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Measurement of bilirubin in cerebrospinal fluid using the oxidase method on automated chemistry system advia XPT 自动化化学系统氧化酶法测定脑脊液中胆红素
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-04-25 DOI: 10.1016/j.plabm.2025.e00473
Ida Branzell , Gabriella Lillsunde Larsson , Dieter Samyn , Paul Pettersson-Pablo

Background and aim

Evaluate the diagnostic performance of automated, quantitative bilirubin measurement, modified to extend its lower measurement ranges, in cerebrospinal fluid (CSF) using the Siemens analyzer Advia XPT. Results were compared with the gold standard spectrophotometry for diagnosis of subarachnoid haemorrhage (SAH).

Method

Eighty clinical samples were analyzed on an Advia XPT, and results were compared to spectrophotometric results using the Agilent Cary 100 bio system. Method performance at low concentrations were evaluated using diluted control material and patient plasma and CSF samples. ROC curve analysis determined a suitable cutoff.

Result

Evaluation of low-concentration performance, below 2 μmol/L on Advia XPT, showed a measurement bias of -1.0 %, and a linear regression equation of y = 0.843x + 0.0351 (R2 of 0.975), describing the relationship between measured and expected concentrations of diluted samples. The coefficient of variation, (CV), was 2.92 % at 0.598 μmol/L and 26.6 % at 0.161 μmol/L. Using the outcome of the analysis on Agilent Cary 100 as reference, sensitivity was 100 % and specificity 96 %, employing a cutoff of 0.41 μmol/L.

