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Free Susceptibility Testing Resources

M100 and M60
Performance Standards for Antimicrobial & Antifungal Susceptibility Testing
Access read-only web versions of M100 and M60 to quickly reference the most trusted AST and antifungal breakpoints. Available online as a convenient companion to our M100 document and M60 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.
Free Method Evaluation Resources

EP19
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition
This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests (LDTs).

EP36
Harmonization of Symbology and Equations, 1st Edition
This report provides a standardized symbology for use throughout CLSI documents.
COVID-19 Testing Resources

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.
Free COVID-19 Webinars

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

GP36 Free Overview Webinar
GP36 Overview: Planning for Laboratory Operations During a Disaster

GP41 Free Overview Webinar
Collection of Diagnostic Venous Blood Specimens

GP44 Free Overview Webinar
GP44 Overview: Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests

M29 Free Overview Webinar
Protection of Laboratory Workers From Occupationally Acquired Infections

M40 Free Overview Webinar
M40 Overview: Quality Control of Microbiological Transport Systems

MM03 Free Overview Webinar
MM03 Overview: Molecular Diagnostic Methods for Infectious Diseases

MM06 Free Overview Webinar
Quantitative Molecular Methods for Infectious Diseases

MM09 Free Overview Webinar
MM09 Overview: Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine

MM13 Free Overview Webinar
MM13 Overview: Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods

MM14 Free Overview Webinar
MM14 Overview: Design of Molecular Proficiency Testing/External Quality Assessment

MM17 Free Overview Webinar
MM17 Overview: Validation and Verification of Multiplex Nucleic Acid Assays

MM19 Free Overview Webinar
MM19 Overview: Establishing Molecular Testing in Clinical Laboratory Environments

MM22 Free Overview Webinar
MM22 Overview: Microarrays for Diagnosis and Monitoring of Infectious Diseases

POCT04OVWR
Essential Tools for Implementation and Management of a Point-of-Care Testing Program

POCT07OVWR
Quality Management: Approaches to Reducing Errors at the Point of Care

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
Quality Management System: Development and Management of Laboratory Documents
Free Recent Webinars

CLSI 2020 AST Webinar
M100-Ed30 Updates
Identify the major changes found in the updated edition of CLSI document M100-Ed30. Learn to design a strategy for implementing M100 and get communication strategies for informing staff changes.

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.

EP17WR
Using EP17, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
Learn about the meaning of detection capability and how it is measured and how to interpret and report results that are close to the detection limits.

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.