Erika Jani, Margherita Bozzola, Elmar Marco Zagler, Massimo Daves
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In our laboratory, total antibodies against heparin/PF4 complex [HemosIL HIT-Ab-(PF4-H), Instrumentation Laboratory] and IgG Ab (HemosIL AcuStar HIT-IgG, Instrumentation Laboratory) are measured simultaneously with two different instruments. Two hundred six samples tested negative for both methods, 23 samples tested positive for at least one method and nine samples tested positive for both methods. The grade of concordance between the two assays shows a weighted Kappa of 0.536 (moderate agreement). No sample tested positive only for IgG-Ab. The sensitivity of HIT-Ab-(PF4-H) was 1, whereas the specificity was 0.95. For the HIT-IgG (PF4-H) method, sensibility and specificity were 0.77 and 1, respectively. Our results suggest that performing these two tests simultaneously does not provide additional useful information in patients with suspicion of HIT. 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The sensitivity of HIT-Ab-(PF4-H) was 1, whereas the specificity was 0.95. For the HIT-IgG (PF4-H) method, sensibility and specificity were 0.77 and 1, respectively. Our results suggest that performing these two tests simultaneously does not provide additional useful information in patients with suspicion of HIT. 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引用次数: 0
摘要
肝素诱导的血小板减少症(HIT)是一种免疫介导的疾病,其特点是血小板数量减少和血栓风险增加。HIT 事件是由可激活血小板的抗血小板因子/肝素(PF4/H)抗体引起的。HIT 的诊断基于临床评估和实验室结果。我们的研究旨在评估联合使用两种快速检测方法诊断 HIT 是否比使用单一自动检测方法更具诊断优势。我们从实验室信息系统中提取了2020年7月至2024年6月期间检测肝素/PF4复合物抗体的所有测定请求(229人)。在我们的实验室中,肝素/PF4 复合物总抗体[HemosIL HIT-Ab-(PF4-H),仪器实验室]和 IgG Ab(HemosIL AcuStar HIT-IgG,仪器实验室)用两台不同的仪器同时检测。有 26 份样本两种方法检测结果均为阴性,23 份样本至少一种方法检测结果为阳性,9 份样本两种方法检测结果均为阳性。两种检测方法的加权卡帕值为 0.536(中度一致)。没有样本仅对 IgG-Ab 检测呈阳性。HIT-Ab-(PF4-H) 的灵敏度为 1,特异性为 0.95。HIT-IgG(PF4-H)方法的敏感性和特异性分别为 0.77 和 1。我们的结果表明,同时进行这两种检测并不能为怀疑患有 HIT 的患者提供更多有用的信息。总 Ab 检测似乎就足够了,因为它的灵敏度较高,但特异性较低。
Is the combination of two automated rapid assays for diagnosis of heparin-induced thrombocytopenia necessary?
Heparin-induced thrombocytopenia (HIT) is an immune-mediated condition characterized by a decrease in platelet count and an increased thrombotic risk. HIT event is caused by antiplatelet factor/heparin (PF4/H) antibodies that can activate the platelets. The diagnosis of HIT is based on a clinical evaluation and laboratory results. Aim of our study was to evaluate whether the combined use of two rapid assays for diagnosis of HIT provides a diagnostic advantage over the use of a single automate assay. We extracted from the laboratory informatic system all the determinations requested for the detection of antibodies against heparin/PF4 complexes from July 2020 to June 2024 (n. 229). In our laboratory, total antibodies against heparin/PF4 complex [HemosIL HIT-Ab-(PF4-H), Instrumentation Laboratory] and IgG Ab (HemosIL AcuStar HIT-IgG, Instrumentation Laboratory) are measured simultaneously with two different instruments. Two hundred six samples tested negative for both methods, 23 samples tested positive for at least one method and nine samples tested positive for both methods. The grade of concordance between the two assays shows a weighted Kappa of 0.536 (moderate agreement). No sample tested positive only for IgG-Ab. The sensitivity of HIT-Ab-(PF4-H) was 1, whereas the specificity was 0.95. For the HIT-IgG (PF4-H) method, sensibility and specificity were 0.77 and 1, respectively. Our results suggest that performing these two tests simultaneously does not provide additional useful information in patients with suspicion of HIT. The total Ab assay seems to be sufficient, as it shows higher sensitivity although at the expense of lower specificity.
期刊介绍:
Blood Coagulation & Fibrinolysis is an international fully refereed journal that features review and original research articles on all clinical, laboratory and experimental aspects of haemostasis and thrombosis. The journal is devoted to publishing significant developments worldwide in the field of blood coagulation, fibrinolysis, thrombosis, platelets and the kininogen-kinin system, as well as dealing with those aspects of blood rheology relevant to haemostasis and the effects of drugs on haemostatic components