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The European Organisation of External Quality Assurance Providers in Laboratory Medicine (EQALM) Statement: guidelines for publishing about interlaboratory comparison studies (PubILC) 欧洲实验室医学外部质量保证提供者组织(EQALM)声明:实验室间比对研究(PubILC)发布指南
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-04-04 DOI: 10.1080/10408363.2024.2335202
Christoph Buchta, Gro Gidske, Gitte M. Henriksen, Tony Badrick, on behalf of the European Organisation of External Quality Assurance Providers in Laboratory Medicine (EQALM)
Data and results from interlaboratory comparison (ILC) studies, external quality assessment (EQA) and proficiency testing (PT) activities are important and valuable contributions both to the furthe...
实验室间比对(ILC)研究、外部质量评估(EQA)和能力验证(PT)活动的数据和结果对于进一步提高实验室的能力和质量都具有重要而宝贵的贡献。
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引用次数: 0
The elusive male microbiome: revealing the link between the genital microbiota and fertility. Critical review and future perspectives. 难以捉摸的男性微生物群:揭示生殖器微生物群与生育能力之间的联系。评论与未来展望。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-25 DOI: 10.1080/10408363.2024.2331489
Magdalena Jendraszak, Izabela Skibińska, Małgorzata Kotwicka, Mirosław Andrusiewicz

There is a growing focus on understanding the role of the male microbiome in fertility issues. Although research on the bacterial communities within the male reproductive system is in its initial phases, recent discoveries highlight notable variations in the microbiome's composition and abundance across distinct anatomical regions like the skin, foreskin, urethra, and coronary sulcus. To assess the relationship between male genitourinary microbiome and reproduction, we queried various databases, including MEDLINE (available via PubMed), SCOPUS, and Web of Science to obtain evidence-based data. The literature search was conducted using the following terms "gut/intestines microbiome," "genitourinary system microbiome," "microbiome and female/male infertility," "external genital tract microbiome," "internal genital tract microbiome," and "semen microbiome." Fifty-one relevant papers were analyzed, and eleven were strictly semen quality or male fertility related. The male microbiome, especially in the accessory glands like the prostate, seminal vesicles, and bulbourethral glands, has garnered significant interest because of its potential link to male fertility and reproduction. Studies have also found differences in bacterial diversity present in the testicular tissue of normozoospermic men compared to azoospermic suggesting a possible role of bacterial dysbiosis and reproduction. Correlation between the bacterial taxa in the genital microbiota of sexual partners has also been found, and sexual activity can influence the composition of the urogenital microbiota. Exploring the microbial world within the male reproductive system and its influence on fertility opens doors to developing ways to prevent, diagnose, and treat infertility. The present work emphasizes the importance of using consistent methods, conducting long-term studies, and deepening our understanding of how the reproductive tract microbiome works. This helps make research comparable, pinpoint potential interventions, and smoothly apply microbiome insights to real-world clinical practices.

人们越来越关注了解男性微生物组在生育问题中的作用。尽管对男性生殖系统内细菌群落的研究还处于起步阶段,但最近的发现突显了不同解剖区域(如皮肤、包皮、尿道和冠状沟)微生物组的组成和丰度存在明显差异。为了评估男性泌尿生殖系统微生物组与生殖之间的关系,我们查询了各种数据库,包括 MEDLINE(可通过 PubMed 获取)、SCOPUS 和 Web of Science,以获取循证数据。文献检索使用了以下术语:"肠道/肠道微生物组"、"泌尿生殖系统微生物组"、"微生物组与女性/男性不孕症"、"外生殖道微生物组"、"内生殖道微生物组 "和 "精液微生物组"。对 51 篇相关论文进行了分析,其中 11 篇严格意义上与精液质量或男性生育能力有关。男性微生物组,尤其是前列腺、精囊腺和球尿道腺等附属腺体中的微生物组,因其与男性生育能力和生殖的潜在联系而备受关注。研究还发现,正常无精子男性与无精子男性睾丸组织中的细菌多样性存在差异,这表明细菌菌群失调可能与生殖有关。性伴侣生殖器微生物群中的细菌类群之间也存在相关性,性活动会影响泌尿生殖器微生物群的组成。探索男性生殖系统内的微生物世界及其对生育的影响,为开发预防、诊断和治疗不育症的方法打开了大门。目前的工作强调了使用一致的方法、进行长期研究以及加深我们对生殖道微生物群如何发挥作用的理解的重要性。这有助于使研究具有可比性,精确定位潜在的干预措施,并顺利地将微生物组的见解应用到现实世界的临床实践中。
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引用次数: 0
Implementation of pharmacogenomics testing for precision medicine. 精准医学药物基因组学测试的实施。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-09-30 DOI: 10.1080/10408363.2023.2255279
Anastasia L Gant Kanegusuku, Clarence W Chan, Peter H O'Donnell, Kiang-Teck J Yeo

