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Serum reference intervals of micronutrients, vitamins, and interleukins among healthy adults in South-Western Nigeria 尼日利亚西南部健康成年人血清中微量营养素、维生素和白细胞介素的参考区间
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00363
Tewogbade Adeoye Adedeji , Nife Olamide Adedeji , Olusola Akanni Jeje , Abiodun Kofoworola Ajeigbe , Olufemi Samuel Smith , Temilola O. Owojuyigbe , Michael Bimbo Fawale , Olabamiji Abiodun Ajose , Simeon Adelani Adebisi , Adeyinka Abdulrasak Akande , Bashiru Adekunle Okesina

Objectives

Clinical decision making depends mostly on appropriate application of numerical pathology reports from laboratory results, interpreted by comparison with reference intervals. We determined serum reference intervals of micronutrients, vitamins, and detectable interleukins among healthy adults in South-Western Nigeria.

Design and methods

This prospective study used a priori selection approach in blood-donors. They were screened for conditions that could elicit cytokine production.

Serum micronutrients were assayed using Atomic Absorption Spectrophotometry; interleukins and vitamins by high Performance Liquid Chromatography. The reference intervals (RIs) were estimated at 2.5th percentile and 97.5th percentile.

Results

One hundred and eighteen (118) apparently healthy subjects, aged 18–56 years; 113 (95.8%) being 18–44years, and 5 (4.2%): 45–56 years; mostly males, 13 (11.02%) females, all Africans of Yoruba ethnicity.

Estimated reference limits were: Zinc: 9.49–20.54 μmol/L, Selenium: 0.50–1.11 μmol/L, Copper: 13.86–27.97 μmol/L, Iron: 14.19–32.07 μmol/L, Manganese: 6.24–16.37 nmol/L; Magnesium: 0.78–1.62 mmol/L.

Vitamins: A-1.08–2.39 μmol/L; D: 59.89–164.42 μmol/L; E: 7.13–19.45 μmol/L; K: 0.16–0.42 nmol/L; B1: 74.09–201.56 nmol/L; B6: 0.12–0.29 nmol/L; B12: 155.55–407.96 pmol/L; C: 47.74–112.99 μmol/L.

Detected interleukins (IL-1 to IL-18): IL-1: 0.58–1.24 ng/L, IL-2: 0.09–0.18 ng/L, IL-3: 0.39–0.89 ng/L, IL-4: 0.27–0.58 ng/L, ….to IL-18: 0.74–1.56 ng/L.

Conclusions

The RI derived from this study for serum micronutrient, vitamin and interleukin concentrations are the first published for our population. They are in general agreement with those published from other geographical climes but there are differences at the lower and upper limits of the RI. The study reinforces the importance of deriving RI for the population that a clinical laboratory will serve.

目的临床决策在很大程度上取决于对实验室结果中的病理数字报告的适当应用,并通过与参考区间的比较进行解释。我们确定了尼日利亚西南部健康成年人血清中微量元素、维生素和可检测到的白细胞介素的参考区间。使用原子吸收分光光度法检测血清微量营养素;使用高效液相色谱法检测白细胞介素和维生素。结果118 名明显健康的受试者,年龄在 18-56 岁之间,其中 113 人(95.8%)在 18-44 岁之间,5 人(4.2%)在 45-56 岁之间:大部分为男性,13 名女性(11.02%),均为约鲁巴族非洲人:锌:9.49-20.54 μmol/L;硒:0.50-1.11 μmol/L;铜:13.86-27.97 μmol/L;铁:14.19-32.07 μmol/L;锰:6.24-16.37 nmol/L;镁:0.78-1.62 mmol/L:镁:0.78-1.62 毫摩尔/升:维生素:A-1.08-2.39 μmol/L;D:59.89-164.42 μmol/L;E:7.13-19.45 μmol/L;K:0.16-0.42 nmol/L;B1:74.09-201.56 nmol/L;B6:0.12-0.29 nmol/L;B12:155.55-407.96 pmol/L;C:47.74-112.99 μmol/L:IL-1: 0.58-1.24 ng/L, IL-2: 0.09-0.18 ng/L, IL-3: 0.39-0.89 ng/L, IL-4: 0.27-0.58 ng/L, ....to IL-18:结论本研究得出的血清微量营养素、维生素和白细胞介素浓度的 RI 是首次针对我国人群公布的。这些数据与其他地区公布的数据基本一致,但在RI的下限和上限上存在差异。这项研究强调了为临床实验室服务的人群得出 RI 的重要性。
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引用次数: 0
Optimizing d-mannose and glyceraldehyde concentrations as glucose preservatives without clinically affecting biochemical test results 优化作为葡萄糖防腐剂的 d-甘露糖和甘油醛浓度,同时不影响临床生化测试结果
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00388
Renu Wiriyaprasit , Khundaw Moonla , Napaporn Apiratmateekul , Anchalee Chittamma , Gerald J. Kost , Wanvisa Treebuphachatsakul

