title: Multicentric validation of a rapid assay for heparin-induced thrombocytopenia with different specimen types.
abstract: The diagnosis of heparin-induced thrombocytopenia type 2 (HIT) requires a combination of clinical and laboratory data. Rapid exclusion of HIT is supported by sensitive immunoassays. Citrated plasma or whole blood are more often available in the laboratory, and may thus, have practical advantages as compared to serum. In this study, various specimens from patients with suspected HIT were compared using a rapid lateral flow immunoassay (LFI-HIT). Serum, citrated whole blood and plasma were obtained from patients in whom HIT was suspected (n = 211) and were tested with LFI-HIT and several other assays. The comparison of plasma vs. serum in 210 samples showed agreement of 93.6% and between whole blood and serum in 183 samples was 96.7%. All serum-positive cases were correctly detected in plasma. Comparison of samples, which were positive in one of the immunoassays with the functional test heparin-induced platelet aggregation assay revealed a negative predictive value of 98.4% for serum, 97.8% for plasma and 96.2% for citrated whole blood. Performance in whole blood was slightly inferior. These data demonstrate that plasma and serum can be used in LFI-HIT with equivalent performance and that negative test results in LFI-HIT exclude HIT with high probability. The use of whole blood is not recommended by the authors.
authors.affiliation: aConsulting Diagnostics, Seefeld bInstitute of Experimental Haematology and Transfusion Medicine, University of Bonn, Bonn cInstitute for Clinical Immunology and Transfusion Medicine, Justus Liebig University, Giessen, Germany dDepartment of Blood Group Serology and Transfusion Medicine, Medical University Vienna, Vienna, Austria eDepartment of Experimental and Clinical Haemostasis, Haemotherapy and Transfusion Medicine and Hemophilia Comprehensive Care Center, Heinrich Heine University Medical Center, Düsseldorf fInstitute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt University Greifswald gCenter for Transfusion Medicine and Hemotherapy, University Hospital Giessen and Marburg, Marburg Campus, Marburg, Germany.
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Kolde
authors.forename: Ursula
authors.initials: U
authors.lastname: Habrecht
authors.forename: Jakob
authors.initials: J
authors.lastname: von Hesberg
authors.forename: Simon
authors.initials: S
authors.lastname: Panzer
authors.forename: Holger
authors.initials: H
authors.lastname: Seidel
authors.forename: Tamam
authors.initials: T
authors.lastname: Bakchoul
authors.forename: Ulrich J
authors.initials: UJ
authors.lastname: Sachs
mesh_terms: D006493:Heparin / Q000009:adverse effects* / Q000494:pharmacology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D010976:Platelet Count; D015203:Reproducibility of Results; D013921:Thrombocytopenia / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis
chemical_list: D006493:Heparin