Conclusion

Quantitative measurement of bilirubin in CSF using the bilirubin oxidase method on the automated Advia XPT platform perform well, with the analysis of low concentrations of bilirubin displaying a high precision and a high concordance with the results of spectrophotometry. These preliminary findings are indicative of the merits of quantitative measurement, that warrants further study of its diagnostic potential as an alternative to the more cumbersome spectrophotometry for diagnosing SAH.
背景和目的:利用西门子Advia XPT分析仪,评估脑脊液(CSF)中胆红素自动定量测量的诊断性能,改进后扩大了其较低的测量范围。结果与金标准分光光度法诊断蛛网膜下腔出血(SAH)进行比较。方法采用Advia XPT对80例临床样品进行分析,并与安捷伦Cary 100生物系统分光光度法结果进行比较。方法用稀释后的对照物和患者血浆及脑脊液样品评价低浓度下的检测效果。ROC曲线分析确定了合适的截止点。结果对Advia XPT在2 μmol/L以下的低浓度性能的评价偏差为- 1.0%,线性回归方程为y = 0.843x + 0.0351 (R2为0.975),描述了稀释后样品的实际浓度与期望浓度之间的关系。变异系数(CV)在0.598 μmol/L时为2.92%,在0.161 μmol/L时为26.6%。以Agilent Cary 100分析结果为参照,灵敏度为100%,特异度为96%,截止值为0.41 μmol/L。结论在Advia XPT自动化平台上应用胆红素氧化酶法定量测定CSF中胆红素,对低浓度胆红素的分析精度高,与分光光度法结果一致性高。这些初步发现表明了定量测量的优点,值得进一步研究其诊断潜力,以替代更繁琐的分光光度法诊断SAH。
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引用次数: 0
Biotin interference in routine clinical immunoassays 生物素在常规临床免疫分析中的干扰
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-05-01 DOI: 10.1016/j.plabm.2025.e00472
Kuo-Chun Chiu , Jia-Rong Jhan , Hsiao-Ni Yan , Yu-Chen Liao , Wen-Hui Lu , Kuan-Yi Lee , Li-Yuan Cheng , Chung-Kang Yeh , Ya-Fen Lee , Chiung-Hui Kuo , Kuei-Pin Chung , Tzu-I Chien
<div><h3>Background</h3><div>Laboratory examinations play a crucial role in medical diagnostics and treatment, necessitating the identification of interference factors to ensure accurate results. Biotin, a common dietary supplement, can interfere with immunoassays utilizing biotin-streptavidin interactions. Studies have documented biotin's significant impact on thyroid function tests and various immunoassays, prompting the need for effective mitigation strategies.</div></div><div><h3>Methods</h3><div>Samples were collected from various clinical departments and analyzed for biotin levels. Biotin interference was evaluated using both old and new Elecsys reagents in assays for thyroglobulin (TG), alpha-fetoprotein (AFP), anti-thyroglobulin (ATG), and free thyroxine (FT4). Biotin spike-in and depletion tests were conducted to assess interference mitigation methods. Additionally, the biotin tolerance of Roche and Abbott immunoassay systems was compared.</div></div><div><h3>Results</h3><div>Biotin levels were measured in 78 participants from different clinical departments: health management center (<em>n</em> = 13), emergency department (<em>n</em> = 21), intensive care unit (<em>n</em> = 12), gynecology department(<em>n</em> = 3), and hemodialysis department (<em>n</em> = 29). Patients undergoing hemodialysis and those in the intensive care unit (ICU) demonstrated significantly elevated biotin levels (mean = 3.282 ng/mL and 3.212 ng/mL, respectively) in comparison to other patient groups (<em>p</em> < 0.05), likely attributable to the intake of biotin-containing supplements. Biotin levels >500 ng/mL caused a 20 % change in assay values, resulting in false-low results for TG and AFP and false-high results for ATG and FT4 with older Elecsys reagents. Setting a 10 % change as the threshold, the newer Elecsys reagents demonstrated improved resistance against biotin interference, tolerating concentrations of 1000 ng/mL to 3000 ng/mL depending on the specific tests, consistent with the Roche package inserts. We employed a biotin depletion method that effectively restored assay accuracy for older reagents, generally resulting in less than a 10 % change when biotin levels were below 400 ng/mL. However, this depletion method was unnecessary with the newer reagents due to their increased biotin tolerance. Comparing the Roche and Abbott systems revealed significant differences in biotin tolerance. The Abbott system demonstrated greater resilience to biotin interference, while the Roche system showed biotin interference in assays for carcinoembryonic antigen, cancer antigen 125, cancer antigen 153, cancer antigen 19-9, with changes exceeding 30 % at 500 ng/mL of biotin.</div></div><div><h3>Conclusions</h3><div>Our study highlights the high prevalence of elevated biotin levels in hemodialysis and ICU patients, serving as a critical reference for clinical result interpretation. We confirm that Roche's newer reagents exhibit enhanced biotin tolerance, consiste