Objectives: The objectives were to evaluate blood additives that combined lithium heparin (LH)-salt with glyceraldehyde (GLY) or d-mannose (MAN) for preserving glucose levels in plasma samples and to simultaneously determine the compatibility of these additives with 14 other biochemical tests.

Methods

Blood samples from 40 subjects, equally divided into healthy and diabetic groups, were collected using five different additives. The three most effective additives, LH/GLY, LH/MAN, and LH/GLY/MAN, were selected for ensuring the best preservation of glucose levels and compatibility with 14 biochemical tests. One-way analysis of variance was used to analyze the mean paired differences of glucose level and biochemical tests. Simultaneously, the clinical criteria from Johns Hopkins Hospital were used to guide the interpretation and set acceptable thresholds for measurements that exceeded the standards.

Results

The combination of 160 mmol/L GLY, 8.4 mmol/L MAN, and LH, maintained glucose levels at approximately 93.4–93.7 % for healthy subjects and 91.3–92.8% for subjects with diabetes mellitus over 8 h. The mean paired differences of glucose levels in preservation were statistically insignificant. The biases in 14 biochemical tests for LH/GLY/MAN and LH/MAN remained within the acceptable clinical criteria during the 8 h.

Conclusions

Combining 160 mmol/L GLY, 8.4 mmol/L MAN, and LH, proved more effective in maintaining glucose levels than individual additives or the conventional sodium fluoride preservative. It did not yield clinical discrepancies in the 14 biochemical tests during 8 h at room temperature.

研究目的方法:使用五种不同的添加剂采集了 40 名受试者的血样,平均分为健康组和糖尿病组。选择了三种最有效的添加剂,即 LH/GLY、LH/MAN 和 LH/GLY/MAN,以确保葡萄糖水平的最佳保存效果以及与 14 种生化检验的兼容性。采用单因素方差分析来分析血糖水平和生化测试的平均配对差异。结果 160 mmol/L GLY、8.4 mmol/L MAN 和 LH 的组合使健康受试者的血糖水平在 8 小时内保持在 93.4-93.7% 左右,使糖尿病受试者的血糖水平在 8 小时内保持在 91.3-92.8% 左右。在 8 小时内,LH/GLY/MAN 和 LH/MAN 的 14 项生化测试的偏差仍在可接受的临床标准范围内。结论与单独的添加剂或传统的氟化钠防腐剂相比,将 160 mmol/L GLY、8.4 mmol/L MAN 和 LH 混合使用能更有效地保持葡萄糖水平。在室温下进行 8 小时的 14 项生化测试中,它不会产生临床差异。
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引用次数: 0
Performance evaluation of the Access HBsAg and Access HBsAg confirmatory assays on the DxI 9000 Access Immunoassay Analyzer DxI 9000 Access 免疫测定分析仪上的 Access HBsAg 和 Access HBsAg 确证测定的性能评估
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00390
Benoit Visseaux , Jérémie Gautier , Françoise Le Boulaire , Catherine Coignard , Claire Vincent , Sandrine Gréaume , Isabelle Voisin , Veronique Lemée , Jean-Christophe Plantier , Yves-Edouard Herpe , Etienne Brochot , Stephanie Bord , Marc Turini , Vanessa Roulet , Juliane Hey

Introduction

This study evaluated the clinical and analytical performances of the Access HBsAg and the Access HBsAg Confirmatory assays on the DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.).

Materials and methods

Diagnostic specificity and sensitivity of the Access HBsAg and Access HBsAg Confirmatory assays were evaluated by comparing the Access assays to the final HBsAg sample status determined using the Architect, PRISM, or Elecsys HBsAg assays, along with Architect or PRISM HBsAg Confirmatory assays. Imprecision, sensitivity on seroconversion panels, analytical sensitivity on WHO, and recognition of HBV variants were also evaluated.

