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Analytical interference on measurement of immunoglobulins in monoclonal gammopathy. 单克隆抗体病中免疫球蛋白测量的分析干扰。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-16 DOI: 10.1080/00365513.2024.2429081
Anders Oest, Maja Boe, Marianne Christina Harbo Mosgaard, Jeanette Elgaard, Simon Lykkeboe, Paw Jensen, Henrik Gregersen, Stine Linding Andersen, Aase Handberg, Stine Krogh Venø

Monoclonal gammopathy has been reported to interfere with several laboratory measurement results. We investigated potential interference in monoclonal gammopathy on immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) concentrations using three different routine chemistry instruments: Alinity (Abbott Laboratories), Cobas 8000 (Roche Diagnostics) and Optilite (Binding Site) at the Department of Clinical Biochemistry, Aalborg University Hospital, Denmark. Blood samples collected from 216 patients with known monoclonal gammopathy were analyzed on Alinity, Cobas and Optilite. Diagnoses were ascertained from clinical records. Scatter plots with Passing-Bablok regression were used to investigate associations between concentrations of IgA, IgG and IgM measured with each of the different instruments. Furthermore, comparison of IgG analyses on Alinity, Optilite and Cobas according to monoclonal IgM concentration was explored with Bland-Altman plots. A total of 81 patients were identified with IgM type monoclonal gammopathy and 8 of these patients (10%) had analytical interference as reflected by more than 25% decrease in the level of IgG measured on Alinity as compared to Optilite and Cobas. All blood samples with interference on IgG measurement using Alinity were from patients with lymphoplasmacytic lymphoma/Waldenströms macroglobulinemia and all of them had monoclonal IgM concentrations above 10 g/L. This study identified a source of interference from IgM monoclonal gammopathy on IgG measurement performed using Alinity. The interferences caused falsely low results of IgG which is important to recognize to ensure proper patient management.

据报道,单克隆抗体可干扰多种实验室测量结果。我们使用三种不同的常规化学仪器调查了单克隆抗体对免疫球蛋白 A (IgA)、免疫球蛋白 G (IgG) 和免疫球蛋白 M (IgM) 浓度的潜在干扰:丹麦奥尔堡大学医院临床生物化学系使用三种不同的常规化学仪器:Alinity(雅培实验室)、Cobas 8000(罗氏诊断公司)和 Optilite(Binding Site)。从 216 名已知患有单克隆丙种球蛋白病的患者身上采集的血液样本在 Alinity、Cobas 和 Optilite 上进行了分析。诊断结果来自临床记录。使用 Passing-Bablok 回归法绘制散点图,研究不同仪器测量的 IgA、IgG 和 IgM 浓度之间的关联。此外,还利用Bland-Altman图对Alinity、Optilite和Cobas上的IgG分析结果与单克隆IgM浓度进行了比较。共有 81 名患者被确诊为 IgM 型单克隆丙种球蛋白病,其中有 8 名患者(10%)受到了分析干扰,表现为 Alinity 与 Optilite 和 Cobas 相比所测得的 IgG 水平下降了 25% 以上。使用 Alinity 检测 IgG 时受到干扰的所有血液样本均来自淋巴浆细胞性淋巴瘤/瓦尔登斯特罗姆巨球蛋白血症患者,他们的单克隆 IgM 浓度均超过 10 克/升。这项研究确定了 IgM 单克隆性腺病对使用 Alinity 进行的 IgG 测量的干扰源。这种干扰会导致 IgG 检测结果偏低,因此必须认识到这一点,以确保对患者进行正确的管理。
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引用次数: 0
Reference intervals for 23 common biochemical parameters during pregnancy and the first six postpartum months. 孕期和产后头 6 个月 23 项常见生化指标的参考区间。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-16 DOI: 10.1080/00365513.2024.2406006
Paul Kjetel Soldal Lillemoen, Kristin Holstad, Anne-Lise Bjørke-Monsen