实验室检查在医学诊断和治疗中起着至关重要的作用,需要识别干扰因素以确保准确的结果。生物素,一种常见的膳食补充剂,可以干扰利用生物素-链亲和素相互作用的免疫测定。研究已经证明生物素对甲状腺功能测试和各种免疫分析的显著影响,促使需要有效的缓解策略。方法采集临床各科室标本,进行生物素水平分析。使用新旧Elecsys试剂对甲状腺球蛋白(TG)、甲胎蛋白(AFP)、抗甲状腺球蛋白(ATG)和游离甲状腺素(FT4)的检测进行生物素干扰评价。生物素峰值和消耗试验进行评估干扰缓解方法。此外,比较了罗氏和雅培免疫测定系统的生物素耐受性。结果78名受试者分别来自不同临床科室:健康管理中心(n = 13)、急诊科(n = 21)、重症监护病房(n = 12)、妇科(n = 3)、血液透析科(n = 29)。与其他患者组相比,接受血液透析的患者和重症监护病房(ICU)患者的生物素水平显著升高(平均分别为3.282 ng/mL和3.212 ng/mL) (p <;0.05),可能是由于摄入了含生物素的补充剂。生物素水平(500 ng/mL)导致测定值变化20%,使用较旧的Elecsys试剂,导致TG和AFP的假低结果和ATG和FT4的假高结果。将10%的变化作为阈值,较新的Elecsys试剂显示出对生物素干扰的抗性增强,根据具体测试,耐受浓度为1000 ng/mL至3000 ng/mL,与罗氏说明书一致。我们采用了一种生物素耗尽法,有效地恢复了旧试剂的测定准确性,当生物素水平低于400 ng/mL时,通常导致不到10%的变化。然而,由于新试剂的生物素耐受性增加,这种消耗方法是不必要的。比较罗氏和雅培系统揭示了生物素耐受性的显著差异。雅培系统对生物素干扰表现出更强的弹性,而罗氏系统在癌胚抗原、癌抗原125、癌抗原153、癌抗原19-9的检测中显示出生物素干扰,在500 ng/mL生物素时变化超过30%。结论我们的研究突出了血液透析和ICU患者中生物素水平升高的高发率,为临床结果解释提供了重要参考。我们证实罗氏的新试剂表现出增强的生物素耐受性,与制造商的声明一致,并证明生物素耗尽有效地恢复了测定准确性。这些发现为减轻临床免疫测定中的生物素干扰提供了有价值的方法学指导。
{"title":"Biotin interference in routine clinical immunoassays","authors":"Kuo-Chun Chiu ,&nbsp;Jia-Rong Jhan ,&nbsp;Hsiao-Ni Yan ,&nbsp;Yu-Chen Liao ,&nbsp;Wen-Hui Lu ,&nbsp;Kuan-Yi Lee ,&nbsp;Li-Yuan Cheng ,&nbsp;Chung-Kang Yeh ,&nbsp;Ya-Fen Lee ,&nbsp;Chiung-Hui Kuo ,&nbsp;Kuei-Pin Chung ,&nbsp;Tzu-I Chien","doi":"10.1016/j.plabm.2025.e00472","DOIUrl":"10.1016/j.plabm.2025.e00472","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Laboratory examinations play a crucial role in medical diagnostics and treatment, necessitating the identification of interference factors to ensure accurate results. Biotin, a common dietary supplement, can interfere with immunoassays utilizing biotin-streptavidin interactions. Studies have documented biotin's significant impact on thyroid function tests and various immunoassays, prompting the need for effective mitigation strategies.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Samples were collected from various clinical departments and analyzed for biotin levels. Biotin interference was evaluated using both old and new Elecsys reagents in assays for thyroglobulin (TG), alpha-fetoprotein (AFP), anti-thyroglobulin (ATG), and free thyroxine (FT4). Biotin spike-in and depletion tests were conducted to assess interference mitigation methods. Additionally, the biotin tolerance of Roche and Abbott immunoassay systems was compared.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Biotin levels were measured in 78 participants from different clinical departments: health management center (&lt;em&gt;n&lt;/em&gt; = 13), emergency department (&lt;em&gt;n&lt;/em&gt; = 21), intensive care unit (&lt;em&gt;n&lt;/em&gt; = 12), gynecology department(&lt;em&gt;n&lt;/em&gt; = 3), and hemodialysis department (&lt;em&gt;n&lt;/em&gt; = 29). Patients undergoing hemodialysis and those in the intensive care unit (ICU) demonstrated significantly elevated biotin levels (mean = 3.282 ng/mL and 3.212 ng/mL, respectively) in comparison to other patient groups (&lt;em&gt;p&lt;/em&gt; &lt; 0.05), likely attributable to the intake of biotin-containing supplements. Biotin levels &gt;500 ng/mL caused a 20 % change in assay values, resulting in false-low results for TG and AFP and false-high results for ATG and FT4 with older Elecsys reagents. Setting a 10 % change as the threshold, the newer Elecsys reagents demonstrated improved resistance against biotin interference, tolerating concentrations of 1000 ng/mL to 3000 ng/mL depending on the specific tests, consistent with the Roche package inserts. We employed a biotin depletion method that effectively restored assay accuracy for older reagents, generally resulting in less than a 10 % change when biotin levels were below 400 ng/mL. However, this depletion method was unnecessary with the newer reagents due to their increased biotin tolerance. Comparing the Roche and Abbott systems revealed significant differences in biotin tolerance. The Abbott system demonstrated greater resilience to biotin interference, while the Roche system showed biotin interference in assays for carcinoembryonic antigen, cancer antigen 125, cancer antigen 153, cancer antigen 19-9, with changes exceeding 30 % at 500 ng/mL of biotin.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;Our study highlights the high prevalence of elevated biotin levels in hemodialysis and ICU patients, serving as a critical reference for clinical result interpretation. We confirm that Roche's newer reagents exhibit enhanced biotin tolerance, consiste","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00472"},"PeriodicalIF":1.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143901916","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
Comparison of routine blood parameters by altitude and residence duration in the Western Sichuan Plateau 川西高原海拔和居住时间对血常规指标的影响
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-03-19 DOI: 10.1016/j.plabm.2025.e00467
Liang Wan , Qing Yuan , Mingxia Tang, Zhu Zhu, Yanwu Liu, Zhenglin Huang, Shuzhi Zhou, Ling Zhang, Qiaoling Wang, Yuntao Guo, Jian Yang

