Practical Laboratory Medicine最新文献_第4页

Application of sigma-based quality control rules for the efficiency of internal quality control 应用基于sigma的质量控制规则提高内部质量控制的效率

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-30 DOI: 10.1016/j.plabm.2025.e00501

Hyunji Choi , Ina Jeong , Jeongeun Cheon , Chul-Min Park , Sun Min Lee

Background

Ensuring stability in medical laboratories through quality control (QC) is crucial and requires fitted rules to prevent false alerts and identify errors. This study demonstrates how the introduction of new QC rules to align with individual total allowable error (TEa) affects laboratory efficiency and error detection.

Methods

Changes in the performance of 26 biochemical tests before and after applying new internal quality control (IQC) rules were studied. Pre-Phase utilized uniform QC rules (1–3s, 2-2s, 2/3-2s, R-4s, 4-1s, and 12-x) while Post-Phase adopted new QC rules selected using Westgard Adviser (Bio-Rad Inc., USA). Sigma metrics were calculated using TEa and precision and bias from IQC data, compared to the peer group. Efficiency was assessed by comparing QC-repeat rates, turnaround times (TAT), and proficiency test (PT) results.

Results

QC-repeats due to violations averaged 5.6 % in the Pre-Phase and decreased to 2.5 % in the Post-Phase. As a result, the rate of out-of-TAT in peak-time decreased from 29.4 % to 15.2 %. In Pre-Phase, 67 of 271 cases exceeded the 2 standard deviation index (SDI) in the PT, which was reduced to 24 cases in Post-Phase. Cases exceeding the 3 SDI significantly decreased from 27 to 4 in the Post-Phase.

Conclusion

The introduction of sigma-based rules in the internal quality control process improved laboratory efficiency by reducing QC-repeat, recalibration, and TAT while maintaining quality, demonstrating a valuable balance between efficiency and analytical performance.

背景：通过质量控制（QC）确保医学实验室的稳定性至关重要，需要适当的规则来防止虚假警报和识别错误。本研究展示了如何引入新的质量控制规则，以配合个人总允许误差（TEa）影响实验室效率和错误检测。方法对26项生化指标应用新内控规则前后的性能变化进行研究。前期采用统一的QC规则（1-3s、2-2s、2/3-2s、R-4s、4-1s和12-x），后期采用由Westgard Adviser （Bio-Rad Inc.， USA）选择的新QC规则。与同行组相比，使用TEa和IQC数据的精度和偏倚来计算Sigma指标。通过比较QC-repeat率、周转时间（TAT）和熟练程度测试（PT）结果来评估效率。结果在前阶段，由于违规导致的qc -repeat平均为5.6%，在后阶段下降到2.5%。其结果是，在高峰时间，不符合tat的比率从29.4%下降到15.2%。在前期，271例患者中有67例超过PT的2标准差指数（SDI），在后期减少到24例。超过3sdi的病例在后期从27例明显减少到4例。在内部质量控制过程中引入基于西格玛的规则，在保持质量的同时，通过减少QC-repeat、重新校准和TAT，提高了实验室效率，展示了效率和分析性能之间的宝贵平衡。

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引用次数: 0

Tumor-informed circulating tumor DNA detection for personalized monitoring of treatment response in epithelial ovarian cancer 肿瘤信息循环肿瘤DNA检测用于上皮性卵巢癌治疗反应的个性化监测

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-26 DOI: 10.1016/j.plabm.2025.e00500

Sung Wan Kang , Ok-Ju Kang , Young-Jae Lee , Hee Jung Jung , Min-Seo Lee , Ji-Young Lee , Yong-Man Kim , Shin-Wha Lee

Background

Circulating tumor DNA (ctDNA) has emerged as a valuable biomarker in liquid biopsies for monitoring treatment responses in cancer patients. However, detecting ctDNA in epithelial ovarian cancer (EOC) is challenging due to its high heterogeneity and the absence of hotspot driver mutations. Therefore, a personalized approach to ctDNA analysis is essential, tailored to the specific tumor mutations of each EOC patient. In this study, we aimed to evaluate a droplet digital PCR (ddPCR) method targeting various genetic alterations in ctDNA identified through a targeted next-generation sequencing (NGS) panel in EOC tumors.

Methods

EOC tumor tissues were sequenced using a targeted NGS panel to identify oncogenic mutations. ddPCR assays were subsequently designed and optimized to detect these tumor-specific mutations in ctDNA. ctDNA levels were monitored and compared with CA-125 for EOC.

