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The urocortin peptides: biological relevance and laboratory aspects of UCN3 and its receptor. 尿皮质素肽:UCN3及其受体的生物学相关性和实验室方面。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-12-01 DOI: 10.1080/10408363.2022.2080175
Norah J Alghamdi, Christopher T Burns, Roland Valdes

The urocortins are polypeptides belonging to the corticotropin-releasing hormone family, known to modulate stress responses in mammals. Stress, whether induced physically or psychologically, is an underlying cause or consequence of numerous clinical syndromes. Identifying biological markers associated with the homeostatic regulation of stress could provide a clinical laboratory approach for the management of stress-related disorders. The neuropeptide, urocortin 3 (UCN3), and the corticotropin-releasing hormone receptor 2 (CRHR2) constitute a regulatory axis known to mediate stress homeostasis. Dysregulation of this peptide/receptor axis is believed to play a role in several clinical conditions including post-traumatic stress, sleep apnea, cardiovascular disease, and other health problems related to stress. Understanding the physiology and measurement of the UCN3/CRHR2 axis is important for establishing a viable clinical laboratory diagnostic. In this article, we focus on evidence supporting the role of UCN3 and its receptor in stress-related clinical syndromes. We also provide insight into the measurements of UCN3 in blood and urine. These potential biomarkers provide new opportunities for clinical research and applications of laboratory medicine diagnostics in stress management.

尿皮质素是属于促肾上腺皮质激素释放激素家族的多肽,已知可调节哺乳动物的应激反应。压力,无论是生理上的还是心理上的,都是许多临床综合征的潜在原因或后果。识别与压力稳态调节相关的生物标志物可以为管理压力相关疾病提供临床实验室方法。神经肽尿皮质素3 (UCN3)和促肾上腺皮质激素释放激素受体2 (CRHR2)构成已知的调节轴,介导应激稳态。这种肽/受体轴的失调被认为在几种临床状况中发挥作用,包括创伤后应激、睡眠呼吸暂停、心血管疾病和其他与压力相关的健康问题。了解UCN3/CRHR2轴的生理和测量对于建立可行的临床实验室诊断非常重要。在这篇文章中,我们关注支持UCN3及其受体在应激相关临床综合征中的作用的证据。我们还提供了对血液和尿液中UCN3的测量的见解。这些潜在的生物标志物为临床研究和实验室医学诊断在压力管理中的应用提供了新的机会。
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引用次数: 1
Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future. 选择 SARS-CoV-2 诊断测试:未来的挑战和主要考虑因素。
IF 6.6 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-11-01 Epub Date: 2022-03-15 DOI: 10.1080/10408363.2022.2045250
Fausto Baldanti, Nirmal K Ganguly, Guiqiang Wang, Martin Möckel, Luke A O'Neill, Harald Renz, Carlos Eduardo Dos Santos Ferreira, Kazuhiro Tateda, Barbara Van Der Pol

A plethora of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic tests are available, each with different performance specifications, detection methods, and targets. This narrative review aims to summarize the diagnostic technologies available and how they are best selected to tackle SARS-CoV-2 infection as the pandemic evolves. Seven key settings have been identified where diagnostic tests are being deployed: symptomatic individuals presenting for diagnostic testing and/or treatment of COVID-19 symptoms; asymptomatic individuals accessing healthcare for planned non-COVID-19-related reasons; patients needing to access emergency care (symptom status unknown); patients being discharged from healthcare following hospitalization for COVID-19; healthy individuals in both single event settings (e.g. airports, restaurants, hotels, concerts, and sporting events) and repeat access settings (e.g. workplaces, schools, and universities); and vaccinated individuals. While molecular diagnostics remain central to SARS-CoV-2 testing strategies, we have offered some discussion on the considerations for when other tools and technologies may be useful, when centralized/point-of-care testing is appropriate, and how the various additional diagnostics can be deployed in differently resourced settings. As the pandemic evolves, molecular testing remains important for definitive diagnosis, but increasingly widespread point-of-care testing is essential to the re-opening of society.

