This guideline describes: appropriate test specimens, reagents and materials, methods of platelet agglutination and ELISA, preparation of reference curves, determination of reference intervals, quality control procedures, result interpretation, and sources of error for assays of von Willebrand factor antigen and ristocetin cofactor activity. A brief description of von Willebrand disease and its various subtypes is included, as well as a list of references to more comprehensive reviews of this commonly inherited and rarely acquired bleeding disorder.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.
