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Indirect reference intervals for TSH in a sample of lebanese pregnant women 黎巴嫩孕妇样本中TSH的间接参考间隔

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-04-01 Epub Date: 2025-03-08 DOI: 10.1016/j.plabm.2025.e00460

Dollen Eid , Nizar El Bcherawi , Georges Abi Tayeh , Nada El Ghorayeb , Marie-Hélène Gannagé-Yared

Background

Thyroid dysfunction in pregnant women can lead to fetal complications. Thyroid-stimulating hormone (TSH) is the key hormone for diagnosis of thyroid dysfunction. No previous study has established reference intervals (RI) for TSH in Lebanese pregnant women. The objective of this study is to define the TSH RIs for each trimester of pregnancy in healthy Lebanese pregnant women using an indirect method.

Materials and methods

This retrospective study included 287 pregnancies selected from the records of an obstetric clinic at Hôtel-Dieu de France University Hospital from January 2021 to May 2023. A control group of 103 non-pregnant women was also included in the study. The collected TSH values were stratified by trimester (first and second) of pregnancy and postpartum. After applying the exclusion criteria, a total of 458 TSH values were included in the analysis.

Results

The respective medians and RIs for TSH during the first, second pregnancy trimesters and postpartum are 1.57 (0.43–3.20 mIU/L), 1.84 (0.56–4.41 mIU/L), and 1.38 (0.30–3.60 mIU/L), while for the control group it is 1.66 (0.64–4.24 mIU/L). There is a significant correlation between TSH values in the first trimester and those in the second trimester and postpartum (p ≤ 0.001 and p = 0.002 respectively). No significant correlation was observed between age and TSH levels in the first and second trimesters and as well as in postpartum.

Conclusion

Our RIs are close to the revised American Thyroid Association (ATA) recommendations. Further research is needed to understand the mechanisms and clinical impact of these differences.

背景：孕妇甲状腺功能障碍可导致胎儿并发症。促甲状腺激素（TSH）是诊断甲状腺功能障碍的关键激素。以前没有研究确定黎巴嫩孕妇TSH的参考区间（RI）。本研究的目的是使用间接方法确定健康黎巴嫩孕妇妊娠每个孕期的TSH RIs水平。材料和方法本回顾性研究选取了2021年1月至2023年5月期间Hôtel-Dieu法兰西大学医院产科门诊287例妊娠病例。研究还包括103名未怀孕妇女作为对照组。收集的TSH值按妊娠初、中期和产后进行分层。应用排除标准后，共有458个TSH值被纳入分析。结果妊娠1、2期及产后TSH的中位值和RIs分别为1.57 （0.43 ~ 3.20 mIU/L）、1.84 （0.56 ~ 4.41 mIU/L）、1.38 (0.30 ~ 3.60 mIU/L)，对照组为1.66 （0.64 ~ 4.24 mIU/L）。妊娠早期TSH值与妊娠中期及产后TSH值有显著相关性（p≤0.001,p = 0.002）。在妊娠早期和中期以及产后，年龄和TSH水平之间没有明显的相关性。结论：我们的ri接近修订后的美国甲状腺协会（ATA）推荐值。需要进一步的研究来了解这些差异的机制和临床影响。

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引用次数: 0

D-dimers or more? Assessing the role of laboratory factors in predicting and confirming pulmonary embolism in high-risk orthopedic patients d -二聚体还是更多？评估实验室因素在预测和确认高危骨科患者肺栓塞中的作用

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-04-01 Epub Date: 2025-01-20 DOI: 10.1016/j.plabm.2025.e00452

Bartosz Borowski , Mateusz Haratym , Piotr Piech , Jaromir Jarecki , Grzegorz Staśkiewicz

引用次数: 0

Comparison of the accuracy of procalcitonin, neutrophil CD64, and C-reactive protein for the diagnosis and prognosis of septic patients after antibiotic therapy 降钙素原、中性粒细胞CD64、c反应蛋白对脓毒症患者抗生素治疗后诊断及预后准确性的比较

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-01 Epub Date: 2024-12-14 DOI: 10.1016/j.plabm.2024.e00444

Qingteng Zhu , Hui Wang , Liang Chen , Yang Yu , Miao Chen

Background

The performance of the inflammatory biomarkers in the management of septic patients who received antimicrobial therapies is largely neglected. This study aimed to compare the accuracy of procalcitonin (PCT), neutrophil CD64 (CD64), and C-reactive protein (CRP) for the diagnosis and prognosis of septic patients after antimicrobial therapy.

Methods

This study prospectively recruited consecutive patients without infection and those diagnosed with infection but had received initial antimicrobial therapies. Sepsis was diagnosed according to sepsis-3 criteria. Serum PCT, CD64 and CRP levels were measured upon entry to the ICU. We also collected each patient's baseline characteristics. The diagnostic and prognostic performance of these parameters was evaluated from the area under the receiver operator characteristic curve (AUC).

Results

A total of 635 consecutive ICU patients were screened for eligible and 289 (45.5 %) patients were diagnosed with sepsis upon entry to the ICU. The area under the curve (AUC) for PCT, CD64 and CRP in the identification of sepsis is 0.726, 0.692 and 0.719, respectively. Neither PCT (p = 0.587) nor CD64 (p = 0.373) is superior to CRP in the diagnosis of septic patients who received antimicrobial therapies. The AUC for PCT, CD64 and CRP in the prediction of ICU mortality in these sepsis patients is 0.702, 0.637 and 0.593, respectively. The prognostic performance of PCT (p = 0.006) rather than CD64 (p = 0.509) is better than CRP.

Conclusions

Both PCT and CD64 are not superior to CRP in the identification of septic patients who received antimicrobial therapies. However, PCT instead of CD64 has a better prognostic accuracy than CRP for the prediction of ICU mortality of these septic patients.

背景：炎症生物标志物在接受抗菌药物治疗的脓毒症患者管理中的表现在很大程度上被忽视。本研究旨在比较降钙素原（PCT）、中性粒细胞CD64 （CD64）和c反应蛋白（CRP）对脓毒症患者抗菌治疗后诊断和预后的准确性。方法：本研究前瞻性地招募了未感染的连续患者和诊断为感染但已接受初始抗菌药物治疗的患者。根据脓毒症-3标准诊断脓毒症。在进入ICU时测定血清PCT、CD64和CRP水平。我们还收集了每位患者的基线特征。这些参数的诊断和预后性能从接受者操作者特征曲线（AUC）下的面积来评估。结果：共筛选了635例符合条件的ICU患者，289例（45.5%）患者在进入ICU时被诊断为败血症。PCT、CD64、CRP在脓毒症诊断中的曲线下面积（AUC）分别为0.726、0.692、0.719。PCT （p = 0.587）和CD64 （p = 0.373）对接受抗菌药物治疗的脓毒症患者的诊断均不优于CRP。PCT、CD64、CRP预测脓毒症患者ICU死亡率的AUC分别为0.702、0.637、0.593。PCT （p = 0.006）的预后优于CD64 （p = 0.509）。结论：PCT和CD64在鉴别接受抗菌药物治疗的脓毒症患者方面并不优于CRP。然而，PCT代替CD64在预测这些脓毒症患者ICU死亡率方面比CRP具有更好的预后准确性。

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引用次数: 0

Liquid biopsy in cancer management: Integrating diagnostics and clinical applications 液体活检在癌症管理：整合诊断和临床应用。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-01 Epub Date: 2024-12-24 DOI: 10.1016/j.plabm.2024.e00446