目前有大量的严重急性呼吸系统综合症冠状病毒 2(SARS-CoV-2)诊断测试,每种测试都有不同的性能指标、检测方法和目标。本综述旨在总结现有的诊断技术,以及随着大流行病的发展,如何以最佳方式选择这些技术来应对 SARS-CoV-2 感染。目前已确定在以下七种关键环境中部署诊断检测:有症状的人前来接受诊断检测和/或治疗 COVID-19 症状;无症状的人因计划中的与 COVID-19 无关的原因就医;需要接受急诊治疗的病人(症状状况不明);因 COVID-19 住院治疗后出院的病人;在单一事件环境(如机场、餐馆、酒店、音乐会和体育赛事)和重复就医环境(如工作场所、学校和大学)中的健康人;以及接种过疫苗的人。虽然分子诊断仍然是 SARS-CoV-2 检测策略的核心,但我们也就以下方面的考虑进行了一些讨论:其他工具和技术何时有用、何时适合集中/定点检测,以及如何在资源不同的环境中部署各种附加诊断。随着疫情的发展,分子检测对于明确诊断仍然非常重要,但日益广泛的护理点检测对于社会的重新开放也至关重要。
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引用次数: 0
Evaluating thyroid function in pregnant women. 评估孕妇的甲状腺功能。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-11-01 DOI: 10.1080/10408363.2022.2050182
K Aaron Geno, Robert D Nerenz

Thyroid hormones are primarily responsible for regulating the basal metabolic rate but also make important contributions to reproductive function and fetal development. Both hyper- and hypothyroidism in pregnancy have been associated with increased risks of complications that include preeclampsia and low birth weight, among others. Furthermore, thyroid hormone deficiency in the developing fetus results in neurodevelopmental delay. As the fetus is exclusively reliant on maternal thyroid hormone for most of the first trimester and requires continued maternal supply until birth, identifying maternal thyroid dysfunction is critically important. However, evaluating thyroid function in pregnancy is challenging because of the many physiological changes that affect concentrations of thyroid-related analytes. Increasing plasma human chorionic gonadotropin (hCG) concentrations in the second half of the first trimester elicit a corresponding transient decrease in thyroid-stimulating hormone (TSH), and continually increasing estradiol concentrations throughout pregnancy cause substantial increases in thyroxine-binding globulin (TBG) and total thyroxine (T4) relative to the nonpregnant state. Lastly, free T4 concentrations gradually decrease with increasing gestational age. For these reasons, it is essential to interpret thyroid function test results in the context of trimester-specific reference intervals to avoid misclassification of thyroid status. This review summarizes the effects of thyroid dysfunction prior to conception and during pregnancy and describes considerations for the laboratory assessment of thyroid function in pregnant women.

甲状腺激素主要负责调节基础代谢率,但对生殖功能和胎儿发育也有重要贡献。妊娠期甲状腺功能亢进和甲状腺功能减退都与并发症的风险增加有关,包括先兆子痫和低出生体重等。此外,发育中的胎儿甲状腺激素缺乏会导致神经发育迟缓。由于胎儿在妊娠前三个月的大部分时间完全依赖母体的甲状腺激素,并且需要持续的母体供应直到出生,因此确定母体甲状腺功能障碍至关重要。然而,评估孕期甲状腺功能是具有挑战性的,因为许多生理变化会影响甲状腺相关分析物的浓度。人绒毛膜促性腺激素(hCG)的血浆浓度在孕早期的后半段会引起相应的促甲状腺激素(TSH)的短暂性下降,而在整个妊娠期间持续增加的雌二醇浓度会导致甲状腺素结合球蛋白(TBG)和总甲状腺素(T4)相对于非妊娠状态大幅增加。最后,随着胎龄的增加,游离T4浓度逐渐降低。由于这些原因,有必要解释甲状腺功能测试结果的背景下,三个月的特定参考间隔,以避免甲状腺状态的错误分类。本文综述了孕前和妊娠期间甲状腺功能障碍的影响,并描述了孕妇甲状腺功能实验室评估的考虑因素。
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引用次数: 5
Systematic review and meta-analysis of C-reactive protein as a biomarker in breast cancer. c反应蛋白作为乳腺癌生物标志物的系统回顾和荟萃分析。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-11-01 DOI: 10.1080/10408363.2022.2050886
Marta Kramer Mikkelsen, Nana Aviaja Frederikke Lindblom, Anne Dyhl-Polk, Carsten Bogh Juhl, Julia Sidenius Johansen, Dorte Nielsen

