Practical Laboratory Medicine最新文献_第2页

Can the icteric index be used instead of total bilirubin in addition to being a preanalytical marker? Icteric index in the laboratory 黄疸指数除了作为分析前标记外，是否可以代替总胆红素？实验室黄疸指数

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-10-22 DOI: 10.1016/j.plabm.2025.e00509

Merve Sena Odabasi, Zeynep Mine Yalcinkaya Kara

Background

The icteric index (I-index) is a practical and low-cost method for screening hyperbilirubinemia and potentially reducing unnecessary total bilirubin (TBil) testing. This study was designed to determine a safe I-index to detect TBil above the upper reference range to avoid unnecessary TBil orders. The reflexive addition of TBil in samples where I-index is above the cut-off value and TBil measurement is not initially planned will be a secondary gain of the study.

Methods

This study included 267185 samples with TBil test results and corresponding I-index values. TBil and I-index values were measured with the Roche Cobas 8000 (c701) and Cobas 6000 (c501) analyzers. Statistical analyses were performed using SPSS 15.0, with ROC curve analysis used to determine the optimal I-index cut-off for TBil screening.

Results

An I-index cut-off of 34.2 μmol/L provided the lowest false negativity (0.45 %), highest specificity (97.1 %), and negative predictive value (99.5 %). Using this cut-off point, if we had reached 100 % NPV, 87.4 % of TBil tests in the group receiving inpatient/outpatient treatment with Cobas-8000 and 89.8 % in the emergency group with Cobas 6000 could have been saved.

Conclusions

This is the study with the largest sample size. The sample size is critical in determining a reliable I-index cut-off point. We conclude that I-index should not replace TBil since the NPV was not 100 %; however, it seems reasonable to reflexively add TBil testing in samples where the I-index is above the cut-off value and TBil measurement was not initially planned.

黄疸指数（I-index）是一种实用且低成本的筛查高胆红素血症的方法，并可能减少不必要的总胆红素（TBil）检测。本研究旨在确定一种安全的i -指数来检测高于上参考范围的TBil，以避免不必要的TBil顺序。在i指数高于临界值且最初未计划测量TBil的样品中反射性添加TBil将是本研究的次要增益。方法本研究纳入267185例TBil检测结果及相应i指数值的样本。采用罗氏Cobas 8000 （c701）和Cobas 6000 （c501）分析仪测定TBil和i指数值。采用SPSS 15.0进行统计学分析，采用ROC曲线分析确定TBil筛选的最佳i指数截止值。结果sani指数截止值为34.2 μmol/L，假阴性最低（0.45%），特异性最高（97.1%），阴性预测值为99.5%。使用这个分界点，如果我们达到100%的NPV，接受Cobas-8000住院/门诊治疗组中87.4%的TBil检测可以挽救，接受Cobas- 6000急诊组中89.8%的TBil检测可以挽救。这是样本量最大的研究。样本量对于确定可靠的i指数截止点至关重要。我们的结论是，由于净现值不是100%，i指数不应该取代TBil；然而，在i指数高于临界值且最初没有计划测量TBil的样品中，条件反射性地增加TBil检测似乎是合理的。

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引用次数: 0

Towards the clinical use of peripheral bile acids: Recommendations to limit their preanalytical and analytical sources of variability 外周胆汁酸的临床应用：限制其分析前和分析变异性来源的建议

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-10-10 DOI: 10.1016/j.plabm.2025.e00508

Sebastian Joseph , Sophie de Buyl , Isabelle A. Leclercq , Kristian Serafimov , Olivier Feron , Laure-Alix Clerbaux

Despite more than three decades of research, the use of peripheral bile acids as biomarkers for human liver injury remains inconclusive due to inconsistent findings. Identifying the factors contributing to the variability in published peripheral bile acid data in humans is needed to propose experimental recommendations that could enhance the robustness and reproducibility of future studies. Besides the peripheral blood bile acid data, the metadata on subject demographics (number of subjects, average age, sex distribution, health status, fasted/fed status), the blood matrix analyzed, the matrix volume analyzed, the bile acid extraction process, and analytical technique were extracted from 65 studies involving 215 patient cohorts. Bile acid concentrations in normal cohorts were found to exhibit large inter-study variability. The analytical technique used to measure bile acid concentrations, the fasted/fed status of patients at the time of sampling, the choice of blood collection matrix, the starting volume of this matrix, and the choice of protein precipitation solvent were found to be determinants of this variability. To address these determinants, procedural recommendations are proposed: liquid chromatography-tandem mass spectrometry should be used to measure absolute bile acid concentrations in 50

