CLSI eNews - 1 October 2005 (Plain Text Version)

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Call for Nominations

Interference With Immunoassay Results by Heterophile Antibodies and Other Binders (New); Apolipoprotein Immunoassays (I/LA15-A); Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities (I/LA20-A)

Clinical and Laboratory Standards Institute requests nominations for representatives of the industry, government, and professional sectors to serve as members on one subcommittee of a newly proposed project and on two subcommittees being formed to revise CLSI documents in the area of immunology and ligand assays. The project descriptions and specific qualifications needed are provided below:

PROJECT 1: (New guideline) Interference With Immunoassay Results by Heterophile Antibodies and Other Binders
Description: The intended users of the guideline are laboratorians performing immunoassays, manufacturers of immunoassay reagents, and organizations responsible for regulatory oversight of immunoassay reagents. The guideline will describe various types of interferences by heterophile antibodies and other binders as well as their effect on patient results. Methods to identify and characterize the interferences will be addressed along with assessment of these methods and their effectiveness in eliminating interference. The guideline will not address other types of immunoassay interference, such as hemolysis, cross reacting substances, and drug interference, except when the drug is an antibody.
Table of Contents:
1. Scope
2. Introduction
3. Definitions/Acronyms
4. Identification of immunoassay interference by binders
5. Mechanisms of interference
6. Effects of interference
7. Elimination of interference
8. References
Specific Expertise/Work Experience Needed:
* Laboratorians with significant experience/expertise in performing and assuring quality of immunoassays
* Laboratory directors responsible for verification and validation of immunoassays to be performed in their laboratories
* IVD manufacturers of immunoassay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of immunoassay reagents and tests
* Representatives of clinical laboratory accrediting agencies

PROJECT 2: (Revision of Approved Guideline): Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline (I/LA15-A)
Description: I/LA15-A, which was reaffirmed in 2001, describes the characterization and preparation of immunogens, antibodies, samples, and methods, and provides guidance for immunochemical testing of apolipoproteins. I/LA15-A will be updated as a basic apolipoprotein document to serve as a highly practical new document on the need, measurement, interpretation, and applications of apos B and A-I. These two apolipoproteins have become of widespread use in research laboratories and are of great interest in control and prevention research programs in cardiovascular diseases and other chronic diseases.
Specific Expertise/Work Experience Needed:
* Laboratorians with significant experience/expertise in performing and assuring quality of apolipoprotein immunoassays
* IVD manufacturers of apolipoprotein immunoassay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of immunoassay reagents and tests
* Representatives of clinical laboratory accrediting agencies

PROJECT 3: (Revision of Approved Document): Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (I/LA20-A)
Description: I/LA20-A, which was reaffirmed in 2001, provides guidance for the design, analytical performance, standardization, and quality assurance of laboratory assays used in the measurement of total serum IgE and IgE antibodies of defined allergen specificity. The revision of I/LA20 will include updating document content with advances in this area, and reorganizing the guideline for ease of use into two parts: the general text and an appendix listing all the allergens.
Specific Expertise/Work Experience Needed:
* Laboratorians with significant experience/expertise in performing and assuring quality of immunological assays for human immunoglobulin E (IgE) antibodies
* IVD manufacturers of immunoassay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of immunoassay reagents and tests
* Representatives of clinical laboratory accrediting agencies

Review the objective of the proposed project, and the requested volunteer expertise, and:
submit a nomination.
The deadline to submit the nomination form, including a curriculum vitae and disclosure of interests form by 1 December 2005, to the CLSI Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087.