1 March 2007   

 

CLSI 2007 Leadership Conference
18-20 April 2007
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Facing the Challenge: Practical Approaches to Evaluate Analytical Performance Workshop Explores CLSI Evaluation Protocols
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Standards Status
Vote and Deadlines

General Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory (C50-P); User Protocol for Evaluation of Qualitative Test Performance (EP12-A2); Laboratory Detection and Identification of Mycobacteria (M48-P)

CLSI submits the following for vote as a candidate-for-advancement consensus documents.  The documents and ballots are available to delegates and alternates of Active and Associate Active member organizations through CLSI Forums.  

C50-PGeneral Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory; Proposed Guideline
This guideline provides a general understanding of mass spectrometry and the principles that dictate its application in the clinical laboratory. It includes guidance, references, and quality assurance markers that will assist with the implementation and correct operation of a mass spectrometry (MS) system for its many applications. Information on maintaining optimum performance, approaches to ensuring accurate and precise mass measurement, verification of methods, quality control of assays within and between instruments, instrument troubleshooting, sample preparation, interpretation of results, and limitations of the technology are included. The deadline for the completed ballot for C50-P to be received at the CLSI offices is 16 April 2007.

M48-PLaboratory Detection and Identification of Mycobacteria; Proposed Guideline
This document provides guidance to clinical mycobacteriology laboratories on the most optimum approach for the diagnosis of mycobacterial infections. The deadline for the completed ballot for M48-P to be received at the CLSI offices is 16 April 2007.

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. The deadline for the completed ballot for EP12-A2 to be received at the CLSI offices is 2 April 2007.


Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.

As a delegate, your vote is to affirm (or reject) the document for advancement as a CLSI document. Please send your completed ballot to the CLSI offices by the above deadline.

In the consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement.

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