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High sensitivity and specificity of a new functional flow cytometry assay for clinically significant heparin‐induced thrombocytopenia antibodies
Author(s) -
Garritsen H. S.,
ProbstKepper M.,
Legath N.,
Eberl W.,
Samaniego S.,
Woudenberg J.,
Schuitemaker J. H. N.,
Kroll H.,
Gurney D. A.,
Moore G. W.,
Zehnder J. L.
Publication year - 2014
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.12136
Subject(s) - heparin induced thrombocytopenia , medicine , antibody , platelet , heparin , flow cytometry , anticoagulant , immunology , platelet factor 4 , platelet activation , single center , gastroenterology
Summary Introduction Heparin‐induced thrombocytopenia ( HIT ) is a life‐threatening condition, in which the anticoagulant heparin, platelet factor 4 ( PF 4), and platelet‐activating antibodies form complexes with prothrombotic properties. Laboratory tests to support clinical diagnosis are subdivided into functional, platelet activation assays, which lack standardization, or immunological assays, which have moderate specificity toward HIT . In this study, clinical performance of HIT A lert , a novel in vitro diagnostic ( IVD ) registered platelet activation assay, was tested in a large cohort of HIT ‐suspected patients and compared with immunological assays. Methods From 346 HIT ‐suspected patients (single center), clinical data including 4T pretest probability results, citrated platelet‐poor plasmas, and sera were collected, allowing direct comparison of clinical observations with HIT A lert results. HIT A lert performance was compared with PF 4 IgG ELISA (246 patients, three centers) and PF 4 Pa GIA (298 patients, single center). Results HITA lert showed high sensitivity (88.2%) and specificity (99.1%) when compared with clinical diagnosis. Agreement of HIT A lert with PF 4 ELISA ‐ and PF 4 P a GIA ‐positive patients is low (52.7 and 23.2%, respectively), while agreement with PF 4 IgG ELISA ‐ and PF 4 P a GIA ‐negative patients is very high (98.1 and 99.1%, respectively). Conclusion HIT A lert performance is excellent when compared with clinical HIT diagnosis, making it a suitable assay for rapid testing of platelet activation due to anticoagulant therapy.