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Performance evaluation of the automated body fluid analysis of the new Sysmex XR haematology analyser 新型Sysmex XR血液分析仪的自动体液分析性能评估
4区 医学 Q2 Mathematics Pub Date : 2023-11-13 DOI: 10.1515/labmed-2023-0064
Christine Van Laer, Lieselot Dedeene, Lien Gruwier, Bram Vanmechelen, Talent Hwandih, Konstantinos Mintzas, Marion Münster, Nancy Boeckx
Abstract Objectives The cellular composition of body fluids (BF) provides insight into disease pathology and is an important diagnostic parameter. The well-established Sysmex XN haematology analyser (XN) offers automated BF analysis and is in routine use in many laboratories. In this study the performance of the new Sysmex XR analyser (XR) in testing BF is compared to the XN. Methods Cerebrospinal, pleural, peritoneal, and synovial fluids, as well as bronchoalveolar lavage (BAL) samples, were processed in BF mode on both analysers. Standard statistical methods were used to evaluate the performance of XR compared to the reference XN. Results Cell counts were generated from a total of 356 measurements from 307 patient BF samples. After application of exclusion criteria, 86 cerebrospinal, 77 peritoneal, 78 pleural, and 89 synovial fluid sample pairs were compared. An excellent correlation coefficient (r) between the two analysers was observed for all diagnostic parameters; WBC-BF: 0.996, RBC-BF: 0.974, TC-BF: 0.995, MN#: 0.994, MN%: 0.830, PMN#: 0.985 and PMN%: 0.835. The research parameters also performed equally well (r values of 0.900–0.994). The performance of diluted and undiluted samples was equally good. Similar results for diagnostic and research parameters were obtained from 62 BAL samples (r values of 0.899–0.992). Conclusions This study demonstrates that the automated BF counts on the new Sysmex XR analyser are equivalent to that of the XN for all BF types analysed.
【摘要】目的体液的细胞组成(BF)为了解疾病病理提供了依据,是一个重要的诊断参数。成熟的Sysmex XN血液学分析仪(XN)提供自动化BF分析,并在许多实验室中常规使用。在本研究中,比较了Sysmex新型XR分析仪(XR)与XN检测BF的性能。方法在这两种分析仪上以BF模式处理脑脊髓、胸膜、腹膜和滑液以及支气管肺泡灌洗液(BAL)样本。采用标准统计方法比较XR与参考XN的性能。结果从307例患者BF样本中共356次测量产生细胞计数。应用排除标准后,对86对脑脊液、77对腹膜、78对胸膜和89对滑液样本进行比较。两种分析仪之间的所有诊断参数均具有良好的相关系数(r);WBC-BF: 0.996, RBC-BF: 0.974, TC-BF: 0.995, MN#: 0.994, MN%: 0.830, PMN#: 0.985, PMN%: 0.835。研究参数也同样表现良好(r值为0.900 ~ 0.994)。稀释样品和未稀释样品的性能同样好。62份BAL样本的诊断参数和研究参数结果相似(r值为0.899 ~ 0.992)。本研究表明,新Sysmex XR分析仪上的自动BF计数与所分析的所有BF类型的XN相等。
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引用次数: 0
The quality and quantity of compounds affected by viral inactivation methods in dried blood spots 干血斑中病毒灭活方法对化合物质量和数量的影响
4区 医学 Q2 Mathematics Pub Date : 2023-11-13 DOI: 10.1515/labmed-2023-0099
Ming Wang, Chaowen Yu, Shi Tang, Zhihong Liao, Kexing Wan, Shan Liu
Abstract Objectives The aim is to evaluate the effect of viral inactivation methods on the quality and quantity of compounds in dried blood spots (DBS). Methods Three effective and common inactivation methods were selected via the literature search, including: heating at 56 °C for 30 min, irradiation with UVC for 30 min, and surface wetting with 70 % ethanol. The concentration and clinical predicting significance of hormones, amino acids, and acylcarnitines from DBS were assessed, and the quality and quantity of extracted deoxyribonucleic acid (DNA) from DBS were evaluated. Results Compared to control, we found that there was no significant difference on hormones concentration in the DBS treated by heating at 56 °C for 30 min (thyroid stimulating hormone p=0.36, 17-hydroxyprogesterone p=0.52). And heating at 56 °C for 30 min had a minimal changed coefficient of variation on the concentration of amino acids and acylcarnitines. All three inactivation methods slightly changed the yield of DNA extraction, but did not affect the quality of the DNA. Importantly, the three inactivation methods wouldn’t change the clinical predicting significance of above-compounds mostly, especially heating at 56 °C for 30 min. Conclusions Considering the minimal effect on the quality and quantity of various compounds, the contaminated DBS could be pretreated by the three inactivation methods, as temporary emergency inactivation methods, especially heating at 56 °C for 30 min.