Results

A total of 7534 samples were included in the analysis (6047 blood donors, 1032 hospitalized patients, 455 positive patients’ samples). Access HBsAg assay sensitivity and specificity were at 100.00% (99.19–100.0) and 99.92% (99.82–99.97), respectively. Sensitivity of Access HBsAg Confirmatory assay was 100.00% (99.21–100.0) on the 464 HBsAg positive samples. The use of a high positive algorithm for the Access HBsAg assay, wherein samples with S/CO ≥ 100.00 were considered positive without requiring repeat or confirmatory testing, was successfully evaluated with all 450 specimens with S/CO greater than 100.00 (sensitivity 100.00%; 99.19–100.0). Access HBsAg assay demonstrated good analytical performance, equivalent recognition of seroconversion panels compared to Architect assay, and an analytical sensitivity between 0.022 and 0.025 IU/mL. All HBV genotypes, subtypes and mutants were well detected without analytical sensitivity loss.

Conclusion

Access HBsAg and Access HBsAg Confirmatory assays demonstrated robust performances. They provide low samples volume requirements and a simplified process, no systematic retesting for high positive samples.

导言本研究评估了 DxI 9000 Access 免疫分析仪(贝克曼库尔特公司)上的 Access HBsAg 和 Access HBsAg 确证测定的临床和分析性能。材料与方法通过比较 Access 检测法与使用 Architect、PRISM 或 Elecsys HBsAg 检测法以及 Architect 或 PRISM HBsAg Confirmatory 检测法确定的最终 HBsAg 样品状态,评估 Access HBsAg 检测法和 Access HBsAg Confirmatory 检测法的诊断特异性和灵敏度。此外,还评估了不精确度、血清转换面板的灵敏度、WHO 分析灵敏度以及 HBV 变体的识别能力。结果 共有 7534 份样本纳入分析(6047 位献血者、1032 位住院患者、455 位阳性患者样本)。Access HBsAg 检测的灵敏度和特异性分别为 100.00%(99.19-100.0)和 99.92%(99.82-99.97)。在 464 份 HBsAg 阳性样本中,Access HBsAg 确证测定的灵敏度为 100.00%(99.21-100.0)。对所有 450 份 S/CO 大于 100.00 的样本成功评估了 Access HBsAg 检测的高阳性算法,即 S/CO ≥ 100.00 的样本视为阳性,无需重复或确证检测(灵敏度为 100.00%;99.19-100.0)。Access HBsAg 检测法显示出良好的分析性能,与 Architect 检测法相比,血清转换面板的识别率相当,分析灵敏度介于 0.022 和 0.025 IU/mL 之间。所有 HBV 基因型、亚型和突变型都能很好地检测出来,而不会降低分析灵敏度。它们对样本量要求低,流程简化,无需对高阳性样本进行系统性重测。
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引用次数: 0
Biological variation of PIVKA-II in blood serum of healthy subjects measured by automated electrochemiluminescent assay 通过自动电化学发光法测定健康受试者血清中 PIVKA-II 的生物变化
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00389
Antonín Jabor , Zdenek Kubíček , Jitka Čásenská , Tereza Vacková , Vanda Filová , Janka Franeková

Background

Prothrombin/Protein Induced by Vitamin K Absence-II (PIVKA-II) is a candidate biomarker of hepatocellular cancer, recommended both for diagnostics and monitoring. The aim was to evaluate biological variation (BV) of serum PIVKA-II.

Methods

Within-subject (CVI) and between-subject (CVG) BV estimates were assessed in 14 healthy volunteers in a 6-week protocol. Serum concentrations of PIVKA-II were measured by a Roche Elecsys PIVKA-II diagnostic kit (cobas e8000). Precision (CVA) was assessed from duplicate measurements of all volunteers' samples. Two methods were used for the estimation of CVI: SD-ANOVA and CV-ANOVA method. We calculated the index of individuality (II) and reference change value. The experiment was fully compliant with EFLM database checklist.