Background

This study explores how routine blood test parameters change over time in acclimatized individuals at different altitudes on the Western Sichuan Plateau.

Methods

Healthy men aged 20–40 from low-altitude areas who moved to Ganzi Prefecture to live and work were recruited. The observation sites were Guzan Town (1400 m), Kangding County Seat (2500 m), Luhuo County Seat (3400 m), and Litang County Seat (4100 m). Participants at the same altitude were grouped according to residence duration. The relationships between blood test parameters, altitude, and residence duration were analyzed.

Results

After moving to the plateau, white blood cell, red blood cell, hemoglobin, and hematocrit levels rose quickly in the short term, then declined and stabilized. In contrast, platelet levels increased steadily and were positively correlated with altitude.

Conclusions

Changes in blood parameters during high-altitude acclimatization are significant physiological responses to hypoxia and are affected by both altitude and residence duration.
本研究探讨川西高原不同海拔环境下个体血常规检测参数随时间的变化。方法招募20 ~ 40岁低海拔地区迁入甘孜州生活和工作的健康男性。观察点为古瓒镇(1400米)、康定县城(2500米)、鲁火县城(3400米)、理塘县城(4100米)。同一海拔的参与者按居住时间分组。分析血检参数与海拔、居住时间的关系。结果进入高原后,白细胞、红细胞、血红蛋白和红细胞压积在短期内迅速上升,随后下降并趋于稳定。相比之下,血小板水平稳步上升,并与海拔高度呈正相关。结论高原适应过程中血液参数的变化是对缺氧的显著生理反应,受海拔和停留时间的影响。
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引用次数: 0
Breath fingerprint of colorectal cancer patients by gas chromatography-mass spectrometry analysis preparatory to e-nose analyses 气相色谱-质谱分析结直肠癌患者呼吸指纹为电子鼻分析做准备
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-05-10 DOI: 10.1016/j.plabm.2025.e00475
Stefano Dugheri , Ilaria Rapi , Giovanni Cappelli , Niccolò Fanfani , Donato Squillaci , Simone De Sio , Beatrice Mallardi , Paola Mantellini , Fabio Staderini , Veronica Traversini , Antonio Baldassarre , Fabio Cianchi , Nicola Mucci
Colorectal cancer (CRC), according to the most recent data provided by GLOBOCAN, ranks fourth worldwide in incidence and third in mortality among all cancers. Current estimates project a global increase in colorectal cancer incidence of 60.5 % and mortality of 76.9 % between 2022 and 2045. The low sensitivity and adherence, coupled with the high costs associated with current diagnostic methods for CRC, underscore the need to explore innovative procedures for the early detection of tissue abnormalities. Existing research suggests that patients affected by this condition exhibit distinctive alterations in volatile organic compounds (VOCs) ratios in their exhaled breath.
This study presents a characterization of exhaled breath using Gas Chromatography-Mass Spectrometry (GC-MS) in patients with varying stages of the disease, as determined by conventional medical and clinical analyses. An electronic nose was utilized to develop a method aimed at rapidly analyzing a subject's exhaled breath to identify the group of belonging (healthy, affected). The aim of the study was to develop a rapid, cost-effective, and non-invasive early diagnostic system employing an electronic nose. Statistical analysis identified 12 compounds with the potential to distinguish between healthy and affected individuals and were selected for testing the application potential of the Cyranose 320 electronic nose. The ability of the method to identify the 40 subjects analyzed as Healthy Controls (HC) or CRC in terms of sensitivity and specificity (0.8 and 0.85, respectively) demonstrates the feasibility of using this method for rapid, low-cost, and non-invasive disease recognition.
根据GLOBOCAN提供的最新数据,结直肠癌(CRC)在全球所有癌症中发病率排名第四,死亡率排名第三。根据目前的估计,2022年至2045年期间,全球结直肠癌发病率将增加60.5%,死亡率将增加76.9%。当前CRC诊断方法的低灵敏度和低依从性,加上高成本,强调了探索早期发现组织异常的创新方法的必要性。现有的研究表明,受这种情况影响的患者在呼出的气体中挥发性有机化合物(VOCs)的比例表现出明显的变化。本研究采用气相色谱-质谱(GC-MS)对不同阶段患者的呼出气体进行表征,并通过常规医学和临床分析确定。利用电子鼻开发了一种方法,旨在快速分析受试者呼出的气体,以确定所属群体(健康,受影响)。本研究的目的是开发一种采用电子鼻的快速、经济、无创的早期诊断系统。统计分析确定了12种有可能区分健康和患病个体的化合物,并选择它们来测试Cyranose 320电子鼻的应用潜力。该方法在敏感性和特异性方面(分别为0.8和0.85)将40名受试者识别为健康对照(HC)或结直肠癌的能力表明,使用该方法进行快速,低成本和无创疾病识别的可行性。
{"title":"Breath fingerprint of colorectal cancer patients by gas chromatography-mass spectrometry analysis preparatory to e-nose analyses","authors":"Stefano Dugheri ,&nbsp;Ilaria Rapi ,&nbsp;Giovanni Cappelli ,&nbsp;Niccolò Fanfani ,&nbsp;Donato Squillaci ,&nbsp;Simone De Sio ,&nbsp;Beatrice Mallardi ,&nbsp;Paola Mantellini ,&nbsp;Fabio Staderini ,&nbsp;Veronica Traversini ,&nbsp;Antonio Baldassarre ,&nbsp;Fabio Cianchi ,&nbsp;Nicola Mucci","doi":"10.1016/j.plabm.2025.e00475","DOIUrl":"10.1016/j.plabm.2025.e00475","url":null,"abstract":"<div><div>Colorectal cancer (CRC), according to the most recent data provided by GLOBOCAN, ranks fourth worldwide in incidence and third in mortality among all cancers. Current estimates project a global increase in colorectal cancer incidence of 60.5 % and mortality of 76.9 % between 2022 and 2045. The low sensitivity and adherence, coupled with the high costs associated with current diagnostic methods for CRC, underscore the need to explore innovative procedures for the early detection of tissue abnormalities. Existing research suggests that patients affected by this condition exhibit distinctive alterations in volatile organic compounds (VOCs) ratios in their exhaled breath.</div><div>This study presents a characterization of exhaled breath using Gas Chromatography-Mass Spectrometry (GC-MS) in patients with varying stages of the disease, as determined by conventional medical and clinical analyses. An electronic nose was utilized to develop a method aimed at rapidly analyzing a subject's exhaled breath to identify the group of belonging (healthy, affected). The aim of the study was to develop a rapid, cost-effective, and non-invasive early diagnostic system employing an electronic nose. Statistical analysis identified 12 compounds with the potential to distinguish between healthy and affected individuals and were selected for testing the application potential of the Cyranose 320 electronic nose. The ability of the method to identify the 40 subjects analyzed as Healthy Controls (HC) or CRC in terms of sensitivity and specificity (0.8 and 0.85, respectively) demonstrates the feasibility of using this method for rapid, low-cost, and non-invasive disease recognition.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00475"},"PeriodicalIF":1.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068373","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
A 9-year-old child presenting with anemia accompanied by abnormal red blood cell morphology 一名9岁儿童,表现为贫血并伴有红细胞形态异常
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-03-20 DOI: 10.1016/j.plabm.2025.e00459
Huijun Qin , Yuan He , Zaixiang Xie
Cases of anemia presenting with abnormal erythrocyte morphology often pose diagnostic challenges, particularly in patients with refractory anemia. Here, we present the case of a 9-year-old male patient under investigation for anemia, who had a history of anemia and received a blood transfusion at birth. Despite the absence of obvious clinical manifestations related to anemia thereafter, his condition was not given due consideration. The patient experienced a sudden onset of illness and was initially suspected to have thalassemia. However, subsequent pertinent examinations, notably bone marrow aspiration and genetic testing, led to the diagnosis of hereditary sideroblastic anemia alongside chronic atrophic gastritis. This case illustrates the diagnostic journey of anemia characterized by abnormal red blood cell morphology, aiming to facilitate early and accurate diagnosis, as well as prompt treatment, for such patients in clinical practice.
以红细胞形态异常为表现的贫血病例常常给诊断带来挑战,特别是难治性贫血患者。在这里,我们提出的情况下,9岁的男性患者贫血接受调查,谁有贫血史,并接受输血出生。尽管此后没有明显的与贫血相关的临床表现,但他的病情没有得到应有的考虑。患者突然发病,最初被怀疑患有地中海贫血。然而,随后的相关检查,特别是骨髓穿刺和基因检测,导致遗传性铁母细胞性贫血和慢性萎缩性胃炎的诊断。本病例阐述了以红细胞形态异常为特征的贫血的诊断历程,旨在促进临床对这类患者的早期准确诊断和及时治疗。
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引用次数: 0
Evaluation of CircHIPK3 biomarker potential in breast cancer CircHIPK3生物标志物在乳腺癌中的潜力评估
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-03-20 DOI: 10.1016/j.plabm.2025.e00470
Ensiyeh Bahadoran , Davood Mohammadi , Manijeh Jalilvand , Sahar Moghbelinejad

