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Measurement uncertainty. 测量不确定度。
Pub Date : 2023-01-01 Epub Date: 2023-09-27 DOI: 10.1016/bs.acc.2023.06.001
Neda Milinković, Snežana Jovičić

Over time, the metrological concept of uncertainty in measurement has been very successfully integrated into laboratory sciences. For proper implementation, an understanding of specific metrology terminology and additional concepts such as metrology traceability and commutability is necessary. Although the original thinking about measurement uncertainty in laboratory medicine suggests the complexity of the concept, it basically refers to the result as the end product of the entire laboratory process. Although the data on measurement uncertainty can be expressed quantitatively, the basis of this concept is the continuous evaluation of all phases of the laboratory process. This means that laboratory experts should keep in mind that the extra-analytical phases (on which the uncertainty of the measurement results may depend the most) must be continuously monitored. The analytical phase can be "held in check" by established internal and external quality control processes. It is the internal/external quality control data that is used to calculate the numerical value of the measurement uncertainty of the measurement results. Although over time the awareness of laboratory experts regarding the concept of measurement uncertainty has increased, there are still many challenges that need to be followed, and the last one is how to achieve a balance between understanding, evaluation process and application of measurement uncertainty data of measurement results for complete and ultimate practical use.

随着时间的推移,测量不确定度的计量概念已经非常成功地融入了实验室科学。为了正确实施,有必要了解特定的计量术语和其他概念,如计量可追溯性和可交换性。尽管实验室医学中关于测量不确定性的最初想法表明了概念的复杂性,但它基本上是指作为整个实验室过程的最终产品的结果。尽管测量不确定度的数据可以定量表示,但这一概念的基础是对实验室过程所有阶段的连续评估。这意味着实验室专家应记住,必须持续监测额外的分析阶段(测量结果的不确定性可能最为依赖)。分析阶段可以通过已建立的内部和外部质量控制流程进行“检查”。用于计算测量结果的测量不确定度数值的是内部/外部质量控制数据。尽管随着时间的推移,实验室专家对测量不确定性概念的认识有所提高,但仍有许多挑战需要遵循,最后一个挑战是如何在理解、评估过程和应用测量结果的测量不确定性数据之间取得平衡,以供完整和最终的实际使用。
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引用次数: 0
Predictive risk markers in alcoholism. 酒精中毒的预测风险标志物。
Pub Date : 2023-01-01 Epub Date: 2023-06-14 DOI: 10.1016/bs.acc.2023.05.002
Onni Niemelä

The medical disorders of alcoholism rank among the leading public health problems worldwide and the need for predictive and prognostic risk markers for assessing alcohol use disorders (AUD) has been widely acknowledged. Early-phase detection of problem drinking and associated tissue toxicity are important prerequisites for timely initiations of appropriate treatments and improving patient's committing to the objective of reducing drinking. Recent advances in clinical chemistry have provided novel approaches for a specific detection of heavy drinking through assays of unique ethanol metabolites, phosphatidylethanol (PEth) or ethyl glucuronide (EtG). Carbohydrate-deficient transferrin (CDT) measurements can be used to indicate severe alcohol problems. Hazardous drinking frequently manifests as heavy episodic drinking or in combinations with other unfavorable lifestyle factors, such as smoking, physical inactivity, poor diet or adiposity, which aggravate the metabolic consequences of alcohol intake in a supra-additive manner. Such interactions are also reflected in multiple disease outcomes and distinct abnormalities in biomarkers of liver function, inflammation and oxidative stress. Use of predictive biomarkers either alone or as part of specifically designed biological algorithms helps to predict both hepatic and extrahepatic morbidity in individuals with such risk factors. Novel approaches for assessing progression of fibrosis, a major determinant of prognosis in AUD, have also been made available. Predictive algorithms based on the combined use of biomarkers and clinical observations may prove to have a major impact on clinical decisions to detect AUD in early pre-symptomatic stages, stratify patients according to their substantially different disease risks and predict individual responses to treatment.