μ

l of plasma obtained from a fasted subject, with methanol as the protein precipitation solvent. A lack of studies meeting the recommended criteria makes it difficult to conclude whether variability is reduced. These recommendations must be standardized across future studies to enhance the clinical use of peripheral bile acids as biomarkers of liver injury in humans.

尽管经过三十多年的研究，由于研究结果不一致，外周胆汁酸作为人肝损伤的生物标志物的使用仍然没有定论。需要确定导致已发表的人类外周胆汁酸数据变异性的因素，以提出可以增强未来研究的稳健性和可重复性的实验建议。除外周血胆汁酸数据外，还从涉及215个患者队列的65项研究中提取了受试者人口统计数据（受试者人数、平均年龄、性别分布、健康状况、禁食/进食状况）、血液基质分析、基质体积分析、胆汁酸提取过程和分析技术。在正常队列中发现胆汁酸浓度表现出较大的研究间变异性。用于测量胆汁酸浓度的分析技术、取样时患者的禁食/喂养状态、血液采集基质的选择、基质的起始体积以及蛋白质沉淀溶剂的选择被发现是这种可变性的决定因素。为了解决这些决定因素，提出了程序建议：应使用液相色谱-串联质谱法测量从禁食受试者获得的50 μl血浆中绝对胆汁酸浓度，甲醇作为蛋白质沉淀溶剂。由于缺乏符合推荐标准的研究，因此很难得出是否减少了变异的结论。这些建议必须在未来的研究中标准化，以加强外周胆汁酸作为人类肝损伤生物标志物的临床应用。

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引用次数: 0

Performance evaluation of the new Dymind automated hematology analyzer 新型Dymind全自动血液学分析仪的性能评估

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-09-22 DOI: 10.1016/j.plabm.2025.e00507

Tipparat Penglong , Wanicha Tepakhan , Nasra Tehyoh , Yanisa Na Songkhla , Chakkrit Songnak , Kanitta Srinoun

Introduction

The Dymind automated hematology analyzer includes the five-part analyzers DF55 and DH76 and the six-part analyzer DH615, which features reticulocyte parameters and an artificial intelligence-driven analysis technology. This study evaluated the performance of these analyzers in assessing precision and conducting method comparisons to determine the diagnostic accuracy and clinical efficacy of the Dymind automated system.

Methods

We assessed precision and conducted a method comparison by analyzing complete blood count (CBC) and white blood cell (WBC) differential data from the Dymind DF55, DH76, and DH615. Results were compared with those from the Sysmex XN-3000 analyzer.

Results

The Dymind-series analyzers demonstrated high between-run precision for all CBC and WBC differential parameters. Method comparison revealed a strong correlation (r = 0.80–0.99) between the Dymind and Sysmex analyzers for most CBC parameters, except for mean corpuscular hemoglobin concentration and basophil counts.

Conclusions

The Dymind-series analyzer exhibited a strong analytical performance across all standard CBC and WBC differential count parameters, validating their precision and comparability with a reference system for routine hematological testing.

Dymind全自动血液学分析仪包括五部分分析仪DF55和DH76以及六部分分析仪DH615，其特点是网状红细胞参数和人工智能驱动的分析技术。本研究评估了这些分析仪在评估精度和进行方法比较方面的性能，以确定Dymind自动化系统的诊断准确性和临床疗效。方法通过分析Dymind DF55、DH76和DH615的全血细胞计数（CBC）和白细胞计数（WBC）差异数据，评估准确性并进行方法比较。将结果与Sysmex XN-3000分析仪进行比较。结果dymind系列分析仪对所有CBC和WBC差异参数均具有较高的运行间精度。方法比较显示，除了平均红细胞血红蛋白浓度和嗜碱性粒细胞计数外，Dymind和Sysmex分析仪在大多数CBC参数上具有很强的相关性（r = 0.80-0.99）。结论dymind系列分析仪在所有标准CBC和WBC差异计数参数中表现出很强的分析性能，验证了其精确性和与常规血液检测参考系统的可比性。