摘要目的评价不同病毒灭活方法对干血斑(DBS)中化合物质量和数量的影响。方法通过文献检索,选择3种有效、常用的灭活方法:56℃加热30 min、UVC照射30 min、70%乙醇表面润湿。评估DBS中激素、氨基酸和酰基肉碱的浓度和临床预测意义,并评估DBS中提取的脱氧核糖核酸(DNA)的质量和数量。结果与对照组相比,经56°C加热30 min处理的DBS中激素浓度无显著差异(促甲状腺激素p=0.36, 17-羟孕酮p=0.52)。在56°C下加热30分钟对氨基酸和酰基肉碱浓度的变化系数最小。三种失活方法对DNA提取率有轻微影响,但不影响DNA的质量。重要的是,这三种失活方法大多不会改变上述化合物的临床预测意义,特别是在56°C下加热30 min。结论考虑到对各种化合物的质量和数量影响最小,污染的DBS可以通过三种失活方法进行预处理,作为临时应急失活方法,特别是在56°C下加热30 min。
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引用次数: 0
Acknowledgment 鸣谢
4区 医学 Q2 Mathematics Pub Date : 2023-11-10 DOI: 10.1515/labmed-2023-2001
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引用次数: 0
Proof of concept: stabilized whole blood material suitable for external quality assessment of near-patient testing devices 概念证明:稳定的全血材料适用于近患者检测设备的外部质量评估
4区 医学 Q2 Mathematics Pub Date : 2023-11-10 DOI: 10.1515/labmed-2023-0082
Jana Wütherich, Stephanie Zylla, Emmanuel Bissé, Matthias Nauck, Astrid Petersmann
Abstract Objectives Even though reliable glucose concentration measurements are essential in diagnosis and monitoring of diabetes mellitus, external quality assurance based on mandatory reference method values can only be conducted to a limited extent for measurements in whole blood. The reason is the lack of stabilized whole blood materials suitable for the application in glucose measurement devices used in near-patient testing. Methods Two patented whole blood stabilizers were tested using four commercially available near-patient testing devices and one patient self-testing device for plasma-referenced glucose measurements. Furthermore, a laboratory method for plasma-glucose measurements was included. Venous whole blood samples from 30 apparently healthy volunteers were used. Two whole blood samples (stabilizer A and B) per subject were kept at room temperature over the study period of seven days and aliquots were taken each day from the original sample for measurement on all devices. After venous puncture, left over whole blood from the collection system was used for immediate glucose measurements without stabilizer on the near-patient testing devices. Results Each investigated device gave stable results at least for one of the two stabilizers for a period of four days. Imprecision based on quality controls ranged between 1.7 and 4.8 % coefficient of variation for near-patient testing devices, but did not reflect observed variability in measurement results from stabilized and unstabilized whole blood in one device. In addition, a considerable deviation of 0.8 mmol/L was observed among the near-patient testing devices underlining the need for reference method values in external quality control. Conclusions Our study provides proof of concept that for each investigated device at least one stabilizer of glucose in whole blood shows a good performance for at least four days. Therefore, these stabilizers appear to be suitable candidate materials for external quality assessment of near-patient testing devices.