Inflammation is an enabling characteristic of the hallmarks of cancer. There has therefore been increasing interest in the clinical value of circulating inflammatory biomarkers in cancer. In this review, we summarize results on C-reactive protein (CRP), alone or as part of the Glasgow Prognostic Score (GPS, composed of CRP and serum albumin), as a biomarker of prognosis or prediction and monitoring of therapeutic response in patients with breast cancer. A systematic literature search was performed in Medline and Embase from 1990 to August 2021. The association of serum CRP and overall survival and disease/progression-free survival was summarized in meta-analyses using a random effects model. The results from a total of 35 included studies (20,936 patients) were divided according to three identified patient settings (metastatic, non-metastatic, and general setting). Most of the studies examined prognostic utility. Several larger studies observed associations between high serum CRP and poor survival, but the meta-analyses suggested a limited value in a non-metastatic and general breast cancer setting (populations with unknown or varied disease stage). In metastatic patients, however, more consistent findings supported an association between serum CRP and prognosis (hazard ratio for overall survival: 1.87 (95% CI 1.31-2.67). Only five studies examined a role in prediction or monitoring of therapeutic response. One study reported a significant association between serum CRP levels and response to chemotherapy. Findings regarding serum CRP as a biomarker in breast cancer appear inconsistent, particularly in non-metastatic and general breast cancer, where the prognostic value could not be confirmed. In patients with metastatic breast cancer we suggest that high serum CRP is an indicator of poor prognosis. Too few studies assessed the role of serum CRP in prediction or monitoring of treatment response to allow conclusions.

炎症是癌症的特征之一。因此,人们对循环炎症生物标志物在癌症中的临床价值越来越感兴趣。在这篇综述中,我们总结了c反应蛋白(CRP)单独或作为格拉斯哥预后评分(GPS,由CRP和血清白蛋白组成)的一部分,作为乳腺癌患者预后或预测和监测治疗反应的生物标志物的结果。从1990年到2021年8月在Medline和Embase进行了系统的文献检索。采用随机效应模型进行meta分析,总结血清CRP与总生存期和疾病/无进展生存期的关系。共纳入35项研究(20,936例患者)的结果根据三种确定的患者情况(转移性、非转移性和一般情况)进行划分。大多数研究考察了预后效用。几项较大的研究观察到高血清CRP与低生存率之间的关联,但荟萃分析表明,在非转移性和一般乳腺癌情况下(疾病分期未知或不同的人群),其价值有限。然而,在转移性患者中,更一致的发现支持血清CRP与预后之间的关联(总生存的危险比:1.87 (95% CI 1.31-2.67))。只有5项研究检查了在预测或监测治疗反应中的作用。一项研究报告了血清CRP水平与化疗反应之间的显著关联。关于血清CRP作为乳腺癌生物标志物的研究结果似乎不一致,特别是在非转移性乳腺癌和一般乳腺癌中,其预后价值无法证实。在转移性乳腺癌患者中,我们认为高血清CRP是预后不良的一个指标。评估血清CRP在预测或监测治疗反应中的作用的研究太少,无法得出结论。
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引用次数: 8
Personalized reference intervals: from theory to practice. 个性化参考区间:从理论到实践。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-11-01 DOI: 10.1080/10408363.2022.2070905
Abdurrahman Coskun, Sverre Sandberg, Ibrahim Unsal, Mustafa Serteser, Aasne K Aarsand

