The dynamic range of immunoassays for heparin-induced thrombocytopenia.

IF 5.5 2区医学 Q1 HEMATOLOGY

Journal of Thrombosis and Haemostasis Pub Date : 2024-11-11 DOI:10.1016/j.jtha.2024.10.026

Henning Nilius, Samra Naas, Jan-Dirk Studt, Dimitrios A Tsakiris, Andreas Greinacher, Adriana Mendez, Adrian Schmidt, Walter A Wuillemin, Bernhard Gerber, Prakash Vishnu, Lukas Graf, Johanna A Kremer Hovinga, Tamam Bakchoul, Christos Nakas, Michael Nagler

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Abstract

Background: Following the current guidelines, immunoassays for the diagnosis of heparin-induced thrombocytopenia (HIT) are interpreted dichotomously, with test results categorized as either positive or negative. However, the extent to which test results hold diagnostic significance across the entire dynamic range remains unclear.

Objectives: We utilized data from the prospective TORADI-HIT study, comprising 1,393 consecutive patients with suspected HIT, to assess the diagnostic significance of two H/PF4 immunoassay test results across their respective dynamic ranges: HemoSil Acustar HIT IgG [CLIA] and Lifecodes PF4 IgG [ELISA].

Methods: HIT diagnosis was determined by a washed-platelet heparin-induced platelet activation assay (HIPA). For each measurement point in the dataset, we computed likelihood ratios (LR), sensitivities, and specificities. To provide post-test probabilities for individual test results, we calculated interval-specific likelihood ratios and integrated it into a web-based calculator.

Results: The prevalence of HIT was 8.5% (n = 119). A likelihood ratio of ≥ 10 was first achieved at 0.3% of the dynamic range (0.4 U/ml; CLIA) and 16% (0.64 OD; ELISA), respectively. A likelihood ratio of ≥ 100 was present at 9.4% (12 U/ml; CLIA) and 75.0% (3.0 OD; ELISA). The slope of the linear regression line (LR ∼ dynamic range) was 9.5 (CLIA) and 0.9 (ELISA).

Conclusion: Despite both immunoassays showing an association between results and diagnostic significance, the strength of that association varies by assay. CLIA has a larger increase per measurement unit. Post-test probabilities for individual patients can be estimated using a web-based calculator: https://pcd-research.shinyapps.io/BayesianCalculator/.

查看原文本刊更多论文

肝素诱导的血小板减少症免疫测定的动态范围。

背景：根据现行指南，诊断肝素诱导血小板减少症（HIT）的免疫测定采用二分法解释，检测结果分为阳性或阴性。然而，检测结果在整个动态范围内的诊断意义仍不明确：我们利用由 1393 名连续疑似 HIT 患者组成的前瞻性 TORADI-HIT 研究数据，评估了两种 H/PF4 免疫测定检验结果在各自动态范围内的诊断意义：方法：通过洗血小板肝素诱导血小板活化试验（HIPA）确定 HIT 诊断。对于数据集中的每个测量点，我们都计算了似然比 (LR)、敏感性和特异性。为了提供单个检测结果的检测后概率，我们计算了特定区间的似然比，并将其整合到一个基于网络的计算器中：结果：HIT 患病率为 8.5%（n = 119）。在动态范围的 0.3%（0.4 U/ml；CLIA）和 16%（0.64 OD；ELISA）时，似然比首次达到≥10。9.4%（12 U/ml；CLIA）和 75.0%（3.0 OD；ELISA）时的似然比≥100。线性回归线的斜率（LR ∼ 动态范围）分别为 9.5（CLIA）和 0.9（ELISA）：结论：尽管两种免疫测定都显示出结果与诊断意义之间的联系，但这种联系的强度因检测方法而异。CLIA 每测量单位的增幅较大。个别患者的检测后概率可通过网络计算器进行估算：https://pcd-research.shinyapps.io/BayesianCalculator/。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Thrombosis and Haemostasis 医学-外周血管病

CiteScore

24.30

自引率

3.80%

发文量

321

审稿时长

1 months

期刊介绍： The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.