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Recently Approved Documents
User Protocol for Evaluation of Qualitative Test Performance (EP12-A2)
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays (H21-A5)
Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline (H57-A)
Antimicrobial Susceptibility Testing Standard (M100-S18)
EP12-A2—User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition
This document provides a consistent approach for protocol design and data analysis when evaluating qualitative diagnostic tests. Guidance is provided for both precision and method-comparison studies.
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H21-A5—Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition
This guideline contains procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests.
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H57-A—Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline
This document provides guidance and procedures to the end user and manufacturer for the selection, evaluation, validation, and implementation of a laboratory coagulometer.
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Second Notice
M100-S18— Performance Standards for Antimicrobial Susceptibility Testing; Eighteenth Informational Supplement
The latest recommendations for detecting emerging resistance—arranged in tabular form. Includes updated tables from CLSI’s newest disk (M02-A9) susceptibility and MIC (M07-A7) testing standards.
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Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community that participates in the consensus process by carefully reviewing and commenting on the standard or guideline.
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