The concentration of many biochemical parameters changes significantly during pregnancy and the postpartum period, causing a need for specific reference values for biochemical parameters in these life periods. We have collected blood samples in pregnancy week 18, 28 and 36 and six weeks, four months and six months postpartum from 139 healthy women. Blood samples from 59 healthy never-pregnant women were included as controls. Serum samples were analyzed for 23 common biochemical parameters and reference intervals for pregnancy and postpartum periods were computed with the non-parametric method in accordance with recommendations from IFCC and CLSI. The dynamics of different biochemical parameters during and after pregnancy vary considerably between parameters. Some analytes like serum amylase and HDL cholesterol do not differ from never-pregnant values. Of the 23 parameters, serum alkaline phosphatase, chloride, gamma-glutamyl transferase and sodium and urea which were still significantly changed at six months postpartum compared to never-pregnant women. The physiological changes related to pregnancy and lactation have profound effects on biochemical parameters, denoting the use of specific reference intervals for both pregnancy and the postpartum period.

许多生化指标的浓度在孕期和产后会发生显著变化,因此需要为这些生命时期的生化指标提供特定的参考值。我们采集了 139 名健康妇女在妊娠第 18、28 和 36 周以及产后 6 周、4 个月和 6 个月的血液样本。59 名从未怀孕过的健康妇女的血液样本作为对照。根据 IFCC 和 CLSI 的建议,对血清样本进行了 23 项常见生化参数的分析,并采用非参数法计算了孕期和产后的参考区间。不同生化指标在孕期和产后的动态变化差异很大。一些分析指标,如血清淀粉酶和高密度脂蛋白胆固醇,与从未怀孕时的数值没有差异。在 23 项参数中,血清碱性磷酸酶、氯化物、γ-谷氨酰转移酶、钠和尿素在产后 6 个月与未孕妇女相比仍有显著变化。与妊娠和哺乳有关的生理变化对生化指标有深远的影响,因此需要对妊娠期和产后使用特定的参考区间。
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引用次数: 0
FlowDiff: a simple, flow cytometry-based approach for performing a leukocyte differential count. FlowDiff:一种基于流式细胞仪进行白细胞差分计数的简单方法。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-16 DOI: 10.1080/00365513.2024.2426140
Konstantinos Dimopoulos, Delphine Bonneau, Jens Hannibal

To overcome the challenges of a manual leukocyte differential count, we have developed FlowDiff, an 8-colour, single tube flow cytometry panel, and investigated whether it could potentially replace the manual differential in our laboratory. The instrument was set up in accordance with the EuroFlow settings, and the protocol comprised a stain-lyse no wash process, taking approximately 30 min of working time, without the addition of a toxic lysis reagent. We found a very good correlation for all leukocyte populations between FlowDiff and the Sysmex XN analyzer in 80 normal, non-flagged samples. In addition, FlowDiff showed a very good correlation with manual differential in 168 abnormal samples, as well as a high diagnostic accuracy. FlowDiff correctly identified all samples with acute leukemia (N = 13) and differentiated all B-lymphomas (N = 49) in samples with lymphocytosis. Moreover, FlowDiff detected an additional five samples with B-lymphocytosis without any prior hematological malignancy, which turned out to be a B-lymphoma. Our data suggest that FlowDiff, our 8-colour flow cytometry-based differential, is comparable to, and can successfully substitute the manual differential.

为了克服人工白细胞鉴别计数的难题,我们开发了一种 8 色单管流式细胞计数板 FlowDiff,并研究了它是否有可能取代实验室中的人工鉴别计数。该仪器按照 EuroFlow 的设置进行设置,操作规程包括染色-溶解-免清洗过程,工作时间约为 30 分钟,不添加有毒的裂解试剂。我们发现,在 80 份正常的非滞后样本中,FlowDiff 和 Sysmex XN 分析仪对所有白细胞群的检测结果都有很好的相关性。此外,在 168 份异常样本中,FlowDiff 与人工鉴别的相关性非常好,诊断准确率也很高。FlowDiff 能正确识别所有急性白血病样本(13 例),并能区分淋巴细胞增多样本中的所有 B 淋巴瘤(49 例)。此外,FlowDiff 还检测出另外 5 份 B 淋巴细胞增多的样本,这些样本之前未患任何血液恶性肿瘤,但后来发现是 B 淋巴瘤。我们的数据表明,FlowDiff--我们基于 8 色流式细胞仪的鉴别方法--可与人工鉴别方法相媲美,并能成功替代人工鉴别方法。
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引用次数: 0
Prevalence of monoclonal proteins in patients with isolated hypogammaglobulinemia on serum protein electrophoresis. 血清蛋白电泳中孤立性低丙种球蛋白血症患者的单克隆蛋白患病率。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-14 DOI: 10.1080/00365513.2024.2429090
Joris Godelaine, Toon Schiemsky, Ben Persy, Joris Penders