Results

The CVI of PIVKA-II in healthy persons, as calculated by two statistical methods, were 8.2% (SD-ANOVA with CVA of 3.2%) and 9.4% (CV-ANOVA) with CVA of 2.7%). The CVG was 19.5% (SD-ANOVA), and respective II and RCV were 0.42 and 24.4%.

Conclusions

CVI and CVG of PIVKA-II were 8.2% and 19.5%, respectively, with CVA below 4%. The low II and RCV below 25% enable the use of this biomarker both for diagnostics and monitoring. More data are needed before the introduction of PIVKA-II into clinical practice.

背景凝血酶原/维生素 K 缺失诱导蛋白-II(PIVKA-II)是肝细胞癌的候选生物标志物,推荐用于诊断和监测。该研究旨在评估血清 PIVKA-II 的生物变异(BV)。方法在为期 6 周的方案中,对 14 名健康志愿者的受试者内(CVI)和受试者间(CVG)BV 估计值进行了评估。血清中的 PIVKA-II 浓度由罗氏 Elecsys PIVKA-II 诊断试剂盒(cobas e8000)测定。精确度(CVA)通过对所有志愿者样本的重复测量进行评估。在估算 CVI 时使用了两种方法:SD-ANOVA 法和 CV-ANOVA 法。我们计算了个体化指数(II)和参考变化值。实验完全符合 EFLM 数据库核对表的要求。结果两种统计方法计算出的健康人 PIVKA-II 的 CVI 分别为 8.2%(SD-ANOVA,CVA 为 3.2%)和 9.4%(CV-ANOVA,CVA 为 2.7%)。结论PIVKA-II的CVI和CVG分别为8.2%和19.5%,CVA低于4%。低 II 值和低于 25% 的 RCV 使该生物标记物可用于诊断和监测。在将 PIVKA-II 引入临床实践之前,还需要更多的数据。
{"title":"Biological variation of PIVKA-II in blood serum of healthy subjects measured by automated electrochemiluminescent assay","authors":"Antonín Jabor ,&nbsp;Zdenek Kubíček ,&nbsp;Jitka Čásenská ,&nbsp;Tereza Vacková ,&nbsp;Vanda Filová ,&nbsp;Janka Franeková","doi":"10.1016/j.plabm.2024.e00389","DOIUrl":"10.1016/j.plabm.2024.e00389","url":null,"abstract":"<div><h3>Background</h3><p>Prothrombin/Protein Induced by Vitamin K Absence-II (PIVKA-II) is a candidate biomarker of hepatocellular cancer, recommended both for diagnostics and monitoring. The aim was to evaluate biological variation (BV) of serum PIVKA-II.</p></div><div><h3>Methods</h3><p>Within-subject (CV<sub>I</sub>) and between-subject (CV<sub>G</sub>) BV estimates were assessed in 14 healthy volunteers in a 6-week protocol. Serum concentrations of PIVKA-II were measured by a Roche Elecsys PIVKA-II diagnostic kit (cobas e8000). Precision (CV<sub>A</sub>) was assessed from duplicate measurements of all volunteers' samples. Two methods were used for the estimation of CV<sub>I</sub>: SD-ANOVA and CV-ANOVA method. We calculated the index of individuality (II) and reference change value. The experiment was fully compliant with EFLM database checklist.</p></div><div><h3>Results</h3><p>The CV<sub>I</sub> of PIVKA-II in healthy persons, as calculated by two statistical methods, were 8.2% (SD-ANOVA with CV<sub>A</sub> of 3.2%) and 9.4% (CV-ANOVA) with CV<sub>A</sub> of 2.7%). The CV<sub>G</sub> was 19.5% (SD-ANOVA), and respective II and RCV were 0.42 and 24.4%.</p></div><div><h3>Conclusions</h3><p>CV<sub>I</sub> and CV<sub>G</sub> of PIVKA-II were 8.2% and 19.5%, respectively, with CV<sub>A</sub> below 4%. The low II and RCV below 25% enable the use of this biomarker both for diagnostics and monitoring. More data are needed before the introduction of PIVKA-II into clinical practice.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00389"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000350/pdfft?md5=844de81587423e7d4dbacb9cd70469dd&pid=1-s2.0-S2352551724000350-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140280317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of ELISA with automated ECLIA for IL-6 determination in COVID-19 patients: An Italian real-life experience 比较 ELISA 和自动 ECLIA 对 COVID-19 患者 IL-6 的测定:意大利的实际经验
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00392
Francesca Romano , Luisa Lanzilao , Edda Russo , Maria Infantino , Francesca Nencini , Giovanni Cappelli , Stefano Dugheri , Mariangela Manfredi , Alessandra Fanelli , Amedeo Amedei , Nicola Mucci

