Practical Laboratory Medicine最新文献_第4页

External quality assessment of genetic testing for hereditary hearing loss in Shanghai and other regions 上海及其他地区遗传性听力损失基因检测的外部质量评价

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-07-01 DOI: 10.1016/j.plabm.2025.e00488

Yun Bao, Pengyin Zhang, Jing Quan, Xue Yang, Yanqun Xiao, Xiaobo Hu

Objectives

Hereditary hearing loss is one of the most common birth defects in humans. Genetic screen in pregnant women and newborns could provide prenatal intervention or guidance on the early diagnosis and treatment. Currently, this screen has been widely applied; however, its accuracy and reliability have not been determined. The objective of this pioneering study was to evaluate the performance of clinical laboratories in Shanghai and other regions for their ability to analyze the genetic variants related with hearing loss.

Methods

The EQA program were carried out twice a year. We generated a sample panel consisting of five dry blood spots with genomic DNA from different cell lines with normal whole blood as the matrix. The panel included four samples with nine different pathogenic variants of GJB2, GJB3, SLC26A4 as well as mitochondria DNA (mt DNA) and one wild type sample. The panel was distributed to participant laboratories for genetic analysis, and the results were compared and scored.

Results

Thirty and twenty-nine clinical laboratories participated in the two EQA scheme in 2023, respectively. 28 (93.33 %) and 27 (93.10 %) laboratories achieved an acceptable or superior performance score(≥80). There were ten errors with eight false-negative and two false-positive results in the first EQA scheme, and seven errors with five false-negative and two false-positive in the second EQA scheme.

Conclusions

The results indicate that the majority of the clinical genetic analysis of deafness-related genes were satisfactory in China, while some participant laboratories needed further improvement. In addition, external quality assessment was demonstrated as an important method for monitoring the performance of clinical laboratories.

目的遗传性听力损失是人类最常见的先天缺陷之一。孕妇和新生儿基因筛查可提供产前干预或早期诊断和治疗指导。目前，这种筛网已得到广泛应用；然而，其准确性和可靠性尚未确定。这项开创性研究的目的是评估上海和其他地区临床实验室在分析与听力损失相关的遗传变异方面的表现。方法EQA项目每年实施2次。我们以正常全血为基质，用来自不同细胞系的基因组DNA生成了一个由五个干血斑点组成的样本板。该小组包括4个样本，其中包含GJB2， GJB3， SLC26A4的9种不同致病变异以及线粒体DNA （mt DNA）和1个野生型样本。该小组被分发到参与实验室进行遗传分析，并对结果进行比较和评分。结果2023年分别有30家和29家临床实验室参与了两次EQA计划。28个（93.33%）和27个（93.10%）的实验室达到了可接受或优异的绩效评分（≥80）。第一个EQA方案有10个错误，8个假阴性，2个假阳性；第二个EQA方案有7个错误，5个假阴性，2个假阳性。结论国内大部分耳聋相关基因的临床遗传分析较为满意，但部分实验室有待进一步完善。此外，外部质量评价是监测临床实验室绩效的重要方法。

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引用次数: 0

Performance validation of Abbott Alinity i chemiluminescence analyzer for five thyroid function tests 雅培Alinity i化学发光分析仪用于五项甲状腺功能检测的性能验证

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-06-25 DOI: 10.1016/j.plabm.2025.e00487

Hongyu Zhang , Baixiu Wu , Liuhua Ke , Zheng Peng

Objective

To verify and evaluate the performance of the Abbott Alinity i chemiluminescence analyzer for five thyroid function tests.

Method

Referring to the relevant documents of the Clinical and Laboratory Standards Institute (CLSI) and related literature, the precision, accuracy, linear range, reference interval, and sample carryover effect of Abbott Alinity i immunoassay system for measuring FT3, FT4, T3, T4, and TSH were verified and analyzed.

Results

Precision: Repeatability ranged from 1.23 % to 6.11 %, and intermediate precision ranged from 1.84 % to 7.33 %, both meeting the quality targets (≤6.25 % and ≤8.33 %, respectively). Accuracy: The deviation between the mean value and the target value was less than 12.5 %, indicating good agreement. Linearity: For T3, T4, and TSH, the 95 % confidence intervals of the deviation from linearity (difference between measured and expected value) were entirely within the allowable deviation limits (ADL). For FT3 and FT4, manufacturer guidelines preclude dilution; thus, linearity verification was omitted. Reference interval: All test values of 20 healthy individuals were within the reference intervals provided by the manufacturer. Sample carryover effect: The sample carryover effect ranged from −0.4 % to 0.17 %, which met the requirement of less than 1 %.

Conclusion

The Abbott Alinity i analyzer demonstrated acceptable performance in precision, accuracy, linearity (for T3, T4, and TSH), reference interval, and carry-over effect for the five thyroid function tests, meeting manufacturer specifications.

