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Evidence-based approach for the generation of a multivariate logistic regression model that predicts instrument failure. 基于证据的方法,生成可预测仪器故障的多元逻辑回归模型。
Pub Date : 2024-11-21 DOI: 10.1093/labmed/lmae092
Stephan L Cleveland, Carol A Carman, Niti Vyas, Jose H Salazar, Juan U Rojo

Objective: Identification of instrument failure (IF) represents a point to improve the quality of services provided by medical laboratories. Here, a logistic regression model was created to define the relationship between instrument downtime and laboratory quality management systems.

Methods: Interval-level quality control (QC) and categorical quality assurance data from 3 identical chemistry analyzers was utilized to generate a logistic regression model able to predict IF. A case-control approach and the forward stepwise likelihood-ratio method was used to develop the logistic regression model. The model was tested using a case-control dataset and again using the complete sample.

Results: A total of 650 downtime events were identified. A total of 22,880 QC data points, 187 calibrations, 24 proficiency testing events, and 107 maintenance records were analyzed. The regression model was able to correctly predict 59.2% of no instrument downtime events and 69.2% of instrument downtime events using the case-control data. Using the entire data set, the sensitivity of the model was 69.2% and the specificity was 58.2%.

Conclusion: A logistic regression model can predict instrument downtime nearly 70% of the time. This study acts as a proof of concept using a limited data set collected by the chemistry laboratory.

目的:仪器故障(IF)的识别是提高医学实验室服务质量的关键。在此,我们建立了一个逻辑回归模型,以确定仪器故障时间与实验室质量管理系统之间的关系:方法:利用来自 3 台相同化学分析仪的区间质量控制(QC)和分类质量保证数据,建立了一个能够预测 IF 的逻辑回归模型。在建立逻辑回归模型时,采用了病例对照方法和前向逐步似然比方法。该模型使用病例对照数据集进行了测试,并再次使用完整样本进行了测试:结果:共发现了 650 起停机事件。共分析了 22,880 个质控数据点、187 次校准、24 次能力测试事件和 107 份维护记录。使用病例对照数据,回归模型能够正确预测 59.2% 的无仪器停机事件和 69.2% 的仪器停机事件。使用整个数据集,该模型的灵敏度为 69.2%,特异度为 58.2%:逻辑回归模型可以预测近 70% 的仪器停机时间。这项研究利用化学实验室收集的有限数据集证明了这一概念。
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引用次数: 0
Comparison of basic lymphocyte phenotype results between a diagnostic and a research laboratory. 比较诊断实验室和研究实验室的基本淋巴细胞表型结果。
Pub Date : 2024-11-21 DOI: 10.1093/labmed/lmae091
Najib Aziz, Erik LaBelle, Beth D Jamieson, Matthew J Mimiaga, Roger Detels

Objective: Lymphocyte phenotyping is a valuable tool for monitoring the effects of antiretroviral therapy on individuals living with HIV-1. A switch study was conducted to compare T-cell subset quantification performed by a research laboratory and a diagnostic, laboratory to understand the impact on the retrospective and prospective results of a long-term study.

Methods: Using FACSCanto II Flow Cytometers, EDTA anticoagulated peripheral blood from 73 males enrolled in the Multicenter AIDS Cohort Study/Women Interagency HIV Combined Cohort Study was analyzed by both a research (laboratory 1) and a diagnostics laboratory (laboratory 2) for quantification of cluster of differentiation (CD)3, CD4, and CD8 T-cells. There were 47 males living with and 26 living without HIV-1.

Results: Bland-Altman (B-A) analysis was applied to assess the agreement between laboratory 1 and laboratory 2 results. There were 69 out of 73 CD3, 71 out of 73CD4, and 72 out of 73 CD8 T-cell results that fell within acceptable B-A limits of agreement. The mean differences between the 2 laboratories were -1.000, -0.945, and +0.685(%), respectively.

Conclusion: The strong agreement between results from laboratory 1 and laboratory 2 for CD3, CD4, and CD8 T-cell percentage suggests that the difference between laboratories using the same instrumentation and methodology will have a minimal effect on long-term study results.