Results

Fourteen pathogenic mutations, including TP53, PIK3CA, PTEN, KRAS, and RB1, were identified in 13 patients with EOC and selected as targets for ctDNA detection. The performance of ddPCR assays was validated for 10 mutations, and mutated ctDNA was successfully detected for 8 mutations in 7 patients. In most cases, ctDNA levels showed trends consistent with CA-125 levels, reflecting the treatment response. However, in one case, PTEN (E91∗) mutated ctDNA was detected during recurrence, while CA-125 levels remained within the normal range.

Conclusion

This study demonstrates the clinical utility of ddPCR for monitoring treatment responses in EOC by targeting patient-specific mutations. Integrating ddPCR with NGS-based mutation identification offers an effective approach for assessing therapeutic outcomes in EOC patients.

循环肿瘤DNA （ctDNA）已成为监测癌症患者治疗反应的液体活检中有价值的生物标志物。然而，由于上皮性卵巢癌（EOC）的高异质性和缺乏热点驱动突变，检测ctDNA具有挑战性。因此，针对每个EOC患者的特定肿瘤突变，个性化的ctDNA分析方法至关重要。在这项研究中，我们旨在评估一种液滴数字PCR （ddPCR）方法，该方法针对通过靶向下一代测序（NGS）小组鉴定的EOC肿瘤中ctDNA的各种遗传改变。方法采用靶向NGS技术对seoc肿瘤组织进行测序，鉴定致癌突变。随后设计并优化了ddPCR检测方法，以检测ctDNA中这些肿瘤特异性突变。监测ctDNA水平，并与CA-125进行比较。结果13例EOC患者共检出TP53、PIK3CA、PTEN、KRAS、RB1等14个致病突变，并选择这些突变作为ctDNA检测的靶点。验证了ddPCR检测10个突变的性能，并成功检测了7例患者中8个突变的ctDNA。在大多数情况下，ctDNA水平显示出与CA-125水平一致的趋势，反映了治疗反应。然而，在一个病例中，复发期间检测到PTEN （E91∗）突变的ctDNA，而CA-125水平仍在正常范围内。结论本研究证明了ddPCR通过靶向患者特异性突变来监测EOC治疗反应的临床应用价值。将ddPCR与基于ngs的突变鉴定相结合，为评估EOC患者的治疗效果提供了有效的方法。

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引用次数: 0

Prognostic value of baseline plasma D-dimer levels in sepsis: a prospective cohort study 基线血浆d -二聚体水平在脓毒症中的预后价值：一项前瞻性队列研究

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-23 DOI: 10.1016/j.plabm.2025.e00498

Xiaoxiao Qu , Shishi Wang , Xuanmei Ye , Guosong Jiang , Mihereguli Kuerban , Qipeng Xie

Background

Plasma D-dimer, a fibrin degradation product, reflects coagulation activation and is often elevated in critically ill patients. Its prognostic significance in sepsis, particularly for short-term outcomes, remains unclear.

Methods

In this prospective cohort study, we enrolled 175 adult ICU patients with sepsis (Sepsis-3 criteria) from March 2024 to February 2025. Plasma D-dimer levels were measured at ICU admission and daily for five days. D-dimer levels were categorized into quartiles. The primary outcome was 30-day all-cause mortality; secondary outcome was in-hospital septic shock. Associations were analyzed using Cox regression, Kaplan–Meier analysis, and subgroup analysis.

Results

Elevated admission D-dimer levels were significantly associated with increased risks of 30-day mortality and septic shock. Each 1 μg/mL increase in D-dimer was linked to a 6 % higher mortality risk (HR = 1.06; 95 % CI: 1.02–1.11; P = 0.008) and an 8 % higher septic shock risk (HR = 1.08; 95 % CI: 1.03–1.12; P < 0.001), after adjusting for confounders. Patients in the highest quartile had the worst outcomes. A significant interaction with serum amyloid A (SAA) was observed for mortality (P = 0.043), but not for septic shock.

Conclusion

Baseline plasma D-dimer levels independently predict 30-day mortality and septic shock in sepsis. D-dimer may serve as a valuable early biomarker for risk stratification in sepsis management.

