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New biomarkers in acute kidney injury. 急性肾损伤的新生物标志物。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-09-05 DOI: 10.1080/10408363.2023.2242481
Adam Rossiter, Ashley La, Jay L Koyner, Lui G Forni

Acute kidney injury (AKI) is a commonly encountered clinical syndrome. Although it often complicates community acquired illness, it is more common in hospitalized patients, particularly those who are critically ill or who have undergone major surgery. Approximately 20% of hospitalized adult patients develop an AKI during their hospital care, and this rises to nearly 60% in the critically ill, depending on the population being considered. In general, AKI is more common in older adults, in those with preexisting chronic kidney disease and in those with known risk factors for AKI (including diabetes and hypertension). The development of AKI is associated with an increase in both mortality and morbidity, including the development of post-AKI chronic kidney disease. Currently, AKI is defined by a rise in serum creatinine from either a known or derived baseline value and/or oliguria or anuria. However, clinicians may fail to recognize the initial development of AKI because of a delay in the rise of serum creatinine or because of inaccurate urine output monitoring. This, in turn, delays any putative measures to treat AKI or to limit its degree. Consequently, efforts have focused on new biomarkers associated with AKI that may allow early recognition of this syndrome with the intent that this will translate into improved patient outcomes. Here we outline current biomarkers associated with AKI and explore their potential in aiding diagnosis, understanding the pathophysiology and directing therapy.

急性肾损伤(AKI)是一种常见的临床综合征。虽然它经常与社区获得性疾病并发,但在住院患者中更为常见,尤其是重症患者或接受过大手术的患者。约有 20% 的住院成人患者在住院治疗期间发生了 AKI,而在重症患者中,这一比例上升到近 60%,这取决于所考虑的人群。一般来说,AKI 更常见于老年人、原有慢性肾脏疾病的患者以及有已知 AKI 危险因素(包括糖尿病和高血压)的患者。发生 AKI 会增加死亡率和发病率,包括发生 AKI 后慢性肾病。目前,AKI 的定义是血清肌酐从已知或推导的基线值升高和/或少尿或无尿。然而,由于血清肌酐上升延迟或尿量监测不准确,临床医生可能无法识别 AKI 的最初发展。这反过来又会延误任何治疗 AKI 或限制其程度的措施。因此,人们开始关注与 AKI 相关的新生物标志物,以便及早识别这种综合征,从而改善患者的预后。在此,我们概述了目前与 AKI 相关的生物标志物,并探讨了它们在帮助诊断、了解病理生理学和指导治疗方面的潜力。
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引用次数: 0
Pathologist workload, burnout, and wellness: connecting the dots 病理学家的工作量、职业倦怠和健康:联系起来
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-18 DOI: 10.1080/10408363.2023.2285284
Ziyad Khatab, Kattreen Hanna, Andrew Rofaeil, Catherine Wang, Raymond Maung, George M. Yousef
No standard tool to measure pathologist workload currently exists. An accurate measure of workload is needed for determining the number of pathologists to be hired, distributing the workload fairly...
目前还没有衡量病理学家工作量的标准工具。需要对工作量进行精确测量,以确定需要聘用的病理学家人数,公平分配工作量......
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引用次数: 0
Hereditary breast and ovarian cancer: from genes to molecular targeted therapies. 遗传性乳腺癌和卵巢癌:从基因到分子靶向治疗。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-07-16 DOI: 10.1080/10408363.2023.2234488
Giovanni Ponti, Carmine De Angelis, Rosamaria Ponti, Linda Pongetti, Lorena Losi, Alberto Sticchi, Aldo Tomasi, Tomris Ozben