Background

Nowadays, the investigation of circular RNAs (circRNAs) in various cancers is of great interest. In this research, we evaluated circHIPK3 biomarker potential in breast cancer (BC).

Methods

The studied samples were 100 cancer and adjacent normal tissues, plasma from 95 cancer patients, 42 patients with fibroadenomatosis, and 93 healthy donors. Illumina high-throughput Hi Seq 2000 sequencing performed expression profiling on 4 pairs of cancerous and normal breast tissues. For expression confirmation, Quantitative real-time fluorescent polymerase chain reaction (qRT-PCR) was used to detect the expression level of circHIPK3. CircHIPK3 diagnostic efficacy was evaluated by the receiver operating characteristic curve (ROC).

Results

Based on high-throughput sequencing and bioinformatics results circHIPK3 had the highest expression in cancer tissues (P = 0.00034). Real-time results showed expression upregulation of circHIPK3 in BC tissues and plasma in comparison to healthy controls (P < 0.0001). For diagnostic potential, the area under the curve (AUC) result was 0.8087 (95 % CI: 0.7309 to 0.8866, P < 0.0001). Also, our results showed high specificity and sensitivity of circHIPK3 when evaluated alongside the CA-15-3 and CEA. Pathologic criteria evaluation showed that upregulation of circHIPK3 correlates with tumor size.

