3 March 2008   
 

CLSI 2008 Leadership Conference
2 – 4 April 2008
Renaissance Harborplace Hotel
Baltimore, Maryland USA

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Rima Khabbaz, MD, Director of CDC’s National Center for Preparedness, Detection, and Control of Infectious Diseases, to Deliver Keynote Address at To Your Good Health Workshop
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Recently Approved Documents
  • (EP12-A2) User Protocol for Evaluation of Qualitative Test Performance
  • (H21-A5) Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
  • (H57-A) Protocol for the Evaluation, Validation, and Implementation of Coagulometers 
  • (I/LA30-A) Immunoassay Interference by Endogenous Antibodies
  • (M31-A3) Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals
  • (M37-A3) Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents


I/LA30-AImmunoassay Interference by Endogenous Antibodies; Approved Guideline
This guideline discusses the nature and causes of interfering antibodies, as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences are addressed along with assessment of methods used to eliminate interference.
Purchase here.

M31-A3Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard—Third Edition
This document provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use.
Purchase here.

M37-A3Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline—Third Edition
This document addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents.
Purchase here.

Second Notice

EP12-A2User 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.
Purchase here.

H21-A5Collection, 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.
Purchase here.

H57-AProtocol 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.
Purchase here.


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.

You may automatically receive or select approved-level documents as a member benefit.  Find out more about joining CLSI:  view membership options and benefits. [ return to top ]

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