Objectives

Coronavirus disease 2019 (COVID-19) has a wide spectrum of clinical severity. A cytokine storm is associated with COVID-19 severity. Of these, IL-6 is significantly associated with higher mortality and is also a marker for predicting disease prognosis. IL-6 may act as a target for therapeutics and, a blockade of IL-6 function by Tocilizumab has been described as a treatment of the inflammatory process COVID-19-related. This study aims to describe our experience comparing two different methods, in detail Human IL-6 Instant ELISA and the Elecsys IL-6 based on ECLIA, for the IL-6 assessment.

Design and methods

IL-6 levels from serum samples of 104 COVID-19 patients, admitted to the AOU Careggi (Hospital in Florence -Italy), were assessed by using the two above-mentioned methods, and the results were analysed through Passing-Bablok regression fit and Bland-Altman plot.

Results

The regression exhibited a linear relation between the methods with a regression equation (y = - 0.13 + 0.63 x; 95 % C.I. intercept = − 0.13 to 4.55; 95 % C.I. slope = 1.03 to 1.26 with R2 = 0.89, p > 0.05), showing a positive slope. The agreement of the two methods reported a bias of −25.0 pg/mL. Thus, the two methods correlate but do not agree in terms of numeric results.

Conclusions

The two assays showed good comparability. However, because of the extremely wide linear range of the ECLIA, its throughput and its capacity for immune profiling, it represents an interesting emerging technology in the immunology field.

目标2019年冠状病毒病(COVID-19)的临床严重程度范围很广。细胞因子风暴与 COVID-19 的严重程度相关。其中,IL-6 与较高的死亡率密切相关,也是预测疾病预后的标志物。IL-6可作为治疗药物的靶点,Tocilizumab阻断IL-6的功能已被描述为治疗COVID-19相关炎症过程的一种方法。本研究旨在介绍我们比较两种不同方法评估 IL-6 的经验,分别是人类 IL-6 瞬时 ELISA 和基于 ECLIA 的 Elecsys IL-6。设计和方法使用上述两种方法评估 104 名 COVID-19 患者的血清样本中的 IL-6 水平,并通过 Passing-Bablok 回归拟合和 Bland-Altman 图分析结果。结果回归结果显示,两种方法之间呈线性关系,回归方程为(y = - 0.13 + 0.63 x; 95 % C.I. 截距 = - 0.13 至 4.55; 95 % C.I. 斜率 = 1.03 至 1.26,R2 = 0.89,p > 0.05),斜率为正。两种方法的一致性报告偏差为-25.0 pg/mL。因此,这两种方法具有相关性,但在数值结果上并不一致。不过,由于 ECLIA 的线性范围极宽、通量大且可用于免疫分析,因此它是免疫学领域一项令人感兴趣的新兴技术。
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引用次数: 0
A novel XNA-based Luminex assay to detect UBA1 somatic mutations associated with VEXAS syndrome 基于 XNA 的新型 Luminex 检测法可检测与 VEXAS 综合征相关的 UBA1 体细胞突变
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00380
Yunqing Ma , ShianPin Hu , Rui Ni , Wei Liu , Andrew Fu , Michael Sha , Aiguo Zhang , Chuanyi M. Lu

Objectives

Patients with VEXAS syndrome carry mutations of UBA1 gene coding for the E1 enzyme. The three most frequent mutations are p.M41T(122T > C), p.M41V (c.121A > G), and p.M41L (c.121A > C) in codon 41 of exon 3. Currently, sanger sequencing was mainly used to detect these mutations, which has low sensitivity and low throughput. There is a need of high sensitivity, simple and high throughput method to characterize patients with VEXAS syndrome.

Methods

Based on our proprietary XNA technology, we have developed a QClamp® Plex platform to detect eight mutations in a single reaction using the Luminex xMap technology. The assay sensitivity, specificity and precision were subsequently evaluated. Furthermore, the reference interval and clinical sensitivity/specificity were estimated using clinical healthy/positive DNA samples and the sanger sequencing method was used for comparison.