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引用次数: 0

Patient-based pre-classified real-time quality control with neural network (PCRTQC-NN) 基于患者的神经网络预分类实时质量控制

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-09-15 DOI: 10.1016/j.plabm.2025.e00506

Bo Zhou , Xiaoying Li , Shitong Cheng , Zhiwei Zhou , Hui Kang

Objectives

Patient-based real-time quality control (PBRTQC) is essential for clinical laboratory management but struggles with detecting small systematic errors. This study presents the patient-based pre-classified real-time quality control with neural network (PCRTQC-NN) model, utilizing neural networks to improve error detection by extracting analytical features from testing instruments.

Methods

Using PCRTQC's clustering analysis, we pre-classified and processed Na, CHOL, ALT, and CR data from 611,031 patients. A neural network autoencoder, trained using TensorFlow with mean squared error (MSE) as the loss function, extracted the testing instrument's analytical features under error-free conditions. Systematic errors were identified by comparing reconstruction residuals between test and reconstructed data. The average number of patient samples until error detection (ANPed) evaluated the model performance.

Results

The PCRTQC-NN's error detection surpasses traditional algorithms Compared to PCRTQC, it reduced the ANPed for ALT by 37 % (constant error, CE) and 22 % (proportional error, PE) at 1 total error allowable (TEa), with comparable results for other analytes. For 0.5 TEa errors, the ANPed for CHOL decreased by 23 % (CE) and 22 % (PE), for ALT by 14 % (CE) and 6 % (PE), and for CR by 4 % (CE) and 9 % (PE), enhancing error detection capabilities for analytes with high inter-individual variability and sensitivity to smaller errors.

Conclusions

PCRTQC-NN significantly enhances systematic error detection compared to PCRTQC, leveraging autoencoders to extract analytical features as discrete signals, thus improving SNR for high-variability analytes. It promises improved laboratory efficiency and inter-laboratory standardization via robust feature models. Future multi-center studies will validate broad applicability across diverse settings.

目的基于患者的实时质量控制（PBRTQC）对临床实验室管理至关重要，但难以发现小的系统错误。本研究提出了基于患者的神经网络预分类实时质量控制（PCRTQC-NN）模型，利用神经网络通过提取检测仪器的分析特征来改进错误检测。方法采用PCRTQC聚类分析，对611031例患者的Na、CHOL、ALT和CR数据进行预分类和处理。使用TensorFlow训练神经网络自编码器，以均方误差（MSE）作为损失函数，在无误差条件下提取测试仪器的分析特征。通过对比试验数据和重建数据的残差，识别系统误差。直到错误检测（ANPed）的患者样本的平均数量评估模型的性能。结果PCRTQC- nn的误差检测优于传统的PCRTQC算法，在允许的总误差（TEa）为1时，它将ALT的ANPed降低了37%（恒定误差，CE）和22%（比例误差，PE），与其他分析物的结果相似。对于0.5 TEa误差，CHOL的ANPed降低了23% （CE）和22% (PE)， ALT降低了14% （CE）和6% (PE)， CR降低了4% （CE）和9% (PE)，增强了对具有高个体间变异性和对较小误差敏感的分析物的错误检测能力。结论与PCRTQC相比，spcrtqc - nn显著增强了系统错误检测，利用自编码器作为离散信号提取分析特征，从而提高了高变异性分析的信噪比。它承诺通过鲁棒特征模型提高实验室效率和实验室间标准化。未来的多中心研究将验证在不同环境下的广泛适用性。

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引用次数: 0

Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening 无刮擦多靶点粪便RNA检测用于结直肠癌筛查的分析验证

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-09-03 DOI: 10.1016/j.plabm.2025.e00502

Erica K. Barnell , Kimberly Kruse , Elizabeth M. Wurtzler , Maya Crowder Scott , Andrew R. Barnell , Eric J. Duncavage

Background & aims

Traditional stool-based colorectal cancer (CRC) screening tests require patients to collect and swab their own stool, which can reduce adherence due to aversion and introduce variability from user error. A novel multitarget stool RNA test (mt-sRNA, ColoSense) eliminates the need for scraping or swabbing stool. Instead, patients merely deposit and ship a sample to the lab. Once recieved, laboratory technologists swab the sample and quantify hemoglobin concentrations using the fecal immunochemical test (FIT). This study evaluates the reliability and reproducibility of this in-laboratory fecal sampling method.

