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M100 and M27M44S

Performance Standards for Antimicrobial & Antifungal Susceptibility Testing

Access read-only web versions of M100 and M27M44S to quickly reference the most trusted AST and antifungal breakpoints. Available online as a convenient companion to our M100 document and M27M44S document.

M23

Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters, 5th Edition

This guideline discusses the necessary and recommended data for selecting appropriate breakpoints and quality control ranges for antimicrobial agents.

M23S

Procedure for Optimizing Disk Contents (Potencies) for Disk Diffusion Testing of Antimicrobial Agents Using Harmonized CLSI and EUCAST Criteria, 1st Edition

This document describes the necessary technical steps for establishing the optimal disk content (potency) for single antimicrobial agents without the addition of enhancing or inhibiting substances.

VET01S

Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals

Quickly reference the most trusted AST veterinary breakpoint tables as a convenient, complimentary supplement to the AST VET01 document.

AST Rationale Documents

Package of Rationale Documents

Providing the scientific reasons behind breakpoint decisions.

Using M100-Ed32

Using M100-Ed32

Improve your lab's antimicrobial susceptibility testing (AST) by using this self-paced, online learning program. This interactive program will teach you how to navigate the many tables found in CLSI's document M100—Performance Standards for Antimicrobial Susceptibility Testing, 32nd Edition.

BPIU

Breakpoints in Use (BPIU)

The College of American Pathologists (CAP) is introducing two new requirements for clinical laboratories to use updated breakpoints (BPs) when interpreting antimicrobial susceptibility testing (AST) results. CAP has recognized that some laboratories are using obsolete breakpoints, even when devices have achieved US Food and Drug Administration (FDA) clearance for updates, which could lead to adverse consequences in managing patients.

EP36

Harmonization of Symbology and Equations, 1st Edition

This report provides a standardized symbology for use throughout CLSI documents.

GP36

Planning for Laboratory Operations During a Disaster, 1st Edition

This document provides guidance for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters. 

MM14

Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition

This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. 

MM22

Microarrays for Diagnosis and Monitoring of Infectious Diseases, 1st Edition

This document provides guidance for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases. It also presents recommendations for validation and verification, quality control, and interpretation of results. 

POCT07

Quality Management: Approaches to Reducing Errors at the Point of Care, 1st Edition

This document presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use. 

QSRLDT

Quality System Regulations for Laboratory Developed Tests: A Practical Guide for the Laboratory

This practical guide is intended for the laboratory that is creating laboratory developed tests.

EP07 Free Overview Webinar

EP07 Overview: Interference Testing in Clinical Chemistry

EP12OVWR

User Protocol for Evaluation of Qualitative Test Performance

EP17 Free Overview Webinar

EP17 Overview: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures

GP41 Free Overview Webinar

Collection of Diagnostic Venous Blood Specimens

M29 Free Overview Webinar

Protection of Laboratory Workers From Occupationally Acquired Infections

MM03 Free Overview Webinar

MM03 Overview: Molecular Diagnostic Methods for Infectious Diseases

Free: POCT for COVID-19 Testing

Best Practices for Point-of-Care Implementation of COVID-19 Testing

Best Practices for Point-of-Care Implementation of COVID-19 Testing

QMS03 Free Overview Webinar

Using QMS03, Training and Competence Assessment, On-Demand Webinar

Rationale Webinar

FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions

Learn about the FDA’s Role in increasing the availability and reliability of ASTs and about CLSI’s commitment to ensure updated and new breakpoints are available to clinical laboratories.

EP19 Webinar

Help Validate and Verify Laboratory Developed Tests: Using EP19, A Framework for Using CLSI Documents

Learn what testing you need to do to validate your laboratory-developed test (LDT) and what testing you need to do to verify a new manufacturer's test.