Great strides have been made in the past decade to lower barriers to clinical pharmacogenomics implementation. Nevertheless, PGx consultation prior to prescribing therapeutics is not yet mainstream. This review addresses the current climate surrounding PGx implementation, focusing primarily on strategies for implementation at academic institutions, particularly at The University of Chicago, and provides an up-to-date guide of resources supporting the development of PGx programs. Remaining challenges and recent strategies for overcoming these challenges to implementation are discussed.

在过去的十年里,在降低临床药物基因组学实施的障碍方面取得了长足的进步。尽管如此,在开具治疗处方之前进行PGx咨询还不是主流。这篇综述探讨了当前围绕PGx实施的气候,主要关注学术机构,特别是芝加哥大学的实施策略,并提供了支持PGx项目开发的最新资源指南。讨论了剩余的挑战以及克服这些执行挑战的最新战略。
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引用次数: 0
Emerging applications of machine learning in genomic medicine and healthcare. 机器学习在基因组医学和医疗保健中的新兴应用。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-10 DOI: 10.1080/10408363.2023.2259466
Narjice Chafai, Luigi Bonizzi, Sara Botti, Bouabid Badaoui

The integration of artificial intelligence technologies has propelled the progress of clinical and genomic medicine in recent years. The significant increase in computing power has facilitated the ability of artificial intelligence models to analyze and extract features from extensive medical data and images, thereby contributing to the advancement of intelligent diagnostic tools. Artificial intelligence (AI) models have been utilized in the field of personalized medicine to integrate clinical data and genomic information of patients. This integration allows for the identification of customized treatment recommendations, ultimately leading to enhanced patient outcomes. Notwithstanding the notable advancements, the application of artificial intelligence (AI) in the field of medicine is impeded by various obstacles such as the limited availability of clinical and genomic data, the diversity of datasets, ethical implications, and the inconclusive interpretation of AI models' results. In this review, a comprehensive evaluation of multiple machine learning algorithms utilized in the fields of clinical and genomic medicine is conducted. Furthermore, we present an overview of the implementation of artificial intelligence (AI) in the fields of clinical medicine, drug discovery, and genomic medicine. Finally, a number of constraints pertaining to the implementation of artificial intelligence within the healthcare industry are examined.

近年来,人工智能技术的融合推动了临床和基因组医学的进步。计算能力的显著提高促进了人工智能模型从大量医学数据和图像中分析和提取特征的能力,从而有助于智能诊断工具的进步。人工智能(AI)模型已被用于个性化医学领域,以整合患者的临床数据和基因组信息。这种集成可以确定定制的治疗建议,最终提高患者的治疗效果。尽管取得了显著进展,但人工智能在医学领域的应用仍受到各种障碍的阻碍,如临床和基因组数据的有限可用性、数据集的多样性、伦理影响以及对人工智能模型结果的不确定解释。在这篇综述中,对临床和基因组医学领域中使用的多种机器学习算法进行了全面评估。此外,我们还概述了人工智能在临床医学、药物发现和基因组医学领域的应用。最后,研究了在医疗保健行业中实施人工智能的一些限制因素。
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引用次数: 0
Optimizing the data in direct access testing: information technology to support an emerging care model. 优化直接访问测试中的数据:支持新兴护理模式的信息技术。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-10-06 DOI: 10.1080/10408363.2023.2258973
Michelle Stoffel, Stacy G Beal, Khalda A Ibrahim, Michael Rummel, Dina N Greene