Using laboratory test results for diagnosis and monitoring requires a reliable reference to which the results can be compared. Currently, most reference data is derived from the population, and patients in this context are considered members of a population group rather than individuals. However, such reference data has limitations when used as the reference for an individual. A patient's test results preferably should be compared with their own, individualized reference intervals (RI), i.e. a personalized RI (prRI).The prRI is based on the homeostatic model and can be calculated using an individual's previous test results obtained in a steady-state situation and estimates of analytical (CVA) and biological variation (BV). BV used to calculate the prRI can be obtained from the population (within-subject biological variation, CVI) or an individual's own data (within-person biological variation, CVP). Statistically, the prediction interval provides a useful tool to calculate the interval (i.e. prRI) for future observation based on previous measurements. With the development of information technology, the data of millions of patients is stored and processed in medical laboratories, allowing the implementation of personalized laboratory medicine. PrRI for each individual should be made available as part of the laboratory information system and should be continually updated as new test results become available.In this review, we summarize the limitations of population-based RI for the diagnosis and monitoring of disease, provide an outline of the prRI concept and different approaches to its determination, including statistical considerations for deriving prRI, and discuss aspects which must be further investigated prior to implementation of prRI in clinical practice.

使用实验室检测结果进行诊断和监测需要可靠的参考,以便对结果进行比较。目前,大多数参考数据来自人群,在这种情况下,患者被认为是一个人群群体的成员,而不是个体。然而,这些参考数据在作为个人参考时具有局限性。患者的检测结果最好与他们自己的个性化参考区间(RI)进行比较,即个性化的RI (prRI)。prRI基于稳态模型,可以使用个人在稳态情况下获得的先前测试结果以及分析(CVA)和生物变异(BV)的估计来计算。用于计算prRI的BV可以从群体(受试者内生物变异,CVI)或个人自身数据(人内生物变异,CVP)中获得。在统计上,预测区间提供了一个有用的工具来计算基于先前测量的未来观测的区间(即prRI)。随着信息技术的发展,数百万患者的数据在医学实验室中存储和处理,从而实现个性化的实验室医学。每个人的PrRI应作为实验室信息系统的一部分提供,并应在获得新的检测结果时不断更新。在这篇综述中,我们总结了基于人群的prRI在疾病诊断和监测方面的局限性,概述了prRI的概念和确定prRI的不同方法,包括推导prRI的统计考虑因素,并讨论了在临床实践中实施prRI之前必须进一步研究的方面。
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引用次数: 6
Current and emerging technologies for the timely screening and diagnosis of neonatal jaundice. 及时筛查和诊断新生儿黄疸的现有和新兴技术。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-08-01 Epub Date: 2022-02-21 DOI: 10.1080/10408363.2022.2038074
Mercy Thomas, Ronda F Greaves, David G Tingay, Tze Ping Loh, Vera Ignjatovic, Fiona Newall, Michelle Oeum, Mai Thi Chi Tran, Anushi E Rajapaksa

Neonatal jaundice is one of the most common clinical conditions affecting newborns. For most newborns, jaundice is harmless, however, a proportion of newborns develops severe neonatal jaundice requiring therapeutic interventions, accentuating the need to have reliable and accurate screening tools for timely recognition across different health settings. The gold standard method in diagnosing jaundice involves a blood test and requires specialized hospital-based laboratory instruments. Despite technological advancements in point-of-care laboratory medicine, there is limited accessibility of the specialized devices and sample stability in geographically remote areas. Lack of suitable testing options leads to delays in timely diagnosis and treatment of clinically significant jaundice in developed and developing countries alike. There has been an ever-increasing need for a low-cost, simple to use screening technology to improve timely diagnosis and management of neonatal jaundice. Consequently, several point-of-care (POC) devices have been developed to address this concern. This paper aims to review the literature, focusing on emerging technologies in the screening and diagnosing of neonatal jaundice. We report on the challenges associated with the existing screening tools, followed by an overview of emerging sensors currently in pre-clinical development and the emerging POC devices in clinical trials to advance the screening of neonatal jaundice. The benefits offered by emerging POC devices include their ease of use, low cost, and the accessibility of rapid response test results. However, further clinical trials are required to overcome the current limitations of the emerging POC's before their implementation in clinical settings. Hence, the need for a simple to use, low-cost POC jaundice detection technology for newborns remains an unsolved challenge globally.

