New CLSI Guideline Provides Optimal Methods For Utilizing Flow Cytometry And Solid Phase Assays

Main Category: Transplants / Organ Donations
Article Date: 10 Jan 2008 - 1:00 PDT

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The current and emerging technologies for detecting and characterizing human leukocyte antigen (HLA) alloantibodies provide powerful tools for predicting the risk of immunological response to a transplant. By standardizing methods, quality control, and clinical interpretations, transplant centers can more readily identify optimal donor recipient pairs and encourage organ sharing.

Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Proposed Guideline (I/LA29-P), which describes criteria for optimizing flow cytometry crossmatching and the detection of HLA alloantibody by solid-phase methods in conventional and multiplex platforms.

The specific areas addressed in the guideline include:

- technical consideration for instrument setup and staining procedures;
- screening methods;
- single-antigen and multiantigen approaches;
- reporting formats;
- clinical interpretation; and
- multicenter quality assurance.

This guideline is intended for solid organ and stem cell transplant laboratories, manufacturers of systems for histocompatibility testing, and organizations that manage organ sharing. For additional information on CLSI or for further information regarding this release, visit the CLSI website at http://www.clsi.org.

CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.

Clinical and Laboratory Standards Institute

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