血浆d -二聚体是一种纤维蛋白降解产物，反映凝血激活，在危重患者中经常升高。其在脓毒症中的预后意义，特别是短期预后，尚不清楚。方法在这项前瞻性队列研究中，我们从2024年3月至2025年2月招募了175名患有脓毒症（脓毒症-3标准）的成人ICU患者。在ICU入院时和连续5天每天测量血浆d -二聚体水平。d -二聚体水平分为四分位数。主要终点为30天全因死亡率；次要结局是院内感染性休克。采用Cox回归、Kaplan-Meier分析和亚组分析分析相关性。结果入院d -二聚体水平升高与30天死亡率和感染性休克风险增加显著相关。校正混杂因素后，d -二聚体每增加1 μg/mL，死亡风险增加6% (HR = 1.06; 95% CI: 1.02-1.11; P = 0.008)，感染性休克风险增加8% （HR = 1.08; 95% CI: 1.03-1.12; P < 0.001）。最高四分位数的患者预后最差。血清淀粉样蛋白A （SAA）与死亡率有显著的相互作用（P = 0.043），但与感染性休克无关。结论基线血浆d -二聚体水平可独立预测败血症患者30天死亡率和感染性休克。d -二聚体可以作为脓毒症管理风险分层的有价值的早期生物标志物。

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引用次数: 0

Quantitative diagnostic method to detect Gardnerella vaginalis by droplet digital PCR 应用微滴数字PCR检测阴道加德纳菌的定量诊断方法

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-22 DOI: 10.1016/j.plabm.2025.e00499

Yong-Zhuo Zhou , Yun-Hu Zhao , Yan-Lan Chen , Wei-Zhen Fang , Bi-Si Liang , Xu-Guang Guo , Chao-Hui Duan , Hui-Ling Hu

Background

Nucleic Acid Amplification Tests (NAAT) remain one of the most reliable methods for pathogen identification. Given the high false-negative rates associated with traditional staining and microscopic examination, the time-consuming nature and low sensitivity of bacterial culture methods, as well as the inability of conventional NAAT to achieve absolute quantification.

Methods

To achieve rapid and quantitative detection of Gardnerella vaginalis, we selected the 23S rRNA gene as the target for identification and developed a droplet digital PCR detection method.

Results

The entire detection process can be completed within 92 min, demonstrating high efficiency. The sensitivity reached 4.4 pg/μL, and no positive droplets were detected in experiments involving eight negative control pathogens, confirming high specificity. Additionally, the ddPCR assay for Gardnerella vaginalis exhibited excellent repeatability, with a calculated coefficient of variation of 1 %.

Conclusion

The ddPCR detection technology demonstrates characteristics such as absolute quantification, high sensitivity, high specificity, and high reproducibility for Gardnerella vaginalis, showing promise as an excellent testing platform. This advancement could provide a more scientific basis for clinical diagnosis and treatment.

核酸扩增试验（NAAT）仍然是最可靠的病原体鉴定方法之一。鉴于传统染色和显微镜检查的高假阴性率，细菌培养方法的耗时和低灵敏度，以及传统NAAT无法实现绝对定量。方法为了实现对阴道加德纳菌的快速定量检测，我们选择23S rRNA基因作为鉴定靶点，建立了一种液滴数字PCR检测方法。结果整个检测过程可在92 min内完成，效率高。灵敏度达4.4 pg/μL， 8种阴性对照病原菌均未检出阳性液滴，具有较高的特异性。此外，阴道加德纳菌的ddPCR检测具有良好的重复性，计算的变异系数为1%。结论ddPCR检测技术对阴道加德纳菌具有绝对定量、高灵敏度、高特异性、高重复性等特点，是一种良好的检测平台。这一进展可为临床诊断和治疗提供更科学的依据。

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引用次数: 0

Comprehensive and translational pathobiology of COVID-19 based on cellular and molecular techniques 基于细胞和分子技术的COVID-19综合和转化病理生物学

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-11 DOI: 10.1016/j.plabm.2025.e00497

Ali Akbar Samadani , Sogand Vahidi , Kosar Babaei , Seyedeh Elham Norollahi , Kourosh Delpasand , Elaheh Asghari Gharakhyli

The biggest health issue in the world right now is the COVID-19 pandemic. This outbreak has caused a lot more people to be hospitalized for pneumonia and serious health problems, leading to many deaths. This report talks about many studies that showed the causes and how common COVID-19 is, as well as how to diagnose it in clinics and labs, and how to prevent and control it. These studies are very important and directly related to COVID-19 to help manage the current public emergency. Many parts of this dangerous disease, like how it spreads, how to diagnose it, how it infects people, and how to treat it, are still not well understood. It's important that to prevent, diagnose, and treat COVID-19 well, we need research at the molecular and clinical levels, along with public health measures and medical treatments. Clearly, new treatments like mesenchymal stem cell therapy have shown great promise in this area. Here, we will talk about and show the advanced lab methods used to understand how COVID-19 spreads, how it is diagnosed, and how it can be treated.