Isolated hypogammaglobulinemia (IH) is an electrophoretic pattern that can be encountered on serum protein electrophoresis (SPEP) and is defined as a decreased but morphologically normal γ-globulin fraction with normal α- and β-globulin fractions. SPEP is mainly used to detect monoclonal proteins which are usually observed as additional peaks in the electropherogram. However, they may also be more discretely present in a significant proportion of patients presenting with IH. Therefore, we aimed to evaluate i) via both retrospective and prospective analysis to what extent paraproteins as identified by immunofixation are present in patients demonstrating IH on SPEP and ii) whether other parameters may predict their presence in IH-patients. For this purpose, we first reviewed historic SPEP- and immunofixation results in our tertiary hospital and determined paraprotein prevalence in this retrospective cohort. This analysis showed immunofixation was requested in only 519/3938 (13.2%) historic IH-results with 52/519 (10%) patients demonstrating paraproteins. Next, various laboratory parameters were compared between paraprotein-positive and -negative patients and subjected to logistic regression models but regrettably, no parameter could be retained as promising predictor of paraproteins. Lastly, to confirm paraprotein prevalence seen in the historical query, we conducted a six-month prospective analysis during which immunofixation was requested more frequently in IH-cases during routine diagnostics and which showed paraproteins to be present in 20/83 (24.1%) of IH-patients. Hence, as up to 24% of patients with IH may harbour paraproteins, one should consider performing follow-up analyses (e.g. immunofixation, urine electrophoresis and/or free light chain analysis) for all IH-cases identified via SPEP.

孤立性低丙种球蛋白血症(IH)是血清蛋白电泳(SPEP)中可能出现的一种电泳模式,其定义为γ-球蛋白部分减少但形态正常,α-和β-球蛋白部分正常。SPEP 主要用于检测单克隆蛋白,这些蛋白通常在电泳图中以附加峰的形式出现。然而,在相当一部分 IH 患者中,它们也可能更离散地存在。因此,我们的目的是通过回顾性和前瞻性分析,评估 i) 通过免疫固定法鉴定出的副蛋白在 SPEP 显示 IH 的患者中的存在程度;ii) 其他参数是否可以预测副蛋白在 IH 患者中的存在。为此,我们首先回顾了我们三级医院的 SPEP 和免疫固定的历史结果,并确定了这一回顾性队列中副蛋白的流行率。分析结果显示,仅有 519/3938 例(13.2%)历史 IH 结果需要进行免疫固定,其中 52/519 例(10%)患者显示出副蛋白。接下来,对副蛋白阳性和阴性患者的各种实验室参数进行了比较,并建立了逻辑回归模型,但遗憾的是,没有任何参数可作为副蛋白的预测指标。最后,为了证实历史查询中发现的副蛋白流行率,我们进行了为期六个月的前瞻性分析,在此期间,IH 病例在常规诊断中更频繁地要求进行免疫固定,结果显示,20/83(24.1%)的 IH 患者体内存在副蛋白。因此,由于高达24%的IH患者可能携带副蛋白,因此应考虑对所有通过SPEP发现的IH病例进行后续分析(如免疫固定、尿电泳和/或游离轻链分析)。
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引用次数: 0
Challenges of preanalytical variables in erythrocyte sedimentation rate: a CUBE 30 touch evaluation. 红细胞沉降率分析前变量的挑战:CUBE 30 touch 评估。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-10 DOI: 10.1080/00365513.2024.2422397
Flaminia Tomassetti, Roberto Guerranti, Roberto Leoncini, Carolina Pieroni, Daniela Diamanti, Michele Cirianni, Caterina Silvestrini, Lucrezia Galasso, Martina Pelagalli, Eleonora Nicolai, Alfredo Giovannelli, Massimo Pieri, Sergio Bernardini