酒精中毒的医学障碍是世界范围内主要的公共卫生问题之一,对评估酒精使用障碍(AUD)的预测和预后风险标志物的需求已得到广泛认可。早期发现问题饮酒和相关组织毒性是及时开始适当治疗和提高患者对减少饮酒目标的承诺的重要先决条件。临床化学的最新进展为通过检测独特的乙醇代谢产物磷脂酰乙醇(PEth)或乙基葡糖苷酸(EtG)来特异性检测重度饮酒提供了新的方法。碳水化合物缺乏转铁蛋白(CDT)测量可用于指示严重的酒精问题。危险饮酒通常表现为大量的偶发性饮酒,或与其他不利的生活方式因素相结合,如吸烟、身体不活动、不良饮食或肥胖,这些因素以超加性的方式加剧了酒精摄入的代谢后果。这种相互作用也反映在多种疾病的结果以及肝功能、炎症和氧化应激生物标志物的明显异常中。单独使用预测性生物标志物或将其作为专门设计的生物算法的一部分,有助于预测具有此类风险因素的个体的肝脏和肝外发病率。评估纤维化进展(AUD预后的主要决定因素)的新方法也已问世。基于生物标志物和临床观察的联合使用的预测算法可能会对临床决策产生重大影响,这些决策包括在症状前期早期检测AUD,根据患者明显不同的疾病风险对患者进行分层,并预测个体对治疗的反应。
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引用次数: 1
Advances in preeclampsia testing. 子痫前期检测的进展。
Pub Date : 2023-01-01 Epub Date: 2023-09-26 DOI: 10.1016/bs.acc.2023.08.004
Jessica J Miller, Victoria Higgins, Annie Ren, Samantha Logan, Paul M Yip, Lei Fu

Preeclampsia is a multisystem hypertensive disorder and one of the leading causes of maternal and fetal morbidity and mortality. The clinical hallmarks such as hypertension and proteinuria, and additional laboratory tests currently available including liver enzyme testing, are neither specific nor sufficiently sensitive. Therefore, biomarkers for timely and accurate identification of patients at risk of developing preeclampsia are extremely valuable to improve patient outcomes and safety. In this chapter, we will first discuss the clinical characteristics of preeclampsia and current evidence of the role of angiogenic factors, such as placental growth factor (PlGF) and soluble FMS like tyrosine kinase 1 (sFlt-1) in the pathogenesis of preeclampsia. Second, we will review the clinical practice guidelines for preeclampsia diagnostic criteria and their recommendations on laboratory testing. Third, we will review the currently available PlGF and sFlt-1 assays in terms of their methodologies, analytical performance, and clinical diagnostic values. Finally, we will discuss the future research needs from both an analytical and clinical perspective.

子痫前期是一种多系统高血压疾病,是孕产妇和胎儿发病和死亡的主要原因之一。高血压和蛋白尿等临床标志,以及目前可用的其他实验室检测,包括肝酶检测,既不具有特异性,也不够敏感。因此,及时准确地识别有子痫前期风险的患者的生物标志物对于改善患者的预后和安全性是非常有价值的。在本章中,我们将首先讨论子痫前期的临床特征和血管生成因子,如胎盘生长因子(PlGF)和可溶性FMS如酪氨酸激酶1 (sFlt-1)在子痫前期发病机制中的作用的最新证据。其次,我们将回顾临床实践指南子痫前期诊断标准和他们的实验室检测建议。第三,我们将回顾目前可用的PlGF和sFlt-1检测方法,分析性能和临床诊断价值。最后,我们将从分析和临床的角度讨论未来的研究需求。
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引用次数: 0
Immunohematological testing and transfusion management of the prenatal patient. 产前患者的免疫血液学检测与输血管理。
Pub Date : 2023-01-01 Epub Date: 2023-09-19 DOI: 10.1016/bs.acc.2023.08.002
NurJehan Quraishy, Suneeti Sapatnekar