Conclusions

CircHIPK3 is significantly upregulated in BC tissues and plasma compared to healthy controls, demonstrating high diagnostic potential with an AUC of 0.8087. The expression of circHIPK3 correlates with tumor size, indicating its relevance in the pathologic assessment of BC.
目前,环状rna (circRNAs)在各种癌症中的研究引起了人们极大的兴趣。在这项研究中,我们评估了circHIPK3生物标志物在乳腺癌(BC)中的潜力。方法选取100例肿瘤及邻近正常组织、95例肿瘤患者、42例纤维腺瘤患者和93例健康供体的血浆。Illumina高通量Hi Seq 2000测序对4对癌性和正常乳腺组织进行了表达谱分析。为确认表达,采用定量实时荧光聚合酶链反应(qRT-PCR)检测circHIPK3的表达水平。采用受试者工作特征曲线(ROC)评价CircHIPK3的诊断效果。结果基于高通量测序和生物信息学结果,circHIPK3在肿瘤组织中表达最高(P = 0.00034)。实时结果显示,与健康对照组相比,circHIPK3在BC组织和血浆中的表达上调(P <;0.0001)。对于诊断潜力,曲线下面积(AUC)结果为0.8087 (95% CI: 0.7309 ~ 0.8866, P <;0.0001)。此外,我们的结果显示,当与CA-15-3和CEA一起评估时,circHIPK3具有很高的特异性和敏感性。病理标准评估显示circHIPK3的上调与肿瘤大小相关。结论与健康对照相比,scirchipk3在BC组织和血浆中表达显著上调,AUC为0.8087,具有较高的诊断潜力。circHIPK3的表达与肿瘤大小相关,表明其与BC的病理评估相关。
{"title":"Evaluation of CircHIPK3 biomarker potential in breast cancer","authors":"Ensiyeh Bahadoran ,&nbsp;Davood Mohammadi ,&nbsp;Manijeh Jalilvand ,&nbsp;Sahar Moghbelinejad","doi":"10.1016/j.plabm.2025.e00470","DOIUrl":"10.1016/j.plabm.2025.e00470","url":null,"abstract":"<div><h3>Background</h3><div>Nowadays, the investigation of circular RNAs (circRNAs) in various cancers is of great interest. In this research, we evaluated circHIPK3 biomarker potential in breast cancer (BC).</div></div><div><h3>Methods</h3><div>The studied samples were 100 cancer and adjacent normal tissues, plasma from 95 cancer patients, 42 patients with fibroadenomatosis, and 93 healthy donors. Illumina high-throughput Hi Seq 2000 sequencing performed expression profiling on 4 pairs of cancerous and normal breast tissues. For expression confirmation, Quantitative real-time fluorescent polymerase chain reaction (qRT-PCR) was used to detect the expression level of circHIPK3. CircHIPK3 diagnostic efficacy was evaluated by the receiver operating characteristic curve (ROC).</div></div><div><h3>Results</h3><div>Based on high-throughput sequencing and bioinformatics results circHIPK3 had the highest expression in cancer tissues (<em>P</em> = 0.00034). Real-time results showed expression upregulation of circHIPK3 in BC tissues and plasma in comparison to healthy controls (<em>P</em> &lt; 0.0001). For diagnostic potential, the area under the curve (AUC) result was 0.8087 (95 % CI: 0.7309 to 0.8866, <em>P</em> &lt; 0.0001). Also, our results showed high specificity and sensitivity of circHIPK3 when evaluated alongside the CA-15-3 and CEA. Pathologic criteria evaluation showed that upregulation of circHIPK3 correlates with tumor size.</div></div><div><h3>Conclusions</h3><div>CircHIPK3 is significantly upregulated in BC tissues and plasma compared to healthy controls, demonstrating high diagnostic potential with an AUC of 0.8087. The expression of circHIPK3 correlates with tumor size, indicating its relevance in the pathologic assessment of BC.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00470"},"PeriodicalIF":1.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143682981","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
SII as a predictor of mortality in patients with non-ST-segment elevation myocardial infarction and diabetes mellitus SII作为非st段抬高型心肌梗死和糖尿病患者死亡率的预测因子
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-05-16 DOI: 10.1016/j.plabm.2025.e00476
Cuiyuan Huang , Jiajuan Yang , Wenqiang Li , Li Liu , Wei Wang , Haiyan Hu , Jing Zhang , Jian Yang

Background

Systemic immune inflammation index (SII) is an innovative marker reflecting immune and inflammatory responses.

Objectives

To explore the predictive value of SII on the risk of death in patients with NSTEMI combined with T2DM.

Methods

An analysis of 448 patients with NSTEMI and T2DM admitted to our institution between December 2017 and May 2022 was conducted in this retrospective study. SII values were used to divide patients into high and low SII groups and investigate their impact on mortality.

Results

According to the analysis results, elevated SII levels are significantly linked to a poor prognosis in patients with NSTEMI and T2DM. Over an average follow-up period of 22.75 months, 106 (23.7 %) all-cause deaths were recorded. The optimal threshold for predicting death was found to be an SII value of 1384.596 × 109/L through ROC curve analysis. Kaplan-Meier analysis indicated that the survival rates were higher in the low SII group compared to the high SII group (P < 0.001). Elevated SII levels were independently linked to increased mortality in patients with NSTEMI and T2DM, according to univariate (HR:3.19, 95 % Cl: 2.18–4.68) and multivariate COX (HR: 2.72, 95 % Cl: 1.81–4.09) regression analyses.