Direct access testing (DAT) is an emerging care model that provides on-demand laboratory services for certain preventative, diagnostic, and monitoring indications. Unlike conventional testing models where health care providers order tests and where sample collection is performed onsite at the clinic or laboratory, most interactions between DAT consumers and the laboratory are virtual. Tests are ordered and results delivered online, and specimens are frequently self-collected at home with virtual support. Thus, DAT depends on high-quality information technology (IT) tools and optimized data utilization to a greater degree than conventional laboratory testing. This review critically discusses the United States DAT landscape in relation to IT to highlight digital challenges and opportunities for consumers, health care systems, providers, and laboratories. DAT offers consumers increased autonomy over the testing experience, cost, and data sharing, but the current capacity to integrate DAT as a care option into the conventional patient-provider model is lacking and will require innovative approaches to accommodate. Likewise, both consumers and health care providers need transparent information about the quality of DAT laboratories and clinical decision support to optimize appropriate use of DAT as a part of comprehensive care. Interoperability barriers will require intentional approaches to integrating DAT-derived data into the electronic health records of health systems nationally. This includes ensuring the laboratory results are appropriately captured for downstream data analytic pipelines that are used to satisfy population health and research needs. Despite the data- and IT-related challenges for widespread incorporation of DAT into routine health care, DAT has the potential to improve health equity by providing versatile, discreet, and affordable testing options for patients who have been marginalized by the current limitations of health care delivery in the United States.

直接访问检测(DAT)是一种新兴的护理模式,为某些预防、诊断和监测指征提供按需实验室服务。与医疗保健提供者订购测试以及在诊所或实验室现场进行样本采集的传统测试模式不同,DAT消费者和实验室之间的大多数互动都是虚拟的。测试是在线订购和结果交付的,样本经常在家里通过虚拟支持自行采集。因此,DAT在很大程度上依赖于高质量的信息技术(IT)工具和优化的数据利用率,而不是传统的实验室测试。这篇综述批判性地讨论了美国DAT与IT的关系,以强调消费者、医疗保健系统、提供者和实验室面临的数字挑战和机遇。DAT为消费者提供了更多的测试体验、成本和数据共享自主权,但目前缺乏将DAT作为一种护理选项集成到传统患者提供者模式中的能力,需要创新的方法来适应。同样,消费者和医疗保健提供者都需要有关DAT实验室质量的透明信息和临床决策支持,以优化DAT作为综合护理的一部分的适当使用。互操作性障碍将需要有意识地将DAT衍生的数据整合到全国卫生系统的电子健康记录中。这包括确保实验室结果被适当地捕获,用于满足人口健康和研究需求的下游数据分析管道。尽管在将DAT广泛纳入常规医疗保健方面面临着与数据和IT相关的挑战,但DAT有潜力通过为因美国目前医疗保健服务的局限性而被边缘化的患者提供多功能、谨慎和负担得起的检测选项来提高健康公平性。
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引用次数: 0
A review of clinical guidelines, laboratory recommendations and external quality assurance programs for monoclonal gammopathy testing. 单克隆免疫球蛋白病检测的临床指南、实验室建议和外部质量保证计划综述。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 Epub Date: 2023-09-30 DOI: 10.1080/10408363.2023.2257306
Say Min Lim, Nilika Wijeratne, Kay Weng Choy, Thi Thanh Hai Nguyen, Lyana Setiawan, Tze Ping Loh

