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CCL20 chemokine and other proinflammatory markers after Ad26.COV2.S vaccination. 接种 Ad26.COV2.S 疫苗后的 CCL20 趋化因子和其他促炎标记物。
Pub Date : 2024-10-15 DOI: 10.11613/BM.2024.030706
Iva Ivanko, Milena Hanžek, Ivana Ćelap, Sandra Margetić, Domagoj Marijančević, Josipa Josipović, Petar Gaćina

Introduction: In highly stressed circumstances, such as COVID-19 pandemic, biomarkers of the vaccine-induced immunity could be especially convenient. The main aim of our study was to determine C-C motif ligand 20 (CCL20) concentration after Ad26.COV2.S vaccination in regard to more common proinflammatory molecules and its correlation with anti-SARS-CoV-2 antibody concentration. Secondly, we investigated inflammatory and immunologic profile differences between patients with and without arterial hypertension.

Materials and methods: The study included 84 subjects vaccinated with Ad26.COV2.S vaccine. Concentration of CCL20, interleukin (IL) 6, C-reactive protein (CRP) was investigated before, 7 and 14 days after vaccination and concentration of anti-SARS-CoV-2 IgG antibody 7 and 14 days after vaccination. All the markers were measured by well-established laboratory methods.

Results: There were no statistically significant changes of CCL20 and IL-6 concentration after the vaccination. The obtained results have shown statistically significant differences for CRP (P = 0.006) concentrations between 3 time points and SARS-CoV-2 IgG antibody (P < 0.001) concentrations between 2 time points. CCL20 did not correlate with IL-6, CRP or anti-SARS-CoV-2 IgG antibody concentration. Statistically significant difference for CRP (P = 0.025) concentration between 3 time points was observed in the subgroup of subjects with arterial hypertension.

Conclusions: Although our results did not show changes in CCL20 concentration after the vaccination, possibly due to the study timeframe, further investigations on chemokine profile post SARS-CoV-2 immunization could facilitate the recognition of specific patterns of response (supra- or sub-optimal) to the vaccine.

导言:在 COVID-19 大流行等高度紧张的情况下,疫苗诱导免疫的生物标志物可能特别方便。我们研究的主要目的是确定 Ad26.COV2.S 疫苗接种后 C-C motif ligand 20(CCL20)浓度与更常见的促炎分子的关系,以及它与抗 SARS-CoV-2 抗体浓度的相关性。其次,我们研究了动脉高血压患者和非动脉高血压患者的炎症和免疫特征差异:研究包括接种 Ad26.COV2.S 疫苗的 84 名受试者。调查了接种前、接种后 7 天和 14 天 CCL20、白细胞介素 (IL) 6 和 C 反应蛋白 (CRP) 的浓度,以及接种后 7 天和 14 天抗 SARS-CoV-2 IgG 抗体的浓度。所有指标均采用成熟的实验室方法进行测量:结果:接种疫苗后,CCL20 和 IL-6 的浓度没有明显的统计学变化。结果显示,3个时间点之间的 CRP(P = 0.006)浓度和 2 个时间点之间的 SARS-CoV-2 IgG 抗体(P < 0.001)浓度差异有统计学意义。CCL20 与 IL-6、CRP 或抗 SARS-CoV-2 IgG 抗体的浓度无关。在患有动脉高血压的受试者亚组中,3个时间点之间的 CRP(P = 0.025)浓度差异具有统计学意义:虽然我们的研究结果没有显示接种疫苗后 CCL20 浓度的变化,但可能是由于研究时间框架的原因,进一步调查 SARS-CoV-2 免疫接种后趋化因子的分布情况有助于识别对疫苗的特定反应模式(超优或次优)。
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引用次数: 0
Primary pulmonary Hodgkin's lymphoma coexisting with extreme erythrocyte sedimentation rate. 原发性肺部霍奇金淋巴瘤并发极高红细胞沉降率。
Pub Date : 2024-10-15 DOI: 10.11613/BM.2024.030802
Darko Katalinic, Ivan Aleric, Ivana Skrlec, Jasminka Talapko, Elke Kattner, Damir Tentor, Aleksandar Vcev

