Vote and Deadlines
Specimen Container Identification (AUTO2-A2); Dehydrated Mueller-Hinton Agar (M6-A2); Diagnostic Nucleic Acid Microarrays (MM12-P); External RNA Controls in Gene Expression Assays (MM16-P)

Clinical and Laboratory Standards Institute (CLSI) announces that the following are submitted for vote as candidate-for-advancement consensus documents:

AUTO2-A2—Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition
This standard defines the way bar-coded sample identification labels are applied to clinical specimen containers. It documents the form, placement, and content of bar-code labels on specimen container tubes used on clinical laboratory analyzers.  The deadline for the completed ballot for AUTO2-A2 to be received at CLSI is 12 September 2005.

M6-A2—Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition
M6-A2 describes three protocols for the evaluation of dehydrated Mueller-Hinton agar in the disk diffusion procedure for antimicrobial susceptibility testing.  The first is for use by manufacturers to evaluate production lots of Mueller-Hinton agar.  The second and third are for selection and stability testing of primary and secondary reference lots of Mueller-Hinton agar.  The deadline for the completed ballot for M6-A2 to be received at CLSI is 12 September 2005.

MM12-P—Diagnostic Nucleic Acid Microarrays; Proposed Guideline
This guideline will define the most favorable conditions and principles for the provision of accurate molecular information.  Recommendations will be provided for many aspects of the array process, including: a method overview; nucleic acid extraction; the preparation, handling, and assessment of genetic material; quality control; analytic validation; and interpretation and reporting of results.  The deadline for the completed ballot for MM12-P to be received at CLSI is 11 October 2005.

MM16-P—Use of External RNA Controls in Gene Expression Assays; Proposed Guideline
This document provides protocols supporting the use of external RNA controls in microarray and QRT-PCR-based gene expression experiments, including preparation of control transcripts, design of primers and amplicons, quality control, use in final experimental or clinical test application, and analysis and interpretation of data obtained.  The deadline for the completed ballot for MM16-P to be received at CLSI is 11 October 2005.


Second Notice

EP7-A2—Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition
EP7-A2 enables manufacturers and laboratories to evaluate interfering substances in the context of medical needs, and to inform their customers of known sources of medically significant error.  The deadline for the completed ballot for EP7-A2 to be received at CLSI is 8 August 2005.

C3-P4—Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition
This document provides guidelines on water purified for clinical laboratory use; methods for monitoring water quality and testing for specific contaminants; and water system design considerations. The deadline for the completed ballot for C3-P4 to be received at CLSI is 6 September 2005.

Ballots are posted on the Forums section of our website, available to Active and Associate Active members.  Login to Forums to access the candidate-for-advancement forms, and send your completed ballot to CLSI by the listed deadline. 

Not yet a voting member?  Find out more about Active and Associate Active membership.

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.

Remember that we welcome and encourage comments from our voting members at each publication stage.  Comments on a candidate-for-advancement consensus document will be addressed by the committee prior to advancement.  In each document edition, a summary of comments on the prior edition is included, along with committee responses.  

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