目的:淋巴细胞表型分析是监测抗逆转录病毒疗法对 HIV-1 感染者影响的重要工具。我们进行了一项转换研究,比较研究实验室和诊断实验室进行的 T 细胞亚群定量,以了解对一项长期研究的回顾性和前瞻性结果的影响:使用 FACSCanto II 流式细胞仪,由研究实验室(实验室 1)和诊断实验室(实验室 2)对参加多中心艾滋病队列研究/妇女机构间艾滋病联合队列研究的 73 名男性的 EDTA 抗凝外周血进行分析,以量化分化簇 (CD)3、CD4 和 CD8 T 细胞。47 名男性感染者和 26 名男性未感染 HIV-1:结果:采用Bland-Altman(B-A)分析法评估实验室1和实验室2结果的一致性。73 个 CD3 细胞结果中有 69 个、73 个 CD4 细胞结果中有 71 个、73 个 CD8 T 细胞结果中有 72 个在可接受的 B-A 一致性范围内。两个实验室的平均差异分别为-1.000、-0.945和+0.685(%):结论:实验室 1 和实验室 2 的 CD3、CD4 和 CD8 T 细胞百分比结果非常一致,这表明使用相同仪器和方法的实验室之间的差异对长期研究结果的影响微乎其微。
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引用次数: 0
Correlation of the abundance of MDSCs, Tregs, PD-1, and PD-L1 with the efficacy of chemotherapy and prognosis in gastric cancer. 胃癌中 MDSCs、Tregs、PD-1 和 PD-L1 的数量与化疗疗效和预后的相关性。
Pub Date : 2024-11-20 DOI: 10.1093/labmed/lmae090
Na Li, Yun Li, Jing Li, Shimin Tang, Hongbo Gao, Yong Li

Objective: The aim of this study was to investigate the relationship between tumor microenvironment markers (myeloid-derived suppressor cells [MDSCs], regulatory T cells [Tregs], programmed cell death 1 [PD-1], and programmed death ligand 1 [PD-L1]) and chemotherapy efficacy and prognosis in advanced gastric cancer, identifying potential monitoring indicators.

Methods: Advanced gastric cancer patients' MDSC and Treg expression was measured by flow cytometry pre- and postchemotherapy; PD-1 and PD-L1 expression in cancer tissues was assessed by immunohistochemistry. Correlations with chemotherapy outcomes and prognosis were analyzed.

Results: Postchemotherapy reductions in MDSC and Treg levels correlated with chemotherapy efficacy (P <.01). Negative PD-1 and PD-L1 expression in cancer tissues predicted better chemotherapy responses (P <.01). Patients with lower MDSC and Treg levels and negative PD-1 and PD-L1 had significantly longer median progression-free survival (PFS) and overall survival (OS) (P <.05).

Conclusion: In advanced gastric cancer, reduced peripheral blood MDSC and Treg levels postchemotherapy and negative PD-1 and PD-L1 expression in tissues are associated with improved chemotherapy efficacy and are independent prognostic factors for PFS and OS.

研究目的本研究旨在探讨肿瘤微环境标志物(髓源抑制细胞[MDSCs]、调节性T细胞[Tregs]、程序性细胞死亡1[PD-1]和程序性死亡配体1[PD-L1])与晚期胃癌化疗疗效和预后之间的关系,确定潜在的监测指标:方法: 通过流式细胞术检测晚期胃癌患者化疗前后MDSC和Treg的表达;通过免疫组化评估癌组织中PD-1和PD-L1的表达。分析了化疗结果与预后的相关性:结果:化疗后MDSC和Treg水平的降低与化疗疗效相关(P 结论:化疗后MDSC和Treg水平的降低与化疗疗效相关:在晚期胃癌中,化疗后外周血 MDSC 和 Treg 水平的降低以及组织中 PD-1 和 PD-L1 的阴性表达与化疗疗效的改善相关,并且是 PFS 和 OS 的独立预后因素。
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引用次数: 0
Implementing laboratory internal audit to improve compliance and quality of care in the municipal public health system-based ambulatory care health clinics in New York city. 实施实验室内部审计,以提高纽约市基于市政公共卫生系统的非住院医疗诊所的合规性和医疗质量。
Pub Date : 2024-11-18 DOI: 10.1093/labmed/lmae088
Faisal M Huq Ronny, Tshering Sherpa, Faisal N Saquib, Shana Ahmad