The paper aims to present the case of an asymptomatic 22-year-old man who was referred to the hematologist by laboratory experts primarily due to the extreme elevation of the erythrocyte sedimentation rate with a value of 197 mm/h. Additionally, moderate changes in laboratory parameters such as hemoglobin, leukocytes, lactate dehydrogenase, C-reactive protein, fibrinogen, and beta-2-microglobulin were recorded. Upon extensive clinical workup that included laboratory, imaging, and histological methods, a diagnosis of primary pulmonary Hodgkin's lymphoma (PPHL) was established. Primary pulmonary Hodgkin's lymphoma is a rare malignant lymphoproliferative disease that exclusively affects the lungs, and so far, only about 100 cases worldwide have been reported. The patient underwent first-line systemic chemotherapy with chest radiation and complete remission was obtained. Two years after completion of the treatment, a relapsed PPHL was clinically confirmed. Second-line chemotherapy followed by high-dose systemic chemotherapy with autologous hematopoietic stem-cell transplantation was indicated which led to complete remission and continues after 10 years from the initial diagnosis. The case demonstrates the important role of laboratory medicine experts who instantly suspected the possible laboratory-related tumor pathology and referred the patient to further hemato-oncological evaluation. This contributed to the timely diagnosis of PPHL, administration of appropriate treatment, and favorable outcome.

本文旨在介绍一例无症状的 22 岁男性病例,该患者主要因红细胞沉降率极度升高(197 mm/h)而被实验室专家转诊至血液科。此外,血红蛋白、白细胞、乳酸脱氢酶、C 反应蛋白、纤维蛋白原和β-2-微球蛋白等实验室指标也出现了中度变化。经过包括实验室、影像学和组织学方法在内的大量临床检查,确定了原发性肺霍奇金淋巴瘤(PPHL)的诊断。原发性肺霍奇金淋巴瘤是一种罕见的恶性淋巴组织增生性疾病,仅累及肺部,迄今为止全球仅有约 100 例报道。患者接受了一线全身化疗和胸部放射治疗,病情得到完全缓解。治疗结束两年后,临床证实 PPHL 复发。患者接受了二线化疗,随后接受了大剂量全身化疗和自体造血干细胞移植,结果病情完全缓解,并在首次诊断后的10年后仍在继续。该病例显示了实验室医学专家的重要作用,他们即时怀疑可能存在与实验室相关的肿瘤病理,并将患者转诊至进一步的血液肿瘤学评估。这有助于及时诊断 PPHL,给予适当的治疗,并取得良好的疗效。
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引用次数: 0
Laboratory medicine and sports: where are we now? 实验室医学与运动:我们现在在哪里?
Pub Date : 2024-10-15 Epub Date: 2024-08-05 DOI: 10.11613/BM.2024.030501
Lovorka Đerek, Vanja Radišić Biljak, Sanja Marević, Brankica Šimac, Marko Žarak, Antonija Perović, Domagoj Marijančević, Robert Buljubašić, Luka Matanović, Maja Cigrovski Berković

Laboratory medicine in sport and exercise has significantly developed during the last decades with the awareness that physical activity contributes to improved health status, and is present in monitoring both professional and recreational athletes. Training and competitions can modify concentrations of a variety of laboratory parameters, so the accurate laboratory data interpretation includes controlled and known preanalytical and analytical variables to prevent misleading interpretations. The paper represents a comprehensive summary of the lectures presented during the 35th Annual Symposium of the Croatian Society of Medical Biochemistry and Laboratory Medicine. It describes management of frequent sport injuries and sums up current knowledge of selected areas in laboratory medicine and sports including biological variation, changes in biochemical parameters and glycemic status. Additionally, the paper polemicizes sex hormone disorders in sports, encourages and comments research in recreational sports and laboratory medicine. In order to give the wider view, the connection of legal training protocols as well as monitoring prohibited substances in training is also considered through the eyes of laboratory medicine.

