Verification of Automated Devices for Immunohematologic Testing
Quantitative Molecular Methods for Infectious Diseases (MM6-A)

The Clinical and Laboratory Standards Institute requests volunteers to serve as subcommittee members for a new voluntary consensus project and a project revision. The project descriptions and specific qualifications needed are provided below:

NEW PROJECT:
Verification of Automated Devices for Immunohematologic Testing

Description:
Every acute-care hospital laboratory performs routine testing in support of its transfusion service. Such testing includes ABO and Rh typing and screening for unexpected red cell antibodies. Most perform more complex immunohematologic procedures as well, including antibody identification and the screening of red cell products for specific antigens. Until recently, all such testing was exclusively a manual process. Automated devices for in vitro testing are now available for hospital use. The purchaser must develop an implementation plan, a significant portion of which is a verification protocol. Issues such as comparability of methods, identification of matrix effects and interfering substances, and computer interfacing must be included in the laboratory's plan. The technology is more sensitive than typical manual methods, which presents a particular challenge for choosing reference methods and determining the limits of detection during the verification routine. No guideline has been published that addresses the verification issues peculiar to automated immunohematology devices.

Specific Expertise/Work Experience Needed:

• Representatives from manufacturers of Automated Devices for Immunohematologic Testing
• Representative with knowledge of regulatory policies and various local and regional policies
• Laboratory professional experienced in immunohematologic testing using automated devices
• Biostatistician familiar with CLSI Evaluation Protocols

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 31 January 2008. Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.

PROJECT REVISION:
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline (MM6-A)

Description: 
MM6-A, which was published in 2003 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing, and interpretation of results.

In revising MM6 the following issues/revisions will be considered:

• Address the widespread use of real-time amplification methods, including a discussion of the advantages, challenges and limitations of these methods.
• Outline issues regarding the limited availability of standardized reference material and calibrators, and how this impacts test design and performance. Discuss the available options for laboratories and the issues that need to be considered depending on which option is used.
• Provide additional details on how laboratories could approach verification and validation of tests, with a focus on differences between FDA-cleared/approved assays and those that are developed by the laboratory.
• Update sections on technologies used in molecular quantitation  and clinical validation

Specific Expertise/Work Experience Needed:
Nominees should have experience with the development, verification and validation, or application of quantitative nucleic acid test for agents of infectious diseases. 

The deadline to submit a nomination form, including a curriculum vitae and disclosure of interests form, is 31 January 2008. Send to Donna Connery (dconnery@clsi.org) at Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087.
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