The erythrocyte sedimentation rate (ESR) is a widely used diagnostic test, influenced by all physiological and pathological conditions that can bias blood rheology by interfering factors. This study aimed to evaluate the performance of the CUBE 30 touch ESR analyzer in samples with preanalytical variables, as lipemia, hemolysis, and icterus or in presence of fibrinogen., Moreover we focused to define the maximum time limits to ensure a reliable ESR measure. Accuracy, intra-run and inter-run precision, and stability studies were performed. Moreover, hemolytic, jaundiced, lipemic samples and fibrinogen sensitivity were analyzed for interference study. Statistical analyses were performed. CUBE 30 touch and Westergren method comparison showed no statistical differences (Spearman Coefficient, R2=0,95). In the intra-run precision, the CV% mean obtained on samples with normal ESR level was 8,9%; with middle ESR level was 5,9% and with high ESR level the CV% was 4,3%. Inter-run precision test showed CV% of for single samples and overall samples in the range (12,3% for normal level and 4,8% for abnormal level). The samples stored at 4 °C showed good stability up to 3 h from collecting time. ESR samples showing lipemia, hemolysis or jaundice showed good correlations with the gold standard method (R2 0,901, 0,940, 0,911; p < 0,0001), however, Westergren tests were more sensitive than CUBE 30 touch to fibrinogen additions. The high comparability with the Westergren method, both in normal and interfering samples, and the good precision, support the usefulness of CUBE 30 touch in the clinical routine laboratory.

红细胞沉降率(ESR)是一种广泛使用的诊断测试,受各种生理和病理条件的影响,干扰因素会使血液流变学产生偏差。本研究旨在评估 CUBE 30 touch 血沉分析仪在分析前变量(如脂血、溶血和黄疸)或存在纤维蛋白原的样本中的性能。我们还进行了准确度、运行内和运行间精密度以及稳定性研究。此外,我们还对溶血、黄疸、脂血样本和纤维蛋白原敏感性进行了干扰研究分析。进行了统计分析。CUBE 30 touch 与 Westergren 方法的比较显示没有统计学差异(Spearman Coefficient,R2=0,95)。在运行内精确度方面,血沉正常样本的 CV% 平均值为 8.9%;血沉中等样本的 CV% 平均值为 5.9%;血沉高样本的 CV% 平均值为 4.3%。运行间精密度测试表明,单个样品和整体样品的 CV%在一定范围内(正常水平为 12.3%,异常水平为 4.8%)。在 4 °C 下保存的样本在采集后 3 小时内稳定性良好。出现脂血、溶血或黄疸的血沉样本与金标准方法有良好的相关性(R2 0,901, 0,940, 0,911; p
{"title":"Challenges of preanalytical variables in erythrocyte sedimentation rate: a CUBE 30 touch evaluation.","authors":"Flaminia Tomassetti, Roberto Guerranti, Roberto Leoncini, Carolina Pieroni, Daniela Diamanti, Michele Cirianni, Caterina Silvestrini, Lucrezia Galasso, Martina Pelagalli, Eleonora Nicolai, Alfredo Giovannelli, Massimo Pieri, Sergio Bernardini","doi":"10.1080/00365513.2024.2422397","DOIUrl":"https://doi.org/10.1080/00365513.2024.2422397","url":null,"abstract":"<p><p>The erythrocyte sedimentation rate (ESR) is a widely used diagnostic test, influenced by all physiological and pathological conditions that can bias blood rheology by interfering factors. This study aimed to evaluate the performance of the CUBE 30 touch ESR analyzer in samples with preanalytical variables, as lipemia, hemolysis, and icterus or in presence of fibrinogen., Moreover we focused to define the maximum time limits to ensure a reliable ESR measure. Accuracy, intra-run and inter-run precision, and stability studies were performed. Moreover, hemolytic, jaundiced, lipemic samples and fibrinogen sensitivity were analyzed for interference study. Statistical analyses were performed. CUBE 30 touch and Westergren method comparison showed no statistical differences (Spearman Coefficient, R<sup>2</sup>=0,95). In the intra-run precision, the CV% mean obtained on samples with normal ESR level was 8,9%; with middle ESR level was 5,9% and with high ESR level the CV% was 4,3%. Inter-run precision test showed CV% of for single samples and overall samples in the range (12,3% for normal level and 4,8% for abnormal level). The samples stored at 4 °C showed good stability up to 3 h from collecting time. ESR samples showing lipemia, hemolysis or jaundice showed good correlations with the gold standard method (R<sup>2</sup> 0,901, 0,940, 0,911; <i>p</i> < 0,0001), however, Westergren tests were more sensitive than CUBE 30 touch to fibrinogen additions. The high comparability with the Westergren method, both in normal and interfering samples, and the good precision, support the usefulness of CUBE 30 touch in the clinical routine laboratory.</p>","PeriodicalId":21474,"journal":{"name":"Scandinavian Journal of Clinical & Laboratory Investigation","volume":" ","pages":"1-9"},"PeriodicalIF":1.3,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Significance of myeloperoxidase, pentraxin-3 and soluble urokinase plasminogen activator receptor determination in patients with moderate carotid artery stenosis. 颈动脉中度狭窄患者髓过氧化物酶、五肽-3 和可溶性尿激酶纤溶酶原激活剂受体测定的意义。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-07 DOI: 10.1080/00365513.2024.2422404
Ana Ruzanovic, Marija Saric-Matutinovic, Neda Milinkovic, Snezana Jovicic, Andreja Dimic, David Matejevic, Ognjen Kostic, Igor Koncar, Svetlana Ignjatovic