过去几十年来,随着人们认识到体育锻炼有助于改善健康状况,体育运动中的化验医学得到了长足的发展。训练和比赛会改变各种实验室参数的浓度,因此,准确的实验室数据解读包括可控和已知的分析前和分析变量,以防止误导性解读。本文全面总结了克罗地亚医学生物化学和实验室医学学会第 35 届年度研讨会上的演讲内容。论文介绍了常见运动损伤的处理方法,并总结了当前实验室医学和运动领域的部分知识,包括生物变异、生化参数变化和血糖状况。此外,论文还对运动中的性激素紊乱进行了论证,鼓励并评论了休闲运动和实验医学方面的研究。为了提供更广阔的视野,本文还从检验医学的角度探讨了合法训练规程与训练中违禁物质监测之间的联系。
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引用次数: 0
Comparative analysis of the color change in blue-green inclusions within neutrophils between two patients with different clinical outcomes. 对临床结果不同的两名患者中性粒细胞内蓝绿色包涵体颜色变化的比较分析。
Pub Date : 2024-10-15 Epub Date: 2024-08-05 DOI: 10.11613/BM.2024.030801
Junkun Chen, Ming Huang, Guo Li, Chi Zhang

Blue-green neutrophilic inclusions (BGNI), also known as "death bodies," are bright green structures observed in the cytoplasm of neutrophils or monocytes and are closely associated with acute liver failure, lactic acidosis, and other serious diseases. Some studies suggested a potential association with phagocytic lipofuscin released by damaged liver cells. The presence of BGNI typically indicated a poor prognosis. We presented two cases. Case 1 was diagnosed with novel bunyavirus infection and exhibited severe hepatic impairment and coagulation dysfunction along with the presence of BGNI in neutrophils. Despite receiving comprehensive symptomatic treatment, the patient's condition rapidly deteriorated leading to eventual demise. Case 2 had severe liver injury caused by wasp stings, and BGNI was observed. Following active treatment measures, the patient eventually achieved recovery. Throughout the disease course of case 1, there was a progressive deepening in color and increase in quantity of BGNI. Conversely, case 2 demonstrated an opposite trend. Based on the comparison of clinical outcomes and variations in color and quantity of BGNI between these two patients, it was found that an increase in the number and deepening of BGNI color corresponded to worsening condition. Conversely, a decrease in quantity and lightening of color indicated improvement. Hence, these findings suggest a possible association between changes in BGNI characteristics and prognosis.

蓝绿色嗜中性粒细胞包涵体(BGNI)又称 "死亡体",是在嗜中性粒细胞或单核细胞胞浆中观察到的亮绿色结构,与急性肝衰竭、乳酸酸中毒和其他严重疾病密切相关。一些研究表明,这可能与受损肝细胞释放的吞噬性脂褐素有关。出现 BGNI 通常预示着预后不良。我们介绍了两个病例。病例 1 被诊断为新型布尼亚病毒感染,表现出严重的肝功能损害和凝血功能障碍,中性粒细胞中也出现了 BGNI。尽管患者接受了全面的对症治疗,但病情迅速恶化,最终死亡。病例 2 因被马蜂蜇伤导致严重肝损伤,并观察到 BGNI。经过积极治疗,患者最终康复。在病例 1 的整个病程中,BGNI 的颜色逐渐加深,数量逐渐增多。相反,病例 2 则表现出相反的趋势。通过比较这两名患者的临床结果以及 BGNI 颜色和数量的变化,发现 BGNI 数量增加和颜色加深与病情恶化相对应。相反,数量减少和颜色变浅则表示病情好转。因此,这些研究结果表明,BGNI 特征的变化与预后之间可能存在关联。
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引用次数: 0
National recommendations of the Croatian Chamber of Medical Biochemists and Working group for Laboratory hematology of the Croatian Society of Medical Biochemistry and Laboratory Medicine: Management of samples with suspected EDTA-induced pseudothrombocytopenia. 克罗地亚医学生物化学家商会和克罗地亚医学生物化学和实验室医学学会实验室血液学工作组的国家建议:疑似 EDTA 引起的假性血小板减少症样本的处理。
Pub Date : 2024-10-15 DOI: 10.11613/BM.2024.030504
Lara Milevoj Kopčinović, Gordana Juričić, Dragana Antončić, Fran Smaić, Brankica Šimac, Ivana Lapić, Vanja Radišić Biljak