尽管可靠的葡萄糖浓度测量在糖尿病的诊断和监测中至关重要,但基于强制性参考方法值的外部质量保证只能在有限的程度上用于全血测量。原因是缺乏稳定的全血材料,适合应用于近病人测试中使用的葡萄糖测量设备。方法采用4台市售近患者检测装置和1台患者自检装置对两种专利全血稳定剂进行血浆参考血糖测定。此外,还包括一种血浆葡萄糖测量的实验室方法。使用30名表面健康的志愿者的静脉全血样本。在7天的研究期间,每个受试者的两份全血样本(稳定剂A和B)在室温下保存,每天从原始样本中取出等量的血液,在所有设备上进行测量。静脉穿刺后,收集系统剩余的全血在近患者检测装置上进行即时血糖测量,不使用稳定剂。结果两种稳定剂中的一种至少在4天内稳定。近病人检测装置的质量控制不精确性在1.7 - 4.8%的变异系数之间,但不能反映在一个设备中稳定和不稳定全血测量结果的可变性。此外,在近患者检测装置之间观察到0.8 mmol/L的相当大的偏差,强调了在外部质量控制中需要参考方法值。我们的研究提供了概念证明,对于每个被研究的设备,至少有一种全血葡萄糖稳定剂表现出至少四天的良好性能。因此,这些稳定剂似乎是近患者检测装置外部质量评估的合适候选材料。
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引用次数: 0
Predictive value of combined serum IL-6 with UREA on severity of neonatal pneumonia: an observational study 血清IL-6与尿素联合检测对新生儿肺炎严重程度的预测价值:一项观察性研究
4区 医学 Q2 Mathematics Pub Date : 2023-11-10 DOI: 10.1515/labmed-2023-0077
Ci Li, Zhe Xu, Hongqi Sun, Liu Yang, Manjie Nie, Weihua Gong, Junmei Yang, Tiewei Li
Abstract Objectives IL-6 is an inflammatory marker and urea nitrogen (UREA) is a common indicator of glomerular filtration function. Their combined detection has predictive value for the severity of neonatal pneumonia. Methods We performed a cross-sectional analysis of the clinical and laboratory data, collected from 105 neonatal patients (including 76 mild to moderate pneumonia patients and 29 severe pneumonia patients). Results Mann–Whitney U-test showed serum IL-6 and UREA levels were significantly increased in severe pneumonia, compared with that in mild to moderate pneumonia (p<0.05). Correlation analysis showed the severity of neonatal pneumonia was positively correlated with serum IL-6 (r=0.284, p<0.05) and UREA (r=0.303, p<0.05) levels. Multivariate logistic regression analysis showed the increased levels of IL-6 (OR=1.002, 95 % CI 1.001–1.004) and UREA (OR=1.420, 95 % CI 1.046–1.926) were independent risk factors for the severity of neonatal pneumonia. ROC curve analysis showed that the predictive value of combined detection of serum IL-6 and UREA in the severity of neonatal pneumonia was better than that of either detection alone (area under curve [AUC] = 0.809, 95 % CI 0.711–0.894, p<0.001). Conclusions Combined detection of IL-6 and UREA had a good predictive value for evaluating the severity of neonatal pneumonia.
目的IL-6是炎症标志物,尿素氮(urea)是肾小球滤过功能的常用指标。它们的联合检测对新生儿肺炎的严重程度有预测价值。方法对105例新生儿患者(包括76例轻中度肺炎患者和29例重症肺炎患者)的临床和实验室资料进行横断面分析。结果Mann-Whitney u检验显示,重症肺炎患者血清IL-6和尿素水平明显高于轻、中度肺炎患者(p < 0.05)。相关性分析显示,新生儿肺炎严重程度与血清IL-6 (r=0.284, p < 0.05)、尿素(r=0.303, p < 0.05)水平呈正相关。多因素logistic回归分析显示,IL-6水平升高(OR=1.002, 95% CI 1.001 ~ 1.004)和尿素水平升高(OR=1.420, 95% CI 1.046 ~ 1.926)是新生儿肺炎严重程度的独立危险因素。ROC曲线分析显示,联合检测血清IL-6和尿素对新生儿肺炎严重程度的预测价值优于单独检测两者(曲线下面积[AUC] = 0.809, 95% CI = 0.711-0.894, p<0.001)。结论IL-6与尿素联合检测对评价新生儿肺炎严重程度有较好的预测价值。
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引用次数: 0
Improving turn-around times in low-throughput distributed hematology laboratory settings with the CellaVision® DC-1 instrument 改善低通量分布式血液学实验室设置与CellaVision®DC-1仪器的周转时间
4区 医学 Q2 Mathematics Pub Date : 2023-11-07 DOI: 10.1515/labmed-2023-0073
Cheri Mayes, Tracey Gwilliam, Etienne R. Mahe
Abstract Objectives Digital pathology is becoming standard in the delivery of timely, high-quality clinical services, inclusive of morphological assessment in laboratory hematology. While many digital hematology systems are designed with high-throughput in mind, CellaVision ® has recently developed a low-throughput instrument, the CellaVision ® DC-1. The utility of the CellaVision ® DC-1 was tested in a distributed laboratory system, with a focus on turn-around times (TATs). Methods We evaluated the TATs of a CellaVision ® DC-1 workflow, with specimens originating in a small spoke-laboratory referring materials to a central hub-laboratory. Our spoke-laboratories perform on-site complete blood counts (CBC’s) and manual peripheral blood smears (PBS’s), with complex cases referred for review to the hub-laboratory. Baseline TATs were collected, followed by prospective evaluation of 21 cases analyzed using the CellaVision ® DC-1, with digital review by spoke-laboratory staff in concert with remote review by hub-laboratory staff. The TATs for the same 21 cases by standard manual assessment were compared. Results Improvement in the distribution of TATs using the CellaVision ® DC-1 was noted relative to the retrospective spoke-laboratory data (Mann–Whitney U=26, p<0.0001) and the parallel manual PBS review (Wilcoxon W=190, p<0.0001). The CellaVision ® DC-1 permitted a significant reduction in case-assessment times (Wilcoxon W=105, p=0.0001). No significant diagnostic discrepancies were identified during the testing timeframe. Conclusions We describe a real-world assessment of the CellaVision ® DC-1 analyzer in a distributed (hub-and-spoke) laboratory network, linking low-volume laboratories to high-throughput sites. Our evaluation highlights significant improvements in case TATs with a CellaVision ® DC-1 assisted digital pathology workflow.
