Detecting factor XIa in immune globulin products: Commutability of international reference materials for traditional and global hemostasis assays.
Yideng LiangJoseph W JacksonSamuel A WoodleStepan S SurovLeonid A ParunovDorothy E ScottMark WeinsteinTimothy K LeeMikhail V OvanesovPublished in: Research and practice in thrombosis and haemostasis (2020)
Purified FXIa reference standards support quantitation of FXIa levels in IG products in all tested assay methodologies. This should help to standardize the measurement of thrombotic potentials in IG products and prevent products exhibiting high procoagulant activity from distribution for patient use. Further research is needed to address the effect of IG product-specific matrixes on assay performance.