Hereditary familial tumors constitute 10-15% of all malignancies and present opportunities for the identification of therapeutic approaches against specific germline genetic defects. Hereditary breast and ovarian cancer (HBOC) syndrome, which is linked to the pathogenic mutations of the breast cancer 1 (BRCA1) and breast cancer 2 (BRCA2) genes, is an important research model for personalized therapeutic approaches for specific germline mutations. HBOC is characterized by multiple cases of breast and ovarian carcinoma in association with other tumors (prostate, pancreas and stomach carcinoma) within the same family branch, a young age of onset (<36 years), bilaterality and an autosomal dominant pattern of inheritance. Counseling, evaluation of the clinical criteria for the diagnosis of HBOC, and the performance of genetic testing allow for the identification of subjects with BRCA1/2 mutations and provide crucial information for clinical and therapeutic management. The identification of a BRCA gene mutation has therapeutic implications for women with metastatic and non-metastatic breast cancer. In the therapeutic setting of BRCA+ breast cancer, treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, which keep cancer cells from repairing their damaged DNA and cause cell death, is remarkable. This review summarizes the evidence demonstrating the value of BRCA1/2 status as a diagnostic and prognostic tool and as a predictive biomarker in the personalized approach to hereditary BRCA + cancers.

遗传性家族性肿瘤占所有恶性肿瘤的10-15%,为确定针对特定种系遗传缺陷的治疗方法提供了机会。遗传性乳腺癌和卵巢癌(HBOC)综合征与乳腺癌1 (BRCA1)和乳腺癌2 (BRCA2)基因的致病性突变有关,是针对特定种系突变的个性化治疗方法的重要研究模型。HBOC的特点是在同一家族分支中,多例乳腺癌和卵巢癌与其他肿瘤(前列腺癌、胰腺癌和胃癌)相关,发病年龄小(BRCA1/2突变),为临床和治疗管理提供了重要信息。BRCA基因突变的鉴定对女性转移性和非转移性乳腺癌具有治疗意义。在BRCA+乳腺癌的治疗环境中,聚(adp -核糖)聚合酶(PARP)抑制剂的治疗是显著的,它可以阻止癌细胞修复其受损的DNA并导致细胞死亡。这篇综述总结了证明BRCA1/2状态作为诊断和预后工具以及作为遗传性BRCA +癌症个性化方法的预测性生物标志物的价值的证据。
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引用次数: 0
It's in the blood: a review of the hematological system in SARS-CoV-2-associated COVID-19. 它存在于血液中:对sars - cov -2相关COVID-19的血液系统的回顾。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-07-13 DOI: 10.1080/10408363.2023.2232010
James V Harte, Caroline Coleman-Vaughan, Maeve P Crowley, Vitaliy Mykytiv

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an unprecedented global healthcare crisis. While SARS-CoV-2-associated COVID-19 affects primarily the respiratory system, patients with COVID-19 frequently develop extrapulmonary manifestations. Notably, changes in the hematological system, including lymphocytopenia, neutrophilia and significant abnormalities of hemostatic markers, were observed early in the pandemic. Hematological manifestations have since been recognized as important parameters in the pathophysiology of SARS-CoV-2 and in the management of patients with COVID-19. In this narrative review, we summarize the state-of-the-art regarding the hematological and hemostatic abnormalities observed in patients with SARS-CoV-2-associated COVID-19, as well as the current understanding of the hematological system in the pathophysiology of acute and chronic SARS-CoV-2-associated COVID-19.

严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)的出现导致了前所未有的全球卫生保健危机。虽然sars - cov -2相关的COVID-19主要影响呼吸系统,但COVID-19患者经常出现肺外表现。值得注意的是,在大流行早期就观察到血液系统的变化,包括淋巴细胞减少症、中性粒细胞增多症和止血标志物的显著异常。此后,血液学表现被认为是SARS-CoV-2病理生理和COVID-19患者管理的重要参数。在这篇叙述性综述中,我们总结了在sars - cov -2相关的COVID-19患者中观察到的血液学和止血异常的最新进展,以及目前对急性和慢性sars - cov -2相关的COVID-19病理生理学中血液系统的理解。
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引用次数: 0
Laboratory investigation and diagnosis of thrombotic thrombocytopenic purpura. 血栓性血小板减少性紫癜的实验室调查和诊断。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-07-14 DOI: 10.1080/10408363.2023.2232039
Konstantinos Dimopoulos, Armando Tripodi, Jens P Goetze