Conclusion

High SII values were strongly associated with mortality in patients with NSTEMI and T2DM. SII serves as a valuable prognostic tool, enhancing the management and prognosis of patients with concurrent NSTEMI and T2DM.
系统性免疫炎症指数(SII)是一种反映免疫和炎症反应的创新指标。目的探讨SII对NSTEMI合并T2DM患者死亡风险的预测价值。方法回顾性分析我院2017年12月至2022年5月收治的448例非stemi合并T2DM患者。使用SII值将患者分为高SII组和低SII组,并调查其对死亡率的影响。结果分析结果显示,SII水平升高与NSTEMI合并T2DM患者预后不良显著相关。在平均22.75个月的随访期间,记录了106例(23.7%)全因死亡。通过ROC曲线分析,预测死亡的最佳阈值为SII值为1384.596 × 109/L。Kaplan-Meier分析显示,低SII组的生存率高于高SII组(P <;0.001)。根据单因素(HR:3.19, 95% Cl: 2.18-4.68)和多因素COX (HR: 2.72, 95% Cl: 1.81-4.09)回归分析,SII水平升高与NSTEMI和T2DM患者死亡率增加独立相关。结论高SII值与NSTEMI合并T2DM患者的死亡率密切相关。SII作为一种有价值的预后工具,可以加强NSTEMI合并T2DM患者的管理和预后。
{"title":"SII as a predictor of mortality in patients with non-ST-segment elevation myocardial infarction and diabetes mellitus","authors":"Cuiyuan Huang ,&nbsp;Jiajuan Yang ,&nbsp;Wenqiang Li ,&nbsp;Li Liu ,&nbsp;Wei Wang ,&nbsp;Haiyan Hu ,&nbsp;Jing Zhang ,&nbsp;Jian Yang","doi":"10.1016/j.plabm.2025.e00476","DOIUrl":"10.1016/j.plabm.2025.e00476","url":null,"abstract":"<div><h3>Background</h3><div>Systemic immune inflammation index (SII) is an innovative marker reflecting immune and inflammatory responses.</div></div><div><h3>Objectives</h3><div>To explore the predictive value of SII on the risk of death in patients with NSTEMI combined with T2DM.</div></div><div><h3>Methods</h3><div>An analysis of 448 patients with NSTEMI and T2DM admitted to our institution between December 2017 and May 2022 was conducted in this retrospective study. SII values were used to divide patients into high and low SII groups and investigate their impact on mortality.</div></div><div><h3>Results</h3><div>According to the analysis results, elevated SII levels are significantly linked to a poor prognosis in patients with NSTEMI and T2DM. Over an average follow-up period of 22.75 months, 106 (23.7 %) all-cause deaths were recorded. The optimal threshold for predicting death was found to be an SII value of 1384.596 × 10<sup>9</sup>/L through ROC curve analysis. Kaplan-Meier analysis indicated that the survival rates were higher in the low SII group compared to the high SII group (<em>P</em> &lt; 0.001). Elevated SII levels were independently linked to increased mortality in patients with NSTEMI and T2DM, according to univariate (HR:3.19, 95 % Cl: 2.18–4.68) and multivariate COX (HR: 2.72, 95 % Cl: 1.81–4.09) regression analyses.</div></div><div><h3>Conclusion</h3><div>High SII values were strongly associated with mortality in patients with NSTEMI and T2DM. SII serves as a valuable prognostic tool, enhancing the management and prognosis of patients with concurrent NSTEMI and T2DM.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"45 ","pages":"Article e00476"},"PeriodicalIF":1.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144177880","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
Liquid chromatography-tandem mass spectrometry assay for simultaneous quantification of catecholamines and metabolites in human plasma and cerebrospinal fluid 同时定量测定人血浆和脑脊液中儿茶酚胺及其代谢物的液相色谱-串联质谱法
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-07-01 Epub Date: 2025-04-17 DOI: 10.1016/j.plabm.2025.e00471
Yuting Wang , Quan Li , Yuhang Deng , Wenqing Wu , Cuiping Zhang , Yichi Zheng , Ming Guan , Haoqin Jiang
Catecholamines (CAs) and their metabolites in human cerebrospinal fluid (CSF) and plasma are potential biomarkers of Alzheimer's disease (AD) and facilitate early diagnosis. Liquid chromatography-tandem mass spectrometry is the gold standard method for analyzing CAs. The objective of this study was to develop and validate a liquid chromatography-tandem mass spectrometry assay capable of simultaneously quantifying dopamine (DA), epinephrine (E), norepinephrine (NE), metanephrine (MN), normetanephrine (NMN), and 3-methoxytyramine (3-MT) in both human CSF and plasma. Samples were processed by solid-phase extraction with a weak cation exchange adsorbent and then separated using an ultra-performance reversed-phase chromatography column. Analyte detection was performed using a triple quadrupole mass spectrometer operated in positive-ion multiple reaction monitoring mode. The developed assay was validated according to standard guidelines. The linearity, specificity, precision, accuracy, carryover and stability were assessed to ensure compliance with specified criteria. The lower limits of quantification for DA, E, NE, MN, NMN, and 3-MT were 4.5, 2.5, 4.5, 2.5, 2, and 0.3 pg mL−1, respectively. The total runtime for a single sample was 6.5 min. These results demonstrated that the method was sensitive, rapid, and reliable for the simultaneous quantification of DA, E, NE, MN, NMN, and 3-MT in clinical practice. We successfully detected CAs and their metabolites in plasma and CSF samples from patients with normal cognition and AD. This study demonstrates an efficient laboratory workflow for high-throughput analysis of CAs and their metabolites and lays a foundation for further studies on AD biomarkers.
人脑脊液(CSF)和血浆中的儿茶酚胺(CAs)及其代谢物是阿尔茨海默病(AD)的潜在生物标志物,有助于早期诊断。液相色谱-串联质谱法是分析CAs的金标准方法。本研究的目的是建立并验证一种液相色谱-串联质谱分析方法,该方法能够同时定量人脑脊液和血浆中的多巴胺(DA)、肾上腺素(E)、去甲肾上腺素(NE)、肾上腺素(MN)、去甲肾上腺素(NMN)和3-甲氧基酪胺(3-MT)。样品经弱阳离子交换吸附剂固相萃取处理后,采用高性能反相色谱柱分离。分析物检测使用三联四极质谱计进行,以正离子多重反应监测模式操作。根据标准指南对所建立的测定方法进行了验证。对其进行线性、特异性、精密度、准确度、结转性和稳定性评估,确保符合规定标准。DA、E、NE、MN、NMN和3-MT的定量下限分别为4.5、2.5、4.5、2.5、2和0.3 pg mL−1。结果表明,该方法对DA、E、NE、MN、NMN和3-MT的同时定量检测灵敏、快速、可靠。我们成功地在正常认知和AD患者的血浆和脑脊液样本中检测到CAs及其代谢物。本研究为CAs及其代谢物的高通量分析提供了高效的实验室工作流程,为进一步研究AD生物标志物奠定了基础。
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引用次数: 0
Technical improvement on next-generation sequencing in clinical application 新一代测序在临床应用中的技术改进
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-04-01 Epub Date: 2025-03-08 DOI: 10.1016/j.plabm.2025.e00465
Xiaolei Xie, Weiguo Yin, Shuxia Xuan, Fuguang Li
The next-generation sequencing (NGS) technology is currently widely utilized in clinical laboratories. This paper describes a method of technical improvement on NGS, which increases the success rates of NGS detection. This study reveals that the DNA library concentration is the highest at a molar ratio of 100:1 for the adapter to DNA. The self-revised method for adaptor ligation can effectively improve the success rate of DNA library, particularly in manual operations. Additionally, the modified pooling method, which incorporates various DNA fragment sizes for different NGS projects, proves beneficial for medical laboratory applications.
新一代测序(NGS)技术目前广泛应用于临床实验室。本文介绍了一种对NGS进行技术改进的方法,提高了NGS检测的成功率。这项研究表明,DNA库浓度是最高的摩尔比为100:1的适配器DNA。自修订的接头连接方法可以有效提高DNA文库的成功率,特别是人工操作的成功率。此外,改进的汇集方法为不同的NGS项目纳入了不同的DNA片段大小,证明对医学实验室应用有益。
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引用次数: 0
Biogenic amine testing in the South African public health care system 南非公共卫生保健系统中的生物胺检测
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-04-01 Epub Date: 2025-01-28 DOI: 10.1016/j.plabm.2025.e00457
D. Legg-E’Silva , E.M. Cave , T. Snyman, S. Currin, N. Kone, K.L. Prigge