Shashwat Pandey , Preeti Yadav

Liquid biopsy is an innovative, minimally invasive diagnostic tool revolutionizing cancer management by enabling the detection and analysis of cancer-related biomarkers from bodily fluids such as blood, urine, or cerebrospinal fluid. Unlike traditional tissue biopsies, which require invasive procedures, liquid biopsy offers a more accessible and repeatable method for tracking cancer progression, detecting early-stage cancers, and monitoring therapeutic responses. The technology primarily focuses on analyzing circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and other cancer-derived genetic materials. These biomarkers provide critical information on tumor heterogeneity, mutation profiles, and potential drug resistance. In clinical practice, liquid biopsy has demonstrated its utility in identifying actionable mutations, guiding personalized treatment strategies, and assessing minimal residual disease (MRD). While liquid biopsy holds immense promise, challenges related to its sensitivity, specificity, and standardization remain. Efforts to optimize pre-analytical and analytical processes, along with the establishment of robust regulatory frameworks, are crucial for its widespread clinical adoption. This abstract highlights the transformative potential of liquid biopsy in cancer diagnosis, prognosis, and treatment monitoring, emphasizing its role in advancing personalized oncology. Further research, clinical trials, and regulatory harmonization will be vital in realizing its full potential in precision cancer care.

液体活检是一种创新的微创诊断工具，通过检测和分析血液、尿液或脑脊液等体液中与癌症相关的生物标志物，彻底改变了癌症管理。与传统的组织活检不同，液体活检提供了一种更容易获得和可重复的方法来跟踪癌症进展，检测早期癌症，并监测治疗反应。该技术主要侧重于分析循环肿瘤细胞（CTCs）、循环肿瘤DNA （ctDNA）和其他癌症来源的遗传物质。这些生物标志物提供了肿瘤异质性、突变谱和潜在耐药性的关键信息。在临床实践中，液体活检已经证明了它在识别可操作的突变、指导个性化治疗策略和评估最小残留病（MRD）方面的效用。虽然液体活检具有巨大的前景，但其敏感性、特异性和标准化方面的挑战仍然存在。优化分析前和分析过程的努力，以及建立健全的监管框架，对于其广泛的临床应用至关重要。本摘要强调液体活检在癌症诊断、预后和治疗监测方面的变革潜力，强调其在推进个性化肿瘤学中的作用。进一步的研究、临床试验和监管协调对于实现其在精确癌症治疗中的全部潜力至关重要。

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引用次数: 0

Development of a droplet digital PCR method for the detection of Ureaplasma urealyticum 解脲支原体液滴数字PCR检测方法的建立。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-01 Epub Date: 2024-12-14 DOI: 10.1016/j.plabm.2024.e00443

Yong-Zhuo Zhou , Yun-Hu Zhao , Yan-Lan Chen , Hua Luo , Yu-lin Zhou , Bing Gu , Wei-Zhen Fang , Chao-Hui Duan , Xu-Guang Guo

Background

Human infection with Ureaplasma urealyticum(UU) is mainly manifested as non-gonococcal urethritis, where it can lead to cervicitis, premature rupture of membranes and abortion in women, as well as infertility in males, which becomes a major problem in clinical diagnosis and treatment. At present, real-time fluorescence quantitative PCR and culture are the two main methods for detecting UU. The real-time fluorescence quantitative PCR method is cumbersome and cannot accomplish absolute quantification on nucleic acids, while the cultivation method has limitations such as low sensitivity and being time-consuming. The aim of this study is to establish a more rapid and accurate droplet digital PCR(ddPCR) method for the detection of UU.

Methods

Primers were designed for the ParC gene of UU. Nucleic acids from a standard strain of UU were extracted. Specificity, sensitivity, and repeatability detection was performed using ddPCR, and the detection performance of ddPCR was evaluated.

Results

The detection process could be completed in 92 min. It has a high sensitivity of up to 3.8 pg/μL. With a high specificity, no positive microdrop were detected in eight negative control pathogens in this experiment. In addition, ddPCR detection of UU has good repeatability, and the calculated CV is 2.1 %.

Conclusion

Our data indicated that ddPCR detection technology has the characteristics of absolute quantification, high stability, high specificity and high sensitivity of UU. It can promote the accurate detection of UU, providing a more scientific basis for clinical diagnosis and treatment.