Thrombotic thrombocytopenic purpura (TTP) is a rare and potentially fatal disease for which rapid diagnosis is crucial for patient outcomes. Deficient activity (< 10%) of the liver enzyme, ADAMTS13, is the pathophysiological hallmark of TTP, and measurement of the enzyme activity can establish the diagnosis of TTP with high accuracy. Thus, along with the clinical history, appropriate laboratory assessment of a suspected case of TTP is essential for diagnosis and treatment. Here, we present a review of the available laboratory tests that can assist clinicians in establishing the diagnosis of TTP, with special focus on ADAMTS13 assays, including the measurement of the antigen and activity, and detection of autoantibodies to ADAMTS13.

血栓性血小板减少性紫癜(TTP)是一种罕见且潜在致命的疾病,快速诊断对患者预后至关重要。肝酶ADAMTS13活性不足(< 10%)是TTP的病理生理标志,测定酶活性可以建立TTP的高精度诊断。因此,结合临床病史,对疑似TTP病例进行适当的实验室评估对于诊断和治疗至关重要。在这里,我们回顾了现有的实验室测试,可以帮助临床医生建立TTP的诊断,特别关注ADAMTS13的测定,包括抗原和活性的测量,以及对ADAMTS13的自身抗体的检测。
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引用次数: 0
Pre-analytical conditions and implementation of quality control steps in liquid biopsy analysis. 液体活检分析前分析条件及质量控制步骤的实施。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-07-30 DOI: 10.1080/10408363.2023.2230290
Aliki Ntzifa, Evi Lianidou

Over the last decade, great advancements have been made in the field of liquid biopsy through extensive research and the development of new technologies that facilitate the use of liquid biopsy for cancer patients. This is shown by the numerous liquid biopsy tests that gained clearance by the US Food and Drug Administration (FDA) in recent years. Liquid biopsy has significantly altered cancer treatment by providing clinicians with powerful and immediate information about therapeutic decisions. However, the clinical integration of liquid biopsy is still challenging and there are many critical factors to consider prior to its implementation into routine clinical practice. Lack of standardization due to technical challenges and the definition of the clinical utility of specific assays further complicates the establishment of Standard Operating Procedures (SOPs) in liquid biopsy. Harmonization of laboratories to established guidelines is of major importance to overcome inter-lab variabilities observed. Quality control assessment in diagnostic laboratories that offer liquid biopsy testing will ensure that clinicians can base their therapeutic decisions on robust results. The regular participation of laboratories in external quality assessment schemes for liquid biopsy testing aims to promptly pinpoint deficiencies and efficiently educate laboratories to improve their quality of services. Accreditation of liquid biopsy diagnostic laboratories based on the ISO15189 standard in Europe or by CLIA/CAP accreditation procedures in the US is the best way to achieve the adaptation of liquid biopsy into the clinical setting by assuring reliable results for the clinicians and their cancer patients. Nowadays, various organizations from academia, industry, and regulatory agencies collaborate to set a framework that will include all procedures from the pre-analytical phase and the analytical process to the final interpretation of results. In this review, we underline several challenges in the analysis of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) concerning standardization of protocols, quality control assessment, harmonization of laboratories, and compliance to specific guidelines that need to be thoroughly considered before liquid biopsy enters the clinic.

