WAYNE, PA--(Marketwire - January 05, 2010) -
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CLSI website |
Immunohematological Testing |
Immunohematological laboratory testing has evolved from test tube-based methods to automated systems that employ a variety of techniques and methods. Automated systems for such testing may bring potential advantages to a laboratory, such as improvements in turnaround time, standardized interpretation of reactions, and positive sample identification using bar-code technology. Increasing use of automated systems in immunohematological testing necessitates the development of a guideline for laboratories for validation of these automated systems.
Katharine Appleton Downes, MD, chairholder of the committee that developed the document, says, "I/LA33-A is beneficial to the laboratory because it is comprehensive in design and was developed based on input from a variety of stakeholders. It includes the key elements and tasks of the validation process, including installation qualification, operational qualification, and performance qualification. The appendix is especially practical because it contains easy-to-use templates for the laboratory to apply to meet its needs for data gathering, statistical calculations, and testing of materials."
CLSI is a volunteer-driven, membership-supported, nonprofit organization
dedicated to developing standards and guidelines for the health care and
medical testing community through a consensus process that balances the
perspectives of industry, government, and the health care professions. For
additional information on CLSI, visit the CLSI website at www.clsi.org or
call 610.688.0100.
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