目的数字病理学正在成为提供及时、高质量临床服务的标准,包括实验室血液学形态学评估。虽然许多数字血液学系统在设计时考虑到高通量,但CellaVision®最近开发了一种低通量仪器CellaVision®DC-1。CellaVision®DC-1的实用性在分布式实验室系统中进行了测试,重点是周转时间(tat)。方法:我们评估CellaVision®DC-1工作流程的TATs,将来自小型辐条实验室的标本转到中心中心实验室。我们的口腔实验室进行现场全血细胞计数(CBC)和手工外周血涂片(PBS),复杂病例转介到中心实验室审查。收集基线tat,然后使用CellaVision®DC-1对21例病例进行前瞻性评估,由语音实验室工作人员进行数字评估,同时由中心实验室工作人员进行远程评估。采用标准人工评估方法对21例患者的TATs进行比较。结果与回顾性口腔实验室数据(Mann-Whitney U=26, p<0.0001)和平行手动PBS评估(Wilcoxon W=190, p<0.0001)相比,使用CellaVision®DC-1可改善tat分布。CellaVision®DC-1可显著减少病例评估时间(Wilcoxon W=105, p=0.0001)。在测试期间没有发现显著的诊断差异。我们描述了CellaVision®DC-1分析仪在分布式(中心辐射式)实验室网络中的真实评估,将小容量实验室连接到高通量站点。我们的评估强调了使用CellaVision®DC-1辅助数字病理工作流程的病例tat的显着改进。
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引用次数: 0
Second generation of soluble transferrin receptor assay – consequences for the interpretation of the ‘Thomas plot’ 第二代可溶性转铁蛋白受体测定——“托马斯图”解释的结果
4区 医学 Q2 Mathematics Pub Date : 2023-10-18 DOI: 10.1515/labmed-2023-0078
Peter Mirtschink, Volker Neumeister, Mario Menschikowski, Rayan Suliman, Gunter Wolf, Jana Kade, Oliver Tiebel, David M. Poitz
Abstract Objectives The ‘Thomas plot’ is a very helpful diagnostic tool for evaluation, monitoring and therapy of the iron status and on the hemoglobinization of the reticulocytes of patients. In 2021 Roche Diagnostics launched a second generation assay for determination of the soluble transferrin receptor (sTfR). Here we compare the old and the new assay for sTfR and analyze the consequences for the ‘Thomas plot’. Methods Measurement of sTfR, ferritin and CRP were done using a Cobas8000 system. Hemoglobin content of reticulocytes (Ret-He) was determined using a Sysmex XN9000 system. Results The second generation of sTfR assay showed consistently lower sTfR values compared to the first generation, which would result in a left shift of the ‘Thomas plot’ and may lead to false diagnosis of patients using the original cut-offs. Fifteen thousand five hundred ninty two data sets for ‘Thomas plot’ from 2016 to 2021 were retrospectively analyzed to estimate how many patients in our hospital would be affected. In result around 5 % of all ‘Thomas plots’ would be affected by the lower sTfR values of the second generation assays. Conclusions Due to the lower sTfR values measured with the second generation assay new cut-offs for the Ferritin-Index (sTfR/lg Ferritin) should be used in order to correctly diagnose the iron status of patients.
