--- Tracy Dooley <tdooley@nccls.orgwrote:

From: "Tracy Dooley" <tdooley@nccls.orgTo: "DivC" <divc@mail.asmusa.orgSubject: [divc] CLSI Issues Call for Nominations
Date: Wed, 9 Aug 2006 12:12:17 -0000

Volunteers Needed: Please review the objective of the project, and the
requested volunteer expertise, and submit a nomination including
complete contact information. For consideration as a member of a
subcommittee, the nomination must be accompanied by a curriculum
vitae. Please submit all nominations by Friday, 18 August 2006.

Fax to: +610.688.0700
E-Mail to: customerservice@clsi.org
Or send via post to:
Clinical and Laboratory Standards Institute 940 West Valley Road,
Suite 1400 Wayne, PA 19087-1898

CLSI is considering a new project entitled:
“Interpretive Criteria for Microorganism Identification by Gene


Established guidelines for gene sequencing are essential to enable
clinical laboratory professionals to provide reproducible, consistent,
and accurate results for microbial identification.
Historically laboratories have used manual biochemical,
semi-automated, and automated methods for identification but these
methods are time-consuming, labor-intensive, and often presumptive.
Partial gene sequencing has emerged as an important method for
microbial identification for many clinical laboratories. This
document will address the importance of quality control, selection of
appropriate reference sequences/databases, quality scores for
sequencing results, identity scores for sequence analysis,
interpretive criteria for specific groups of microorganisms, and
limitations of gene sequencing method.

The objectives of this subcommittee are to:

1. Provide quality control parameters for gene
2. Develop guidelines for querying reference
3. Establish interpretive criteria for identity
scores generated by 16S rRNA sequencing for bacteria (aerobic and
anaerobic) and mycobacteria.
4. Establish interpretive criteria for identity
scores generated by sequencing the ITS region for yeasts and molds.
5. Suggest reporting strategies that are clinically
relevant for specific groups of microorganisms.
6. Discuss the limitations of gene sequencing for
microbial identification.
7. Continue to refine case definitions for specific
genera and species for clinical purposes only.

This guideline will enable laboratories to report meaningful results
to clinicians that directly impact patient management. The final
identification of a microorganism is greatly influenced by (1)
nucleotide sequence length, (2) quality of generated sequence
(ambiguous bases, intracellular polymorphisms), (3) identity scores
which are unique for defining specific genera and species (for
clinical purposes only), (4) intergenus, intragenus, interspecies, and
intraspecies variability, and (5) reference databases (RIDOM, GenBank,
RDP, etc.).
This document will establish guidelines for interpretive criteria to
ensure intralaboratory and interlaboratory reproducibility. This
document will require frequent updates to incorporate our evolving
knowledge in this area and to address other sequence based-methods
(e.g. rpoB, recA, D1/D2) when indicated.


Clinical microbiologists who direct laboratories; basic scientists in
microbiology with expertise in bacterial/mycobacterial/fungal
nomenclature/taxonomy and sequencing analysis; classical
microbiologists with expertise in traditional
bacterial/mycobacterial/fungal identification; experience with
reference databases ; representation from industry with experience in
developing reagents and instruments used in sequencing analysis.


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