在过去的十年中,通过广泛的研究和新技术的开发,液体活检领域取得了巨大的进步,这些技术促进了液体活检在癌症患者中的应用。近年来获得美国食品和药物管理局(FDA)批准的大量液体活检试验表明了这一点。液体活检通过为临床医生提供有关治疗决策的强大和即时信息,显着改变了癌症治疗。然而,液体活检的临床整合仍然具有挑战性,在将其应用于常规临床实践之前,需要考虑许多关键因素。由于技术挑战和特定检测的临床应用定义而缺乏标准化,进一步使液体活检标准操作程序(sop)的建立复杂化。使实验室按照既定的指导方针进行协调对于克服实验室间观察到的差异具有重要意义。提供液体活检检测的诊断实验室的质量控制评估将确保临床医生能够根据可靠的结果做出治疗决定。化验室定期参与液体活检检测的外部质量评估计划,目的是及时找出不足之处,并有效地教育化验室提高服务质量。根据欧洲的ISO15189标准或美国的CLIA/CAP认证程序对液体活检诊断实验室进行认证,是通过确保临床医生及其癌症患者的可靠结果,实现液体活检适应临床环境的最佳途径。如今,来自学术界、工业界和监管机构的各种组织合作建立了一个框架,该框架将包括从分析前阶段和分析过程到结果的最终解释的所有程序。在这篇综述中,我们强调了循环肿瘤DNA (ctDNA)和循环肿瘤细胞(CTCs)分析中的几个挑战,包括方案的标准化、质量控制评估、实验室的协调以及在液体活检进入临床之前需要彻底考虑的特定指南的依从性。
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引用次数: 0
Lipoprotein(a): a genetically determined risk factor for Cardiovascular disease. 脂蛋白(a):基因决定的心血管疾病危险因素。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-12-01 Epub Date: 2023-07-14 DOI: 10.1080/10408363.2023.2229915
Santica M Marcovina

Lipoprotein(a) is a complex lipoprotein with unique characteristics distinguishing it from all the other apolipoprotein B-containing lipoprotein particles. Its lipid composition and the presence of a single molecule of apolipoprotein B per particle, render lipoprotein(a) similar to low-density lipoproteins. However, the presence of a unique, carbohydrate-rich protein termed apolipoprotein(a), linked by a covalent bond to apolipoprotein B imparts unique characteristics to lipoprotein(a) distinguishing it from all the other lipoproteins. Apolipoprotein(a) is highly polymorphic in size ranging in molecular weight from <300 KDa to >800 kDa. Both the size polymorphism and the concentration of lipoprotein(a) in plasma are genetically determined and unlike other lipoproteins, plasma concentration is minimally impacted by lifestyle modifications or lipid-lowering drugs. Many studies involving hundreds of thousands of individuals have provided strong evidence that elevated lipoprotein(a) is genetically determined and a causal risk factor for atherosclerotic cardiovascular disease. The concentration attained in adulthood is already present in children at around 5 years of age and therefore, those with elevated lipoprotein(a) are prematurely exposed to a high risk of cardiovascular disease. Despite the large number of guidelines and consensus statements on the management of lipoprotein(a) in atherosclerotic cardiovascular disease published in the last decade, lipoprotein(a) is still seldom measured in clinical settings. In this review, we provide an overview of the most important features that characterize lipoprotein(a), its role in cardiovascular disease, and the importance of adding the measurement of lipoprotein(a) for screening adults and youths to identify those at increased risk of atherosclerotic cardiovascular disease due to their elevated plasma concentration of lipoprotein(a).