新生儿黄疸是影响新生儿最常见的临床疾病之一。对于大多数新生儿来说,黄疸是无害的,然而,一部分新生儿出现严重的新生儿黄疸,需要采取治疗干预措施,这就强调需要有可靠和准确的筛查工具,以便在不同的卫生机构中及时识别。诊断黄疸的金标准方法包括验血,并需要专门的医院实验室仪器。尽管在护理点实验室医学的技术进步,有有限的专业设备的可及性和样品稳定性在地理偏远地区。在发达国家和发展中国家,缺乏适当的检测选择导致临床上显著黄疸的及时诊断和治疗出现延误。人们越来越需要一种低成本、易于使用的筛查技术,以改善对新生儿黄疸的及时诊断和管理。因此,已经开发了几种护理点(POC)设备来解决这一问题。本文旨在回顾文献,重点介绍新生儿黄疸筛查和诊断的新兴技术。我们报告了与现有筛查工具相关的挑战,然后概述了目前处于临床前开发阶段的新兴传感器和临床试验中新兴的POC设备,以促进新生儿黄疸的筛查。新兴POC设备提供的好处包括其易于使用,低成本和快速响应测试结果的可访问性。然而,在临床环境中实施新出现的POC之前,需要进一步的临床试验来克服目前的局限性。因此,需要一种简单易用、低成本的新生儿POC黄疸检测技术仍然是全球尚未解决的挑战。
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引用次数: 1
Breathing new life into clinical testing and diagnostics: perspectives on volatile biomarkers from breath. 为临床测试和诊断注入新的生命:呼吸挥发性生物标志物的观点。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-08-01 Epub Date: 2022-02-21 DOI: 10.1080/10408363.2022.2038075
Jordan J Haworth, Charlotte K Pitcher, Giuseppe Ferrandino, Anthony R Hobson, Kirk L Pappan, Jonathan L D Lawson

Human breath offers several benefits for diagnostic applications, including simple, noninvasive collection. Breath is a rich source of clinically-relevant biological information; this includes a volatile fraction, where greater than 1,000 volatile organic compounds (VOCs) have been described so far, and breath aerosols that carry nucleic acids, proteins, signaling molecules, and pathogens. Many of these factors, especially VOCs, are delivered to the lung by the systemic circulation, and diffusion of candidate biomarkers from blood into breath allows systematic profiling of organismal health. Biomarkers on breath offer the capability to advance early detection and precision medicine in areas of global clinical need. Breath tests are noninvasive and can be performed at home or in a primary care setting, which makes them well-suited for the kind of public screening program that could dramatically improve the early detection of conditions such as lung cancer. Since measurements of VOCs on breath largely report on metabolic changes, this too aids in the early detection of a broader range of illnesses and can be used to detect metabolic shifts that could be targeted through precision medicine. Furthermore, the ability to perform frequent sampling has envisioned applications in monitoring treatment responses. Breath has been investigated in respiratory, liver, gut, and neurological diseases and in contexts as diverse as infectious diseases and cancer. Preclinical research studies using breath have been ongoing for some time, yet only a few breath-based diagnostics tests are currently available and in widespread clinical use. Most recently, tests assessing the gut microbiome using hydrogen and methane on breath, in addition to tests using urea to detect Helicobacter pylori infections have been released, yet there are many more applications of breath tests still to be realized. Here, we discuss the strengths of breath as a clinical sampling matrix and the technical challenges to be addressed in developing it for clinical use. Historically, a lack of standardized methodologies has delayed the discovery and validation of biomarker candidates, resulting in a proliferation of early-stage pilot studies. We will explore how advancements in breath collection and analysis are in the process of driving renewed progress in the field, particularly in the context of gastrointestinal and chronic liver disease. Finally, we will provide a forward-looking outlook for developing the next generation of clinically relevant breath tests and how they may emerge into clinical practice.

