To view a list of CLSI documents helpful for COVID-19 testing click here.
To view a list of CLSI documents helpful for COVID-19 testing click here.

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M100 and M60 Free

With these read-only web versions of M100 and M60, you can now quickly reference the most trusted AST and antifungal breakpoints from anywhere with an Internet connection. Available online as a convenient companion to our M100 document and M60 document.

Access M100 and M60 Free

 



m23

M23-Ed5

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

Download M23 

 



 

m23

M23S

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.

This document is intended for use with M23.

Download M23S 

 

 

vet08

VET08 Free

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

 

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mr04

AST Rationale Documents

Providing the scientific reasons behind breakpoint decisions.

 

Access AST Rationale Documents

 

 

 

ep19

EP19-Ed2

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.

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ep36

EP36-Ed1

This report provides a standardized symbology for use throughout CLSI documents. Use of these standardized symbols is expected to be of great benefit to the CLSI readership, volunteers participating in CLSI committees, and the scientific community in general.

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ep36

MM14-A2

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.

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ep36

MM22-A3

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.

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ep36

POCT07-A

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.

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ep36

GP36-A

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.

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ep36

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

This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part 820.

Download QSRLDT