The primary indication for immunohematological testing in the prenatal patient is to detect and identify maternal red cell antibodies. If there are antibodies that are expected to hemolyze the fetus' red cells, their strength of reactivity must be tested, and the fetus' antigen status determined. After delivery, testing is performed to assess the extent of fetomaternal hemorrhage, as a large hemorrhage may require other therapeutic interventions. Another major role for immunohematological testing is to select blood components appropriately when intrauterine transfusion is required for fetal anemia resulting from maternal alloimmunization or some other cause. Supplementation with molecular methods has transformed the practice of immunohematology, particularly as it applies to typing for the D antigen of the Rh blood group system. Notwithstanding the advances in testing, close coordination and communication between the transfusion service and the obstetrics service are the foundation for ensuring the finest care for prenatal patients, and for new mothers and their infants. This review describes testing and transfusion practices for prenatal patients, using case presentations to highlight the management of selected immunohematological findings. It also includes a discussion of key patient management topics that are currently unresolved.

产前患者免疫血液学检测的主要指征是检测和识别母体红细胞抗体。如果有抗体预期会溶血胎儿的红细胞,则必须检测其反应强度,并确定胎儿的抗原状态。分娩后,进行测试以评估胎母出血的程度,因为大出血可能需要其他治疗干预。免疫血液学检测的另一个主要作用是,当因母体同种异体免疫或其他原因引起的胎儿贫血需要宫内输血时,选择适当的血液成分。补充分子方法已经改变了免疫血液学的实践,特别是当它适用于Rh血型系统的D抗原分型时。尽管在检测方面取得了进展,但输血服务和产科服务之间的密切协调和沟通是确保对产前病人和新生儿及其婴儿提供最佳护理的基础。这篇综述描述了产前患者的检测和输血实践,使用病例介绍来强调选定的免疫血液学发现的管理。它还包括对目前尚未解决的关键患者管理主题的讨论。
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引用次数: 0
Biomarkers in psychiatric disorders. 精神疾病的生物标志物。
Pub Date : 2023-01-01 Epub Date: 2023-09-26 DOI: 10.1016/bs.acc.2023.05.005
Jemmyson Romário de Jesus, Tatianny de Araujo Andrade, Eduardo Costa de Figueiredo

Psychiatric disorders represent a significant socioeconomic and healthcare burden worldwide. Of these, schizophrenia, bipolar disorder, major depressive disorder and anxiety are among the most prevalent. Unfortunately, diagnosis remains problematic and largely complicated by the lack of disease specific biomarkers. Accordingly, much research has focused on elucidating these conditions to more fully understand underlying pathophysiology and potentially identify biomarkers, especially those of early stage disease. In this chapter, we review current status of this endeavor as well as the potential development of novel biomarkers for clinical applications and future research study.

精神疾病是世界范围内一个重大的社会经济和医疗负担。其中,精神分裂症、双相情感障碍、重度抑郁障碍和焦虑症最为普遍。不幸的是,诊断仍然存在问题,并且由于缺乏疾病特异性生物标志物而在很大程度上变得复杂。因此,许多研究都集中在阐明这些情况上,以更全面地了解潜在的病理生理学,并潜在地识别生物标志物,尤其是早期疾病的生物标志物。在本章中,我们回顾了这项工作的现状,以及用于临床应用和未来研究的新型生物标志物的潜在发展。
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引用次数: 0
Phosphorylated tau in Alzheimer's disease. 阿尔茨海默病中磷酸化的tau。
Pub Date : 2023-01-01 Epub Date: 2023-06-09 DOI: 10.1016/bs.acc.2023.05.001
Julia Telser, Kirsten Grossmann, Niklas Wohlwend, Lorenz Risch, Christoph H Saely, Philipp Werner