Pseudothrombocytopenia (PTCP) is defined by the occurence of spouriously low platelet count as a consequence of in vitro platelet aggregation. It is a rare and benign artifact, not associated with any specific disorder or therapy, that becomes clinically relevant when it is not timely and reliably recognized. Thus, it may result in inappropriate clinical decisions (i.e. unnecessary further testing, misdiagnoses and potential patients' mismanagement) unavoidably compromising patient safety. The most common form of PTCP is caused by ethylenediaminetetraacetic acid (EDTA). Several approaches for the management of samples with EDTA-induced PTCP have been described in the literature. However, expert recommendations are scarce. The scope of these recommendations is to assist in achieving national harmonisation in laboratory management (i.e. detecting and reporting platelet counts) of samples with EDTA-induced PTCP. These minimal recommendations were prepared by the members of the joint working group of the Croatian Chamber of Medical Biochemists and Working group for Laboratory Hematology of the Croatian Society of Medical Biochemistry and Laboratory Medicine, and might be customized according to specific conditions (i.e. personnel and equipment) of each individual laboratory. These recommendations are primarily intended to all laboratory professionals involved in the management of samples with EDTA-induced PTCP, but also to other healthcare professionals involved in collecting samples and interpreting complete blood count results.

假性血小板减少症(Pseudothrombocytopenia,PTCP)是指由于体外血小板聚集而出现的血小板数量极低的现象。它是一种罕见的良性假象,与任何特定疾病或治疗无关,但如果不能及时可靠地识别,就会与临床相关。因此,它可能会导致不恰当的临床决策(即不必要的进一步检查、误诊和潜在的患者管理不当),不可避免地危及患者安全。最常见的 PTCP 由乙二胺四乙酸(EDTA)引起。文献中介绍了几种处理 EDTA 引起的 PTCP 样品的方法。然而,专家建议却很少。这些建议的目的是帮助各国统一对 EDTA 诱导的 PTCP 样品的实验室管理(即检测和报告血小板计数)。这些最基本的建议由克罗地亚医学生物化学家商会联合工作组和克罗地亚医学生物化学和检验医学学会实验室血液学工作组的成员编写,可根据各实验室的具体条件(如人员和设备)进行定制。这些建议主要面向所有参与 EDTA 引起的 PTCP 样品管理的实验室专业人员,同时也面向参与采集样本和解释全血细胞计数结果的其他医疗保健专业人员。
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引用次数: 0
Short- and long-term stability of synovial fluid calprotectin. 滑液钙蛋白的短期和长期稳定性。
Pub Date : 2024-10-15 DOI: 10.11613/BM.2024.030704
Helena Čičak, Stjepan Bulat, Joško Jeličić, Alan Ivković, Ksenija Maštrović Radončić, Vanja Radišić Biljak, Lora Dukić, Ana-Maria Šimundić

Introduction: Information about analyte stability is of crucial importance. The aims of this study were to determine the short- and long-term stability of synovial fluid calprotectin at various temperature conditions (4-8 °C for 7 days, - 20 °C and - 80 °C for 6 weeks).

Materials and methods: Eleven samples from patients were included in this study. The samples were promptly transported at room temperature (RT) to the laboratory immediately after arthrocentesis. Upon arrival, the samples were transferred into plastic tubes without additives and pretreated with hyaluronidase solution. After centrifugation at 1500xg for 10 minutes at RT, the baseline calprotectin concentrations were determined. Seven aliquots were stored in LoBind tubes (Eppendorf) at 4-8 °C and the calprotectin was measured every day. Six additional aliquots were stored at temperatures - 20 °C and - 80 °C and the concentration of calprotectin was measured weekly. Analysis was done using Buhlmann fCAL turbo reagent on analyzer Siemens Atellica Solution (Siemens Healthcare, Erlangen, Germany). Data were analyzed by Microsoft Excel and MedCalc statistical software. The percentage difference (PD%) was calculated. The maximum permissible difference (MPD) was 9.1% for PD%.