人类呼吸为诊断应用提供了几个好处,包括简单、无创收集。呼吸是临床相关生物信息的丰富来源;这包括挥发性部分,其中迄今已描述的挥发性有机化合物(VOCs)超过1000种,以及携带核酸、蛋白质、信号分子和病原体的呼吸气溶胶。其中许多因素,特别是挥发性有机化合物,通过体循环输送到肺部,候选生物标志物从血液扩散到呼吸,可以系统地分析机体健康状况。呼吸生物标志物提供了在全球临床需求领域推进早期检测和精准医疗的能力。呼吸测试是非侵入性的,可以在家里或初级保健机构进行,这使得它们非常适合用于公共筛查项目,可以显著提高对肺癌等疾病的早期发现。由于呼吸中挥发性有机化合物的测量主要报告代谢变化,这也有助于早期发现更广泛的疾病,并可用于检测代谢变化,从而通过精准医疗进行针对性治疗。此外,执行频繁采样的能力已经设想应用于监测处理反应。呼吸在呼吸系统、肝脏、肠道和神经系统疾病以及传染病和癌症等多种情况下都得到了研究。使用呼吸的临床前研究已经进行了一段时间,但目前只有少数基于呼吸的诊断测试可用并在临床广泛使用。最近,除了使用尿素检测幽门螺杆菌感染之外,还发布了使用氢气和甲烷呼气评估肠道微生物组的测试,但还有更多的呼气测试应用有待实现。在这里,我们讨论呼吸的强度作为临床采样矩阵和技术上的挑战要解决在开发它用于临床使用。从历史上看,标准化方法的缺乏推迟了候选生物标志物的发现和验证,导致早期试点研究的激增。我们将探讨呼吸收集和分析的进步如何推动该领域的新进展,特别是在胃肠道和慢性肝病的背景下。最后,我们将对开发下一代临床相关呼吸测试及其如何进入临床实践提供前瞻性展望。
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引用次数: 21
Prostate cancer biomarkers: a practical review based on different clinical scenarios. 前列腺癌生物标志物:基于不同临床情况的实用回顾。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-08-01 Epub Date: 2022-02-24 DOI: 10.1080/10408363.2022.2033161
Ugo Giovanni Falagario, Francesca Sanguedolce, Zach Dovey, Umberto Carbonara, Fabio Crocerossa, George Papastefanou, Riccardo Autorino, Marco Recchia, Antonella Ninivaggi, Gian Maria Busetto, Pasquale Annese, Giuseppe Carrieri, Luigi Cormio

Traditionally, diagnosis and staging of prostate cancer (PCa) have been based on prostate-specific antigen (PSA) level, digital rectal examination (DRE), and transrectal ultrasound (TRUS) guided prostate biopsy. Biomarkers have been introduced into clinical practice to reduce the overdiagnosis and overtreatment of low-grade PCa and increase the success of personalized therapies for high-grade and high-stage PCa. The purpose of this review was to describe available PCa biomarkers and examine their use in clinical practice. A nonsystematic literature review was performed using PubMed and Scopus to retrieve papers related to PCa biomarkers. In addition, we manually searched websites of major urological associations for PCa guidelines to evaluate available evidence and recommendations on the role of biomarkers and their potential contribution to PCa decision-making. In addition to PSA and its derivates, thirteen blood, urine, and tissue biomarkers are mentioned in various PCa guidelines. Retrospective studies have shown their utility in three main clinical scenarios: (1) deciding whether to perform a biopsy, (2) distinguishing patients who require active treatment from those who can benefit from active surveillance, and (3) defining a subset of high-risk PCa patients who can benefit from additional therapies after RP. Several validated PCa biomarkers have become commercially available in recent years. Guidelines now recommend offering these tests in situations in which the assay result, when considered in combination with routine clinical factors, is likely to affect management. However, the lack of direct comparisons and the unproven benefits, in terms of long-term survival and cost-effectiveness, prevent these biomarkers from being integrated into routine clinical use.

