CLSI eNews - 1 May 2008
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President's Message
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Call for Nominations
- Evaluation of Precision Performance of Quantitative Measurement Methods (EP5-A2)
- User Verification of Performance for Precision and Trueness (EP15-A2(e))
- Sweat Testing: Sample Collection and Quantitative Analysis (C34-A2)
Clinical and Laboratory Standards Institute's Area Committee on Evaluations Protocols has requested nominations to serve as subcommittee members to revise the CLSI guidelines described below.
PROJECT REVISION:
EP5-A2 to A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline
Description:
This document provides guidance for designing an experiment to evaluate the precision performance of quantitative measurement methods; recommendations on comparing the resulting precision estimates with manufacturers’ precision performance claims and determining when such comparisons are valid; as well as manufacturers’ guidelines for establishing claims.
Specific Expertise/Work Experience Needed:
- Manufacturers of in vitro diagnostic (IVD) devices and developers of clinical laboratory measurement methods
- Representatives of industry
- Statisticians
- Chemists
- Laboratory personnel
- Regulatory authorities
- Medical personnel
The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 31 May 2008.
Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion.
Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.
PROJECT REVISION:
EP15-A2(e) to A3, User Verification of Performance for Precision and Trueness; Approved Guideline
Description:
This document describes the demonstration of method precision and trueness for clinical laboratory quantitative methods utilizing a protocol designed to be completed within five working days or less.
Specific Expertise/Work Experience Needed:
- Laboratory directors/Laboratory managers
- Manufacturers of in vitro diagnostic (IVD) devices and developers of clinical laboratory measurement methods
- Representatives of industry
- Statisticians
- Clinical chemists
- Laboratory personnel
- Regulatory authorities
- Medical personnel
The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 31 May 2008.
Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion.
Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.
Clinical and Laboratory Standards Institute's Area Committee on Clinical Chemistry and Toxicology has requested nominations to serve as subcommittee members to revise the CLSI guideline described below.
PROJECT REVISION:
C34-A2 to A3, Sweat Testing: Sample Collection and Quantitative Analysis; Approved Guideline
Description:
This is a guideline for the performance of the sweat test for the diagnosis of cystic fibrosis. The document addresses appropriate methods of collection and analysis, quality control, and the evaluation and reporting of test results.
Specific Expertise/Work Experience Needed:
- Laboratory directors/Laboratory managers
- Manufacturers of in vitro diagnostic (IVD) devices and developers of clinical laboratory measurement methods
- Representatives of industry
- Statisticians
- Clinical chemists
- Laboratory personnel
- Regulatory authorities
- Medical personnel.
The deadline to submit notification of interest in serving on the subcommittee with a curriculum vitae is 31 May 2008.
Upon receipt of your statement of interest in serving on the subcommittee a disclosure of interests form will be sent to you for completion.
Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, or via Fax at +610.688.0700.
For more information or to contact us directly, please visit www.clsi.org
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