Results: The PD% with the corresponding 95% confidence intervals were inside the predefined MPD. The instability equations and correlation coefficient for storage temperatures were PD% = 0.1644 x time (day), r = 0.06, P = 0.614 for 4-8°C, PD% = 0.5190 x time (week), r = - 0.22, P = 0.080 for - 20°C, and PD% = 0.1316 x time (week), r = 0.08, P = 0.545 for - 80°C.

Conclusions: The calprotectin in the synovial fluid is stable when stored long-term for 6 weeks at - 20 °C or at - 80 °C or short-term (7 days) at 4-8 °C.

引言有关分析物稳定性的信息至关重要。本研究旨在确定滑液钙粘蛋白在不同温度条件下(4-8 °C,7 天;- 20 °C和- 80 °C,6 周)的短期和长期稳定性:本研究共纳入 11 份患者样本。样本在关节穿刺术后立即在室温(RT)下运送到实验室。到达后,将样本转移到不含添加剂的塑料管中,并用透明质酸酶溶液进行预处理。在 RT 条件下以 1500xg 离心 10 分钟后,测定基线钙蛋白浓度。在 LoBind 管(Eppendorf)中储存 7 份等分样品,温度为 4-8 °C,每天测量钙黏蛋白。另外六份等分试样分别保存在-20 °C和-80 °C的温度下,每周测量一次钙蛋白的浓度。使用 Buhlmann fCAL turbo 试剂在西门子 Atellica Solution(德国埃尔兰根,西门子医疗集团)分析仪上进行分析。数据由 Microsoft Excel 和 MedCalc 统计软件进行分析。计算差异百分比(PD%)。PD% 的最大允许差异 (MPD) 为 9.1%:结果:PD% 及相应的 95% 置信区间均在预定的 MPD 范围内。储存温度的不稳定方程和相关系数分别为:4-8℃时,PD% = 0.1644 x 时间(天),r = 0.06,P = 0.614;-20℃时,PD% = 0.5190 x 时间(周),r = - 0.22,P = 0.080;-80℃时,PD% = 0.1316 x 时间(周),r = 0.08,P = 0.545:结论:滑膜液中的钙粘蛋白在-20°C或-80°C条件下长期保存6周或在4-8°C条件下短期保存(7天)均保持稳定。
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引用次数: 0
Introducing prediction intervals for sample means. 引入样本均值的预测区间。
Pub Date : 2024-10-15 Epub Date: 2024-08-05 DOI: 10.11613/BM.2024.030101
Molly E Contini, Jeffrey R Spence, David J Stanley

Researchers and practitioners are typically familiar with descriptive statistics and statistical inference. However, outside of regression techniques, little attention may be given to questions around prediction. In the current paper, we introduce prediction intervals using fundamental concepts that are learned in descriptive and inferential statistical training (i.e., sampling error, standard deviation). We walk through an example using simple hand calculations and reference a simple R package that can be used to calculate prediction intervals.

研究人员和从业人员通常都熟悉描述性统计和统计推断。然而,在回归技术之外,人们可能很少关注与预测有关的问题。在本文中,我们使用描述性和推断性统计培训中学到的基本概念(即抽样误差、标准偏差)来介绍预测区间。我们用简单的手工计算举例说明,并参考了一个可用于计算预测区间的简单 R 软件包。
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引用次数: 0
The influence of calibration on bias in quality control and patient results for TSH on Vitros XT 7600 analyzer. 校准对 Vitros XT 7600 分析仪 TSH 质量控制和患者结果偏差的影响。
Pub Date : 2024-10-15 Epub Date: 2024-08-05 DOI: 10.11613/BM.2024.030703
Jill Boreyko, Josko Ivica

Introduction: Thyroid-stimulating hormone (TSH) is a glycoprotein secreted by the anterior pituitary gland and is regulated by negative feedback from the serum free thyroid hormones. In this study we aimed to quantitate the relative bias caused by calibration drifting as seen in our TSH Levey-Jennings quality control (QC) charts and assess the magnitude of bias on patients' samples.

