{"title":"Exploring strategies to rapidly identify false positives in high-sensitivity cardiac troponin I assay: A prospective study","authors":"Anthony Desaegher , Victor Marin , Marie-Christine Beauvieux , Brigitte Colombiès , Margaux Lauga , Sonia Alloug , Selen Kalkan , Gladys Castaing-Mouhica , Geneviève Lacape , Benoit Rucheton , Julien Doublet , Sandrine Dabernat , Marie-Lise Bats","doi":"10.1016/j.cca.2024.119996","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Cardiac troponin is the pivotal biomarker of myocardial injury, playing a central role in the diagnosis of acute coronary syndrome and various clinical situations. Nevertheless, challenges arise when patients exhibit elevated cardiac troponin levels in the absence of evident cardiac origin, as evidenced by extensive cardiac exploration, which suggests the presence of an interfering factor. Despite the high performance of high-sensitive cardiac troponin immunoassays, these tests remain susceptible to interferences that may lead to false-positives.</div></div><div><h3>Methods</h3><div>In the period between July 2021 and July 2024, 8129 patients were hospitalized in the cardiology departments of Bordeaux University Hospital with positive results for high-sensitivity cardiac troponin I. Among them, 15 patients were suspected of having false-positive results, based on clinical and biological observations.</div></div><div><h3>Results</h3><div>In this subpopulation, we evaluated prospectively various techniques, including serial dilutions, antibody-binding tubes, and alternative immunoassays (for cardiac troponin I and T) with the objective of identifying any potential analytical interference in their high-sensitive cardiac troponin I measurements. Our investigations revealed that 12 out of 15 suspected cases exhibited an interference on the high-sensitive cardiac troponin I assay.</div></div><div><h3>Conclusion</h3><div>In conclusion, we propose an original algorithm designed to identify high-sensitive cardiac troponin I false-positives. This algorithm can help clinicians to make prompt and informed decisions about patient care, and to avoid erroneous clinical interventions that may result from such interferences.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"565 ","pages":"Article 119996"},"PeriodicalIF":3.2000,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0009898124022496","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Cardiac troponin is the pivotal biomarker of myocardial injury, playing a central role in the diagnosis of acute coronary syndrome and various clinical situations. Nevertheless, challenges arise when patients exhibit elevated cardiac troponin levels in the absence of evident cardiac origin, as evidenced by extensive cardiac exploration, which suggests the presence of an interfering factor. Despite the high performance of high-sensitive cardiac troponin immunoassays, these tests remain susceptible to interferences that may lead to false-positives.
Methods
In the period between July 2021 and July 2024, 8129 patients were hospitalized in the cardiology departments of Bordeaux University Hospital with positive results for high-sensitivity cardiac troponin I. Among them, 15 patients were suspected of having false-positive results, based on clinical and biological observations.
Results
In this subpopulation, we evaluated prospectively various techniques, including serial dilutions, antibody-binding tubes, and alternative immunoassays (for cardiac troponin I and T) with the objective of identifying any potential analytical interference in their high-sensitive cardiac troponin I measurements. Our investigations revealed that 12 out of 15 suspected cases exhibited an interference on the high-sensitive cardiac troponin I assay.
Conclusion
In conclusion, we propose an original algorithm designed to identify high-sensitive cardiac troponin I false-positives. This algorithm can help clinicians to make prompt and informed decisions about patient care, and to avoid erroneous clinical interventions that may result from such interferences.
背景:心肌肌钙蛋白是心肌损伤的关键生物标志物,在诊断急性冠状动脉综合征和各种临床情况中发挥着核心作用。然而,当患者表现出心肌肌钙蛋白水平升高,但没有明显的心脏源性病变时,就会出现挑战,广泛的心脏探查就证明了这一点,这表明存在干扰因素。尽管高灵敏度心肌肌钙蛋白免疫测定的性能很高,但这些测试仍然容易受到干扰,从而导致假阳性:在 2021 年 7 月至 2024 年 7 月期间,波尔多大学医院心脏科共收治了 8129 名高敏心肌肌钙蛋白 I 检测结果呈阳性的住院患者:在这部分患者中,我们对各种技术进行了前瞻性评估,包括连续稀释法、抗体结合试管和替代免疫测定法(心肌肌钙蛋白 I 和 T),目的是找出高敏心肌肌钙蛋白 I 检测中可能存在的分析干扰。我们的调查显示,15 个疑似病例中有 12 个在高灵敏度心肌肌钙蛋白 I 检测中表现出干扰:总之,我们提出了一种旨在识别高敏心肌肌钙蛋白 I 假阳性的原创算法。该算法可帮助临床医生对患者的护理做出及时、明智的决定,并避免因此类干扰而导致的错误临床干预。
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.