目前世界上最大的健康问题是COVID-19大流行。这次疫情爆发导致更多的人因肺炎和严重的健康问题住院，导致许多人死亡。本报告讨论了许多研究，这些研究显示了COVID-19的原因和常见程度，以及如何在诊所和实验室诊断它，以及如何预防和控制它。这些研究对帮助管理当前的突发公共事件非常重要，并与COVID-19直接相关。这种危险疾病的许多方面，如它如何传播、如何诊断、如何感染人以及如何治疗，仍然没有得到很好的了解。重要的是，为了预防、诊断和治疗COVID-19，我们需要在分子和临床层面进行研究，以及公共卫生措施和医学治疗。显然，像间充质干细胞疗法这样的新疗法在这一领域显示出巨大的希望。在这里，我们将讨论并展示用于了解COVID-19如何传播，如何诊断以及如何治疗的先进实验室方法。

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引用次数: 0

Target recycling amplification (TRA) combined with multiple strand displacement amplification (SDA) for sensitive detection of Epstein-Barr virus microRNA. 靶向再循环扩增（TRA）联合多链位移扩增（SDA）灵敏检测eb病毒microRNA。

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-06 eCollection Date: 2025-09-01 DOI: 10.1016/j.plabm.2025.e00496

Yuying Ye, Guoqing Wu, Siying Wang, Feng Zhou, Yafei Su, Guiyu Zhou, Yusheng Lu, Hui Wu

Objectives: Epstein-Barr virus (EBV) infection is strongly associated with the development of nasopharyngeal carcinoma. However, existing diagnostic methods based on EBV antibodies and plasma DNA exhibit insufficient sensitivity and specificity for early detection. This study aimed to overcome this limitation by developing a highly sensitive and specific method for detecting the EBV-encoded biomarker microRNA miR-BART6-3p.

Methods: We designed a probe (EB4) containing a C-rich sequence, a restriction endonuclease half-recognition site, a G-rich stem-loop structure, and a target recognition domain. Based on this probe, an isothermal fluorescence platform was developed by integrating target recycling amplification (TRA) with strand displacement amplification (SDA). The detection mechanism relies on miR-BART6-3p initiating a polymerase-endonuclease cycle, which generates G-quadruplex structures and target-like DNA. The fluorescence signal is produced when Thioflavin T (ThT) binds to these G-quadruplexes. The sensitivity, specificity, and anti-interference capability of the method were systematically evaluated.

Results: The assay exhibited a broad linear detection range for miR-BART6-3p, spanning from 1 pM to 100 nM, with an ultra-low detection limit of 0.143 pM, thereby demonstrating significantly enhanced sensitivity compared to conventional methods. The assay also displayed high specificity, effectively differentiating targets with single-base mismatches. Clinical evaluation using serum samples revealed markedly elevated fluorescence signals in EBV-positive patients relative to healthy controls. Furthermore, the platform exhibited strong anti-interference capability, ensuring reliable performance under complex biological conditions.

Conclusions: This study successfully developed a one-step, single-probe method for detecting EBV miRNA (miR-BART6-3p) with high sensitivity and specificity. The TRA-SDA platform provides operational simplicity, high interference resistance, and superior diagnostic performance. This innovative approach shows great clinical application prospects as a molecular diagnostic tool for the early detection of nasopharyngeal carcinoma.