There is a need for blood biomarkers to detect individuals at different Alzheimer's disease (AD) stages because obtaining cerebrospinal fluid-based biomarkers is invasive and costly. Plasma phosphorylated tau proteins (p-tau) have shown potential as such biomarkers. This systematic review was conducted according to the PRISMA guidelines and aimed to determine whether quantification of plasma tau phosphorylated at threonine 181 (p-tau181), threonine 217 (p-tau217) and threonine 231 (p-tau231) is informative in the diagnosis of AD. All p-tau isoforms increase as a function of Aβ-accumulation and discriminate healthy individuals from those at preclinical AD stages with high accuracy. P-tau231 increases earliest, followed by p-tau181 and p-tau217. In advanced stages, all p-tau isoforms are associated with the clinical classification of AD and increase with disease severity, with the greatest increase seen for p-tau217. This is also reflected by a better correlation of p-tau217 with Aβ scans, whereas both, p-tau217 and p-tau181 correlated equally with tau scans. However, at the very advanced stages, p-tau181 begins to plateau, which may mirror the trajectory of the Aβ pathology and indicate an association with a more intermediate risk of AD. Across the AD continuum, the incremental increase in all biomarkers is associated with structural changes in widespread brain regions and underlying cognitive decline. Furthermore, all isoforms differentiate AD from non-AD neurodegenerative disorders, making them specific for AD. Incorporating p-tau181, p-tau217 and p-tau231 in clinical use requires further studies to examine ideal cut-points and harmonize assays.

需要血液生物标志物来检测不同阿尔茨海默病(AD)阶段的个体,因为获得基于脑脊液的生物标志物具有侵入性且成本高昂。血浆磷酸化tau蛋白(p-tau)已显示出作为此类生物标志物的潜力。这项系统综述是根据PRISMA指南进行的,旨在确定苏氨酸181(p-tau181)、苏氨酸217(p-tau217)和苏氨酸231(p-tau231)磷酸化的血浆tau的定量是否对AD的诊断有帮助。所有p-au亚型都作为aβ-积累的函数而增加,并以高精度将健康个体与临床前AD阶段的个体区分开来。P-tau231增加最早,其次是P-tau181和P-tau217。在晚期,所有p-tau亚型都与AD的临床分类有关,并随着疾病严重程度的增加而增加,其中p-tau217的增加最大。这也反映在p-tau217与aβ扫描的更好相关性上,而p-tau218和p-tau181与tau扫描的相关性相等。然而,在非常晚期,p-tau181开始趋于平稳,这可能反映了Aβ病理学的轨迹,并表明与AD的中等风险有关。在整个AD连续体中,所有生物标志物的增量增加与广泛的大脑区域的结构变化和潜在的认知能力下降有关。此外,所有亚型都将AD与非AD神经退行性疾病区分开来,使其对AD具有特异性。在临床应用中结合p-tau181、p-tau217和p-tau231需要进一步的研究来检查理想的分界点并协调测定。
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引用次数: 0
Viscoelastic Testing Methods. 粘弹性试验方法。
Pub Date : 2023-01-01 Epub Date: 2023-11-03 DOI: 10.1016/bs.acc.2023.09.001
Timothy Carll

Viscoelastic testing methods examine the real-time formation of a clot in a whole blood sample, and include thromboelastography (TEG), rotational thromboelastometry (ROTEM), and several other testing platforms. They allow for concurrent assessment of multiple aspects of clotting, including plasmatic coagulation factors, platelets, fibrinogen, and the fibrinolytic pathway. This testing is rapid and may be performed at the point-of-care, allowing for prompt identification of coagulopathies to guide focused and rational administration of blood products as well as the identification of anticoagulant effect. With recent industry progression towards user-friendly, cartridge-based, portable instruments, viscoelastic testing has emerged in the 21st century as a powerful tool to guide blood transfusions in the bleeding patient, and to identify and treat both bleeding and thrombotic conditions in many operative settings, including trauma surgery, liver transplant surgery, cardiac surgery, and obstetrics. In these settings, the use of transfusion algorithms guided by viscoelastic testing data has resulted in widespread improvements in patient blood management as well as modest improvements in select patient outcomes. To address the increasingly wide adoption of viscoelastic methods and the growing number of medical and laboratory personnel tasked with implementing, performing, and interpreting these methods, this chapter provides an overview of the history, physiology, and technology behind viscoelastic testing, as well as a practical review of its clinical utility and current evidence supporting its use. Also included is a review of testing limitations and the contextual role played by viscoelastic methods among all coagulation laboratory testing.