We investigated serum concentrations of specific inflammatory parameters in patients with significant carotid artery stenosis (CAS) of 50-99%, with an additional focus on patients with moderate stenosis (50-69%), in terms of both symptomatic status and plaque morphology, to determine whether there are certain parameters that can be associated with plaque instability before the progression of CAS to a high degree. The study included 119 CAS patients, 29 of whom had moderate stenosis, and 46 controls. Ultrasonography of the carotid arteries was performed using color flow Doppler and B-mode duplex ultrasound, and serum inflammatory parameters were measured using commercially available enzyme immunoassays. When comparing patients with 50-99% stenosis, only serum amyloid A (SAA) was higher in symptomatic patients, while in the group of patients with 50-69% stenosis, myeloperoxidase (MPO) was higher and pentraxin-3 (PTX-3) was lower in symptomatic compared to asymptomatic patients, and soluble urokinase plasminogen activator receptor (suPAR) was higher in patients with carotid plaque of unstable compared to stable morphology. Our results suggest that the importance of different inflammatory parameters in patients with moderate CAS is not the same as in CAS patients in general, and therefore their separate investigation in patients with high and moderate stenosis may be beneficial. SAA has the potential to be further considered in research to predict CAS symptom risk. There is a possibility that MPO and PTX-3 play a role in the development of CAS symptoms originating from less stenotic plaques and that suPAR is involved in the destabilisation of such plaques.