目的：eb病毒（EBV）感染与鼻咽癌的发展密切相关。然而，现有的基于EBV抗体和血浆DNA的诊断方法对早期发现的敏感性和特异性不足。本研究旨在通过开发一种高灵敏度和特异性的方法来检测ebv编码的生物标志物microRNA miR-BART6-3p，从而克服这一限制。方法：我们设计了一个探针（EB4），包含一个富含c的序列、一个限制性内切酶半识别位点、一个富含g的茎环结构和一个目标识别域。基于该探针，将靶循环扩增（TRA）与链位移扩增（SDA）相结合，建立了等温荧光平台。检测机制依赖于miR-BART6-3p启动聚合酶-核酸内切酶循环，产生g -四重体结构和靶样DNA。当硫黄素T （ThT）与这些g -四联体结合时产生荧光信号。系统评价了该方法的灵敏度、特异度和抗干扰能力。结果：该方法对miR-BART6-3p具有较宽的线性检测范围，从1 pM到100 nM，超低检出限为0.143 pM，与传统方法相比，灵敏度显着提高。该检测还显示出高特异性，可以有效地区分单碱基不匹配的靶标。使用血清样本的临床评估显示ebv阳性患者的荧光信号明显高于健康对照组。此外，该平台具有较强的抗干扰能力，确保了在复杂生物条件下的可靠性能。结论：本研究成功建立了一步、单探针检测EBV miRNA （miR-BART6-3p）的方法，具有较高的灵敏度和特异性。TRA-SDA平台提供操作简单，高抗干扰性和卓越的诊断性能。该方法作为鼻咽癌早期诊断的分子诊断工具具有广阔的临床应用前景。

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引用次数: 0

Prenatal diagnosis and genetic counseling of a case with trisomy 20 mosaicism and mixed-type maternal UPD20 20三体嵌合伴混型母体UPD20 1例的产前诊断与遗传咨询

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-08-02 DOI: 10.1016/j.plabm.2025.e00495

Yun Huang , Fang Li , Xiaofeng Li , He Wang

Background

To genetically analyze a prenatal specimen exhibiting mosaic 20q11.2 microdeletion syndrome with uniparental disomy of chromosome 20 (UPD20). The aim is to summarize the symptoms and prognosis of fetuses with this condition and provide guidance for genetic counseling and prenatal diagnosis in similar cases.

Methods

Chromosomal karyotyping and Chromosomal Microarray Analysis (CMA) were performed on prenatal amniotic fluid specimens and peripheral blood samples from the parents.

Results

The karyotype analysis of the fetal amniotic fluid cells revealed a mosaic pattern of 46,XN,+20[80]/46,XN[20], indicating an 80 % mosaicism ratio. The CMA results showed arr20p13q13.33(61,662–62,913,645)x2-3 mos with an 11 % mosaicism ratio and arr20p12.2q13.2(9,484,368–50,586,616)x2 hmz, inherited from the mother.

Conclusion

Through interdisciplinary team discussion and analysis of a 42-year-old pregnant woman's fetus exhibiting mosaic 20q11.2 microdeletion syndrome with mixed-type maternal UPD20, relevant genetic counseling was provided to the pregnant woman, assisting in informed decision-making. The reporting of this case is significant for summarizing the symptoms and prognosis of fetuses with this condition and guiding prenatal diagnosis and genetic counseling in similar cases.

背景：对一例20号染色体单亲二体嵌合20q11.2微缺失综合征的产前标本进行遗传分析。目的是总结该疾病胎儿的症状和预后，并为类似病例的遗传咨询和产前诊断提供指导。方法对父母产前羊水标本和外周血标本进行染色体核型分析和染色体微阵列分析。结果胎儿羊水细胞核型分析显示46、XN、+20[80]/46、XN[20]的嵌合模式，嵌合比例为80%。CMA结果显示，arr20p13q13.33(61,662-62,913,645)x2-3 mhz，嵌合率为11%，arr20p12.2q13.2(9,484,368-50,586,616)x2 mhz遗传自母亲。结论通过跨学科团队讨论和分析一名42岁孕妇胎儿嵌合20q11.2微缺失综合征伴混型母体UPD20，为孕妇提供相关的遗传咨询，帮助其做出明智的决策。本病例的报道对总结本病胎儿的症状和预后，指导类似病例的产前诊断和遗传咨询具有重要意义。

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引用次数: 0

Diagnostic value of full blood count derived systemic inflammatory biomarkers in malaria infection 全血细胞计数衍生的全身炎症生物标志物在疟疾感染中的诊断价值

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-07-17 DOI: 10.1016/j.plabm.2025.e00494

Joseph Boachie , Derrick Ahiable , Leticia Awonbiistemi Ajabuin , Richard Amissah , Abigail Asmah-Brown , Safianu Apalebilah , Ama Gyasiwaah Owusu-Poku , Henrietta Eshun , Patrick Adu , Joel Karikari Nyarkoh

Background

Malaria remains a public health issue. Its associated inflammatory responses can easily shift from benefit to detriment, making early detection of malarial inflammation crucial. The full blood count promises to be a less expensive assay serving as a surrogate marker for inflammation. This study, therefore, aimed to determine the diagnostic value of FBC-derived systemic inflammatory biomarkers in malaria infection.

