuberculosis complex (MTBC) detection.
Product Details
M48Ed2E
978-1-68440-020-1
102
Additional Details
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
Authors
Betty A. Forbes, PhD, D(ABMM), F(AAM)
Melissa B. Miller, PhD, D(ABMM), F(AAM)
Niaz Banaei, MD
Barbara A. Brown-Elliott, MS, MT(ASCP)SM
Sanchita Das, MD, D(ABMM)
Max Salfinger, MD, F(IDSA), F(AAM)
Meenu K. Sharma, PhD
Akos Somoskovi, MD, PhD, ScD
Julie Tans-Kersten, MS, BSMT(ASCP)
Fred C. Tenover, PhD, D(ABMM), F(AAM), F(IDSA)
David Warshauer, PhD, D(ABMM)
Adrian M. Zelazny, PhD, D(ABMM)
Abstract
Clinical and Laboratory Standards Institute guideline M48—Laboratory Detection and Identification of Mycobacteria covers topics related to laboratory diagnosis of mycobacterial infections, including safety and risk assessment, referrals, clinical significance, acceptable specimen types, specimen collection, transport, and storage, specimen processing methods, microscopy for direct detection, molecular methods for directly detecting mycobacteria in patient specimens, culture methods, contamination issues, reporting, quality control, and conventional identification methods as they relate to mass spectrometry and genotypic procedures. Recommendations for managing the unique challenges associated with the increasing incidence of Mycobacterium tuberculosis and nontuberculous mycobacteria infections are included.
Overview of Changes
This guideline replaces the previous edition of the approved guideline, M48-A, published in 2008. Several changes were made in this edition, including: • Reorganized to fit the CLSI quality management system and path of workflow format • Removed information on service levels for mycobacteriology laboratory services • Revised the safety and risk assessment chapter • Expanded the review of the clinically significant NTM isolates from various patient specimens to reflect the significant increase in the number of different species and emerging roles in various clinical settings • Expanded the discussion and review of the role of nucleic acid amplification tests for detecting Mycobacterium tuberculosis complex directly in patient specimens • Described the method for determining contamination rates for mycobacterial culture • Removed information on conventional biochemical tests and high-performance liquid chromatography, because these methods are no longer recommended for mycobacterial identification – Other conventional phenotypic tests such as growth rate on subculture to solid mycobacterial media, pigment production, and colony morphology were retained, because these tests remain essential for accurate identification of some mycobacterial species. • Added guidance for using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry for mycobacterial identification • Expanded the discussion of molecular sequencing methods for mycobacterial identification • Developed an algorithm for mycobacterial identification using different methods • Added a subchapter discussing the collection of performance parameters for monitoring internal QC indicators
Scope
This guideline provides recommendations for laboratories on the total testing process for patients with suspected mycobacterial infections. Recommendations are provided for patient specimen collection, preservation, and transport. Procedures for detecting mycobacteria directly in specimens using microscopy and amplification techniques, optimal recovery of mycobacteria from patient specimens, and identification of mycobacterial species by traditional (phenotypic) and alternative (phenotypic and genotypic) laboratory methods are discussed. Mycobacterial susceptibility testing is not included in this guideline and is covered in CLSI document M24.3 This guideline is intended for medical and public health laboratories performing procedures for identifying mycobacteria from patient specimens. However, many chapters of this guideline, especially those related to identification methods, are intended for full-service mycobacteriology laboratories in industrialized countries. It is recognized that providing various laboratory services depends on existing local conditions and resources. For many laboratories in tuberculosis (TB)-endemic countries, implementing quality-assured, direct sputum smear microscopy may be a higher priority than the more equipment- and reagent-dependent methods described. Additional information for such laboratories is publicly available from the World Health Organization (WHO) and other scientific and public health organizations. However, these guidelines should provide useful information for international laboratories providing or planning to provide services beyond microscopy, such as solid media culture or rapid methods for Mycobacterium tuberculosis complex (MTBC) detection.
Additional Details
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