我们研究了颈动脉明显狭窄(CAS)50%-99% 患者血清中特定炎症参数的浓度,重点关注中度狭窄(50%-69%)患者的症状状况和斑块形态,以确定在 CAS 发展到高度狭窄之前,是否有某些参数与斑块的不稳定性有关。该研究包括 119 名 CAS 患者(其中 29 人有中度狭窄)和 46 名对照组患者。研究人员使用彩色血流多普勒和B型双工超声对颈动脉进行了超声检查,并使用市售酶免疫测定法测定了血清炎症参数。与 50-99% 狭窄的患者相比,有症状的患者只有血清淀粉样蛋白 A(SAA)较高,而在 50-69% 狭窄的患者组中,与无症状的患者相比,有症状的患者髓过氧化物酶(MPO)较高,五肽-3(PTX-3)较低,形态不稳定的颈动脉斑块患者的可溶性尿激酶纤溶酶原激活剂受体(suPAR)较高。我们的研究结果表明,不同炎症指标在中度 CAS 患者中的重要性与一般 CAS 患者不同,因此对高度和中度狭窄患者分别进行研究可能是有益的。在预测 CAS 症状风险的研究中,有可能进一步考虑 SAA。MPO和PTX-3有可能在狭窄程度较轻的斑块引发的CAS症状中发挥作用,而suPAR则参与了此类斑块的失稳。
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引用次数: 0
Reliability of albumin bromocresol green colorimetric method and clinical impact. 白蛋白溴甲酚绿比色法的可靠性及临床影响
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-11-05 DOI: 10.1080/00365513.2024.2420311
Slavka Penickova, Sara Benyaich, Ibrahim Ambar, Frédéric Cotton

Measuring plasma albumin is a common and important laboratory test. We compared the results obtained with the bromocresol green (BCG) colorimetric, immunoturbidimetric (IT), and capillary electrophoresis (CE) methods and evaluated the clinical reliability of the colorimetric test. Samples from 320 patients including 227 patients with hypoalbuminemia (albumin levels <35 g/L) were analyzed. Results were compared between different patient groups. The BCG method indicated significantly higher plasma albumin levels than the CE and IT methods, especially in patients with elevated C-reactive protein, alpha-1 globulin (a1G), and alpha-2 globulin (a2G) values. A significant proportion of patients with mild hypoalbuminemia tested using the BCG method (albBCG) and were classified as severely hypoalbuminemic (albumin <20 g/L) when switching to the CE or IT method (albCE and albIT). These patients had elevated a1G and/or a2G levels. This change of result implied an additional indication for albumin replacement therapy. The BCG method significantly overestimates albumin levels in patients with inflammation and hypoalbuminemia, which may lead to inappropriate therapeutic decisions.

测量血浆白蛋白是一项常见而重要的实验室检验。我们比较了溴甲酚绿(BCG)比色法、免疫比浊法(IT)和毛细管电泳法(CE)得出的结果,并评估了比色法检验的临床可靠性。样本来自 320 名患者,包括 227 名低蛋白血症患者(白蛋白水平 BCG)和被归类为严重低蛋白血症患者(白蛋白 CE 和 albIT)。这些患者的 a1G 和/或 a2G 水平升高。这一结果的变化意味着白蛋白替代疗法有了新的适应症。BCG 方法明显高估了炎症和低白蛋白血症患者的白蛋白水平,这可能会导致不恰当的治疗决策。
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引用次数: 0
Hb Tacoma by seven HbA1c methods - one with significant interference. 用七种 HbA1c 方法检测血红蛋白塔科马--其中一种干扰很大。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-27 DOI: 10.1080/00365513.2024.2417383
Anni Mäenpää, Moona Kangastie, Päivikki Kangastupa

Hemoglobin Tacoma is known to potentially interfere HbA1c assays. The variant is common in Finland with prevalence of up to 2% regionally and cases are also reported in areas that have attracted Finnish immigrants, especially in Sweden and North America. Here, we investigated the effect of Hb Tacoma on seven HbA1c methods. 20 non-variant and 20 Hb Tacoma samples were measured with Tina-quant Gen. 3 (immunoassay, considered as reference) and the following point of care instruments: Afinion 2, HbA1c 501 (both utilizing boronate affinity), QuikRead go, cobas b 101, DCA Atellica, and Standard F (all immunoassays). Repeatability was also assessed by measuring both non-variant and Hb Tacoma samples five times each at two different levels. For non-variant samples, the mean relative bias with all methods was < ±4%, whereas for Hb Tacoma samples Standard F had 38% mean relative bias. In absolute bias, the difference was 17 mmol/mol on average and constant through the measured range. For other methods the mean relative bias for Hb Tacoma samples was < ±6%. The repeatability with all methods was similar for non-variant and Hb Tacoma samples and at highest 4.1% (mean CV% of two levels). The observed interference by Standard F is likely due to two-antibody assay design as Hb Tacoma has been shown to result in conformational change. This interference is clinically significant and highlight the need for better controlling and better understanding hemoglobin variants in HbA1c testing.