Materials and methods: In the period from October 2021 to August 2022 we looked at the QC results of ten 28-days' calibration time intervals and calculated relative bias compared to the mean. For each time interval the mean from three QC points before and after calibration was calculated. The average from 10 pre- and post-calibration means was calculated and the relative bias, pre- and post-calibration, was then calculated. We used 5 patient samples with low, normal and high TSH concentrations and calculated relative bias pre- and post-calibration. The allowed relative bias for TSH is ± 6.7%.

Results: At both QC levels, with the respective means of 5.14 mIU/L (coefficient of variation, CV% = 3.1%) and 27.80 mIU/L (CV% = 3.2%) had their respective relative bias - 8.2% and - 7.9%. The patient samples with low (0.586 mIU/L), normal (2.89 mIU/L and 5.19 mIU/L) and high (20.5 mIU/L and 39.8 mIU/L) TSH had - 4.1%, - 4.0%, - 3.5%, - 5.1% and - 4.1%, respectively.

Conclusion: Even though the relative bias exceeded allowable criteria for the QC samples, this was not manifested on the patients' samples.

简介促甲状腺激素(TSH)是垂体前叶分泌的一种糖蛋白,受血清游离甲状腺激素的负反馈调节。在这项研究中,我们旨在量化 TSH Levey-Jennings 质量控制(QC)图表中校准漂移造成的相对偏差,并评估患者样本的偏差程度:在 2021 年 10 月至 2022 年 8 月期间,我们查看了 10 个 28 天校准时间间隔的质控结果,并计算了与平均值相比的相对偏差。对于每个时间间隔,计算校准前后三个质控点的平均值。计算校准前后 10 个平均值,然后计算校准前后的相对偏差。我们使用了 TSH 浓度较低、正常和较高的 5 份患者样本,并计算了校准前后的相对偏差。TSH 允许的相对偏差为 ± 6.7%:在两个质控水平上,平均值分别为 5.14 mIU/L(变异系数,CV% = 3.1%)和 27.80 mIU/L(CV% = 3.2%)的相对偏差分别为 - 8.2% 和 - 7.9%。低 TSH(0.586 mIU/L)、正常 TSH(2.89 mIU/L 和 5.19 mIU/L)和高 TSH(20.5 mIU/L 和 39.8 mIU/L)患者样本的相对偏差分别为-4.1%、-4.0%、-3.5%、-5.1%和-4.1%:尽管质控样本的相对偏差超过了允许的标准,但这在患者样本中并不明显。
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引用次数: 0
A case of alkaptonuria presenting with unexplained dark-stained diapers and spurious hyperoxaluria and proteinuria due to homogentisic acid interference. 一例碱蛋白尿患者因同源五味子酸干扰而出现原因不明的深色尿布、假性高草酸尿和蛋白尿。
Pub Date : 2024-10-15 DOI: 10.11613/BM.2024.031002
Thibault Vanhove, Margo Aertgeerts, Peter Witters, Daisy Rymen, Detlef Böckenhauer, Glynis Frans, Pieter Vermeersch

Alkaptonuria is characterized by the accumulation of homogentisic acid which causes dark coloration of urine upon standing, ochronosis, and arthritis. A 4-year old child was referred to our pediatric nephrologist with hyperoxaluria and a history of unexplained pink-to-brown discolouration of his diapers associated with a brown-staining of clothes and skin since he was six months old. He had no other symptoms and his past medical history only included minor child illnesses. His 11-month-old brother had the same dark discoloration of his diapers. Laboratory testing on a spot urine sample showed hyperoxaluria and nephrotic range proteinuria with low creatinine and normal albumin concentrations. Considered causes were hyperoxaluria, alkaptonuria, interfering substance, adulteration. The further diagnostic work-up revealed increased homogentisic acid in urine, compatible with alkaptonuria. Urinary creatinine and total protein measurements on Roche Cobas were, respectively, falsely decreased and increased in the presence of homogentisic acid. The false-low creatinine resulted in an elevated oxalate/creatinine ratio. Alkaptonuria can cause a false increase of results expressed per creatinine and should be excluded in case of an unexplained marked increase of urine total protein without a concomitant increase of albumin.