目的“托马斯图”是一种非常有用的诊断工具,用于评估、监测和治疗患者的铁状态和网织红细胞的血红蛋白。2021年,罗氏诊断推出了第二代可溶性转铁蛋白受体(sTfR)测定方法。在这里,我们比较了sTfR的旧方法和新方法,并分析了“托马斯图”的结果。方法采用Cobas8000系统测定sTfR、铁蛋白和CRP。使用Sysmex XN9000系统测定网织红细胞血红蛋白(Ret-He)含量。结果与第一代相比,第二代sTfR检测显示sTfR值始终较低,这将导致“托马斯图”的左移,并可能导致使用原始截止值对患者进行错误诊断。回顾性分析2016年至2021年“托马斯图”的一万五千五百九十二组数据集,以估计我院有多少患者会受到影响。结果,大约5%的“Thomas地块”将受到第二代检测的较低sTfR值的影响。结论由于第二代铁蛋白检测的sTfR值较低,为了正确诊断患者的铁状态,应使用新的铁蛋白指数(sTfR/lg铁蛋白)截止值。
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引用次数: 0
Frontmatter 头版头条
4区 医学 Q2 Mathematics Pub Date : 2023-10-01 DOI: 10.1515/labmed-2023-frontmatter5
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引用次数: 0
German Congress of Laboratory Medicine: 18th Annual Congress of the DGKL and 5th Symposium of the Biomedical Analytics of the DVTA e. V. 德国检验医学大会:第18届DGKL年会和第五届DVTA生物医学分析研讨会。
4区 医学 Q2 Mathematics Pub Date : 2023-09-12 DOI: 10.1515/labmed-2023-0101
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引用次数: 0
A novel multimodal approach for the assessment of phlebotomy performance in nurses 一种新的多模态方法评估护士的静脉切开术表现
4区 医学 Q2 Mathematics Pub Date : 2023-09-12 DOI: 10.1515/labmed-2023-0055
Oana Roxana Oprea, Anca Alexandra Molnar, Ion Bogdan Mănescu
Abstract Objectives Phlebotomy is presumably the most challenging preanalytical aspect in laboratory medicine. In Europe, inpatient phlebotomy is performed by nurses in 45–60 % of cases. We aimed to develop and test a novel phlebotomy assessment tool for nurses. Methods A group of 24 nurses working in a surgical ward was investigated. A three-pronged approach was devised: (1) a standardized knowledge test, (2) three blinded phlebotomy audits, and (3) prospective monitoring of samples sent from the investigated surgical ward for the calculation of preanalytical quality indicators. Results The average knowledge test score was 22.7/31 points (12–31, interquartile range 20.5–25). The average audit score was 14.5/18 points (13.7–14.7, interquartile range 14–15). No statistically significant correlations were found between phlebotomy knowledge (or lack of) and corresponding phlebotomy practices (or errors, respectively). Moreover, there was no statistically significant correlation between individual knowledge scores and audit scores. Several misconceptions about the preanalytical phase were identified, along with common phlebotomy errors. Conclusions Sometimes, nurses do not follow guidelines due to lack of theoretical knowledge. Other times, nurses fail to follow procedures despite having the prerequisite theoretical knowledge. We observed a discordance between theory and practice regarding certain aspects of phlebotomy. The novel multimodal methodology presented here describes an improved assessment tool and a superior alternative to the popular survey studies. This tool may be used to identify specific and recurrent phlebotomy issues and to improve institutional continuing education programs for nurses through targeted training programs.
目的在检验医学中,静脉切开术可能是最具挑战性的分析前工作。在欧洲,住院病人的静脉切开术在45 - 60%的病例中由护士进行。我们旨在为护士开发和测试一种新的静脉切开术评估工具。方法对某外科病房24名护士进行调查。设计了一种三管齐下的方法:(1)标准化知识测试,(2)三次盲法采血审计,以及(3)对调查外科病房送来的样本进行前瞻性监测,以计算分析前质量指标。结果知识测验平均得分为22.7/31分(12 ~ 31分,四分位数差为20.5 ~ 25分)。审计平均得分为14.5/18分(13.7-14.7分,四分位数范围14-15分)。静脉切开术知识(或缺乏)与相应的静脉切开术实践(或错误)之间没有统计学上显著的相关性。此外,个人知识得分与审计得分之间没有统计学上的显著相关。关于分析前阶段的几个误解被确定,以及常见的静脉切开术错误。结论护士有时因缺乏理论知识而不遵医嘱。其他时候,尽管护士有必要的理论知识,但他们没有遵循程序。我们观察到理论和实践之间的不一致,关于某些方面的静脉切开术。本文提出的新型多模态方法描述了一种改进的评估工具和一种优于流行调查研究的替代方法。该工具可用于识别特定的和复发性的静脉切开术问题,并通过有针对性的培训计划改善护士的机构继续教育计划。
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引用次数: 0
期刊
Journal of Laboratory Medicine
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