众所周知,血红蛋白塔科马可能会干扰 HbA1c 检测。该变异体在芬兰很常见,地区流行率高达 2%,在吸引芬兰移民的地区,尤其是瑞典和北美,也有相关病例报道。在这里,我们研究了 Hb Tacoma 对七种 HbA1c 方法的影响。20 份非变异样本和 20 份 Hb Tacoma 样本是用 Tina-quant Gen:Afinion 2、HbA1c 501(均采用硼酸盐亲和法)、QuikRead go、cobas b 101、DCA Atellica 和 Standard F(均为免疫测定法)。重复性也是通过测量非变异样本和 Hb Tacoma 样本进行评估的,每种样本在两种不同水平下各测量五次。对于非变异样本,所有方法的平均相对偏差为
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引用次数: 0
A retrospective study on biotinidase deficiency: analysis of the Eastern Anatolia region patient cohort. 生物素酶缺乏症回顾性研究:东安纳托利亚地区患者队列分析。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-25 DOI: 10.1080/00365513.2024.2420320
Oğuzhan Yaralı, Sezai Arslan, Özge Beyza Gündoğdu Öğütlü, Mustafa Can Guler, Büşra Nur Akgül

ABTRACTThis study retrospectively reviews individuals diagnosed with biotinidase deficiency in Eastern Anatolia to analyze the genetic variants and their relationship with biotinidase activity levels. The research focuses on determining the percentage impact of different variants on enzyme activity. The study included 357 patients who presented to Erzurum City Hospital with symptoms of biotinidase deficiency between 2018 and 2023 and were referred to the medical genetics department. Biotinidase enzyme levels were determined using spectrophotometric and colorimetric techniques, while Sanger sequencing analyzed the four exons and intron boundaries of the BTD gene. In the analysis of 357 patients (181 boys, 176 girls), the most frequent variant was c.1270G > C | p.Asp424His. Biotinidase enzyme activity was above 30% in 97.3% of patients with a homozygous p.D424His mutation. The mutations that caused the most significant decrease in enzyme activity were c.410G > A p.Arg137His, c.38_delinsTCC p.Cys13phefs*36, and c.1535C > T p.Thr512Met. Hearing loss (4 patients) and optic atrophy (1 patient) were mainly observed in patients with the c.38_delinsTCC mutation (homozygous or heterozygous). Most patients were asymptomatic, and mild symptoms were effectively prevented with biotin treatment. This study provides a detailed analysis of genetic diversity and clinical presentation in biotinidase deficiency cases in Eastern Anatolia, demonstrating the efficacy of biotin treatment. It highlights the significant role of genetic variants in phenotypic diversity and the need for personalized treatment, calling for further genetic research to enhance understanding of variant diversity and its impact on enzyme activity.

摘要本研究回顾了东安纳托利亚地区被诊断为生物素酶缺乏症的个体,分析了基因变异及其与生物素酶活性水平的关系。研究重点是确定不同变体对酶活性的影响百分比。研究纳入了2018年至2023年期间因生物素酶缺乏症状到埃尔祖鲁姆市医院就诊并转诊至医学遗传学部门的357名患者。采用分光光度法和比色法测定了生物素酶的酶水平,同时对 BTD 基因的四个外显子和内含子边界进行了 Sanger 测序分析。在对 357 名患者(181 名男孩,176 名女孩)的分析中,最常见的变异是 c.1270G > C | p.Asp424His。97.3% 的同源 p.D424His 突变患者的生物素酶活性高于 30%。导致酶活性显著下降的突变是 c.410G > A p.Arg137His、c.38_delinsTCC p.Cys13phefs*36 和 c.1535C > T p.Thr512Met。听力损失(4 名患者)和视神经萎缩(1 名患者)主要出现在 c.38_delinsTCC 突变(同卵或异卵)的患者中。大多数患者无症状,生物素治疗可有效预防轻微症状。这项研究详细分析了东安纳托利亚地区生物素酶缺乏症病例的遗传多样性和临床表现,证明了生物素治疗的有效性。它强调了基因变异在表型多样性中的重要作用以及个性化治疗的必要性,呼吁进一步开展基因研究,以加深对变异多样性及其对酶活性影响的了解。
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引用次数: 0
The eGFRcystatin C/eGFRcreatinine-ratio is associated with maternal morbidity in hypertensive disorders in pregnancy and may indicate optimal timing of delivery. eGFRcystatin C/eGFRcreatinine-ratio 与妊娠期高血压疾病的孕产妇发病率有关,可指示最佳分娩时间。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-18 DOI: 10.1080/00365513.2024.2417379
Danielle Damm, Anders Grubb, Helena Strevens