Introduction: System-wide laboratory internal audits are useful to help laboratories prepare for external audits in addition to being part of the ongoing program for compliance improvement and quality assurance in the laboratory to track and enhance care quality.

Methods: A formal plan was developed and a modified audit checklist was prepared by our laboratory management team, applicable and uniquely tailored for our ambulatory care clinic settings to track operational, quality, and compliance metrics according to the New York State Department of Health Clinical Laboratory Evaluation Program. Two audits were conducted 6 months apart and the conformity documented.

Results: An overall 84% increase in compliance and conformity was observed between first and second audits, which ranged from 63% to 100% across different categories, with 100% improvement (0% nonconformity) in 75% of the sites in the second audit.

Conclusion: A system-wide laboratory internal audit was created and carried out. Staff shortages, rapid turnover, and lack of retraining were found to be contributing factors to sites that did not achieve 100% conformance. Continuous assessment and monitoring are key elements to success in the laboratory quality management system, and through this scheduled audit process, we were able to achieve continual laboratory quality improvement.

介绍:全系统范围的实验室内部审核除了是实验室合规性改进和质量保证持续计划的一部分,以跟踪和提高医疗质量外,还有助于帮助实验室为外部审核做好准备:我们的实验室管理团队根据纽约州卫生部临床实验室评估计划制定了一项正式计划,并准备了一份经过修改的审核清单,该清单适用于我们的非住院医疗诊所,并为其量身定制,用于跟踪运营、质量和合规性指标。相隔 6 个月进行了两次审核,并将审核结果记录在案:结果:在第一次和第二次审核之间,合规性和符合性总体提高了 84%,不同类别的合规性和符合性从 63% 到 100% 不等,在第二次审核中,75% 的医疗机构的合规性和符合性得到了 100% 的改善(0% 不符合):结论:建立并实施了全系统的实验室内部审核。结论:建立并开展了全系统实验室内部审核,发现人员短缺、人员流动快和缺乏再培训是导致审核结果达不到 100% 的原因。持续的评估和监控是实验室质量管理体系取得成功的关键因素,而通过这种定期审核程序,我们能够实现实验室质量的持续改进。
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引用次数: 0
Correction to: The utility of an algorithm based on procalcitonin monitoring in patients with sepsis. 更正:基于脓毒症患者降钙素原监测的算法的实用性。
Pub Date : 2024-11-18 DOI: 10.1093/labmed/lmae093
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引用次数: 0
Ascorbic acid and glucose can cause significant interference on quantitative measurement of biochemistry analytes in urine. 抗坏血酸和葡萄糖会对尿液中生化分析物的定量检测造成严重干扰。
Pub Date : 2024-11-16 DOI: 10.1093/labmed/lmae089
Sara Mašković, Nora Nikolac Gabaj

Background and aims: Preanalytical errors due to interferences can lead to inaccurate results, necessitating an understanding of potential interferences for each test. This study explores the impact of elevated concentrations of ascorbic acid and glucose on urine analysis, a pivotal diagnostic tool.

Methods: Conducted at the Clinical Institute of Chemistry, KBC Sestre milosrdnice, the research utilized a 24-hour urine sample. Parameters assessed included total proteins, albumin, amylase, sodium, potassium, chlorides, calcium, phosphates, magnesium, creatinine, urea, and uric acid. Various concentrations of added interferents were prepared for duplicate measurements using statistical analysis in Microsoft Excel.

