Evaluation of a rapid immunochromatographic diagnostic test for heparin-induced thrombocytopenia: validation of delayed test and whole blood test

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-04-11 DOI:10.1016/j.cca.2025.120291

Paul Billoir , Virginie Barbay , Marielle Fresel , Sabine Brunel , Véronique Le Cam Duchez

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引用次数: 0

Abstract

Heparin-induced thrombocytopenia (HIT) is a rare, iatrogenic condition, characterized by its potential severity and diagnostic difficulties. There are rapid diagnostic tests for suspected HIT. Among these, the STic Expert® HIT has a good sensitivity to detect HIT. However, it must be performed within 2 h after sampling. The aim of this study was to evaluate a delayed STic Expert® HIT test in plasma and whole blood.

Thirty-six patients were prospectively included for HIT testing delayed analysis and 64 for whole blood analysis. For any request for HIT testing, an analysis by STic Expert® HIT was performed within 2 h and 8 h post-sampling. Any positive result was confirmed by a functional test, platelet aggregation with heparin, release of ¹⁴C-serotonin assay (SRA), and immunological assay for anti-platelet factor 4 IgG antibodies.

Among the 36 patients for delayed analysis, 20 had an initially positive STic Expert® HIT test. Among the 64 patients for whole blood analysis, 20 had an initially positive STic Expert® HIT test, and 24 positives in whole blood. For the test performed at T0, Se = 100 %, Sp = 68.4 %, PPV = 73.9 %, and NPV = 100 %. The Chi-square (X²) = 18.2 with p < 0.001.

For the test performed at T = 8 h, Se = 100 %, Sp = 68.4 %, PPV = 73.9 %, and NPV = 100 %. The X² = 18.2 with p < 0.001. For the test performed in whole blood, Se = 100 %, Sp = 74.4 %, PPV = 37.5 %, and NPV = 100 %. The X² = 18.6 with p < 0.001.

In conclusion, we have demonstrated that the STic Expert® can be used to perform an HIT diagnostic test 8 h after sampling and on whole blood. However, this study needs to be confirmed on a larger number of samples.

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评价肝素诱导的血小板减少症的快速免疫层析诊断试验：延迟试验和全血试验的验证

肝素诱导的血小板减少症（HIT）是一种罕见的医源性疾病，其特点是其潜在的严重性和诊断困难。有对疑似HIT的快速诊断测试。其中，STic Expert®HIT对HIT的检测灵敏度较高。但必须在采样后2小时内进行。本研究的目的是评估延迟STic Expert®HIT测试在血浆和全血中的应用。36例患者前瞻性纳入HIT检测延迟分析，64例纳入全血分析。对于任何HIT测试要求，在采样后2小时和8小时内进行STic Expert®HIT分析。任何阳性结果都要通过功能测试、肝素血小板聚集、14c - 5 -羟色胺释放试验（SRA）和抗血小板因子4 IgG抗体免疫试验来证实。在36例延迟分析的患者中，20例STic Expert®HIT测试最初呈阳性。在64例全血分析患者中，20例STic Expert®HIT试验初始阳性，24例全血阳性。对于测试在T0, Se = 100%, Sp = 68.4%, PPV = 73.9%,净现值= 100%。χ 2 = 18.2, p <；0.001.对于测试在T = 8 h, Se = 100%, Sp = 68.4%, PPV = 73.9%,净现值= 100%。X2 = 18.2, p <；0.001. 全血检测Se = 100%, Sp = 74.4%, PPV = 37.5%, NPV = 100%。X2 = 18.6, p <；0.001.总之，我们已经证明STic Expert®可以在取样后8小时对全血进行HIT诊断测试。然而，这一研究需要在更大的样本上得到证实。

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

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.