脂蛋白(a)是一种复杂的脂蛋白,具有独特的特征,区别于所有其他载脂蛋白b -含脂蛋白颗粒。它的脂质组成和每颗粒单个载脂蛋白B分子的存在,使脂蛋白(a)类似于低密度脂蛋白。然而,存在一种独特的富含碳水化合物的蛋白质,称为载脂蛋白(a),通过共价键与载脂蛋白B相连,赋予脂蛋白(a)独特的特征,使其区别于所有其他脂蛋白。载脂蛋白(a)在大小上具有高度多态性,分子量从800 kDa不等。血浆中脂蛋白(a)的大小多态性和浓度都是由基因决定的,与其他脂蛋白不同,血浆浓度受生活方式改变或降脂药物的影响最小。许多涉及数十万人的研究提供了强有力的证据,表明脂蛋白(a)升高是由遗传决定的,是动脉粥样硬化性心血管疾病的因果危险因素。成年期达到的浓度在5岁左右的儿童中已经存在,因此,脂蛋白(a)升高的儿童过早暴露于心血管疾病的高风险中。尽管在过去十年中发表了大量关于动脉粥样硬化性心血管疾病中脂蛋白(a)管理的指南和共识声明,但在临床环境中脂蛋白(a)仍然很少被测量。在这篇综述中,我们概述了表征脂蛋白(a)的最重要特征,它在心血管疾病中的作用,以及增加脂蛋白(a)测量的重要性,以筛选成人和青少年,以识别由于血浆脂蛋白浓度升高而增加动脉粥样硬化性心血管疾病风险(a)。
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引用次数: 0
Advances in internal quality control. 内部质量控制的进展。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-05-17 DOI: 10.1080/10408363.2023.2209174
Tze Ping Loh, Chun Yee Lim, Sunil Kumar Sethi, Rui Zhen Tan, Corey Markus

Quality control practices in the modern laboratory are the result of significant advances over the many years of the profession. Major advance in conventional internal quality control has undergone a philosophical shift from a focus solely on the statistical assessment of the probability of error identification to more recent thinking on the capability of the measurement procedure (e.g. sigma metrics), and most recently, the risk of harm to the patient (the probability of patient results being affected by an error or the number of patient results with unacceptable analytical quality). Nonetheless, conventional internal quality control strategies still face significant limitations, such as the lack of (proven) commutability of the material with patient samples, the frequency of episodic testing, and the impact of operational and financial costs, that cannot be overcome by statistical advances. In contrast, patient-based quality control has seen significant developments including algorithms that improve the detection of specific errors, parameter optimization approaches, systematic validation protocols, and advanced algorithms that require very low numbers of patient results while retaining sensitive error detection. Patient-based quality control will continue to improve with the development of new algorithms that reduce biological noise and improve analytical error detection. Patient-based quality control provides continuous and commutable information about the measurement procedure that cannot be easily replicated by conventional internal quality control. Most importantly, the use of patient-based quality control helps laboratories to improve their appreciation of the clinical impact of the laboratory results produced, bringing them closer to the patients.Laboratories are encouraged to implement patient-based quality control processes to overcome the limitations of conventional internal quality control practices. Regulatory changes to recognize the capability of patient-based quality approaches, as well as laboratory informatics advances, are required for this tool to be adopted more widely.

现代实验室的质量控制实践是该行业多年来取得重大进步的结果。传统内部质量控制的重大进展经历了哲学上的转变,从仅仅关注错误识别概率的统计评估,到最近对测量程序能力的思考(例如西格玛度量),最近,对患者造成伤害的风险(患者结果受到错误影响的概率或具有不可接受的分析质量的患者结果的数量)。尽管如此,传统的内部质量控制策略仍然面临着重大的局限性,例如材料与患者样本缺乏(已证明的)可转换性、偶发性测试的频率以及运营和财务成本的影响,这些都是统计进步无法克服的。相比之下,基于患者的质量控制已经取得了重大进展,包括改进特定错误检测的算法、参数优化方法、系统验证协议,以及在保持敏感错误检测的同时需要非常低数量的患者结果的高级算法。随着减少生物噪声和改进分析误差检测的新算法的开发,基于患者的质量控制将继续改进。基于患者的质量控制提供了传统内部质量控制无法轻易复制的关于测量过程的连续且可交换的信息。最重要的是,使用基于患者的质量控制有助于实验室提高对实验室结果的临床影响的认识,使他们更接近患者。鼓励实验室实施基于患者的质量控制流程,以克服传统内部质量控制实践的局限性。为了更广泛地采用这一工具,需要进行监管改革,以认识到基于患者的质量方法的能力,以及实验室信息学的进步。
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引用次数: 1
Advances and challenges in the measurement of 1,25-dihydroxyvitamin D: a comprehensive review. 1,25-二羟基维生素D测定的进展和挑战:综述。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-06-05 DOI: 10.1080/10408363.2023.2212765
Zhicheng Jin, Roger L Bertholf, Xin Yi