Results

With spiking synthetic mutant DNA in wildtype GM24385 cell line DNA, this assay can detect UBA1 mutations with a detection limit of variant allele frequency (VAF) at 0.1–5%. Our assay shows 100% concordance with Sanger sequencing results when used for analyzing 15 positive and 19 negative clinical samples.

Conclusions

The QClamps® Plex UBA1 Mutation Detection Assay is a quicker, simpler, and more sensitive assay that can accurately detect the UBA1 mutations even at early stages with low mutation frequency.

目的VEXAS综合征患者携带编码E1酶的UBA1基因突变。最常见的三种突变是第3外显子第41密码子上的p.M41T(122T >C)、p.M41V(c.121A >G)和p.M41L(c.121A >C)。目前,桑格测序法主要用于检测这些突变,但灵敏度低、通量小。方法基于我们专有的 XNA 技术,我们开发了一个 QClamp® Plex 平台,利用 Luminex xMap 技术在一次反应中检测 8 个突变。随后对检测灵敏度、特异性和精确度进行了评估。结果在野生型 GM24385 细胞系 DNA 中添加合成突变 DNA,该检测方法可检测出 UBA1 突变,变异等位基因频率 (VAF) 的检测限为 0.1-5%。结论 QClamps® Plex UBA1 突变检测试剂盒是一种更快速、更简单、更灵敏的检测方法,即使在突变频率较低的早期阶段也能准确检测出 UBA1 突变。
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引用次数: 0
Compound heterozygous with Hb G-Taipei and Hb Lepore-Boston-Washington: An unexpected finding triggered by HbA1c measurement Hb G-台北和 Hb Lepore-波士顿-华盛顿的复合杂合子:HbA1c 测量引发的意外发现
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-03-01 DOI: 10.1016/j.plabm.2024.e00379
Yu Li , Anping Xu , Juan He , Limin Huang , Li Lin , Jie Li , Yong Xia , Ling Ji

Background

Hemoglobin A1c has been widely used to diagnose and monitor diabetes. However, the accuracy of HbA1c analysis can be significantly affected by hemoglobin variants, leading to falsely low or elevated levels and misdiagnosis or inappropriate diabetes management.

Case report

In this study, we present the case of a 23-year-old man with undetectable HbA1c levels during his annual checkup by high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE). To investigate the reason for HbA1c absence, Sanger sequencing, multiplex ligation-dependent probe amplification assay (MLPA), long-read single molecule real-time sequencing (SMRT) and MALDI-TOF mass spectrometry (MS) were performed, and the proband was identified as compound heterozygous of β-thalassemia with Hb G-Taipei (HBB:c.68A > G) and Hb Lepore-Boston-Washington (NG_000007.3:g.63632_71046del).

Conclusion

The combination of these molecular technologies including MLPA, long-read SMRT sequencing and MALDI-TOF MS is beneficial for identifying rare hemoglobin variants. This case also provides essential evidence for uncovering the effect of compound heterozygosity for Hb Lepore-Boston-Washington and Hb G-Taipei on hematological phenotypes and HbA1c analysis.

背景血红蛋白 A1c 已被广泛用于诊断和监测糖尿病。然而,血红蛋白变异会严重影响 HbA1c 分析的准确性,导致 HbA1c 水平过低或过高,从而导致误诊或不恰当的糖尿病管理。本研究中,我们发现一名 23 岁的男性在年度体检中通过高效液相色谱法(HPLC)和毛细管电泳法(CE)检测不到 HbA1c 水平。为了探究 HbA1c 缺失的原因,研究人员进行了桑格测序、多重连接依赖性探针扩增分析(MLPA)、长线程单分子实时测序(SMRT)和 MALDI-TOF 质谱分析(MS)。结论将这些分子技术(包括 MLPA、长线程 SMRT 测序和 MALDI-TOF MS)结合起来,有利于鉴定罕见血红蛋白变异。本病例还为揭示 Hb Lepore-Boston-Washington 和 Hb G-Taipei 复合杂合性对血液表型和 HbA1c 分析的影响提供了重要证据。
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引用次数: 0
New procalcitonin point-of-care test meets analytical performances to stratification of infectious syndrome 新型丙种球蛋白床旁检验符合传染病综合征分层的分析要求
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-02-23 DOI: 10.1016/j.plabm.2024.e00372
Anne Marie Dupuy, Ahmed Yahyaoui, Anne Sophie Bargnoux, Caroline Coulon, Stéphanie Badiou, Jean Paul Cristol
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引用次数: 0
Low specificity of Aspergillus spp. ELITe MGB assay, and potential risks in management of invasive aspergillosis 侵袭性曲霉菌病 ELITe MGB 检测的低特异性和潜在风险
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-02-21 DOI: 10.1016/j.plabm.2024.e00378
Violaine Bothy , Maria A. Argudín , Nathalie Olive , Cindy Barbée , Benoît Kabamba-Mukadi , Hector Rodriguez-Villalobos