目的验证和评价雅培Alinity i化学发光分析仪在甲状腺功能五项检测中的性能。方法参考美国临床与实验室标准协会（CLSI）的相关文件及相关文献，对雅培Alinity i免疫测定系统测量FT3、FT4、T3、T4、TSH的精密度、准确度、线性范围、参考区间及样本携带效应进行验证和分析。结果精密度：重复性为1.23% ~ 6.11%，中间精密度为1.84% ~ 7.33%，均满足质量指标（分别≤6.25%和≤8.33%）。准确度：平均值与目标值偏差小于12.5%，吻合良好。线性：对于T3、T4和TSH，偏离线性（实测值与期望值之差）的95%置信区间完全在允许偏差限（ADL）内。对于FT3和FT4，制造商指南禁止稀释；因此，线性验证被省略。参考区间：20名健康个体的所有测试值均在制造商提供的参考区间内。样品残留效应：样品残留效应范围为- 0.4% ~ 0.17%，满足小于1%的要求。结论雅培Alinity i分析仪在精密度、准确度、线性度（T3、T4和TSH）、参考区间和五项甲状腺功能检测的结转效应方面表现良好，符合生产厂家的要求。

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引用次数: 0

Validation of an assay for NGAL in a pediatric population 小儿NGAL检测方法的验证

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-06-24 DOI: 10.1016/j.plabm.2025.e00486

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

Background and objectives

Acute kidney injury (AKI) poses a serious clinical challenge, particularly in high-risk environments, due to its association with increased morbidity and mortality. Traditional diagnostic markers, such as serum creatinine, often detect AKI only after significant kidney damage has occurred, limiting opportunities for early intervention. Neutrophil gelatinase-associated lipocalin (NGAL) has emerged as a promising early biomarker due to its rapid upregulation following kidney ischemia. NGAL supports renal recovery by reducing toxicity and promoting tubular regeneration via heme oxygenase-1 activity. This study aimed to validate the BioPorto ProNephro AKI™ turbidimetric immunoassay for urinary NGAL on the Ortho Vitros XT7600 analyzer and evaluate its clinical utility in detecting early-stage AKI.

Design and methods

Assay performance was evaluated in accordance with CLSI guidelines, assessing precision, linearity, method agreement, specificity, and reference range. Method comparison involved 20 urine samples, while reference range verification used 57 pediatric samples. A clinical validation study included 21 pediatric CRRT patient samples to assess real-world diagnostic performance.

Results

The assay demonstrated strong precision (intra-assay CV: 1.3–1.8 %; inter-assay CV: 1.8–2.7 %) and excellent linearity (18–1140 ng/mL; extended to 15,000 ng/mL with dilution). High correlation (r = 0.9836) was observed in method comparison. Specificity tests showed minimal interference. Clinical validation yielded 76.19 % sensitivity and 100 % specificity for AKI detection.

Conclusions

The BioPorto ProNephro AKI™ assay on the Ortho Vitros XT7600 shows high sensitivity and specificity for urinary NGAL detection in pediatric patients, enabling early AKI identification, timely intervention, and potentially improved clinical outcomes through enhanced diagnostic performance.

背景和目的急性肾损伤（AKI）是一个严重的临床挑战，特别是在高风险环境中，由于其与发病率和死亡率增加有关。传统的诊断指标，如血清肌酐，通常只有在发生重大肾损害后才能检测到AKI，这限制了早期干预的机会。中性粒细胞明胶酶相关脂钙蛋白（NGAL）因其在肾缺血后的快速上调而成为一种有前景的早期生物标志物。NGAL通过降低毒性和通过血红素氧化酶-1活性促进肾小管再生来支持肾脏恢复。本研究旨在验证BioPorto proonephro AKI™浊度免疫法在Ortho Vitros XT7600分析仪上检测尿液NGAL，并评估其在检测早期AKI中的临床应用。设计和方法按照CLSI指南评估分析性能，评估精密度、线性度、方法一致性、特异性和参考范围。方法比较涉及20份尿液样本，而参考范围验证使用57份儿科样本。一项临床验证研究包括21例儿科CRRT患者样本，以评估真实世界的诊断性能。结果该方法具有较高的精密度(检测内CV: 1.3 ~ 1.8%；检测间CV: 1.8 - 2.7%)，线性良好(18-1140 ng/mL；稀释后延长至15,000 ng/mL)。方法比较具有较高的相关性（r = 0.9836）。特异性试验显示干扰最小。临床验证AKI检测的敏感性为76.19%，特异性为100%。结论基于Ortho Vitros XT7600的BioPorto proonephro AKI™检测在儿科患者尿NGAL检测中具有较高的敏感性和特异性，可以早期识别AKI，及时干预，并通过提高诊断性能改善临床结果。

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引用次数: 0

External quality assessment for nucleic acid quantitative testing of human hepatitis B and hepatitis C virus in Chongqing, China: 2009–2024 重庆市乙型和丙型肝炎病毒核酸定量检测外部质量评价：2009-2024

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-06-18 DOI: 10.1016/j.plabm.2025.e00485

Yuanyuan Guo , Kun Wang , Liying Wang, Shuang Liu, Zhijie Li, Tian Li, Changchun Niu

Background

To achieve the goal of eliminating viral hepatitis as a public health threat by 2030, accurate detection of HBV-DNA and HCV-RNA is crucial. This study presents the implementation of HBV-DNA and HCV-RNA External Quality Assessment (EQA) programs conducted in Chongqing, China, from 2009 to 2024, highlighting the significant contributions made by clinical laboratories.

Methods

Over a span of 16 years, a total of 160 samples were distributed in the HBV-DNA EQA program, while the HCV-RNA EQA program disseminated 105 samples encompassing diverse concentration levels. Factors such as the number of participating laboratories, employed detection methodologies, utilized reagents, and test outcomes were evaluated to assess the HBV-DNA and HCV-RNA detection capabilities of clinical laboratories over the past decade.

Results

By 2024, the number of laboratories participating in HBV-DNA EQA activities had increased from 45 in 2009 to 110 in 2024, representing a 144.44 % increase. Similarly, the number of laboratories participating in HCV-RNA EQA activities had risen from 7 in 2014 to 30 in 2024, marking a 328.57 % increase. The accuracy rate for HBV-DNA EQA activity results improved from 85.37 % in 2009 to 98.18 % in 2024, while the accuracy rate for HCV-RNA EQA activity results rose from 66.67 % in 2014 to 96.67 % in 2024. Satisfactory reproducibility was observed in parallel samples. However, certain laboratories exhibited significant bias in low- and high-concentration samples.

Conclusion

The performance of laboratories in Chongqing, China, for HBV-DNA and HCV-RNA testing has consistently improved through their participation in EQA programs. In the future, sample distribution should include more challenging ones, particularly low- or high-concentration samples. Emphasis should also be placed on standardized operation and performance validation of the assay system.

为了实现到2030年消除作为公共卫生威胁的病毒性肝炎的目标，准确检测HBV-DNA和HCV-RNA至关重要。本研究介绍了2009年至2024年在中国重庆开展的HBV-DNA和HCV-RNA外部质量评估（EQA）项目的实施情况，重点介绍了临床实验室的重要贡献。方法在16年的时间里，HBV-DNA EQA项目共分发了160份样本，HCV-RNA EQA项目分发了105份不同浓度水平的样本。评估了参与实验室数量、采用的检测方法、使用的试剂和检测结果等因素，以评估过去十年临床实验室的HBV-DNA和HCV-RNA检测能力。结果到2024年，参与HBV-DNA EQA活动的实验室数量从2009年的45家增加到2024年的110家，增长了144.44%。同样，参与HCV-RNA EQA活动的实验室数量从2014年的7家增加到2024年的30家，增长了328.57%。HBV-DNA EQA检测结果的准确率由2009年的85.37%提高到2024年的98.18%，HCV-RNA EQA检测结果的准确率由2014年的66.67%提高到2024年的96.67%。在平行样品中观察到令人满意的再现性。然而，某些实验室在低浓度和高浓度样品中表现出明显的偏差。结论通过参与EQA项目，中国重庆实验室在HBV-DNA和HCV-RNA检测方面的表现不断提高。在未来，样品分布应该包括更具挑战性的，特别是低或高浓度的样品。重点还应放在分析系统的标准化操作和性能验证上。

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引用次数: 0

Comparative evaluation of four new immunoassays and LC-MS/MS for the measurement of urinary free cortisol in Cushing's syndrome diagnosis 四种新型免疫测定法与LC-MS/MS测定尿游离皮质醇在库欣综合征诊断中的比较评价

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-06-11 DOI: 10.1016/j.plabm.2025.e00484

Qi Zhang , Danni Mu , Yichen Ma , Yuemeng Li , Yumeng Gao , Yingying Hu , Kui Zhang , Fang Zhao , Ran Gao , Liangyu Xia , Huijuan Zhu , Songlin Yu , Ling Qiu , Xinqi Cheng

Objectives

Twenty-four-hour urinary free cortisol (UFC) measurement is the initial diagnostic test for Cushing's syndrome (CS). We compared UFC determination by four new immunoassays using Autobio A6200, Mindray CL-1200i, Snibe MAGLUMI X8 and Roche 8000 e801 with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Additionally, we evaluated the value of 24-h UFC measured by four direct immunoassays for diagnosing CS.

Methods

Residual 24-hr urine samples of 94 CS and 243 non-CS patients collected from previous cohort were used. A laboratory-developed LC-MS/MS method was used as reference. UFC was measured by immunoassays using Autobio, Mindray, Snibe and Roche platforms. Method was compared using Passing–Bablok regression and Bland–Altman plot analyses. Cut-off values for each assay and corresponding sensitivities and specificities were calculated by ROC analysis.

Results

All four immunoassays showed strong correlations with LC-MS/MS (Spearman coefficient r = 0.950, 0.998, 0.967, and 0.951, respectively). All immunoassays showed proportionally positive bias. The areas under the curve were 0.953 for Autobio, 0.969 for Mindray, 0.963 for Snibe, and 0.958 for Roche. The cut-off values varied from 178.5 to 272.0 nmol/24 h). Assay sensitivity and specificity ranged from 89.66 % to 93.10 % and from 93.33 % to 96.67 %, respectively.

Conclusions

Four newly available direct immunoassays for measuring UFC show good analytical consistency compared to LC-MS/MS. The elimination of organic solvent extraction simplifies workflows while maintaining high diagnostic accuracy. Additionally, they exhibited similarly high diagnostic accuracy for CS identification. Future multi-center studies are needed to validate our findings and establish method-specific UFC cut-off values to enhance clinical utility.

目的：24小时尿游离皮质醇（UFC）测定是库欣综合征（CS）的初步诊断指标。我们比较了使用Autobio A6200、迈瑞CL-1200i、Snibe MAGLUMI X8和罗氏8000 e801的四种新型免疫分析法的液相色谱-串联质谱（LC-MS/MS）对UFC的测定。此外，我们评估了通过四种直接免疫分析法测量的24小时UFC对诊断CS的价值。方法采用既往队列收集的94例CS和243例非CS患者的24小时残尿样本。以实验室建立的LC-MS/MS方法为参照。使用Autobio、Mindray、Snibe和Roche平台进行免疫测定UFC。方法采用Passing-Bablok回归和Bland-Altman图分析进行比较。通过ROC分析计算每个检测的截止值以及相应的灵敏度和特异性。结果4种免疫分析法与LC-MS/MS均具有较强的相关性（Spearman系数r分别为0.950、0.998、0.967、0.951）。所有免疫分析均显示成比例的阳性偏倚。Autobio的曲线下面积为0.953，Mindray为0.969，Snibe为0.963，Roche为0.958。临界值为178.5 ~ 272.0 nmol/24 h)。检测灵敏度和特异度分别为89.66% ~ 93.10%和93.33% ~ 96.67%。结论与LC-MS/MS相比，新建立的4种直接免疫检测方法具有良好的分析一致性。消除有机溶剂萃取简化了工作流程，同时保持了高诊断准确性。此外，它们在CS识别方面表现出类似的高诊断准确性。未来的多中心研究需要验证我们的发现，并建立特定方法的UFC临界值，以提高临床实用性。

{"title":"Comparative evaluation of four new immunoassays and LC-MS/MS for the measurement of urinary free cortisol in Cushing's syndrome diagnosis","authors":"Qi Zhang , Danni Mu , Yichen Ma , Yuemeng Li , Yumeng Gao , Yingying Hu , Kui Zhang , Fang Zhao , Ran Gao , Liangyu Xia , Huijuan Zhu , Songlin Yu , Ling Qiu , Xinqi Cheng","doi":"10.1016/j.plabm.2025.e00484","DOIUrl":"10.1016/j.plabm.2025.e00484","url":null,"abstract":"<div><h3>Objectives</h3><div>Twenty-four-hour urinary free cortisol (UFC) measurement is the initial diagnostic test for Cushing's syndrome (CS). We compared UFC determination by four new immunoassays using Autobio A6200, Mindray CL-1200i, Snibe MAGLUMI X8 and Roche 8000 e801 with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Additionally, we evaluated the value of 24-h UFC measured by four direct immunoassays for diagnosing CS.</div></div><div><h3>Methods</h3><div>Residual 24-hr urine samples of 94 CS and 243 non-CS patients collected from previous cohort were used. A laboratory-developed LC-MS/MS method was used as reference. UFC was measured by immunoassays using Autobio, Mindray, Snibe and Roche platforms. Method was compared using Passing–Bablok regression and Bland–Altman plot analyses. Cut-off values for each assay and corresponding sensitivities and specificities were calculated by ROC analysis.</div></div><div><h3>Results</h3><div>All four immunoassays showed strong correlations with LC-MS/MS (Spearman coefficient r = 0.950, 0.998, 0.967, and 0.951, respectively). All immunoassays showed proportionally positive bias. The areas under the curve were 0.953 for Autobio, 0.969 for Mindray, 0.963 for Snibe, and 0.958 for Roche. The cut-off values varied from 178.5 to 272.0 nmol/24 h). Assay sensitivity and specificity ranged from 89.66 % to 93.10 % and from 93.33 % to 96.67 %, respectively.</div></div><div><h3>Conclusions</h3><div>Four newly available direct immunoassays for measuring UFC show good analytical consistency compared to LC-MS/MS. The elimination of organic solvent extraction simplifies workflows while maintaining high diagnostic accuracy. Additionally, they exhibited similarly high diagnostic accuracy for CS identification. Future multi-center studies are needed to validate our findings and establish method-specific UFC cut-off values to enhance clinical utility.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"46 ","pages":"Article e00484"},"PeriodicalIF":1.7,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144272332","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

Performance evaluation of the Cobas c 703 analytical unit as part of Cobas Pro integrated solutions using LED as the sole photometric light source Cobas c703分析单元的性能评估，作为Cobas Pro集成解决方案的一部分，使用LED作为唯一的光度光源

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-06-03 DOI: 10.1016/j.plabm.2025.e00482

Peter Findeisen , Inger Brandt , Frederic Winnock , Jan Furrer , Kai Klopprogge

Background

Most commercially available clinical chemistry systems today rely on a halogen light source to power photometric measurements, lasting only up to ∼750 h before replacement is required. Halogen lamps will soon be phased out in favor of new longer-lasting light-emitting diodes (LED) in commercial devices.

Methods

We compared the analytical performance of the new Cobas® c 703 analytical unit (LED; Cobas Pro integrated solutions) versus the Cobas c 701/c 702 modules (halogen light source; Cobas 8000 modular analyzer series; all Roche Diagnostics International Ltd). At two evaluation sites, precision of the c 703 analytical unit was evaluated and method comparison experiments comparing the c 703 analytical unit versus c 701/c 702 modules were performed.

Results

Results from 34 selected applications showed robust precision of the c 703 analytical unit (repeatability, intermediate precision, and reproducibility: 80/138 coefficients of variation <1 %, 60/138 < 1 %, and 48/69 < 2 %, respectively). Method comparison experiments with 31 applications showed good comparability between c 703 and c 701/c 702 using LED versus halogen light sources, respectively (median slope = 1.00; median bias = 0.2 %; median Pearson's correlation coefficient = 0.997).

Conclusions

In addition to the newly introduced LED light source having a longer lifetime (10,000 h; data not shown), the c 703 analytical unit demonstrated equivalent analytical performance to that of the c 701/c 702 modules using halogen lamps as the light source as part of high-throughput clinical chemistry analyzers.

目前，大多数商用临床化学系统依赖于卤素光源为光度测量提供动力，在需要更换之前只能持续约750小时。卤素灯将很快被淘汰，取而代之的是新型更持久的发光二极管（LED）。方法比较新型Cobas®c 703分析单元(LED；Cobas Pro集成解决方案)与Cobas c 701/c 702模块(卤素光源；Cobas 8000模块化分析仪系列；所有罗氏诊断国际有限公司)。在两个评价点，对c703分析单元的精密度进行了评价，并对c703分析单元与c701 / c702模块进行了方法对比实验。结果34个选定应用的结果表明，c703分析单元具有良好的精密度(重复性、中间精密度和重现性：80/138变异系数为1%，60/138；1%, 48/69 <；分别为2%)。31个应用的方法对比实验表明，c703和c701 / c702分别在LED光源和卤素光源下具有良好的可比性(斜率中值= 1.00；中位偏差= 0.2%；中位Pearson相关系数= 0.997)。结论除了新推出的LED光源寿命更长(10000 h；数据未显示)，使用卤素灯作为光源作为高通量临床化学分析仪的一部分，c703分析单元显示出与c701 /c 702模块相当的分析性能。

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引用次数: 0

Impact of blood centrifugation on the parameters of thrombin generation assay revisited to look for possible revision of the current guidance 重新审视血液离心对凝血酶生成测定参数的影响，以寻找对当前指南的可能修订

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-05-31 DOI: 10.1016/j.plabm.2025.e00478

Erica Scalambrino , Marigrazia Clerici , Flora Peyvandi , Armando Tripodi

Blood centrifugation affects thrombin generation assays (TGA). Current guidance recommends double-centrifugation, which is uncommon in clinical laboratories.

We evaluated the impact of 4 centrifugation speeds on TGA performed with low-triggers (1pM tissue-factor/1.0 μM phospholipids) or high-triggers (5pM tissue-factor/5.0 μM phospholipids). TGA parameters were evaluated in the presence/absence of thrombomodulin.

We included 20 healthy subjects. Centrifugation speeds were: (i)Double-centrifugation: blood at 2,500g(15min) and plasma at 2500(15min) (reference method). (ii)Single-centrifugation at 3,000g(20min). (iii)Single-centrifugation of blood at 3,000g(20min), plasma freezing, then centrifugation of thawed plasma at 10,000g(5min). (iv)Single-centrifugation at 1,700g(10min). Results were also expressed as percentage difference relative to reference centrifugation.

Lag-time was affected when centrifugation speed was relatively slow (1,700g), regardless of low- or high-triggers, presence or absence of thrombomodulin, whereas it was scarcely affected by centrifugation at 3,000g. Peak-thrombin was marginally affected at relatively low-speed (1,700g). ETP was marginally affected at relatively low-speed (1,700g), except when TGA was performed in the presence of thrombomodulin. Peak-thrombin and ETP were not or were poorly affected by centrifugation at 3,000g or 10,000g after thawing, respectively.

In conclusion, slow-centrifugation (1,700g) had a considerable impact on lag-time. This centrifugation speed represents common practice in clinical laboratories and should not be used for TGA, unless controls samples centrifuged at the same speed are used for comparison. Single-centrifugation at 3,000g may be a suitable alternative, which would allow TGA testing without the complex and time-consuming double-centrifugation as recommended by current guidance. We propose that current guidance on plasma preparation for TGA be switched from double-to a more intense single-centrifugation.

血液离心影响凝血酶生成测定（TGA）。目前的指导建议双重离心，这在临床实验室中并不常见。我们评估了4种离心速度对低触发（1pM组织因子/1.0 μM磷脂）或高触发（5pM组织因子/5.0 μM磷脂）进行TGA的影响。在存在/不存在血栓调节素的情况下评估TGA参数。我们纳入了20名健康受试者。离心速度：(i)双离心：血液2500g (15min)，血浆2500g (15min)（参考方法）。（ii） 3000g单次离心（20min）。（iii） 3000g血液单次离心（20min），血浆冷冻，再10000g解冻血浆离心（5min）。（iv） 1700 g单次离心（10min）。结果也表示为相对于参考离心的百分比差异。当离心速度相对较慢（1,700g）时，滞后时间受到影响，无论低触发还是高触发，存在或不存在血栓调节素，而在3,000g时，它几乎不受影响。峰值凝血酶在相对低速（1,700g）时受到轻微影响。在相对低速（1,700g）时，ETP受到轻微影响，除非在血栓调节素存在的情况下进行TGA。解冻后分别在3000g和10000g离心对凝血酶峰和ETP没有或影响很小。总之，慢速离心（1,700g）对滞后时间有相当大的影响。此离心速度代表临床实验室的常用做法，不应用于TGA，除非以相同速度离心的对照样品用于比较。3000g的单离心可能是一个合适的选择，这将允许TGA测试，而不需要当前指导建议的复杂和耗时的双离心。我们建议将目前TGA血浆制备的指导从双离心改为更强的单离心。

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引用次数: 0

Performance verification of the new UF-1500 urine particle analyser: a new opportunity for small and medium laboratories 新型UF-1500尿液颗粒分析仪的性能验证：中小型实验室的新机遇

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-05-31 DOI: 10.1016/j.plabm.2025.e00481

Giulia Previtali, Michela Seghezzi, Roberto Marozzi, Monica Fortino, Gianluca Agnolet, Mauro Barretta, Claudia Bizzoni, Valeria Bolla, Greta Bolzoni, Alessia Cesani, Matteo Diambrini, Sara Apassiti Esposito, Giorgia Giuliani, Alina Picciau, Maria Grazia Alessio

Background

The UF-1500 is the new fully automated urine particle analyser by Sysmex specifically tailored for small and medium laboratories. This study aim to validate its analytical and diagnostic performance.

Methods

754 first morning mid-stream urines were analysed on UF-1500; 550 samples were used for the UF-5000 comparison and 204 were used for the correlation with manual count on Fuchs-Rosenthal chamber. Carry-over, linearity and imprecision of the UF-1500 were also assessed.

Results

Correlation with the UF-5000 was excellent, with r coefficient range between 0.88 and 1.00. Correlation with Fuchs-Rosenthal chamber was very good for all the parameters; r coefficient ranged between 0.67 and 0.94. Linearity regression coefficient of determination (R²) was excellent for almost all the parameters. No carry-over was observed. The within-run imprecision range between 2.93 % for RBC and 35.63 % for WBC. The between-run imprecision ranged between 2.1 % for RBC and 23.9 % for CAST, using low and high positive quality controls, respectively.

Conclusion

The analytical and diagnostic performance is satisfactory for almost all the parameters, when compared with the UF-5000; the correlation with the reference method is equally good.

UF-1500是Sysmex专门为中小型实验室定制的新型全自动尿液颗粒分析仪。本研究旨在验证其分析和诊断性能。方法对754例清晨中游尿液进行UF-1500检测分析；550个样本用于UF-5000比较，204个样本用于Fuchs-Rosenthal室人工计数的相关性。对UF-1500的结转、线性和不精度也进行了评估。结果与UF-5000相关良好，r系数在0.88 ~ 1.00之间。所有参数与Fuchs-Rosenthal室的相关性都很好；R系数为0.67 ~ 0.94。几乎所有参数的线性回归决定系数（R2）均良好。未观察到结转现象。红细胞和白细胞的运行不精确范围分别为2.93%和35.63%。使用低阳性质量控制和高阳性质量控制时，RBC和CAST的运行间不精确性分别在2.1%和23.9%之间。结论与UF-5000相比，该仪器在几乎所有参数上的分析诊断性能都令人满意；与参考方法的相关性同样良好。

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引用次数: 0

Direct identification of Mycobacterium species from liquid medium (MGIT) using FastPrep-2 bead beating system and MALDI-TOF mass spectrometry technology: a comparison with solid media and PCR-based method 利用FastPrep-2打头系统和MALDI-TOF质谱技术直接鉴定液体培养基中的分枝杆菌种类：与固体培养基和基于pcr的方法的比较

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-05-30 DOI: 10.1016/j.plabm.2025.e00479

Ali M. Bazzi , Abdulaziz A. Sunki , Mohab J. Hamdi , Abdullah O. Khaldi , Jaffar A. Al-Tawfiq

Background

Mycobacterial infections present significant global health challenges. Traditional diagnostic methods are inadequate for the identification of Mycobacterium species, highlighting the need for more efficient techniques. Matrix-assisted laser desorption-ionization time-of-flight (MALDI-TOF) mass spectrometry (MS) technology offers potential advantages in rapid and accurate pathogen identification.

Objective

This study evaluates the accuracy and precision of the MALDI-TOF using the FastPrep-2 bead beating system and VITEK MS version 3.2 for identifying Mycobacterium species directly from Mycobacteria Growth Indicator Tube (MGIT), liquid medium, compared to MALDI-TOF (VITEK MS) based on the traditional solid medium (Lowenstein–Jensen). We also compared the result of the MALDI-TOF from MGIT to M tuberculosis results by PCR-based method.

Methods

The study included 16 mycobacterium tuberculosis (MTB) and 37 nontuberculous mycobacteria (NTM). Isolates were grown in LJ solid medium and MGIT liquid medium, and lysed using the FastPrep-2 bead beating system. Identification was performed using VITEK MS version 3.2 from liquid.

Results

NTM comprised 70 % (37/53) of the total isolates evaluated. Of these, 92 % (34/37) were successfully identified using VITEK MS from MGIT liquid medium. Overall, the method achieved 88.6 % accuracy for identifying Mycobacterium species from liquid medium, compared to 96.2 % from solid medium. The agreement between both methods was moderate (Kappa = 0.470, p < 0.001). MTB isolates were identified with 100 % accuracy, and the approach demonstrated excellent reproducibility with 100 % intra-assay and inter-day consistency.

Conclusion

Using VITEK MS version 3.2 to directly identify MTB and NTM from MGIT liquid medium provides a rapid, cost-effective, and reliable method for identifying Mycobacterium species. Further optimization and database expansion are recommended to enhance accuracy for rare and less common mycobacterial species.

分枝杆菌感染是全球健康面临的重大挑战。传统的诊断方法不足以鉴定分枝杆菌的种类，这突出表明需要更有效的技术。基质辅助激光解吸-电离飞行时间（MALDI-TOF）质谱技术在快速准确鉴定病原体方面具有潜在优势。目的比较基于传统固体培养基（Lowenstein-Jensen）的MALDI-TOF （VITEK MS）与使用fastprep2打头系统和VITEK MS 3.2版本直接从分枝杆菌生长指示管（MGIT）中鉴定分枝杆菌种类的准确性和精密度。我们还通过基于pcr的方法比较了MGIT和M结核的MALDI-TOF结果。方法选取16株结核分枝杆菌（MTB）和37株非结核分枝杆菌（NTM）。分离菌株分别在LJ固体培养基和MGIT液体培养基中培养，采用FastPrep-2打穗系统进行裂解。用VITEK MS 3.2版本从液体中进行鉴定。结果sntm占总分离株的70%（37/53）。其中，92%（34/37）使用MGIT液体培养基中的VITEK MS成功鉴定。总体而言，该方法在液体培养基中鉴定分枝杆菌的准确率为88.6%，而在固体培养基中鉴定分枝杆菌的准确率为96.2%。两种方法的一致性为中等(Kappa = 0.470, p <；0.001)。MTB分离株的鉴定准确率为100%，并且该方法具有良好的重复性，具有100%的测定内和日间一致性。结论使用VITEK MS 3.2版本直接鉴定MGIT液体培养基中的MTB和NTM是一种快速、经济、可靠的分枝杆菌鉴定方法。建议进一步优化和扩展数据库，以提高对罕见和不常见分枝杆菌种类的准确性。