A low eGFRcystatin C/eGFRcreatinine-ratio is characteristic of a group of serious kidney disorders called 'Selective Glomerular Hypofiltration Syndromes'. This study examines if such a low ratio can also be used to evaluate the risk for women with hypertensive disorders in pregnancy to develop severe maternal morbidity. All women discharged from the perinatal ward at the Skåne University Hospital in Lund during the period of 1-9-2016 to 31-8-2017 under one of the diagnoses within hypertensive disorders in pregnancy were considered for inclusion in the study. After delivery and discharge from the hospital, records from included patients were reviewed and all registered measures of renal function were analysed. An eGFRcystatin C/eGFRcreatinine-ratio ≤0.60 in a sample drawn not earlier than three days before delivery was considered as defining a high risk for severe maternal morbidity. A strong association (p-value: 0.035) between severe maternal morbidity and an eGFRcystatin C/eGFRcreatinine-ratio ≤0.60 was found in a subgroup of 32 women diagnosed with 'preeclampsia with severe features'. A total of 69 women were included in the study. Fifty were defined as high-risk and seventeen of them (34%) developed severe maternal morbidity. Among the nineteen women defined as low-risk only two (10.5%) developed severe maternal morbidity (p-value: 0.051). A low eGFRcystatin C/eGFRcreatinine-ratio seems promising as a predictive marker for maternal morbidity in hypertension in pregnancy. Its performance as a tool in the monitoring of progressing disease should be evaluated further in larger cohorts. Delivery before the eGFRcystatin C/eGFRcreatinine-ratio decreases to, or below, 0.60 might help avoid maternal complications.

eGFRcystatin C/eGFRcreatinine 比率低是一组被称为 "选择性肾小球低滤过综合征 "的严重肾脏疾病的特征。本研究探讨了这种低比率是否也可用于评估妊娠期高血压疾病妇女患严重孕产妇疾病的风险。在2016年9月1日至2017年8月31日期间,所有从隆德斯科纳大学医院围产病房出院并被诊断为妊娠期高血压疾病的产妇均被纳入研究范围。在分娩和出院后,对纳入患者的病历进行复查,并对所有登记的肾功能指标进行分析。在不早于分娩前三天抽取的样本中,eGFR胱抑素C/eGFR肌酐比值≤0.60被认为是孕产妇严重发病的高危因素。在 32 名被诊断为 "重度子痫前期 "的产妇分组中发现,重度产妇发病率与 eGFRcystatin C/eGFRcreatinine-ratio ≤0.60 之间存在密切联系(p 值:0.035)。共有 69 名妇女被纳入研究。其中 50 人被定义为高危产妇,其中 17 人(34%)出现了严重的孕产妇并发症。在被定义为低风险的 19 名产妇中,只有两人(10.5%)出现了严重的孕产妇发病率(P 值:0.051)。低 eGFR胱抑素 C/eGFR肌酐比值似乎有望成为妊娠高血压孕产妇发病率的预测指标。其作为监测疾病进展的工具的性能应在更大的队列中进一步评估。在 eGFRcystatin C/eGFRcreatinine-ratio 下降到或低于 0.60 之前分娩可能有助于避免孕产妇并发症。
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Scandinavian Journal of Clinical & Laboratory Investigation
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