Methods

Analytical validation was performed by generating stool pools with known hemoglobin concentrations and exposing pools to various conditions prior to testing with the in-lab FIT. Analytical validation assessed freeze thaw stability, interfering substances, stool input volume, precision, and in-transit stability. Clinical equivalency was also evaluated.

Results

All studies met predefined acceptance criteria. The assay demonstrated stability for up to three freeze-thaw cycles. Interference testing with nine dietary substances showed no impact on assay performance. The in-lab FIT maintained accuracy across five different stool input volumes and demonstrated high precision. In-transit stability was confirmed for up to 120 hours, supporting sample robustness during shipping and handling. Clinical equivalency demonstrated in-lab FIT sensitivity of 78 % for CRC and 33 % for advanced adenomas, aligning with previously reported performance of the at-home FIT method.

Conclusions

Analytical validation of the in-lab FIT demonstrates the reliability and robustness of this streamlined, single-sample collection method. This improvement could enhance adherence and patient ease-of-use in stool-based CRC screening.

传统的基于粪便的结直肠癌（CRC）筛查测试要求患者收集并擦拭自己的粪便，这可能会由于厌恶而降低依从性，并引入用户错误的可变性。一种新型的多靶点粪便RNA测试（mt-sRNA, ColoSense）消除了刮拭粪便的需要。相反，患者只需将样本存放并运送到实验室。一旦收到样本，实验室技术人员将使用粪便免疫化学测试（FIT）擦拭样本并定量血红蛋白浓度。本研究评估了这种实验室粪便取样方法的可靠性和可重复性。方法通过生成已知血红蛋白浓度的粪便池，并在实验室FIT测试前将粪便池暴露于各种条件下进行分析验证。分析验证评估了冻融稳定性、干扰物质、粪便输入量、精度和运输稳定性。临床等效性也进行了评估。结果所有研究均符合预先设定的接受标准。该试验显示了长达三个冻融循环的稳定性。9种膳食物质的干扰试验对分析性能无影响。实验室FIT在五种不同的粪便输入体积中保持精度，并显示出很高的精度。在运输过程中的稳定性被证实长达120小时，支持样品在运输和处理过程中的稳健性。临床等效性表明，实验室FIT对结直肠癌的敏感性为78%，对晚期腺瘤的敏感性为33%，与先前报道的家用FIT方法的性能一致。结论实验室FIT的分析验证证明了该方法的可靠性和稳健性。这一改进可以提高基于粪便的CRC筛查的依从性和患者易用性。