Results: No statistically significant interferences were found in albumin, amylase, sodium, potassium, or phosphate concentrations. However, ascorbic acid interfered with chloride, calcium, and magnesium determinations. Conversely, elevated glucose affected total protein, calcium, magnesium, creatinine, urea, and uric acid determinations. Interference of ascorbic acid with chloride and interference of glucose with total proteins and uric acid displayed a linear relationship.

Conclusions: Results suggest cautious analysis interpretation from certain parameters in patients with elevated glucose and/or ascorbic acid in urine. Whereas ascorbic acid interference may go unnoticed due to its infrequent measurement, routine determination of glucose in urine is crucial, especially for diabetes patients.

背景和目的:干扰导致的分析前误差会导致结果不准确,因此有必要了解每种检验的潜在干扰。本研究探讨了抗坏血酸和葡萄糖浓度升高对尿液分析这一关键诊断工具的影响:研究在 KBC Sestre milosrdnice 临床化学研究所进行,采用 24 小时尿液样本。评估参数包括总蛋白、白蛋白、淀粉酶、钠、钾、氯化物、钙、磷酸盐、镁、肌酐、尿素和尿酸。使用 Microsoft Excel 进行统计分析,准备了不同浓度的添加干扰物进行重复测量:结果:在白蛋白、淀粉酶、钠、钾或磷酸盐浓度方面没有发现统计学意义上的明显干扰。然而,抗坏血酸会干扰氯化物、钙和镁的测定。相反,葡萄糖升高会影响总蛋白、钙、镁、肌酐、尿素和尿酸的测定。抗坏血酸对氯化物的干扰与葡萄糖对总蛋白和尿酸的干扰呈线性关系:结果表明,对于尿液中葡萄糖和/或抗坏血酸升高的患者,对某些参数的分析解释应谨慎。抗坏血酸的干扰可能会因为不经常测量而被忽视,而尿液中葡萄糖的常规测定则至关重要,尤其是对糖尿病患者而言。
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引用次数: 0
SNAP25 as a prognostic marker in transcriptome analysis of meningioma. 脑膜瘤转录组分析中的预后标志物 SNAP25
Pub Date : 2024-11-08 DOI: 10.1093/labmed/lmae085
Yu Ge, Tao Zhang

Background: Meningiomas are the most common intracranial tumors and their diagnosis relies mostly on neuroimaging and histology. However, the histology grades cannot predict the outcome exactly and some meningiomas tend to recur after resection of even benign tumors. Therefore, it is necessary to explore prognostic and diagnostic molecular targets.

Methods: Differential expression analysis between meningiomas and meninges was performed based on the merged data of GSE43290 and GSE84263. Next, we performed gene set enrichment analysis (GSEA), immune cell infiltration analysis, protein-protein interaction analysis, and survival analysis using public data. The expression level of Synaptosome-associated-protein-25kDa (SNAP25) was verified by reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR) and Western blotting in meningioma tissues.

Results: There were 263 upregulated and 592 downregulated genes identified in meningiomas by differential expression analysis. GSEA results revealed that meningiomas were negatively related to the pathway of soluble N-ethylmaleimide sensitive factor attachment protein receptor interactions in vascular transport and chemokine signaling. SNAP25 was characterized as a hub gene and downregulated in meningiomas. The Kaplan-Meier plot indicated that high expression of SNAP25 is a favorable factor.

Conclusion: SNAP25 was downregulated and identified as a potential prognostic marker in meningioma.

