Clinical and Laboratory Standards Institute (CLSI) Guidelines
The Clinical and Laboratory Standards Institute (CLSI) develops internationally recognized
standards for laboratory testing to ensure accuracy, reliability, and consistency in clinical
diagnostics. Below is a summary of key CLSI guidelines across different areas.
1. Antimicrobial Susceptibility Testing (AST)
● CLSI M100: Provides performance standards for antimicrobial susceptibility testing.
● CLSI M02: Guidelines for disk diffusion susceptibility testing.
● CLSI M07: Methods for dilution antimicrobial susceptibility tests for bacteria.
● CLSI M11: Methods for anaerobic bacteria susceptibility testing.
● CLSI M45: Guidelines for testing fastidious and infrequently isolated bacteria.
2. Clinical Laboratory Standards
● CLSI GP41: Collection and handling of blood specimens.
● CLSI EP28: Establishing reference intervals for laboratory tests.
● CLSI EP23: Laboratory quality control based on risk management.
● CLSI H21: Collection, transport, and processing of blood specimens for coagulation
testing.
3. Molecular Diagnostics
● CLSI MM01: Molecular diagnostic methods for infectious diseases.
● CLSI MM03: Molecular diagnostics for human genetic diseases.
● CLSI MM13: Microarray and next-generation sequencing (NGS) guidelines.
● CLSI MM17: Validation of molecular assays.
4. Point-of-Care Testing (POCT)
● CLSI POCT01: Quality management for point-of-care testing.
● CLSI POCT07: Blood glucose monitoring standards.
● CLSI POCT13: Guidelines for infectious disease rapid testing.
5. Hematology and Coagulation
● CLSI H20: A complete blood count (CBC) testing guideline.
● CLSI H26: Erythrocyte sedimentation rate (ESR) testing.
● CLSI H57: Blood cell morphology assessment.
6. Quality Control and Laboratory Management
● CLSI QMS01: Quality management system model.
● CLSI QMS13: Risk management in the laboratory.
● CLSI QMS20: Equipment maintenance and calibration.
These guidelines help laboratories maintain high standards, ensure patient safety, and
comply with regulatory requirements. For more details, refer to the official CLSI website or
specific guideline documents.
Clinical and Laboratory Standards Institute (CLSI) Guidelines
The Clinical and Laboratory Standards Institute (CLSI) develops internationally recognized
standards for laboratory testing to ensure accuracy, reliability, and consistency in clinical
diagnostics. Below is a summary of key CLSI guidelines across different areas.
1. Antimicrobial Susceptibility Testing (AST)
● CLSI M100: Provides performance standards for antimicrobial susceptibility testing.
● CLSI M02: Guidelines for disk diffusion susceptibility testing.
● CLSI M07: Methods for dilution antimicrobial susceptibility tests for bacteria.
● CLSI M11: Methods for anaerobic bacteria susceptibility testing.
● CLSI M45: Guidelines for testing fastidious and infrequently isolated bacteria.
2. Clinical Laboratory Standards
● CLSI GP41: Collection and handling of blood specimens.
● CLSI EP28: Establishing reference intervals for laboratory tests.
● CLSI EP23: Laboratory quality control based on risk management.
● CLSI H21: Collection, transport, and processing of blood specimens for coagulation
testing.
3. Molecular Diagnostics
● CLSI MM01: Molecular diagnostic methods for infectious diseases.
● CLSI MM03: Molecular diagnostics for human genetic diseases.
● CLSI MM13: Microarray and next-generation sequencing (NGS) guidelines.
● CLSI MM17: Validation of molecular assays.
4. Point-of-Care Testing (POCT)
● CLSI POCT01: Quality management for point-of-care testing.
● CLSI POCT07: Blood glucose monitoring standards.
● CLSI POCT13: Guidelines for infectious disease rapid testing.
5. Hematology and Coagulation
● CLSI H20: A complete blood count (CBC) testing guideline.
● CLSI H26: Erythrocyte sedimentation rate (ESR) testing.
● CLSI H57: Blood cell morphology assessment.
6. Quality Control and Laboratory Management
● CLSI QMS01: Quality management system model.
● CLSI QMS13: Risk management in the laboratory.
● CLSI QMS20: Equipment maintenance and calibration.
These guidelines help laboratories maintain high standards, ensure patient safety, and
comply with regulatory requirements. For more details, refer to the official CLSI website or
specific guideline documents.