传统上,前列腺癌(PCa)的诊断和分期是基于前列腺特异性抗原(PSA)水平、直肠指检(DRE)和经直肠超声(TRUS)引导的前列腺活检。生物标志物已被引入临床实践,以减少对低级别PCa的过度诊断和过度治疗,并提高对高级别和高阶段PCa的个性化治疗的成功率。本综述的目的是描述可用的PCa生物标志物,并检查其在临床实践中的应用。使用PubMed和Scopus检索与PCa生物标志物相关的论文进行非系统文献综述。此外,我们人工检索了主要泌尿学协会的PCa指南网站,以评估生物标志物的作用及其对PCa决策的潜在贡献的现有证据和建议。除了PSA及其衍生物,在各种PCa指南中还提到了13种血液、尿液和组织生物标志物。回顾性研究显示其在三个主要临床场景中的效用:(1)决定是否进行活检,(2)区分需要积极治疗的患者和可以从积极监测中获益的患者,(3)确定RP后可以从额外治疗中获益的高危PCa患者子集。近年来,一些经过验证的PCa生物标志物已经商业化。现在的指南建议,在分析结果与常规临床因素结合考虑可能影响管理的情况下,提供这些检测。然而,在长期生存和成本效益方面,缺乏直接比较和未经证实的益处,阻碍了这些生物标志物被纳入常规临床应用。
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引用次数: 3
The North American opioid epidemic: opportunities and challenges for clinical laboratories. 北美阿片类药物流行:临床实验室的机遇和挑战。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-08-01 Epub Date: 2022-02-15 DOI: 10.1080/10408363.2022.2037122
Sarah R Delaney, Danyel H Tacker, Christine L H Snozek

Since 1999, the opioid epidemic in North America has resulted in over 1 million deaths, and it continues to escalate despite numerous efforts in various arenas to combat the upward trend. Clinical laboratories provide drug testing to support practices such as emergency medicine, substance use disorder treatment, and pain management; increasingly, these laboratories are collaborating in novel partnerships including drug-checking services (DCS) and multidisciplinary treatment teams. This review examines drug testing related to management of licit and illicit opioid use, new technologies and test strategies employed by clinical laboratories, barriers hindering laboratory response to the opioid epidemic, and areas for improvement and standardization within drug testing. Literature search terms included combinations of "opioid," "opiate," "fentanyl," "laboratory," "epidemic," "crisis," "mass spectrometry," "immunoassay," "drug screen," "drug test," "guidelines," plus review of PubMed "similar articles" and references within publications. While immunoassay (IA) and point-of-care (POC) test options for synthetic opioids are increasingly available, mass spectrometry (MS) platforms offer the greatest flexibility and sensitivity for detecting novel, potent opioids. Previously reserved as a second-tier application in most drug test algorithms, MS assays are gaining a larger role in initial screening for specific patients and DCS. However, there are substantial differences among laboratories in terms of updating test menus, algorithms, and technologies to meet changing clinical needs. While some clinical laboratories lack the resources and expertise to implement MS, many are also slow to adopt available IA and POC tests for newer opioids such as fentanyl. MS-based testing also presents challenges, including gaps in available guidance for assay validation and ongoing performance assessment that contribute to a dramatic lack of standardization among laboratories. We identify opportunities for improvement in laboratory operations, reporting, and interpretation of drug test results, including laboratorian and provider education and laboratory-focused guidelines. We also highlight the need for collaboration with providers, assay and instrument manufacturers, and national organizations to increase the effectiveness of clinical laboratory and provider efforts in preventing morbidity and mortality associated with opioid use and misuse.

