An Optimized and Standardized Rapid Flow Cytometry Functional Method for HIT

Flow cytometry-based assays appear to be an emerging widely available class of functional tests for Heparin-induced thrombocytopenia (HIT), possibly for frontline diagnostic work-up, according to an article published by Biomedicines, the open access journal from MDPI.

Abstract. The diagnosis of HIT combines a clinical scoring of pretest probability and laboratory testing. First-line routine tests are antigen binding assays detecting specific anti-bodies. The most sensitive of these tests have a high HIT-negative predictive value enabling to rule-out HIT diagnosis when negative. However, HIT-positive predictive value is low, and a functional assay evaluating the pathogenicity of the antibodies should be performed to exclude false-positive results. In contrast to screening assays, functional assays are highly specific but technically challenging, and thus performed in referral laboratories, where platelet activation is detected using radioactive serotonin (SRA; serotonin release assay) or visually (HIPA; heparin-induced platelet activation). Flow cytometry is a possible alternative. It is however currently not widely used, mostly because of the lack of standardization of the published assays. The article describes the analytical assessment and validation underlying the standardization of a flow cytometry assay (HIT-FCA) which subsequently led to the development of a CE mark assay (HIT Confirm®, Emosis, Illkirch, France).

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