CLSI eNews - 11 April 2005  (Plain Text Version)

Clinical and Laboratory Standards Institute announces that the following documents are submitted for vote as candidate-for-advancement consensus documents.

Molecular Diagnostic Methods for Infectious Diseases (MM3-P2); Proposed Guideline— Second Edition

MM3-P2—Molecular Diagnostic Methods for Infectious Diseases:  Proposed Guideline--Second Edition

This guideline addresses topics relating to clinical applications, amplified and non-amplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. 

The deadline for the completed ballot for MM3-P2 to be received in the Executive Offices is 11 July 2005.

Second Notice

Genotyping for Infectious Diseases (MM10-P); Collection and Handling of Specimens for Molecular Methods (MM13-P)

MM10-P—Genotyping for Infectious Diseases: Identification and Characterization; Proposed Guideline
This guideline describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting.  It also provides guidance on the criteria to be considered for design, validation, and determination of clinical utility of such testing.

MM13-P—Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Proposed Guideline
This document provides guidance related to proper and safe biological specimen collection and nucleic acid isolation and purification.  These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type.

The deadline for the completed ballots for MM10-P and MM13-P to be received in the Executive Offices is 8 June 2005.

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 Executive Offices by the above deadline.

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