自1999年以来,北美的类阿片流行病已造成100多万人死亡,尽管在各个领域为遏制上升趋势作出了许多努力,但这种流行病仍在继续升级。临床实验室提供药物测试,以支持急诊医学、物质使用障碍治疗和疼痛管理等实践;这些实验室越来越多地以新型伙伴关系进行合作,包括药物检查服务和多学科治疗小组。本综述审查了与管理合法和非法阿片类药物使用有关的药物测试、临床实验室采用的新技术和测试策略、阻碍实验室应对阿片类药物流行的障碍,以及药物测试中有待改进和标准化的领域。文献搜索词包括“阿片类药物”、“阿片类药物”、“芬太尼”、“实验室”、“流行病”、“危机”、“质谱分析”、“免疫分析”、“药物筛选”、“药物测试”、“指南”的组合,以及PubMed“类似文章”的评论和出版物中的参考文献。虽然合成阿片类药物的免疫测定(IA)和即时检测(POC)方法越来越多,但质谱(MS)平台为检测新型强效阿片类药物提供了最大的灵活性和灵敏度。在大多数药物测试算法中,质谱分析以前被保留为第二级应用,在特定患者和DCS的初始筛选中,质谱分析正在发挥更大的作用。然而,在更新测试菜单、算法和技术以满足不断变化的临床需求方面,实验室之间存在实质性差异。虽然一些临床实验室缺乏实施MS的资源和专业知识,但许多实验室对芬太尼等新型阿片类药物采用现有的IA和POC测试的速度也很慢。基于质谱的检测也带来了挑战,包括现有的分析验证指南和正在进行的性能评估存在差距,这导致实验室之间严重缺乏标准化。我们确定在实验室操作、报告和药物检测结果解释方面的改进机会,包括实验室人员和提供者教育以及以实验室为重点的指南。我们还强调需要与提供者、测定和仪器制造商以及国家组织合作,以提高临床实验室和提供者在预防与阿片类药物使用和滥用相关的发病率和死亡率方面的有效性。
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引用次数: 2
Preterm labor tests: current status and future directions. 早产检查的现状及未来发展方向
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-06-01 Epub Date: 2022-01-25 DOI: 10.1080/10408363.2022.2027864
Wei Huang, Serdar Ural, Yusheng Zhu

Preterm labor (PTL) is a severe issue of neonatal healthcare because its related to preterm birth (PTB) is the leading cause of neonatal mortality and the most common reason for antenatal hospitalizations. The PTB rate is about 11% globally and it is similar in the United States. PTB poses a significant economic burden on the healthcare system. Early diagnosis of PTL is the key to reducing PTB rate, neonatal mortality, and long-term neurological impairment in children. The diagnosis of PTL is usually based on clinical criteria, but the accuracy of the diagnosis is poor. To predict the risk of PTL more accurately, tests of biomarkers with variable clinical diagnostic performances have been developed and some of them have been applied clinically. In this article, we analyze the performance characteristics of these biomarkers, such as sensitivity, specificity, positive predictive value, and negative predictive value, as well as the clinical utility of current biomarkers so that clinical laboratorians and clinicians can better understand the limitations of these tests and utilize them wisely. We also summarize the current recommendations on clinical utilization of PTL biomarkers. Finally, we explore the prospects of future omics-based novel biomarkers, which may improve prediction of PTL in the future.

早产(PTL)是新生儿保健的一个严重问题,因为它与早产(PTB)有关,是新生儿死亡的主要原因,也是产前住院治疗的最常见原因。全球的肺结核发病率约为11%在美国也差不多。肺结核给医疗保健系统带来了巨大的经济负担。早期诊断PTL是降低PTB发病率、新生儿死亡率和儿童长期神经功能损害的关键。PTL的诊断通常基于临床标准,但诊断的准确性较差。为了更准确地预测PTL的风险,已经开发了具有不同临床诊断性能的生物标志物测试,其中一些已应用于临床。在本文中,我们分析了这些生物标志物的性能特点,如敏感性、特异性、阳性预测值和阴性预测值,以及目前生物标志物的临床应用,以便临床实验室人员和临床医生更好地了解这些检测的局限性并明智地利用它们。我们还总结了目前关于PTL生物标志物临床应用的建议。最后,我们探讨了未来基于组学的新型生物标志物的前景,这可能会提高未来PTL的预测。
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引用次数: 3
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Critical reviews in clinical laboratory sciences
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