Monoclonal gammopathy (MG) is a spectrum of diseases ranging from the benign asymptomatic monoclonal gammopathy of undetermined significance to the malignant multiple myeloma. Clinical guidelines and laboratory recommendations have been developed to inform best practices in the diagnosis, monitoring, and management of MG. In this review, the pathophysiology, relevant laboratory testing recommended in clinical practice guidelines and laboratory recommendations related to MG testing and reporting are examined. The clinical guidelines recommend serum protein electrophoresis, serum immunofixation and serum free light chain measurement as initial screening. The laboratory recommendations omit serum immunofixation as it offers limited additional diagnostic value. The laboratory recommendations offer guidance on reporting findings beyond monoclonal protein, which was not required by the clinical guidelines. The clinical guidelines suggested monitoring total IgA concentration by turbidimetry or nephelometry method if the monoclonal protein migrates in the non-gamma region, whereas the laboratory recommendations make allowance for involved IgM and IgG. Additionally, several external quality assurance programs for MG protein electrophoresis and free light chain testing are also appraised. The external quality assurance programs show varied assessment criteria for protein electrophoresis reporting and unit of measurement. There is also significant disparity in reported monoclonal protein concentrations with wide inter-method analytical variation noted for both monoclonal protein quantification and serum free light chain measurement, however this variation appears smaller when the same method was used. Greater harmonization among laboratory recommendations and reporting format may improve clinical interpretation of MG testing.

单克隆免疫球蛋白病(MG)是一系列疾病,从意义不明的良性无症状单克隆免疫球基因病到恶性多发性骨髓瘤。已经制定了临床指南和实验室建议,以告知MG诊断、监测和管理的最佳实践。在这篇综述中,审查了病理生理学、临床实践指南中建议的相关实验室检测以及与MG检测和报告相关的实验室建议。临床指南推荐血清蛋白电泳、血清免疫固定和血清游离轻链测定作为初步筛选。实验室建议省略血清免疫固定,因为它提供的额外诊断价值有限。实验室建议为报告单克隆蛋白以外的发现提供了指导,而临床指南没有要求这一点。临床指南建议,如果单克隆蛋白在非γ区迁移,则通过浊度法或浊度法监测总IgA浓度,而实验室建议考虑相关的IgM和IgG。此外,还对MG蛋白电泳和自由轻链检测的几个外部质量保证方案进行了评估。外部质量保证计划显示了蛋白质电泳报告和测量单位的不同评估标准。报道的单克隆蛋白浓度也存在显著差异,单克隆蛋白定量和血清游离轻链测量的方法间分析差异很大,但使用相同方法时,这种差异似乎较小。实验室建议和报告格式之间的更大协调可能会改善MG测试的临床解释。
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引用次数: 0
Liquid biopsy for the management of NSCLC patients under osimertinib treatment 液体活检用于管理接受奥希替尼治疗的 NSCLC 患者
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-02-02 DOI: 10.1080/10408363.2024.2302116
Aliki Ntzifa, Theodoros Marras, Vasilis Georgoulias, Evi Lianidou
Therapeutic management of NSCLC patients is quite challenging as they are mainly diagnosed at a late stage of disease, and they present a high heterogeneous molecular profile. Osimertinib changed t...
由于NSCLC患者主要在疾病晚期才被确诊,而且他们的分子谱具有高度异质性,因此NSCLC患者的治疗管理相当具有挑战性。奥希替尼改变了NSCLC患者的...
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引用次数: 0
Applications of SARS-CoV-2 serological testing: impact of test performance, sample matrices, and patient characteristics. 严重急性呼吸系统综合征冠状病毒2型血清学检测的应用:检测性能、样本矩阵和患者特征的影响。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-01-05 DOI: 10.1080/10408363.2023.2254390
Chun Yiu Jordan Fung, Mackenzie Scott, Jordan Lerner-Ellis, Jennifer Taher

