Detecting factor XIa in immune globulin products: Commutability of international reference materials for traditional and global hemostasis assays.

ABSTRACT:

Background

Activated coagulation factor XIa (FXIa) is an impurity and primary source of procoagulant activity in thrombosis-implicated immune globulin (IG) products. Several assays, of varying quality and precision are used to assess FXIa-like procoagulant activity in units relevant to their respective principles.

Objectives

To advance unified reporting, we sought to employ the World Health Organization reference reagents (RRs) to present the results of differing methodologies in units of FXIa activity and rank the sensitivity and robustness of these methodologies.

Methods

RR 11/236 served as a calibrator in several FXIa-sensitive blood coagulation tests: two commercial chromogenic FXIa assays (CAs); a nonactivated partial thromboplastin time (NaPTT); an in-house fibr

SUBMITTER: Liang Y 

PROVIDER: S-EPMC7845073 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature