Practical Laboratory Medicine最新文献

Cyclical fluctuations of iron biomarkers in women: Diagnostic implications for iron deficiency 女性铁生物标志物的周期性波动：铁缺乏的诊断意义

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-12-01 DOI: 10.1016/j.plabm.2025.e00512

Sixtus Aguree , Arthur Owora , Patricia Silveyra

Background

Iron deficiency (ID) and iron deficiency anemia (IDA) are common in women of reproductive age, but the influence of menstrual cycle phase on iron biomarkers is not well defined and is often overlooked in clinical and public health assessments.

Aim

To assess phase-specific variation in iron biomarkers and the prevalence of ID and IDA in non-pregnant women aged 18–44 years using 2003–2006 NHANES data.

Methods

We analyzed 1484 women with complete reproductive and iron status data. Menstrual cycle phase was categorized as menstruation (day 1–5), follicular phase (6−15), early/mid luteal phase (16–23), and late luteal phase (24–35). Eight biomarkers were analyzed: serum iron (SI), transferrin saturation (%TS), soluble transferrin receptor (sTfR), ferritin, erythrocyte protoporphyrin (EPP), hemoglobin (Hb), mean corpuscular volume (MCV) and body iron index (BII). ID and IDA were defined using ferritin-, MCV- and BII-based diagnostic models. All statistical models accounted for the complex design of the NHANES survey.

Results

SI and %TS were lowest during menstruation and increased across the cycle, peaking in the early/mid-luteal phase (SI: p = 0.001; %TS: p = 0.003). sTfR was highest during menstruation (p < 0.05) compared to other phases, consistent with increased iron requirements. Ferritin, EPP, Hb and MCV remained stable across phases. The prevalence of ID varied by model (10.5 %–22.0 %) but showed no consistent phase differences. In contrast, the prevalence of IDA decreased after menstruation, with composite IDA estimates dropping from 7.5 % during menstruation to 3.7 % in the late luteal phase (p = 0.033).

Conclusions

Iron biomarkers and IDA prevalence vary systematically across the menstrual cycle, with iron status being lowest during menstruation and recovering in the luteal phase. Consideration of menstrual phase may improve diagnostic accuracy and interpretation of iron biomarkers in women of reproductive age.

背景：铁缺乏症（ID）和缺铁性贫血（IDA）在育龄妇女中很常见，但月经周期对铁生物标志物的影响尚未明确，在临床和公共卫生评估中经常被忽视。目的利用2003-2006年NHANES数据，评估18-44岁非妊娠女性铁生物标志物的阶段性变化以及ID和IDA的患病率。方法对1484例女性进行完整的生殖和铁元素状况分析。月经周期阶段分为月经期（1-5天）、卵泡期（6 - 15天）、早/中黄体期（16-23天）和晚黄体期（24-35天）。分析8项生物指标：血清铁（SI）、转铁蛋白饱和度（%TS）、可溶性转铁蛋白受体（sTfR）、铁蛋白、红细胞原卟啉（EPP）、血红蛋白（Hb）、平均红细胞体积（MCV）和体铁指数（BII）。使用基于铁蛋白、MCV和bii的诊断模型来定义ID和IDA。所有统计模型都解释了NHANES调查的复杂设计。结果SI和%TS在月经期间最低，在月经周期中升高，在黄体前期/中期达到峰值（SI: p = 0.001; %TS: p = 0.003）。与其他时期相比，月经期间sTfR最高（p < 0.05），与铁需求量增加一致。铁蛋白、EPP、Hb和MCV各期均保持稳定。不同模型的ID患病率不同（10.5% - 22.0%），但没有一致的相位差异。相比之下，月经后IDA的患病率下降，综合IDA估计值从月经期间的7.5%下降到黄体晚期的3.7% （p = 0.033）。结论铁生物标志物和IDA患病率在月经周期中存在系统性变化，月经期铁水平最低，在黄体期恢复。考虑月经期可以提高诊断的准确性和对育龄妇女铁生物标志物的解释。

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引用次数: 0

The impact of pathological fluctuations versus biological variation on the interpretation of laboratory values 病理波动与生物学变异对实验室值解释的影响

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-11-13 DOI: 10.1016/j.plabm.2025.e00511

Ariel Mundo Ortiz , Jean-Philippe Emond , Vincent Weng-Jy Cheung , Sahar Saeed , Philippe Desmarais , François Larivière , Pierre-Olivier Hétu , Robert Goulden , Quoc Dinh Nguyen

Objectives

The current criterion used to determine whether the reference interval (RI) can be used for interpretation is based on the index of individuality (II), estimated using biological variation (BV). We hypothesized that pathological variation (PV), the shift between healthy and unhealthy states, varies across biomarkers and may be considered for interpretation with BV. We explored how jointly considering PV and BV impacts the clinical interpretation (diagnostic sensitivity and specificity) of RIs.

Methods

We propose the index of pathology (IP), a ratio of within-to between-subject coefficients of variation that jointly considers PV and BV. Using a large EHR database from a tertiary care center, we obtained IP estimates for 19 laboratory tests. As a means of comparison, the II was obtained from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) BV database. PV impact was analyzed using the absolute difference between IP and II (Δ_IP-II).

Results

798,800 observations from 17,082 adult patients were analyzed. For most biomarkers, the IP (mean = 1.99, range = 0.55–8.03) differed from the II (mean = 0.54, range = 0.27–0.86). Lowest IPs were for creatinine (IP = 0.55, Δ_IP-II = 0.28) and bilirubin (IP = 1.05, Δ_IP-II = 0.24). Highest IPs were for aspartate transaminase (IP = 4.56, Δ_IP-II = 4.13) and creatine kinase (IP = 8.03, Δ_IP-II = 7.60). Hormones and proteins exhibited high PV impact (Δ_IP-II>1.0).

Conclusion

Differences between variational estimates that only account for healthy states (II-BV) and those that consider healthy and unhealthy states (IP-BV + PV) vary widely among biomarkers, highlighting the differential impact of PV on their interpretation. For biomarkers where IP is high, the RI may be useful to identify unhealthy individuals.

目的目前用于确定参考区间（RI）是否可用于解释的标准是基于个体指数（II），使用生物变异（BV）估计。我们假设病理变异（PV），即在健康和不健康状态之间的转变，在不同的生物标志物上是不同的，可以考虑用BV来解释。我们探讨联合考虑PV和BV如何影响RIs的临床解释（诊断敏感性和特异性）。方法我们提出病理指数（index of pathology， IP），即综合考虑PV和BV的受试者内与受试者间变异系数的比值。利用来自三级保健中心的大型电子病历数据库，我们获得了19项实验室检测的IP估计值。作为比较手段，II从欧洲临床化学和检验医学联合会（EFLM） BV数据库中获得。利用IP和II的绝对差值分析PV影响（ΔIP-II）。结果共分析了17082例成人患者的798,800例观察结果。对于大多数生物标志物，IP（平均值= 1.99，范围= 0.55-8.03）与II（平均值= 0.54，范围= 0.27-0.86）不同。最低的IPs是肌酐（IP = 0.55， ΔIP-II = 0.28）和胆红素（IP = 1.05， ΔIP-II = 0.24）。天冬氨酸转氨酶（IP = 4.56， ΔIP-II = 4.13）和肌酸激酶（IP = 8.03， ΔIP-II = 7.60）的IPs值最高。激素和蛋白质表现出高PV影响（ΔIP-II>1.0）。结论仅考虑健康状态（II-BV）和考虑健康和不健康状态（IP-BV + PV）的变分估计之间的差异在生物标志物之间差异很大，突出了PV对其解释的不同影响。对于IP较高的生物标志物，RI可能有助于识别不健康个体。