Laboratory testing has been a key tool in managing the SARS-CoV-2 global pandemic. While rapid antigen and PCR testing has proven useful for diagnosing acute SARS-CoV-2 infections, additional testing methods are required to understand the long-term impact of SARS-CoV-2 infections on immune response. Serological testing, a well-documented laboratory practice, measures the presence of antibodies in a sample to uncover information about host immunity. Although proposed applications of serological testing for clinical use have previously been limited, current research into SARS-CoV-2 has shown growing utility for serological methods in these settings. To name a few, serological testing has been used to identify patients with past infections and long-term active disease and to monitor vaccine efficacy. Test utility and result interpretation, however, are often complicated by factors that include poor test sensitivity early in infection, lack of immune response in some individuals, overlying infection and vaccination responses, lack of standardization of antibody titers/levels between instruments, unknown titers that confer immune protection, and large between-individual biological variation following infection or vaccination. Thus, the three major components of this review will examine (1) factors that affect serological test utility: test performance, testing matrices, seroprevalence concerns and viral variants, (2) patient factors that affect serological response: timing of sampling, age, sex, body mass index, immunosuppression and vaccination, and (3) informative applications of serological testing: identifying past infection, immune surveillance to guide health practices, and examination of protective immunity. SARS-CoV-2 serological testing should be beneficial for clinical care if it is implemented appropriately. However, as with other laboratory developed tests, use of SARS-CoV-2 serology as a testing modality warrants careful consideration of testing limitations and evaluation of its clinical utility.

实验室检测一直是管理严重急性呼吸系统综合征冠状病毒2型全球大流行的关键工具。虽然快速抗原和PCR检测已被证明可用于诊断急性严重急性呼吸系统综合征冠状病毒2型感染,但还需要额外的检测方法来了解严重急性呼吸系综合征病毒2型感染对免疫反应的长期影响。血清学检测是一种有充分记录的实验室实践,它测量样本中抗体的存在,以揭示有关宿主免疫的信息。尽管血清学检测在临床上的应用以前受到限制,但目前对严重急性呼吸系统综合征冠状病毒2型的研究表明,血清学方法在这些环境中的实用性越来越高。仅举几个例子,血清学检测已被用于识别既往感染和长期活动性疾病的患者,并监测疫苗的疗效。然而,测试的实用性和结果解释往往因以下因素而变得复杂:感染早期测试灵敏度低、一些个体缺乏免疫反应、感染和疫苗接种反应重叠、仪器之间抗体滴度/水平缺乏标准化、提供免疫保护的未知滴度、,并且在感染或接种疫苗后个体间的生物变异较大。因此,本综述的三个主要组成部分将研究(1)影响血清学检测实用性的因素:检测性能、检测矩阵、血清流行率问题和病毒变体;(2)影响血清学反应的患者因素:采样时间、年龄、性别、体重指数、免疫抑制和疫苗接种,(3)血清学检测的信息应用:识别既往感染,指导健康实践的免疫监测,以及保护性免疫检查。如果实施得当,严重急性呼吸系统综合征冠状病毒2型血清学检测应该对临床护理有益。然而,与其他实验室开发的检测一样,使用严重急性呼吸系统综合征冠状病毒2型血清学作为检测模式,需要仔细考虑检测的局限性并评估其临床效用。
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引用次数: 0
General features, pathogenesis, and laboratory diagnostics of autoimmune encephalitis. 自身免疫性脑炎的一般特征、发病机制和实验室诊断。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2024-01-05 DOI: 10.1080/10408363.2023.2247482
Stefano Masciocchi, Pietro Businaro, Silvia Scaranzin, Chiara Morandi, Diego Franciotta, Matteo Gastaldi