Vitamin D has received significant attention from clinical societies, researchers, and the general population in recent years. While 25-hydroxyvitamin D (25(OH)D) is the most commonly-used biomarker of vitamin D status, 1α,25-dihydroxyvitamin D (1,25(OH)2D), its bioactive form, plays a critical role in regulating calcium and phosphorus homeostasis and is also involved in the immune system and cellular differentiation. Consequently, accurate measurements of 1,25(OH)2D can aid in the differential diagnosis of calcium-related disorders such as hypocalcemia in vitamin D-dependent rickets and hypercalcemia due to inappropriate increase of serum 1,25(OH)2D in granulomatous diseases. However, due to its lipophilicity and very low circulating concentration, the measurement of 1,25(OH)2D is particularly challenging. Over the past several decades, numerous efforts have been made to develop sensitive, specific, and practical laboratory methods for measuring 1,25(OH)2D. Methods using radioreceptor assay, radioimmunoassay, enzyme immunoassay, enzyme-linked immunosorbent assay, automated chemiluminescent immunoassay, and liquid chromatography-tandem mass spectrometry have been described. Each of these methods has unique advantages and limitations, and some are no longer used. Despite the sophisticated methods in use today, substantial variations between methods still exist. A concerted effort toward standardization of 1,25(OH)2D measurement is needed to ensure accurate and reliable results across laboratories and methods.

近年来,维生素D受到了临床学会、研究人员和普通人群的极大关注。虽然25-羟基维生素D(25(OH)D)是维生素D状态最常用的生物标志物,但其生物活性形式1α,25-二羟维生素D(1,25(OH)2D)在调节钙和磷稳态方面发挥着关键作用,还参与免疫系统和细胞分化。因此,1,25(OH)2D的准确测量有助于钙相关疾病的鉴别诊断,如维生素D依赖性软骨病的低钙血症和肉芽肿性疾病中由于血清1,25。然而,由于其亲脂性和非常低的循环浓度,1,25(OH)2D的测量特别具有挑战性。在过去的几十年里,已经做出了许多努力来开发用于测量1,25(OH)2D的灵敏、特异和实用的实验室方法。介绍了放射受体测定法、放射免疫测定法、酶联免疫吸附测定法、自动化学发光免疫测定法和液相色谱-串联质谱法。每种方法都有其独特的优点和局限性,有些方法已不再使用。尽管目前使用的方法很复杂,但方法之间仍然存在很大的差异。需要共同努力实现1,25(OH)2D测量的标准化,以确保实验室和方法的结果准确可靠。
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引用次数: 0
Developing an SI-traceable Lp(a) reference measurement system: a pilgrimage to selective and accurate apo(a) quantification. 开发一种SI可追踪的Lp(a)参考测量系统:对选择性和准确的apo(a)定量的朝圣之旅。
IF 1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-04-27 DOI: 10.1080/10408363.2023.2199353
Nina M Diederiks, Yuri E M van der Burgt, L Renee Ruhaak, Christa M Cobbaert