背景:脑膜瘤是最常见的颅内肿瘤,其诊断主要依靠神经影像学和组织学。然而,组织学分级并不能准确预测预后,有些脑膜瘤即使是良性肿瘤,切除后也容易复发。因此,有必要探索预后和诊断的分子靶点:方法:基于 GSE43290 和 GSE84263 的合并数据,对脑膜瘤和脑膜进行差异表达分析。接下来,我们利用公开数据进行了基因组富集分析(GSEA)、免疫细胞浸润分析、蛋白-蛋白相互作用分析和生存分析。通过逆转录实时定量聚合酶链式反应(RT-qPCR)和Western印迹检测脑膜瘤组织中突触体相关蛋白-25kDa(SNAP25)的表达水平:结果:通过差异表达分析发现,脑膜瘤中有263个上调基因和592个下调基因。GSEA结果显示,脑膜瘤与可溶性N-乙基马来酰亚胺敏感因子附着蛋白受体在血管运输和趋化因子信号转导中的相互作用途径呈负相关。SNAP25是一个枢纽基因,在脑膜瘤中被下调。Kaplan-Meier图显示,SNAP25的高表达是一个有利因素:结论:SNAP25被下调,并被确定为脑膜瘤潜在的预后标志物。
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引用次数: 0
Acute hemolytic transfusion reaction caused by anti-M antibodies: a case report and literature review. 抗 M 抗体引起的急性溶血性输血反应:病例报告和文献综述。
Pub Date : 2024-11-04 DOI: 10.1093/labmed/lmae038
Yanjing He, Yang Li, Qiushi Wang

Objective: We report a rare case of acute hemolytic reactions caused by immunoglobulin (Ig)M anti-M antibody and present a literature review.

Case report: A 61-year-old male patient who underwent blood transfusion developed fever, chills, soy sauce-colored urine, and changes in laboratory test results, including persistently decreased hemoglobin levels, neutrophilia, elevated lactate dehydrogenase level, acute kidney injury, mild acute liver injury, and activation of the coagulation system, indicating acute hemolytic transfusion reaction (AHTR). Antibody screening and major crossmatching results indicated weak positive at 37°C for both posttransfusion and pretransfusion sample. Subsequent serological examinations indicated the presence of IgM anti-M antibodies in plasma but the direct antiglobulin and elution tests were negative. Antibody hemolytic activity assay confirmed AHTR caused by anti-M. The transfused red blood cells were MM and the patient is NN. These signs and symptoms disappeared rapidly and required no additional interventions before discharge.

Conclusion: The accurate diagnosis of anti-M antibody-mediated acute hemolysis is essential for guiding treatment decisions.

摘要我们报告了一例罕见的由免疫球蛋白(Ig)M 抗 M 抗体引起的急性溶血反应,并进行了文献综述:一名 61 岁的男性患者在接受输血后出现发热、寒战、酱油色尿液,实验室检查结果发生变化,包括血红蛋白水平持续下降、中性粒细胞增多、乳酸脱氢酶水平升高、急性肾损伤、轻度急性肝损伤和凝血系统活化,提示急性溶血性输血反应(AHTR)。抗体筛查和主要交叉配血结果显示,输血后和输血前样本在 37°C 时均呈弱阳性。随后的血清学检查显示血浆中存在 IgM 抗 M 抗体,但直接抗球蛋白和洗脱试验均为阴性。抗体溶血活性检测证实,AHTR 是由抗-M 引起的。输注的红细胞为 MM,患者为 NN。这些症状和体征迅速消失,出院前无需进行其他干预:结论:抗 M 抗体介导的急性溶血的准确诊断对于指导治疗决策至关重要。
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引用次数: 0
A simple method to overcome paraproteinemic interferences in chemistry and immunoassays. 一种克服化学和免疫测定中副蛋白干扰的简单方法。
Pub Date : 2024-11-04 DOI: 10.1093/labmed/lmae042
Rajarshi Sarkar

Background: Interferences on chemistry and immunoassay results due to paraproteinemia may lead to erroneous diagnoses and treatment. Such interferences are difficult to recognize and even more difficult to deal with. This report describes 1 such case where multiple measurands were affected and how the interferant was overcome.

Case report: Paraproteins present in an immunoglobulin (Ig)G-lambda multiple myeloma specimen interfered with results of total bilirubin, direct bilirubin, inorganic phosphate, iron, ferritin, and total thyroxine measured on 3 platforms: AU5800, Alinity ci, and cobas pure. Repeat testing upon dilution with normal saline or deproteinization by polyethylene glycol precipitation gave unsatisfactory results on some or all the affected measurands. Repeat testing after dilution of the interferant serum with a healthy serum corrected the anomalous results for all the affected measurands.