钾丙尿症的特点是同源戊二酸蓄积,导致站立时尿液颜色变深、赭石病和关节炎。一名 4 岁儿童因高草酸尿症被转诊至我们的儿科肾病专家,他自 6 个月大开始就出现尿布不明原因的粉红色至棕色变色,衣服和皮肤也染成棕色。他没有其他症状,既往病史只包括轻微的儿童疾病。他 11 个月大的弟弟的尿布也有同样的深色斑点。对尿液样本进行的实验室检测显示,他患有高草酸尿症和肾病范围蛋白尿,但肌酐和白蛋白浓度较低且正常。考虑的原因包括高草酸尿症、碱通尿症、干扰物质和掺假。进一步的诊断检查发现,尿液中的同戊酸增加,与碱ton尿症相符。罗氏 Cobas 检测仪测定的尿肌酐和总蛋白分别在同型戊二酸存在的情况下出现假性降低和升高。肌酐假性降低导致草酸盐/肌酐比值升高。如果尿液总蛋白不明原因地明显增加,但白蛋白没有同时增加,则应排除碱通尿症。
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引用次数: 0
Establishment and application of autoverification system for HbA1c testing. 建立和应用 HbA1c 检测自动验证系统。
Pub Date : 2024-10-15 DOI: 10.11613/BM.2024.030705
Ran Gao, Fang Zhao, Liangyu Xia, Chaochao Ma, Yingying Hu, Zhihong Qi, Xinqi Cheng, Ling Qiu

Introduction: This study aimed to determine autoverification rules for routine glycated hemoglobin (HbA1c) analysis based on high-performance liquid chromatography (HPLC) principle. Laboratory information system (LIS) and Bio-Rad D-100 Advisor software (Bio-Rad, Hercules, USA) with graphics recognition function were carriers for the autoverification system.

Materials and methods: A total of 105,126 HbA1c results, including 98,249 HbA1c matching fast plasma glucose (FPG) results of real-world data from May 2019 to June 2020, were collected to determine autoverification rules including flags, delta checks, reporting limits, and logical rules. The validation database was composed of 48,045 HbA1c results and 41,083 matching FPG results. Autoverification passing rate and the reduction of turnaround time (TAT) were evaluated.

Results: Four autoverification systems (A, B, C, D) were established by two types of delta check rules, 28 flags, one reporting limits, and two kinds of logical rules. The autoverification passing rates were 80.6%, 78.8%, 83.7%, and 81.3%, and the average time saved in TAT were 117.5 min, 116.7 min, 121.1 min, and 121.7 min, respectively.

Conclusions: Autoverification system C was the optimal one. Application of distribution of FPG corresponding to HbA1c groups had better performance as logical rules. Established HbA1c autoverifcation system shortened the auditing report time and improved work efficiency.

引言本研究旨在根据高效液相色谱(HPLC)原理确定常规糖化血红蛋白(HbA1c)分析的自动判定规则。实验室信息系统(LIS)和具有图形识别功能的 Bio-Rad D-100 Advisor 软件(Bio-Rad, Hercules, USA)是自动转换系统的载体:收集了2019年5月至2020年6月真实世界数据中共计105126个HbA1c结果,其中包括98249个HbA1c匹配快速血浆葡萄糖(FPG)结果,以确定包括标志、三角检查、报告限制和逻辑规则在内的自动核证规则。验证数据库由 48,045 个 HbA1c 结果和 41,083 个匹配的 FPG 结果组成。对自动核对通过率和周转时间(TAT)的缩短进行了评估:通过两种 delta 检查规则、28 个标志、一个报告限制和两种逻辑规则建立了四个自动核查系统(A、B、C、D)。自动核查通过率分别为 80.6%、78.8%、83.7% 和 81.3%,节省的平均 TAT 时间分别为 117.5 分钟、116.7 分钟、121.1 分钟和 121.7 分钟:结论:自体血净化系统 C 是最佳系统。应用与 HbA1c 组别相对应的 FPG 分布作为逻辑规则具有更好的性能。已建立的 HbA1c 自动核查系统缩短了审核报告时间,提高了工作效率。
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引用次数: 0
期刊
Biochemia medica
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