Method

We employ a single point case-control design that included 45 malaria patients and 50 healthy individuals. We collected their anthropometric, sociodemographic, and clinical information. FBC estimation and malaria parasite enumeration were determined for each participant.

Results

Malaria patients had higher values of all the systemic inflammatory biomarkers (monocyte-to-lymphocyte ratio (MLR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and aggregate index of systemic inflammation (AISI)) compared with healthy individuals. There was significant moderate correlation between parasite count and NLR, and MLR (ρ = 0.5 and ρ = 0.4) and a weak negative correlation with PLR and AISI (ρ = - 0.2 each). A receiver operator characteristic (ROC) curve analysis showed that NLR (AUC = 0.937) had an excellent diagnostic and predictive value, with sensitivity of 86.7 % and specificity of 92.0 %.

Conclusion

We have shown that the FBC-derived inflammatory biomarker— NLR— increases as parasite count increases. At a level of 2.12 and above, NLR is 86.7 % sensitive and 92.0 % specific in identifying the inflammatory state in malaria patients. Our findings show that the FBC-derived systemic inflammatory biomarkers provide a solution to the need for cost-effective surrogate inflammatory markers, especially in resource-deprived areas.

疟疾仍然是一个公共卫生问题。疟疾相关的炎症反应很容易由有益转为有害，因此早期发现疟疾炎症至关重要。全血细胞计数有望成为一种较便宜的检测方法，作为炎症的替代标志物。因此，本研究旨在确定fbc来源的全身炎症生物标志物在疟疾感染中的诊断价值。方法采用单点病例对照设计，纳入45例疟疾患者和50例健康人。我们收集了他们的人体测量学、社会人口学和临床信息。确定每个参与者的FBC估计和疟原虫计数。结果疟疾患者的所有全身炎症生物标志物（单核细胞与淋巴细胞比值（MLR）、中性粒细胞与淋巴细胞比值（NLR）、血小板与淋巴细胞比值（PLR）和全身炎症综合指数（AISI））均高于健康人群。寄生虫数量与NLR、MLR呈显著的中度相关（ρ = 0.5和0.4），与PLR和AISI呈弱负相关（ρ = - 0.2）。ROC曲线分析显示NLR （AUC = 0.937）具有良好的诊断和预测价值，敏感性为86.7%，特异性为92.0%。结论fbc衍生的炎症生物标志物NLR随着寄生虫数量的增加而增加。在2.12及以上的水平上，NLR识别疟疾患者炎症状态的敏感性为86.7%，特异性为92.0%。我们的研究结果表明，fbc衍生的系统性炎症生物标志物提供了一个解决方案，以满足对具有成本效益的替代炎症标志物的需求，特别是在资源匮乏地区。

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引用次数: 0

Rapid identification of daratumumab interference with M-protein detection using MALDI-TOF mass spectrometry: a case study involving renal light chain amyloidosis 使用MALDI-TOF质谱快速鉴定daratumumab对m蛋白检测的干扰：涉及肾脏轻链淀粉样变性的案例研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-07-15 DOI: 10.1016/j.plabm.2025.e00493

Hou-Long Luo , Anping Xu , Ling Ji

Therapeutic monoclonal antibodies (t-mAbs), such as daratumumab (anti-CD38), are increasingly used in plasma cell disorders including systemic AL amyloidosis. However, their exogenous IgG kappa/lambda components can mimic endogenous monoclonal immunoglobulins in serum immunofixation electrophoresis (IFE), leading to diagnostic challenges. We report a 48-year-old male with biopsy-confirmed lambda-restricted renal AL amyloidosis. After transitioning to daratumumab-CyBorD therapy following CyBorD failure, his serum IFE unexpectedly revealed biclonal bands—a cathodal IgG kappa and anodal IgG lambda—suggesting biclonal gammopathy. Suspecting daratumumab interference (an IgG kappa antibody), we employed mass spectrometry (iMS-LC assay) for definitive analysis. Post-treatment serum showed two distinct peaks (endogenous lambda: m/z 22,718; daratumumab kappa: m/z 23,389), while pre-treatment serum contained only the endogenous lambda peak (m/z 22,716). This confirms daratumumab generates a cathodal IgG kappa band mimicking pathological gammopathy. To prevent diagnostic errors in plasma cell disorder monitoring, laboratories should proactively identify t-mAb interference using historical controls and targeted mass spectrometry.