{"title":"Analytical validation of a scrape-free multitarget stool RNA test for colorectal cancer screening","authors":"Erica K. Barnell , Kimberly Kruse , Elizabeth M. Wurtzler , Maya Crowder Scott , Andrew R. Barnell , Eric J. Duncavage","doi":"10.1016/j.plabm.2025.e00502","DOIUrl":"10.1016/j.plabm.2025.e00502","url":null,"abstract":"<div><h3>Background & aims</h3><div>Traditional stool-based colorectal cancer (CRC) screening tests require patients to collect and swab their own stool, which can reduce adherence due to aversion and introduce variability from user error. A novel multitarget stool RNA test (mt-sRNA, ColoSense) eliminates the need for scraping or swabbing stool. Instead, patients merely deposit and ship a sample to the lab. Once recieved, laboratory technologists swab the sample and quantify hemoglobin concentrations using the fecal immunochemical test (FIT). This study evaluates the reliability and reproducibility of this in-laboratory fecal sampling method.</div></div><div><h3>Methods</h3><div>Analytical validation was performed by generating stool pools with known hemoglobin concentrations and exposing pools to various conditions prior to testing with the in-lab FIT. Analytical validation assessed freeze thaw stability, interfering substances, stool input volume, precision, and in-transit stability. Clinical equivalency was also evaluated.</div></div><div><h3>Results</h3><div>All studies met predefined acceptance criteria. The assay demonstrated stability for up to three freeze-thaw cycles. Interference testing with nine dietary substances showed no impact on assay performance. The in-lab FIT maintained accuracy across five different stool input volumes and demonstrated high precision. In-transit stability was confirmed for up to 120 hours, supporting sample robustness during shipping and handling. Clinical equivalency demonstrated in-lab FIT sensitivity of 78 % for CRC and 33 % for advanced adenomas, aligning with previously reported performance of the at-home FIT method.</div></div><div><h3>Conclusions</h3><div>Analytical validation of the in-lab FIT demonstrates the reliability and robustness of this streamlined, single-sample collection method. This improvement could enhance adherence and patient ease-of-use in stool-based CRC screening.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"47 ","pages":"Article e00502"},"PeriodicalIF":1.3,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145019276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Advancements in laboratory diagnostics for HIV/MTB coinfection: Integrating conventional methods with emerging technologies HIV/MTB合并感染的实验室诊断进展：将传统方法与新兴技术相结合

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-09-01 DOI: 10.1016/j.plabm.2025.e00503

Yu Li , Hongjuan Wei , Limei Sun , Dongsong Tang , Tiantian Wang , Yanhua Yu

Individuals infected with the Human Immunodeficiency Virus (HIV) face an elevated risk of Mycobacterium tuberculosis (MTB) infection. Clinical diagnosis of HIV/MTB coinfection presents substantial challenges, with co-infected patients exhibiting high mortality rates and representing a critical public health burden. The diagnostic process is complicated by atypical clinical presentations, frequent extrapulmonary tuberculosis involvement, difficulties in obtaining adequate sputum specimens, and low mycobacterial loads in samples—factors that severely limit the utility of conventional diagnostic methods such as sputum smear microscopy. Furthermore, HIV-associated immunosuppression diminishes the reliability of immunological diagnostic approaches. Recent advancements in molecular diagnostics have revolutionized tuberculosis detection in this vulnerable population. This review critically evaluates current laboratory methods for MTB detection in HIV/MTB co-infected individuals, analyzing their diagnostic performance, inherent limitations, and clinical applicability across diverse healthcare settings.

感染人类免疫缺陷病毒（HIV）的个体面临结核分枝杆菌（MTB）感染的风险升高。艾滋病毒/结核分枝杆菌合并感染的临床诊断存在重大挑战，合并感染的患者死亡率高，是一个严重的公共卫生负担。由于临床表现不典型、经常累及肺外结核、难以获得足够的痰标本以及样本中分枝杆菌含量低，诊断过程变得复杂，这些因素严重限制了痰涂片镜检等传统诊断方法的应用。此外，hiv相关的免疫抑制降低了免疫诊断方法的可靠性。分子诊断的最新进展彻底改变了这一弱势群体的结核病检测。本综述批判性地评估了目前用于HIV/MTB合并感染者中MTB检测的实验室方法，分析了其诊断性能、固有局限性以及在不同医疗保健环境中的临床适用性。

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引用次数: 0

Corrigendum to “Validation of an assay for NGAL in a Pediatric Population” [Practical Laboratory Medicine, PLABM 486, e00486] “小儿NGAL测定方法的验证”的勘误表[实用检验医学，PLABM 486, e00486]

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-09-01 DOI: 10.1016/j.plabm.2025.e00489

Nazmin Bithi, Ridwan B. Ibrahim, Estella Tam, Radwa Almamoun, Annett C. Frenk Oquendo, Ayse Akcan-Arikan, Sridevi Devaraj

引用次数: 0

Comparative validation of low-density lipoprotein cholesterol estimation formulas in older Georgian adults 格鲁吉亚老年人低密度脂蛋白胆固醇估算公式的比较验证

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-09-01 DOI: 10.1016/j.plabm.2025.e00504

Gagua Nino, Mokvanidze Lizi, Kekenadze Nino

Introduction

Low-density lipoprotein cholesterol (LDL-C) is a critical marker for cardiovascular risk assessment. Although direct measurement offers high accuracy, it is often cost-prohibitive and impractical for routine use in low- and middle-income countries. Multiple formulas, including those by Friedewald, de Cordova, and Chen, have been proposed to estimate LDL-C, though their accuracy varies across populations. This study evaluated the performance of eight LDL-C estimation formulas against direct measurement in a predominantly older adult Georgian cohort.