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引用次数: 0

Flow cytometry-based validation of soluble biomarker detection 基于流式细胞术的可溶性生物标志物检测验证

IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-11-07 DOI: 10.1016/j.plabm.2025.e00510

Yiting Tang , Xiang Wu , Huating Zhang , Liu Dong , Ruoshui Cao , Jian Chen , Jiajun Zhu , Lianlong Hu , Qingyu Zhou , Jianming Zhou , Ke Qian , Yong Lin , Shuying Chen

Objectives

Accurate and reliable measurement of soluble markers, such as sCD25, sCD40L, sCD130, and sTREM-1, is crucial for understanding their roles in immune responses and inflammatory conditions. This study presents the validation of a multiplex flow cytometry assay using the BD FACSLyric flow cytometer, designed to simultaneously quantify these four soluble markers in serum samples.

Methods

The assay utilizes a bead-based immunoassay kit that is compatible with BD FACSLyric to enable precise detection of low concentrations of these markers. The methodological approach includes detailed sample preparation, bead conjugation, and assay optimization. Data acquisition was performed on the BD FACSLyric, with a minimum of 10 000 events recorded per sample to ensure robust data collection.

Results

The validation results demonstrated that the assay achieved low limits of detection (LOD) for sCD25, sCD40L, sCD130, and sTREM-1. The LOD values were respectively 9.77 pg/ml, 43.95 pg/ml, 219.73 pg/ml, and 12.21 pg/ml, indicating the assay's high sensitivity. Reproducibility was confirmed through intra-assay and inter-assay variability assessments. Studies have shown that the levels of sCD25/sCD40L/sTREM-1 in the body are associated with lung cancer. Therefore, this study also used this detection method to test both lung cancer patients and healthy individuals, finding significant differences in the results, which can be used to assist in clinical diagnosis and treatment.

Conclusions

This assay's ability to detect multiple analytes in a single run, combined with its high sensitivity and reproducibility, makes it a valuable asset for both research and clinical applications. Future work may expand this assay to include additional markers or adapt it for other sample types, further enhancing its utility in diverse biomedical contexts.

准确可靠地测量可溶性标记物，如sCD25、sCD40L、sCD130和sTREM-1，对于了解它们在免疫反应和炎症条件中的作用至关重要。本研究提出了使用BD facslric流式细胞仪的多重流式细胞术检测的验证，旨在同时定量血清样品中的这四种可溶性标记物。方法采用与bdfacslric兼容的免疫检测试剂盒，精确检测低浓度的这些标记物。方法方法包括详细的样品制备，头偶联和分析优化。在BD faclyric上进行数据采集，每个样本至少记录10,000个事件，以确保可靠的数据收集。结果验证结果表明，该方法对sCD25、sCD40L、sCD130和sTREM-1均达到低检出限。检出限分别为9.77、43.95、219.73、12.21 pg/ml，具有较高的灵敏度。通过测定内和测定间的可变性评估确认了再现性。研究表明，体内sCD25/sCD40L/sTREM-1水平与肺癌有关。因此，本研究也采用该检测方法对肺癌患者和健康个体进行检测，发现结果存在显著差异，可用于辅助临床诊断和治疗。结论：该方法能够在一次运行中检测多种分析物，并且具有高灵敏度和重复性，使其成为研究和临床应用的宝贵资产。未来的工作可能会扩展这种分析，包括更多的标记或适应其他样品类型，进一步提高其在不同生物医学背景下的效用。

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引用次数: 0

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。

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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。

{"title":"Advancements in laboratory diagnostics for HIV/MTB coinfection: Integrating conventional methods with emerging technologies","authors":"Yu Li , Hongjuan Wei , Limei Sun , Dongsong Tang , Tiantian Wang , Yanhua Yu","doi":"10.1016/j.plabm.2025.e00503","DOIUrl":"10.1016/j.plabm.2025.e00503","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"47 ","pages":"Article e00503"},"PeriodicalIF":1.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145320997","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

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