治疗性单克隆抗体（t- mab），如达拉单抗（抗cd38），越来越多地用于包括全身性AL淀粉样变性在内的浆细胞疾病。然而，它们的外源性IgG kappa/lambda成分在血清免疫固定电泳（IFE）中可以模拟内源性单克隆免疫球蛋白，从而导致诊断挑战。我们报告一位48岁男性患者，活检证实为lambda-restricted renal AL淀粉样变。在CyBorD失败后改用达拉图单抗-CyBorD治疗后，他的血清IFE出乎意料地显示双克隆带-一个阴性IgG kappa和一个阴性IgG lambda -提示双克隆伽玛病。怀疑是daratumumab干扰（一种IgG kappa抗体），我们采用质谱法（iMS-LC测定）进行确定分析。治疗后血清出现两个明显的峰值(内源性lambda: m/z 22,718；Daratumumab kappa: m/z 23,389)，而预处理血清仅含有内源性lambda峰（m/z 22,716）。这证实了daratumumab产生一个模拟病理性伽玛病的阴极IgG κ pa带。为了防止浆细胞疾病监测中的诊断错误，实验室应使用历史对照和靶向质谱法主动识别t-mAb干扰。

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引用次数: 0

Evaluation of harmonization among thyroid hormone testing systems: A comparative study based on external quality assessment data 甲状腺激素检测系统一致性评价：基于外部质量评价数据的比较研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-07-09 DOI: 10.1016/j.plabm.2025.e00491

Lirui Kong , Yanqun Liu , Chaoqiong Zhou , Dahai He , Xiaoheng Wu , Ying Huang , Yehong Xie , Xiaohua Xu , Lin Wang , Feng Wu , Yan Zhang

Objective

To evaluate thyroid hormone test harmonization using external quality assessment (EQA) data, guiding laboratory quality enhancement and big data interoperability.

Methods

EQA data for T3, T4, FT3, FT4, and TSH from January 2022 to December 2024 were collected. We calculated the total allowable error for both our laboratory (TEa-Lab) and peer groups (TEa-peer) using bias and coefficient of variation data. We derived harmonization indices (HI) by comparing TEa values against three biological variation thresholds (minimum, desirable, and optimal). An HI value ≤ 1 indicated satisfactory harmonization.

Results

The TSH test in our laboratory showed desirable harmonization; however, the HI for T3, T4, FT3, and FT4 ranged from 1.1 to 1.9, failing to reach the minimum harmonization level. Among the peer group tests, the level of coordination of each analysis system varies, and the harmonization levels ranging from below the minimum to the optimal harmonization level, even failing to reach the minimum level. The harmonization level of thyroid hormones between our laboratory and peer groups showed strong consistency.

Conclusion

The HI values quantitatively calculated from EQA data accurately reflect the harmonization level between thyroid hormone testing systems in the laboratory and peer groups. This helps identify laboratory issues and implement corrective actions, providing a reference for laboratory big data interoperability and clinical decision-making.

目的利用外部质量评价（EQA）数据评价甲状腺激素检测的一致性，指导实验室质量提升和大数据互操作性。方法收集2022年1月至2024年12月患者T3、T4、FT3、FT4和TSH的seqa数据。我们使用偏倚和变异系数数据计算了我们实验室（TEa-Lab）和同行组（TEa-peer）的总允许误差。我们通过比较TEa值与三个生物变异阈值（最小值、理想值和最优值），推导出协调指数（HI）。HI值≤1表示协调满意。结果本实验室TSH检测结果一致性较好；然而，T3、T4、FT3和FT4的HI在1.1至1.9之间，未能达到最低协调水平。在同侪组测试中，各分析系统的协调程度各不相同，协调程度从低于最低协调程度到最佳协调程度不等，甚至没有达到最低协调程度。甲状腺激素的协调水平在我们的实验室和同龄人之间显示出很强的一致性。结论根据EQA数据定量计算的HI值准确反映了实验室甲状腺激素检测系统与同行群体的协调水平。这有助于识别实验室问题并实施纠正措施，为实验室大数据互操作性和临床决策提供参考。

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引用次数: 0