Call for Nominations
Verification and Validation of Multiplex Genetic Tests

Extended Notice
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

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, is 1 March 2006.  Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

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