Objectives

In recent years, commercial molecular tools for diagnosis of invasive aspergillosis have emerged, requiring evaluation to ensure quality. Here we assessed the specificity of Aspergillus spp.-ELITe MGB Assay a commercial assay tergeting 18S gene of Aspergillus spp.

Design and methods

As part of a method validation, we evaluate the specificity of the Aspergillus spp.-ELITe MGB Assay by testing fourteen culture based samples of sequenced non-Aspergillus fungal species. The benefits of a pre-lysis treatment was evaluated in parallel on serial dilutions of an Aspergillus fumigatus strain.

Results

Our findings revealed cross-reactivity in five strains using the 50 copies/mL cut-off recommended by the manufacturer, suggesting potential diagnostic errors and inappropriate management of patients. Pre-lysis treatment does not affect the limit of detection at serial dilution.

Conclusions

In conclusion, the Aspergillus spp. ELITe MGB Assay exhibits limited specificity in culture-based samples, underscoring the importance of careful utilization in laboratories. Further studies are warranted to better comprehend of the impact of this cross-reactivity on clinical samples.

目的近年来,用于诊断侵袭性曲霉菌病的商业分子工具不断涌现,需要对其进行评估以确保质量。设计与方法作为方法验证的一部分,我们通过检测 14 个基于培养基的非曲霉菌种测序样本来评估曲霉菌属-ELITe MGB 检测法的特异性。结果我们的研究结果表明,使用制造商推荐的 50 拷贝/毫升临界值,有五种菌株存在交叉反应,这表明可能存在诊断错误和对患者的不当管理。结论总之,曲霉菌属 ELITe MGB 检测试剂盒在基于培养基的样本中表现出有限的特异性,强调了实验室谨慎使用的重要性。为了更好地了解这种交叉反应对临床样本的影响,还需要进一步的研究。
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引用次数: 0
Temperature stability of urinary F2-isoprostane and 8-hydroxy-2′-deoxyguanosine 尿液中 F2-异前列腺素和 8-羟基-2′-脱氧鸟苷的温度稳定性
IF 1.9 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-02-16 DOI: 10.1016/j.plabm.2024.e00373
Katarzyna Kordas , Diala Ghazal , Elena I. Queirolo , James R. Olson , María Inés Beledo , Richard W. Browne

Background

Clinical and epidemiological studies employ long-term temperature storage but the effect of temperature on the stability of oxidative stress (OS) markers is unknown. We investigated the effects of storage at −20 °C and −80 °C over 4–9 months on F2-isoprostanes (F2-IsoP) and 8-hydroxy-2-deoxyguanosine (8-OHdG) levels in urine of children, a population group among whom the measurement of these markers is still limited.

Methods

Paired spot urine samples from 87 children aged 8.9–16.9 years (52.9% boys) were analyzed. Samples were preserved with 0.005% (w/v) butylated hydroxytoluene, portioned and stored within 2.5 h (median) of collection. Samples were analyzed in duplicate or triplicate using commercial ELISA kits and their correlations were evaluated.

Results

F2-IsoP and 8-OHdG showed high correlations (Spearman rho of 0.90 and 0.97, respectively; P < 0.0001) with storage at −20 °C and −80 °C. There was a strong agreement among categories of values for F2-IsoP (Kappa = 0.76 ± 0.08, agreement = 83.9%, P < 0.0001) and 8-OHdG: (Kappa = 0.83 ± 0.08, agreement = 88.4%, P < 0.0001). The correlation between the temperatures for F2-IsoP concentrations was also high when stored for <4 (0.93), 4 (0.93), and 5 months (0.88), all P < 0.0001. For 8-OHdG, Spearman correlations at <8, 8, and 9 months of storage at −20 °C and −80 °C were 0.95, 0.98, and 0.96 (all P < 0.0001), respectively.