粘弹性测试方法检查全血样本中血块的实时形成,包括血栓弹性成像(TEG)、旋转血栓弹性测量(ROTEM)和其他几种测试平台。它们允许同时评估凝血的多个方面,包括血浆凝血因子、血小板、纤维蛋白原和纤溶途径。该检测快速,可在护理点进行,允许及时识别凝血疾病,指导集中和合理的血液制品管理以及抗凝作用的识别。随着最近行业向用户友好、基于卡带的便携式仪器的发展,粘弹性测试已在21世纪成为指导出血患者输血的有力工具,并在许多手术环境中识别和治疗出血和血栓性疾病,包括创伤手术、肝移植手术、心脏手术和产科。在这些情况下,由粘弹性测试数据指导的输血算法的使用导致了患者血液管理的广泛改善,以及选择患者结果的适度改善。为了解决粘弹性方法越来越广泛的应用,以及越来越多的医疗和实验室人员负责实施、执行和解释这些方法,本章概述了粘弹性测试背后的历史、生理学和技术,并对其临床应用和当前支持其使用的证据进行了实际回顾。还包括测试的局限性和粘弹性方法在所有凝血实验室测试中所起的背景作用的回顾。
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引用次数: 0
Lead poisoning: Clinical and laboratory considerations. 铅中毒:临床和实验室考虑。
Pub Date : 2023-01-01 Epub Date: 2023-09-27 DOI: 10.1016/bs.acc.2023.08.001
Dustin Bunch, Amy L Pyle-Eilola

Lead has been a known source of toxicity for millennia due to widespread use until the 20th century. Consequently, there remains significant, though decreasing, exposure to lead throughout the world. Clinical signs and symptoms of lead toxicity are well-documented but is particularly concerning for children six years of age and under, as brain development is rapid and therefore, is likely to be affected by even low levels of lead. Therefore, in the United States, it is recommended that young children to be routinely screened for blood lead levels. Blood lead levels can be measured by various methods in laboratories with blood collection greatly impacting possible lead contamination of samples. The history, presentation, and laboratory testing methodologies will be discussed.

由于铅的广泛使用,直到20世纪,铅一直是一种已知的毒性来源。因此,尽管世界各地的铅接触量在减少,但仍然很大。铅中毒的临床症状和体征有案可查,但对于6岁及以下儿童尤其令人担忧,因为大脑发育迅速,因此即使铅含量很低也可能受到影响。因此,在美国,建议幼儿定期检查血铅水平。血铅水平可以在实验室通过各种方法测量,血液采集对样品可能的铅污染有很大影响。历史,介绍和实验室测试方法将被讨论。
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引用次数: 0
Advances in fentanyl testing. 芬太尼检测的进展。
Pub Date : 2023-01-01 Epub Date: 2023-06-14 DOI: 10.1016/bs.acc.2023.05.004
Sacha Uljon

Fentanyl is a synthetic opioid that was approved by the FDA in the late 1960s. In the decades since, non-prescription use of fentanyl, its analogs, and structurally unrelated novel synthetic opioids (NSO) has become a worsening public health crisis. There is a clear need for accessible testing for these substances in biological specimens and in apprehended drugs. Immunoassays for fentanyl in urine are available but their performance is restricted to facilities that hold moderate complexity laboratory licenses. Immunoassays for other matrices such as oral fluid (OF), blood, and meconium have been developed but are not widely available. Point of care tests (POCT), such as lateral flow immunoassays or fentanyl test strips (FTS), are widely available but not approved by the FDA for clinical use. All immunoassays are vulnerable to false positive and false negative results. Immunoassays may or may not be able to detect fentanyl analogs and NSOs. Mass spectrometry (MS) can accurately and reliably measure fentanyl and its major metabolite norfentanyl in urine and oral fluid. MS is available at reference laboratories and large hospitals. Liquid chromatography paired with tandem mass spectrometry (LC-MS/MS) is the most widely used method and has outstanding specificity and sensitivity for fentanyl and norfentanyl. When compared to immunoassays, MS is more expensive, requires more technical skill, and takes longer to result. Newer mass spectrometry methods can measure fentanyl analogs and NSO. Both mass spectrometry assays and immunoassays [in the form of fentanyl test strips (FTS)] have potential use in harm reduction programs.

