Risk Management Techniques to Identify and Control Laboratory Error Sources (EP18-P2); Clinical Evaluation of Immunoassays (I/LA21-A2); Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents (M37-A3); Interpretive Criteria for Microorganism Identification by DNA Target Sequencing (MM18-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.  

I/LA21-A2—Clinical Evaluation of Immunoassays
This document addresses the need for clinical evaluation of new immunoassays and new applications of existing assays. As a guide to designing and executing a clinical evaluation, this document will aid developers of “in-house” assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.The deadline for the completed ballot for I/LA21-A2 to be received at the CLSI offices is 19 November 2007.

M37-A3— Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents
This document addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents. The deadline for the completed ballot for M37-A3 to be received at the CLSI offices is 27 November 2007.

Second Notice

EP18-P2— Risk Management Techniques to Identify and Control Laboratory Error Sources
This guideline recommends risk management techniques that will aid in identifying, understanding, and managing sources of error (potential failure modes) and help to ensure correct results. It is targeted for those involved in supervision of laboratory-testing quality management, and it addresses issues related to specimen collection through reporting of results. The deadline for the completed ballot for EP18-P2 to be received at the CLSI offices is 23 October 2007.

MM18-P— Interpretive Criteria for Microorganism Identification by DNA Target Sequencing
Sequencing of DNA targets of cultured isolates provides a quantitative metric within which to perceive microbial diversity, and can serve as the basis to identify microorganisms. This document is an effort to catalyze the entry of molecular microbiology into clinical usage by establishing interpretive criteria for microorganism identification. The deadline for the completed ballot for MM18-P to be received at the CLSI offices is 23 October 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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