{"title":"Direct identification of Mycobacterium species from liquid medium (MGIT) using FastPrep-2 bead beating system and MALDI-TOF mass spectrometry technology: a comparison with solid media and PCR-based method","authors":"Ali M. Bazzi , Abdulaziz A. Sunki , Mohab J. Hamdi , Abdullah O. Khaldi , Jaffar A. Al-Tawfiq","doi":"10.1016/j.plabm.2025.e00479","DOIUrl":"10.1016/j.plabm.2025.e00479","url":null,"abstract":"<div><h3>Background</h3><div>Mycobacterial infections present significant global health challenges. Traditional diagnostic methods are inadequate for the identification of Mycobacterium species, highlighting the need for more efficient techniques. Matrix-assisted laser desorption-ionization time-of-flight (MALDI-TOF) mass spectrometry (MS) technology offers potential advantages in rapid and accurate pathogen identification.</div></div><div><h3>Objective</h3><div>This study evaluates the accuracy and precision of the MALDI-TOF using the FastPrep-2 bead beating system and VITEK MS version 3.2 for identifying Mycobacterium species directly from Mycobacteria Growth Indicator Tube (MGIT), liquid medium, compared to MALDI-TOF (VITEK MS) based on the traditional solid medium (Lowenstein–Jensen). We also compared the result of the MALDI-TOF from MGIT to <em>M tuberculosis</em> results by PCR-based method.</div></div><div><h3>Methods</h3><div>The study included 16 <em>mycobacterium tuberculosis</em> (MTB) and 37 <em>nontuberculous mycobacteria</em> (NTM). Isolates were grown in LJ solid medium and MGIT liquid medium, and lysed using the FastPrep-2 bead beating system. Identification was performed using VITEK MS version 3.2 from liquid.</div></div><div><h3>Results</h3><div>NTM comprised 70 % (37/53) of the total isolates evaluated. <strong>Of these, 92 % (34/37) were successfully identified using VITEK MS from MGIT liquid medium.</strong> Overall, the method achieved 88.6 % accuracy for identifying <em>Mycobacterium</em> species from liquid medium, compared to 96.2 % from solid medium. The agreement between both methods was moderate (Kappa = 0.470, p < 0.001). MTB isolates were identified with 100 % accuracy, and the approach demonstrated excellent reproducibility with 100 % intra-assay and inter-day consistency.</div></div><div><h3>Conclusion</h3><div>Using VITEK MS version 3.2 to directly identify MTB and NTM from MGIT liquid medium provides a rapid, cost-effective, and reliable method for identifying Mycobacterium species. Further optimization and database expansion are recommended to enhance accuracy for rare and less common mycobacterial species.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"46 ","pages":"Article e00479"},"PeriodicalIF":1.7,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144212451","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

Analytical performance evaluation of intelligent quality management of blood gas analyzer 血气分析仪智能质量管理分析性能评价

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-05-29 DOI: 10.1016/j.plabm.2025.e00480

Hongting Tang , Yawen Xiao , Hong Luo, Jian Jiang, Hanqing Xu, Jun Yang, Lihua Yang, Xiang Yang

Objective

This study aimed to compare the application effectiveness and quality control (QC) performance of intelligent quality management for blood gas analysis (BGA) with those of traditional quality management.

Methods

We implemented intelligent quality management by employing the GEM Premier 5000 equipped with Intelligent Quality Management 2 (iQM 2). By collecting external quality assessment (EQA) and internal quality control (IQC) data, we compared the clinical application outcomes and quality control (QC) performance between the intelligent management and traditional management approaches.

Results

The average bias of EQA for pH, partial carbon dioxide pressure (pCO₂), partial oxygen pressure (pO₂), sodium (Na⁺) and calcium (Ca²⁺) decreased compared to pre-management levels; except for pO₂, the average coefficient of variation (CV%) of intelligent QC was lower. The average estimated total error (TE) in the intelligent QC met the specified acceptance criterion. According to the average sigma and the goal index ratio (QGI), both QC modes have issues with accuracy and precision; the probabilities of false rejection (Pfr) of traditional QC and intelligent QC are almost the same; except for pO₂ and Na⁺, the probability of error detection (Ped) of intelligent QC is greater, whereas the average detection time (ADT) of traditional QC is greater. In addition, intelligent QC identified errors in approximately 1.46 % of the samples.

Conclusions

The precision and accuracy of the BGA improved significantly compared to those before management, indicating significant advantages of intelligent quality management in quality management applications.

目的比较血气分析（BGA）智能质量管理与传统质量管理的应用效果和质量控制性能。方法采用配备智能质量管理2 （iqm2）的GEM Premier 5000进行智能质量管理。通过收集外部质量评估（EQA）和内部质量控制（IQC）数据，比较智能管理与传统管理方法的临床应用效果和质量控制（QC）绩效。结果EQA对pH、二氧化碳分压（pCO2）、氧气分压（pO2）、钠（Na+）和钙（Ca2+）的平均偏差较管理前有所降低；除pO2外，智能QC的平均变异系数（CV%）均较低。智能QC的平均估计总误差（TE）满足规定的验收标准。从平均西格玛和目标指数比（QGI）来看，两种QC模式都存在准确性和精密度的问题；传统质量控制与智能质量控制的误拒概率基本一致；除了pO2和Na+外，智能QC的错误检测概率（Ped）更大，而传统QC的平均检测时间（ADT）更大。此外，智能QC在大约1.46%的样品中发现了错误。结论BGA的精密度和准确度较管理前有明显提高，说明智能质量管理在质量管理应用中的优势显著。

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引用次数: 0