scope:

This guideline describes criteria for optimizing flow cytometry crossmatching and the detection of human leukocyte antigen (HLA) alloantibody by solid-phase methods in conventional and multiplex platforms. Specific areas include technical consideration for instrument setup and staining procedures, screening methods, single-antigen and multiantigen approaches, reporting formats, clinical interpretation, and multicenter quality assurance. The guideline does not address cytotoxicity assays or standard methods for lymphocyte immunophenotyping, which are covered in CLSI document H42.1 The intended users of this guideline are: 1) laboratories conducting tests of histocompatibility for solid organ and stem cell transplants; 2) manufacturers of reagents and systems for conducting such tests; and 3) organizations that promulgate organ sharing between transplant centers.