Conclusion: Dilution of paraproteinemic serum with a healthy serum of known concentrations appears to be the most suitable method to negate the effects of paraproteinemic interferences.

背景:副蛋白血症对化学和免疫测定结果的干扰可能会导致错误的诊断和治疗。这种干扰很难识别,更难处理。本报告描述了一个受到多种测量因子影响的病例,以及如何克服这种干扰:病例报告:免疫球蛋白 (Ig)G-lambda 多发性骨髓瘤标本中的副蛋白干扰了在 3 个平台上测量总胆红素、直接胆红素、无机磷酸盐、铁、铁蛋白和总甲状腺素的结果:AU5800、Alinity ci 和 cobas pure。用正常生理盐水稀释或聚乙二醇沉淀去蛋白后重复检测,部分或全部受影响的测量值结果不尽人意。用健康血清稀释干扰血清后进行的重复检测纠正了所有受影响测量值的异常结果:结论:用已知浓度的健康血清稀释副蛋白血清似乎是消除副蛋白干扰影响的最合适方法。
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引用次数: 0
Detection of decreased granules in neutrophils by automated hematology analyzers XR-1000 and UniCel DxH 800. 用自动血液分析仪 XR-1000 和 UniCel DxH 800 检测中性粒细胞中减少的颗粒。
Pub Date : 2024-11-04 DOI: 10.1093/labmed/lmae047
Yosuke Kato, Daisuke Sakamoto, Hiroaki Ohnishi, Tomohiko Taki

Objective: This study aimed to investigate the utility of neutrophil-related cell population data obtained by automated hematology analyzers in assessing myelodysplastic syndrome cases with decreased granules in neutrophils.

Methods: A total of 108 subjects were classified into normal granule (n = 35), hypogranulation (n = 37), or hypergranulation (n = 36) groups. Neutrophil cell area and granule area were measured by ImageJ. All samples were analyzed on the XR-1000 and UniCel DxH 800, and neutrophil-related parameters were compared among the 3 groups.

Results: Neutrophil cell area and the ratio of the granular area showed significant differences among the 3 groups; they were the highest in the hypergranulation group and lowest in the hypogranulation group. XR-1000 data showed significant differences in NE-SFL and NE-FSC among the 3 groups (P < .0001). NE-SFL and NE-FSC discriminated most accurately hypogranulation group against other groups. UniCel DxH 800 data showed significant differences in MN-V-NE, MN-MALS-N, MN-UMALS-NE, SD-UMALS-NE (P <.01), MN-LMALS-NE, and SD-LMALS-NE (P <.05) among the 3 groups. The combination of SD-V-NE and SD-LMALS-NE discriminated most accurately the hypogranulation group against the other groups.

Conclusion: NE-SFL and NE-FSC and the combination of SD-V-NE and SD-LMALS-NE are useful in detecting cases with decreased granules in neutrophils.

研究目的本研究旨在探讨自动血液分析仪获得的中性粒细胞相关细胞群数据在评估中性粒细胞颗粒减少的骨髓增生异常综合征病例中的实用性:共有108名受试者被分为颗粒正常组(35人)、颗粒减少组(37人)或颗粒增多组(36人)。中性粒细胞面积和颗粒面积由 ImageJ 测量。所有样本均在 XR-1000 和 UniCel DxH 800 上进行分析,并对 3 组中性粒细胞相关参数进行比较:结果:中性粒细胞面积和颗粒面积比值在3组间存在显著差异;高颗粒化组最高,低颗粒化组最低。XR-1000 数据显示,NE-SFL 和 NE-FSC 在 3 组间存在显著差异(P < .0001)。NE-SFL 和 NE-FSC 对低粒度组和其他组的区分最为准确。UniCel DxH 800 数据显示,MN-V-NE、MN-MALS-N、MN-UMALS-NE、SD-UMALS-NE 存在显著差异(P < 0.0001):NE-SFL和NE-FSC以及SD-V-NE和SD-LMALS-NE组合可用于检测中性粒细胞颗粒减少的病例。
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引用次数: 0
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Laboratory medicine
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