Autoimmune encephalitis (AE) is a group of inflammatory conditions that can associate with the presence of antibodies directed to neuronal intracellular, or cell surface antigens. These disorders are increasingly recognized as an important differential diagnosis of infectious encephalitis and of other common neuropsychiatric conditions. Autoantibody diagnostics plays a pivotal role for accurate diagnosis of AE, which is of utmost importance for the prompt recognition and early treatment. Several AE subgroups can be identified, either according to the prominent clinical phenotype, presence of a concomitant tumor, or type of neuronal autoantibody, and recent diagnostic criteria have provided important insights into AE classification. Antibodies to neuronal intracellular antigens typically associate with paraneoplastic neurological syndromes and poor prognosis, whereas antibodies to synaptic/neuronal cell surface antigens characterize many AE subtypes that associate with tumors less frequently, and that are often immunotherapy-responsive. In addition to the general features of AE, we review current knowledge on the pathogenic mechanisms underlying these disorders, focusing mainly on the potential role of neuronal antibodies in the most frequent conditions, and highlight current theories and controversies. Then, we dissect the crucial aspects of the laboratory diagnostics of neuronal antibodies, which represents an actual challenge for both pathologists and neurologists. Indeed, this diagnostics entails technical difficulties, along with particularly interesting novel features and pitfalls. The novelties especially apply to the wide range of assays used, including specific tissue-based and cell-based assays. These assays can be developed in-house, usually in specialized laboratories, or are commercially available. They are widely used in clinical immunology and in clinical chemistry laboratories, with relevant differences in analytic performance. Indeed, several data indicate that in-house assays could perform better than commercial kits, notwithstanding that the former are based on non-standardized protocols. Moreover, they need expertise and laboratory facilities usually unavailable in clinical chemistry laboratories. Together with the data of the literature, we critically evaluate the analytical performance of the in-house vs commercial kit-based approach. Finally, we propose an algorithm aimed at integrating the present strategies of the laboratory diagnostics in AE for the best clinical management of patients with these disorders.

自身免疫性脑炎(AE)是一组炎症性疾病,可能与针对神经元细胞内或细胞表面抗原的抗体的存在有关。这些疾病越来越被认为是传染性脑炎和其他常见神经精神疾病的重要鉴别诊断。自身抗体诊断在AE的准确诊断中起着关键作用,对及时识别和早期治疗至关重要。根据突出的临床表型、伴发肿瘤的存在或神经元自身抗体的类型,可以确定几个AE亚组,最近的诊断标准为AE分类提供了重要的见解。神经元细胞内抗原抗体通常与副肿瘤性神经综合征和不良预后有关,而突触/神经元细胞表面抗原抗体是许多AE亚型的特征,这些亚型与肿瘤的关联频率较低,并且通常对免疫疗法有反应。除了AE的一般特征外,我们还回顾了目前关于这些疾病致病机制的知识,主要关注神经元抗体在最常见情况下的潜在作用,并强调了当前的理论和争议。然后,我们剖析了神经元抗体实验室诊断的关键方面,这对病理学家和神经学家来说都是一个实际的挑战。事实上,这种诊断带来了技术上的困难,同时也带来了特别有趣的新功能和陷阱。这些新颖性特别适用于广泛使用的测定,包括特定的基于组织和基于细胞的测定。这些测定可以在内部进行,通常在专业实验室进行,也可以在商业上进行。它们广泛用于临床免疫学和临床化学实验室,在分析性能方面存在相关差异。事实上,一些数据表明,尽管前者基于非标准化方案,但内部分析可能比商业试剂盒表现更好。此外,他们需要临床化学实验室通常无法获得的专业知识和实验室设施。结合文献数据,我们对基于内部试剂盒与商业试剂盒的方法的分析性能进行了批判性评估。最后,我们提出了一种算法,旨在整合AE实验室诊断的现有策略,以实现对这些疾病患者的最佳临床管理。
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引用次数: 0
Establishing optimal cutoff values for high-sensitivity cardiac troponin algorithms in risk stratification of acute myocardial infarction. 为急性心肌梗死风险分层中的高敏心肌肌钙蛋白算法确定最佳临界值。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-07-19 DOI: 10.1080/10408363.2023.2235426
Li Liu, Kent Lewandrowski