Background

Phaeochromocytoma, paraganglioma and neuroblastoma are catecholamine secreting neuroendocrine tumours. Biochemical screening for suspected cases of these tumours involves the measurement of catecholamines and their metabolites in either urine or plasma. The South African National Health Laboratory service (NHLS) measures urine fractionated metanephrines (UMF) and normetanephrines (UNF), urine vanillylmandelic acid (UVMA) and urine homovanillic acid (UHVA).

Objectives

To analyse the demographic, biochemical and testing patterns of patients’ UMF, UNF, UVMA and UHVA in the NHLS.

Methods

Data from January 2015 to December 2016 for all patients undergoing UMF, UNF, UVMA and UHVA testing was extracted from the NHLS central data warehouse. Neuroendocrine tumours were biochemically diagnosed when results were >2x multiples of the upper reference limits. Multiple testing was defined as ≥2 tests within a 14-day period. Ethnicity was determined through hot-deck imputation.

Results

Biochemically abnormal test results were identified by UMF/UNF measurements in 98.2 % of cases. In 1.8 % of cases, the addition of UVMA resulted in a previously unidentified biochemical positive. Adult white and coloured populations have significantly less biochemically positive UMF results compared to the African population. Multiple testing resulted in discordant results for 12.8 % of UMF and 13.1 % of UNF testing.

Conclusion

UVMA testing for phaeochromocytoma and paraganglioma offers little benefit over testing with UMF alone. Requesting consecutive multiple samples is preferred, however, a single 24-h fractionated UMF/UNF is efficient and cost-effective for phaeochromocytoma and paraganglioma screening, with further testing recommended when clinically indicated. African individuals are more likely to have raised catecholamines and requires further investigation.
背景嗜铬细胞瘤、副神经节瘤和神经母细胞瘤是分泌儿茶酚胺的神经内分泌肿瘤。对这些肿瘤疑似病例的生化筛查包括测量尿液或血浆中的儿茶酚胺及其代谢物。南非国家卫生实验室服务(NHLS)测量尿分离肾上腺素(UMF)和去甲肾上腺素(UNF)、尿香草酸(UVMA)和尿同型香草酸(UHVA)。目的分析国家健康保险系统患者UMF、UNF、UVMA和UHVA的人口学、生化和检测模式。方法从NHLS中央数据仓库中提取2015年1月至2016年12月所有接受UMF、UNF、UVMA和UHVA检测的患者的数据。当结果为参考上限的2倍时,生物化学诊断神经内分泌肿瘤。多次检测定义为14天内≥2次检测。种族是通过热甲板归罪法确定的。结果98.2%的病例通过UMF/UNF检测发现生化异常。在1.8%的病例中,UVMA的加入导致了先前未知的生化阳性。与非洲人口相比,成年白人和有色人种的生物化学阳性UMF结果明显较少。多重测试导致12.8%的UMF和13.1%的UNF测试结果不一致。结论uvma检测对嗜铬细胞瘤和副神经节瘤的检测效果与单独使用UMF检测相比效果不大。然而,对于嗜铬细胞瘤和副神经节瘤筛查而言,单个24小时分离UMF/UNF是高效且经济的,临床需要时建议进行进一步检测。非洲人更有可能产生儿茶酚胺,这需要进一步的调查。
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Practical Laboratory Medicine
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