Materials and methods

We retrospectively analyzed lipid profiles from 500 adults with complete panels, stratified by triglyceride (TG) levels, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), and age. LDL-C was estimated using eight formulas and compared with direct LDL-C assays. The study adhered to the Helsinki Declaration and was approved by the Bioethics International Committee of Petre Shotadze Tbilisi Medical Academy.

Results

Substantial variability was observed across formulas. Friedewald and Chen showed minimal underestimation, aligning well with direct measurements, particularly at moderate TG levels. The de Cordova formula maintained stable accuracy across TG strata, including borderline hypertriglyceridaemia. The Ahmadi formula, originally developed for mmol/L, produced significant overestimation in mg/dL units and was excluded from threshold-based analyses. Sensitivity testing using CLIA's dual total allowable error (TEa) thresholds (±12 % or 12 mg/dL) improved agreement for all formulas, especially at low LDL-C levels.

Conclusions

Friedewald and de Cordova offer reliable, cost-effective LDL-C estimates for older adults. Formula selection should account for TG levels, demographics, and analytical context. Broader validation in diverse cohorts is needed to enhance generalizability.

低密度脂蛋白胆固醇（LDL-C）是心血管风险评估的重要指标。虽然直接测量具有很高的准确性，但在低收入和中等收入国家常规使用往往成本过高且不切实际。包括Friedewald、de Cordova和Chen的公式在内的多种公式已经被提出用于估计LDL-C，尽管它们的准确性因人群而异。本研究评估了8种LDL-C估计公式与直接测量在格鲁吉亚主要老年人队列中的表现。材料和方法我们回顾性分析了500名成年人的脂质谱，并根据甘油三酯（TG）水平、高密度脂蛋白胆固醇（HDL-C）、总胆固醇（TC）和年龄进行分层。使用8个公式估计LDL-C，并与直接LDL-C测定法进行比较。这项研究遵循《赫尔辛基宣言》，并得到第比利斯彼得·舒塔泽医学院生物伦理国际委员会的批准。结果各配方间存在显著差异。Friedewald和Chen显示了最小的低估，与直接测量结果很好地吻合，特别是在中等TG水平下。de Cordova公式在TG各层（包括交界型高甘油三酯血症）中保持稳定的准确性。最初为mmol/L开发的Ahmadi公式在mg/dL单位上产生了显著的高估，因此被排除在基于阈值的分析之外。使用CLIA的双总允许误差（TEa）阈值（±12%或12 mg/dL）的敏感性测试提高了所有配方的一致性，特别是在低LDL-C水平下。结论friedewald和de Cordova为老年人提供了可靠的、具有成本效益的LDL-C估计。公式选择应考虑到TG水平，人口统计和分析背景。需要在不同的人群中进行更广泛的验证，以增强普遍性。

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引用次数: 0

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。

{"title":"Tumor-informed circulating tumor DNA detection for personalized monitoring of treatment response in epithelial ovarian cancer","authors":"Sung Wan Kang , Ok-Ju Kang , Young-Jae Lee , Hee Jung Jung , Min-Seo Lee , Ji-Young Lee , Yong-Man Kim , Shin-Wha Lee","doi":"10.1016/j.plabm.2025.e00500","DOIUrl":"10.1016/j.plabm.2025.e00500","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>Fourteen pathogenic mutations, including <em>TP53, PIK3CA, PTEN, KRAS,</em> and <em>RB1</em>, 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, <em>PTEN</em> (E91∗) mutated ctDNA was detected during recurrence, while CA-125 levels remained within the normal range.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"47 ","pages":"Article e00500"},"PeriodicalIF":1.3,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145010748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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