Vote and Deadlines
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods (I/LA2-A2)

I/LA2-A2—Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens:  (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second Edition
I/LA2-A2 provides guidance for laboratory scientists and manufacturers who perform immunofluorescence tests for autoantibodies to nuclear antigen to detect diseases.  Topics addressed include:  substrate and fixative variations, fluorochrome-labeled conjugates; microscope optics; assay requirements; assay validation; ELISA enzyme labeled conjugates; ELISA detection methods; coating and blocking concentrations; quantitation of antibodies; reference intervals and reporting test results; intralaboratory quality control; and reference preparations.  The deadline for the completed ballot for I/LA2-A2 to be received at the CLSI offices is 13 December 2005.

Second Notice

M45-P—Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Proposed Guideline
The M45-P guideline addresses organisms that may cause serious infections, such as infective endocarditis; infections associated with trauma and environmental contamination; or device associated infections in immunocompromised or postsurgical patients, such as intravascular catheters, implanted devices, and CNS shunts.  The deadline for the completed ballot for M45-P to be received at the CLSI offices is 2 January 2006.

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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