芬太尼是一种合成阿片类药物,于20世纪60年代末获得美国食品药品监督管理局批准。自那以来的几十年里,非处方使用芬太尼及其类似物和结构无关的新型合成阿片类药物(NSO)已成为一场日益恶化的公共卫生危机。显然有必要在生物标本和缴获的毒品中对这些物质进行方便的检测。尿液中芬太尼的免疫测定是可用的,但其性能仅限于持有中等复杂度实验室许可证的设施。其他基质如口服液(OF)、血液和胎粪的免疫测定法已经开发出来,但尚未广泛使用。护理点测试(POCT),如侧流免疫测定或芬太尼测试条(FTS),广泛可用,但未经美国食品药品监督管理局批准用于临床。所有免疫测定都容易出现假阳性和假阴性结果。免疫测定法可以检测芬太尼类似物和NSO,也可以不检测。质谱法能够准确可靠地测定尿液和口腔液中芬太尼及其主要代谢产物去甲芬太尼。MS可在参考实验室和大型医院获得。液相色谱-串联质谱法(LC-MS/MS)是应用最广泛的方法,对芬太尼和去甲芬太尼具有突出的特异性和敏感性。与免疫测定相比,MS更昂贵,需要更多的技术技能,并且需要更长的时间才能得出结果。较新的质谱法可以测量芬太尼类似物和NSO。质谱分析和免疫分析[以芬太尼试纸条(FTS)的形式]在减少危害计划中都有潜在的用途。
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引用次数: 0
The role of sRAGE in cardiovascular diseases. sRAGE在心血管疾病中的作用。
Pub Date : 2023-01-01 Epub Date: 2023-09-19 DOI: 10.1016/bs.acc.2023.08.005
Charlotte Delrue, Joris R Delanghe, Marijn M Speeckaert

Advanced glycation end products (AGEs), by-products of glucose metabolism, have been linked to the emergence of cardiovascular disorders (CVD). AGEs can cause tissue damage in four different ways: (1) by altering protein function, (2) by crosslinking proteins, which makes tissue stiffer, (3) by causing the generation of free radicals, and (4) by activating an inflammatory response after binding particular AGE receptors, such as the receptor for advanced glycation end products (RAGE). It is suggested that the soluble form of RAGE (sRAGE) blocks ligand-mediated pro-inflammatory and oxidant activities by serving as a decoy. Therefore, several studies have investigated the possible anti-inflammatory and anti-oxidant characteristics of sRAGE, which may help lower the risk of CVD. According to the results of various studies, the relationship between circulating sRAGE, cRAGE, and esRAGE and CVD is inconsistent. To establish the potential function of sRAGE as a therapeutic target in the treatment of cardiovascular illnesses, additional studies are required to better understand the relationship between sRAGE and CVD. In this review, we explored the potential function of sRAGE in different CVD, highlighting unanswered concerns and outlining the possibilities for further investigation.

晚期糖基化终产物(AGEs)是葡萄糖代谢的副产物,与心血管疾病(CVD)的出现有关。AGEs可以通过四种不同的方式引起组织损伤:(1)通过改变蛋白质功能,(2)通过交联蛋白质使组织变硬,(3)通过引起自由基的产生,以及(4)在结合特定的AGE受体后激活炎症反应,例如晚期糖基化终产物受体(RAGE)。这表明RAGE的可溶性形式(sRAGE)通过充当诱饵来阻断配体介导的促炎和氧化活性。因此,一些研究已经调查了sRAGE可能的抗炎和抗氧化特性,这可能有助于降低心血管疾病的风险。根据各种研究结果,循环sRAGE、cRAGE和esRAGE与CVD的关系并不一致。为了确定sRAGE作为治疗心血管疾病的靶点的潜在功能,需要进一步的研究来更好地了解sRAGE与CVD之间的关系。在这篇综述中,我们探讨了sRAGE在不同心血管疾病中的潜在功能,强调了未解决的问题,并概述了进一步研究的可能性。
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引用次数: 0
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Advances in clinical chemistry
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