IgG和IgGAM抗体对肝素性血小板减少症诊断价值的前瞻性多中心比较。

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-04-03 DOI:10.1016/j.cca.2025.120279

Wenjie Zhang , Rui Feng , Yu Su , Jia Kang , Yong Yao , Huiru Zhao , Xiangyu Cao , Qingkun Fan , Jun Wu

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引用次数: 0

摘要

背景和目的：肝素诱导的血小板减少症（HIT）是肝素治疗的一个重要并发症。免疫抗体参与了HIT的发展。本研究的目的是探讨IgGAM和IgG抗体的诊断价值。材料和方法：本前瞻性多中心队列研究纳入了170例疑似HIT患者和120名健康志愿者。当全血细胞计数显示血小板计数减少时，怀疑HIT。根据患者的临床情况和实验室结果确定是否存在HIT。检查参数包括常规凝血试验和IgG和IgGAM抗体。结果：170例疑似HIT患者中，PF4/ h抗体阳性（Ab+患者）69例，确诊HIT 12例。与Ab-患者相比，Ab+患者的4T评分、d -二聚体和血小板减少率水平更高（P ）。结论：HARI可作为疑似HIT预检测患者PF4/ h抗体阳性风险的潜在预测因子。对于高危患者，IgG抗体检测可作为疑似HIT患者的潜在排除诊断指标。

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Prospective multicenter comparison of the diagnostic value of IgG and IgGAM antibodies for heparin-induced thrombocytopenia

Background and aims

Heparin-induced thrombocytopenia (HIT) is a critical complication of heparin therapy. Immune antibodies are involved in the development of HIT. The purpose of this study was to explore the diagnostic value of IgGAM and IgG antibodies.

Materials and methods

This prospective multicenter cohort study enrolled 170 patients with suspected HIT and 120 healthy volunteers. HIT was suspected when the complete blood count indicated a reduced platelet count. The presence of HIT was determined according to the clinical condition and laboratory results of patients. Parameters examined included conventional coagulation tests and IgG and IgGAM antibodies.

Results

Among 170 patients with suspected HIT, 69 were PF4/H-antibody-positive (Ab+ patients), and 12 were diagnosed with HIT. Ab+ patients had higher levels of 4T score, D-dimer, and platelet reduction ratio than Ab- patients (P < 0.001 for all). We defined a HIT antibody risk index (HARI) as 0.807 × 4T score+ 0.028 × platelet reduction ratio (%)+ 0.114 × D-dimer (mg/l FEU), and found that the area under the curve (AUC) for HARI was greatest (0.857). Furthermore, the levels of IgGAM and IgG antibodies were higher in patients with HIT than without (P = 0.003 and P < 0.001, respectively). The AUC for IgG antibody was significantly greater than that for IgGAM antibody (0.870 vs. 0.775).

Conclusions

HARI can serve as a potential predictor for the risk of PF4/H-antibody positivity in patients with suspected HIT pre-test. For high-risk patients, IgG antibody testing may be used as a potential exclusion diagnostic indicator for patients with suspected HIT.

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.