Conclusions

Urine storage with BHT for up to nine months at a temperature of −20 °C to −80 °C yields highly comparable concentrations of F2-IsoP and 8-OHdG.

背景临床和流行病学研究采用长期温度储存,但温度对氧化应激(OS)标志物稳定性的影响尚不清楚。我们研究了在-20 °C和-80 °C条件下储存4-9个月对儿童尿液中F2-异前列腺素(F2-IsoP)和8-羟基-2′-脱氧鸟苷(8-OHdG)水平的影响。样本用 0.005%(w/v)丁基羟基甲苯进行保存,并在采集后 2.5 小时(中位数)内分装和储存。结果F2-IsoP和8-OHdG与-20 °C和-80 °C的储存有很高的相关性(Spearman rho分别为0.90和0.97;P < 0.0001)。F2-IsoP(Kappa = 0.76 ± 0.08,吻合度 = 83.9%,P < 0.0001)和 8-OHdG:(Kappa = 0.83 ± 0.08,吻合度 = 88.4%,P < 0.0001)的各类值之间的吻合度很高。储存 4 个月(0.93)、4 个月(0.93)和 5 个月(0.88)时,F2-IsoP 浓度的温度之间的相关性也很高,均为 P <0.0001。对于 8-OHdG,在 -20 °C 和 -80 °C 下储存 8 个月、8 个月和 9 个月时的 Spearman 相关性分别为 0.95、0.98 和 0.96(均为 P <0.0001)。
{"title":"Temperature stability of urinary F2-isoprostane and 8-hydroxy-2′-deoxyguanosine","authors":"Katarzyna Kordas ,&nbsp;Diala Ghazal ,&nbsp;Elena I. Queirolo ,&nbsp;James R. Olson ,&nbsp;María Inés Beledo ,&nbsp;Richard W. Browne","doi":"10.1016/j.plabm.2024.e00373","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00373","url":null,"abstract":"<div><h3>Background</h3><p>Clinical and epidemiological studies employ long-term temperature storage but the effect of temperature on the stability of oxidative stress (OS) markers is unknown. We investigated the effects of storage at −20 °C and −80 °C over 4–9 months on F<sub>2</sub>-isoprostanes (F<sub>2</sub>-IsoP) and 8-hydroxy-2<em>′</em>-deoxyguanosine (8-OHdG) levels in urine of children, a population group among whom the measurement of these markers is still limited.</p></div><div><h3>Methods</h3><p>Paired spot urine samples from 87 children aged 8.9–16.9 years (52.9% boys) were analyzed. Samples were preserved with 0.005% (w/v) butylated hydroxytoluene, portioned and stored within 2.5 h (median) of collection. Samples were analyzed in duplicate or triplicate using commercial ELISA kits and their correlations were evaluated.</p></div><div><h3>Results</h3><p>F<sub>2</sub>-IsoP and 8-OHdG showed high correlations (Spearman rho of 0.90 and 0.97, respectively; P &lt; 0.0001) with storage at −20 °C and −80 °C. There was a strong agreement among categories of values for F<sub>2</sub>-IsoP (Kappa = 0.76 ± 0.08, agreement = 83.9%, P &lt; 0.0001) and 8-OHdG: (Kappa = 0.83 ± 0.08, agreement = 88.4%, P &lt; 0.0001). The correlation between the temperatures for F<sub>2</sub>-IsoP concentrations was also high when stored for &lt;4 (0.93), 4 (0.93), and 5 months (0.88), all P &lt; 0.0001. For 8-OHdG, Spearman correlations at &lt;8, 8, and 9 months of storage at −20 °C and −80 °C were 0.95, 0.98, and 0.96 (all P &lt; 0.0001), respectively.</p></div><div><h3>Conclusions</h3><p>Urine storage with BHT for up to nine months at a temperature of −20 °C to −80 °C yields highly comparable concentrations of F<sub>2</sub>-IsoP and 8-OHdG.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00373"},"PeriodicalIF":1.9,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000192/pdfft?md5=1f9c3849178398128514fbaedf3434f7&pid=1-s2.0-S2352551724000192-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139935561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Practical Laboratory Medicine
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