Acute myocardial infarction (AMI) is a leading cause of mortality globally, highlighting the need for timely and accurate diagnostic strategies. Cardiac troponin has been the biomarker of choice for detecting myocardial injury. A dynamic change in concentrations supports the diagnosis of AMI in the setting of evidence of acute myocardial ischemia. The new generation of high-sensitivity cardiac troponin (hs-cTn) assays has significantly improved analytical sensitivity but at the expense of decreased clinical specificity. As a result, sophisticated algorithms are required to differentiate AMI from non-AMI patients. Establishing optimal hs-cTn cutoffs for these algorithms to rule out and rule in AMI has been the subject of intensive investigations. These efforts have evolved from examining the utility of the hs-cTn 99th percentile upper reference limit, comparing the percentage versus absolute delta thresholds, and evaluating the performance of an early European Society of Cardiology-recommended 3 h algorithm, to the development of accelerated 1 h and 2 h algorithms that combine the admission hs-cTn concentrations and absolute delta cutoffs to rule out and rule in AMI. Specific cutoffs for individual confounding factors such as sex, age, and renal insufficiency have also been investigated. At the same time, concerns such as whether the small delta thresholds exceed the analytical and biological variations of hs-cTn assays and whether the algorithms developed in European study populations fit all other patient cohorts have been raised. In addition, the accelerated algorithms leave a substantial number of patients in a non-diagnostic observation zone. How to properly diagnose patients falling in this zone and those presenting with elevated baseline hs-cTn concentrations due to the presence of confounding factors or comorbidities remain open questions. Here we discuss the developments described above, focusing on criteria and underlying considerations for establishing optimal cutoffs. In-depth analyses are provided on the influence of biological variation, analytical imprecision, local AMI rate, and the timing of presentation on the performance metrics of the accelerated hs-cTn algorithms. Developing diagnostic strategies for patients who remain in the observation zone and those presenting with confounding factors are also reviewed.

急性心肌梗死(AMI)是导致全球死亡的主要原因之一,因此需要及时、准确的诊断策略。心肌肌钙蛋白一直是检测心肌损伤的首选生物标记物。在有急性心肌缺血证据的情况下,浓度的动态变化有助于诊断急性心肌梗死。新一代高灵敏度心肌肌钙蛋白(hs-cTn)检测方法大大提高了分析灵敏度,但却降低了临床特异性。因此,需要复杂的算法来区分急性心肌梗死和非急性心肌梗死患者。为这些算法确定最佳 hs-cTn 临界值以排除 AMI 一直是深入研究的主题。这些工作从研究 hs-cTn 第 99 百分位数参考上限的效用、比较百分比与绝对 delta 临界值、评估欧洲心脏病学会推荐的早期 3 小时算法的性能,发展到开发 1 小时和 2 小时加速算法,将入院时的 hs-cTn 浓度和绝对 delta 临界值结合起来,以排除和判定急性心肌梗死。此外,还对性别、年龄和肾功能不全等个别混杂因素的特定临界值进行了研究。与此同时,人们也提出了一些担忧,如小 delta 临界值是否超出了 hs-cTn 检测方法的分析和生物学差异,以及在欧洲研究人群中开发的算法是否适用于所有其他患者群体。此外,加速算法使大量患者处于非诊断观察区。如何正确诊断观察区内的患者以及因存在混杂因素或合并症而导致基线 hs-cTn 浓度升高的患者仍是一个未决问题。在此,我们将讨论上述进展,重点是确定最佳临界值的标准和基本考虑因素。我们还深入分析了生物变异、分析不精确度、当地急性心肌梗死发生率和发病时间对加速 hs-cTn 算法性能指标的影响。此外,还回顾了针对仍在观察区的患者和存在混杂因素的患者制定诊断策略的情况。
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Critical reviews in clinical laboratory sciences
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