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TEST
Year : 2011  |  Volume : 2  |  Issue : 1  |  Page : 41-43

Validation of a monospecific enzyme-linked immunosorbent assay as a screening test for heparin-induced thrombocytopenia and its comparison with immunological and functional assays


Department of Pathology and Laboratory Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Correspondence Address:
Tarek Owaidah
Department of Pathology and Laboratory Medicine (MBC 10) King Faisal Specialist Hospital and Research Centre and Center of Excellence for Thrombosis and Homeostasis, King Saud of University PO Box 3354, Riyadh 11211
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


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Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction caused by antibodies to heparin/platelet factor 4 (PF4) complexes and results in the prothrombotic state. Early diagnosis is important for clinical decision making. Various laboratory tests have been examined as a tool for confirming the suspicion of HIT. The monospecific PF4 immunoglobulin G (IgG) assay is a qualitative screening assay for detecting heparin-associated IgG antibodies in human serum. Of 100 patients with clinical suspicion of HIT, the blood samples of 20 patients who had positive clinical pretest probability scores were tested at our institute for particle gel immunoassay (PaGIA; Diamed ID; Switzerland), enzyme-linked immunosorbent assay (ELISA) (HPF4 ELISA; Stago, Asni•r es sur Seine, France), and the new monospecific ELISA (IgG) from GTI, USA. The optical density (OD) of the color that developed was measured using a spectrophotometer. These samples were collected from the patients at the same time as were samples that were sent to a reference laboratory for a gold standard test (serotoninrelease test). Of the 20 samples tested, 1 was clearly positive and another 1 had borderline positivity in the serotonin-release test. The results of all 4 tests were in agreement for all samples, except for the sample with borderline positivity, which was missed by ELISA (STAGO). The frequency of samples positive for HIT antibodies was 10%. Although this study included a low number of cases with clinical suspicion of HIT, our results confirm the good sensitivity and specificity of the monospecific ELISA that could be more sensitive than polyspecific ELISA.


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