In the past decade a remarkable rebirth of serum/plasma lipoprotein(a) (Lp(a)) as an independent risk factor of cardiovascular disease (CVD) occurred. Updated evidence for a causal continuous association in different ethnic groups between Lp(a) concentrations and cardiovascular outcomes has been published in the latest European Atherosclerosis Society (EAS) Lp(a) consensus statement. Interest in measuring Lp(a) at least once in a person's lifetime moreover originates from the development of promising new Lp(a) lowering drugs. Accurate and clinically effective Lp(a) tests are of key importance for the timely detection of high-risk individuals and for future evaluation of the therapeutic effects of Lp(a) lowering medication. To this end, it is necessary to improve the performance and standardization of existing Lp(a) tests, as is also noted in the Lp(a) consensus statement. Consequently, a state-of-the-art internationally endorsed reference measurement system (RMS) must be in place that allows for performance evaluation of Lp(a) field tests in order to certify their validity and accuracy. An ELISA-based RMS from Northwest Lipid Research Laboratory (University of Washington, Seattle, USA) has been available since the 1990s. A next-generation apo(a)/Lp(a) RMS is now being developed by a working group from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The envisioned apo(a) RMS is based on the direct measurement of selected proteotypic fragments generated after proteolytic digestion using quantitative protein mass spectrometry (MS). The choice for an MS-based RMS enables selective measurement of the proteotypic peptides and is by design apo(a) isoform insensitive. Clearly, the equimolar conversion of apo(a) into the surrogate peptide measurands is required to obtain accurate Lp(a) results. The completeness of proteolysis under reaction conditions from the candidate reference measurement procedure (RMP) has been demonstrated for the quantifying apo(a) peptides. Currently, the candidate apo(a) RMP is endorsed by the IFCC and recommendations for suitable secondary reference materials have been made in a recent commutability study paper. Ongoing efforts toward a complete apo(a) RMS that is listed by the Joint Committee on Traceability in Laboratory Medicine (JCTLM) are focused on the peptide-based calibration and the establishment of a network of calibration laboratories running the apo(a) RMS in a harmonized way. Once completed, it will be the holy grail for evaluation and certification of Lp(a) field methods.

在过去的十年中,血清/血浆脂蛋白(a)(Lp(a))作为心血管疾病(CVD)的独立危险因素发生了显著的再生。最新的欧洲动脉粥样硬化学会(EAS)Lp(a)共识声明中发表了Lp(a)浓度与心血管结果之间在不同种族中存在因果持续关联的最新证据。此外,人们对在一个人的一生中至少测量一次Lp(a)的兴趣源于有前景的新型Lp(b)降低药物的开发。准确和临床有效的Lp(a)测试对于及时检测高危个体和未来评估降低Lp(b)药物的治疗效果至关重要。为此,有必要提高现有Lp(a)测试的性能和标准化,正如Lp(a)共识声明中所指出的那样。因此,必须建立一个最先进的国际认可的参考测量系统(RMS),以便对Lp(a)现场测试进行性能评估,以证明其有效性和准确性。自20世纪90年代以来,西北脂质研究实验室(美国西雅图华盛顿大学)提供了一种基于ELISA的RMS。国际临床化学与实验医学联合会(IFCC)的一个工作组正在开发下一代apo(A)/Lp(A)RMS。设想的apo(a)RMS是基于使用定量蛋白质质谱法(MS)对蛋白水解消化后产生的选定蛋白型片段的直接测量。选择基于MS的RMS能够选择性地测量蛋白型肽,并且通过设计对apo(a)异构体不敏感。显然,为了获得准确的Lp(a)结果,需要将apo(a)等摩尔转化为替代肽被测物。在候选参考测量程序(RMP)的反应条件下,蛋白水解的完整性已被证明用于定量apo(a)肽。目前,候选apo(a)RMP得到了IFCC的认可,并在最近的可交换性研究论文中提出了合适的二次参考材料的建议。实验室医学可追溯性联合委员会(JCTLM)列出的完整apo(a)RMS的持续努力集中在基于肽的校准和建立以协调方式运行apo(b)RMS的校准实验室网络上。一旦完成,它将成为评估和认证Lp(a)领域方法的圣杯。
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引用次数: 1
期刊
Critical reviews in clinical laboratory sciences
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