Call for Nominations
Verification and Validation of Multiplex Genetic Tests

Clinical and Laboratory Standards Institute’s Area Committee on Molecular Methods requests volunteers to serve as subcommittee members for a new project described below: 
 
PROJECT: 
Verification and Validation of Multiplex Genetic Tests (New guideline) 
Description: 
More tests are being developed that look at multiple genes or parts of genes simultaneously.  Some examples currently on the market are tests for hepatitis C virus (HCV) Genotyping, Cystic Fibrosis, Ashkenazi Jewish Panel, and deep vein thrombosis (DVT).  There is a significant lack of guidance for how to verify and validate panel assays.  Shortages of reference materials compound the difficulty.  As more and more multiplex tests become available to the laboratory, verifying and validating these tests will be a major effort.
This document is intended for manufacturers of multiplex assays/equipment, laboratorians that develop and/or perform multiplex assays, clinicians that use the results to diagnose or manage patients, and agencies that regulate the use of multiplex assays/equipment. This guideline covers the verification and validation of multiplex genetic tests.  Excluded are multiplex arrays or array based tests.  Topics covered include defining and acquiring test samples, approaches for defining assay performance characteristics, i.e., sensitivity, specificity, accuracy and reproducibility, methods of statistical analysis.  Discussion of how to address reporting of results, when one or more of the multiplex assays may be invalid or wrong.
Table of Contents:
Abstract
Committee Membership
Foreword
1    Scope
2    Introduction
3    Standard Precautions
4    Terminology (Definitions/Acronyms)
5    Multiplex Methods and Technologies
6    Reference and Testing Materials
7    Verification and Validation
8    Genetic Data Analysis
9    Quality Control/ Quality Assurance
10    Reporting Results
References
Specific Expertise/Work Experience Needed: 
- IVD manufacturer of multiplex assays/equipment
- US and EU regulatory expertise for data acquisition and analysis
- Clinical laboratorians that develop in-house multiplex assays
- Clinical laboratorians that use commercial multiplex assays
- Statistician or equivalent for data analysis

Extended Notice
Clinical and Laboratory Standards Institute’s Area Committee on Immunology and Ligand Assay has requested nominations to serve as subcommittee members for two new projects, described below:  

PROJECT 1: 
Interference With Immunoassay Results by Heterophile Antibodies and Other Binders (New guideline) 
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: 
Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics (Revision of 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

Review the objective of the proposed projects, 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, is 1 February 2006.  Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.