背景：人类感染解脲支原体（UU）主要表现为非淋球菌性尿道炎，可导致女性宫颈炎、胎膜早破、流产，男性不育，成为临床诊断和治疗的一大难题。目前，实时荧光定量PCR和培养是检测UU的两种主要方法。实时荧光定量PCR方法操作繁琐，无法完成对核酸的绝对定量，而培养法则存在灵敏度低、耗时等局限性。本研究旨在建立一种快速、准确的液滴数字PCR（ddPCR）检测UU的方法。方法：设计UU ParC基因引物。提取UU标准菌株的核酸。采用ddPCR进行特异性、敏感性和重复性检测，并对其检测性能进行评价。结果：该方法可在92 min内完成检测，灵敏度可达3.8 pg/μL。8种阴性对照病原菌均未检出微滴阳性，特异性高。此外，ddPCR检测UU具有良好的重复性，计算CV为2.1%。结论：本实验数据表明，ddPCR检测技术对UU具有绝对定量、高稳定性、高特异性和高灵敏度的特点。可促进UU的准确检测，为临床诊断和治疗提供更科学的依据。

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引用次数: 0

Comparison of qPCR and chromogenic culture methods for rapid detection of group B streptococcus colonization in Vietnamese pregnant women 比较 qPCR 和色原培养法快速检测越南孕妇 B 群链球菌定植情况

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 Epub Date: 2024-10-15 DOI: 10.1016/j.plabm.2024.e00435

Manh-Tuan Ha , Huyen Tran-Thi-Bich , Thao Bui-Thi-Kim , My-Linh Nguyen-Thi , Thanh Vu-Tri , Thuy-Duong Ho-Huynh , Tuan-Anh Nguyen

Introduction

Neonatal infections can rapidly become severe, with delays in treatment often proving fatal. Streptococcus agalactiae (Group B Streptococcus, GBS) is a common cause, typically transmitted from colonized pregnant women to neonates during childbirth. In Vietnam, routine prenatal care lacks standardized GBS screening protocols. This study aims to compare enhanced qPCR methods with the culture method, evaluate the diagnostic accuracy of these qPCR procedures, and assess the frequency of GBS infection in pregnant Vietnamese women during their final trimester.

Materials and methods

Pregnant women aged 35 weeks gestation or more were recruited. Rectovaginal swabs were collected and analyzed for GBS using chromogenic culture, a commercial real-time PCR kit, and in-house real-time PCR assays targeting the cfb and sip genes. Clinical diagnostic values were calculated, and GBS prevalence was determined.

Results

The study included 259 pregnant women with a mean age of 30.2 ± 5.0 years. Of these, 96.6 % had gestational ages of 37 weeks or more at delivery. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the cfb-based and sip-based qPCR assays were 94.1/92.7, 99.0/99.5, 97.1/98.5, 97.8/97.3, and 97.6 %, respectively. The Kappa values were excellent (0.940 and 0.939), with results available in under 2 h. GBS prevalence was 24.7 % and 25.5 % by cfb-based and sip-based qPCR assays, aligning with the culture method (25.5 %).

Conclusions

Both direct real-time PCR assays demonstrated high accuracy and were comparable to chromogenic culture in diagnosing GBS. A significant prevalence of GBS colonization was found among Vietnamese pregnant women in their final trimester.

导言：新生儿感染会迅速恶化，延误治疗往往会导致死亡。无乳链球菌（B 组链球菌，GBS）是一种常见的致病菌，通常在分娩过程中由带有菌落的孕妇传染给新生儿。在越南，常规产前护理缺乏标准化的 GBS 筛查方案。本研究旨在比较增强型 qPCR 方法和培养方法，评估这些 qPCR 程序的诊断准确性，并评估越南孕妇在最后三个月感染 GBS 的频率。收集直肠阴道拭子，并使用色原培养法、商用实时 PCR 试剂盒和针对 cfb 和 sip 基因的内部实时 PCR 检测法进行 GBS 分析。计算了临床诊断值，并确定了 GBS 患病率。其中，96.6%的孕妇分娩时胎龄为 37 周或以上。基于 cfb 和基于 sip 的 qPCR 检测的灵敏度、特异性、阳性预测值、阴性预测值和准确性分别为 94.1/92.7、99.0/99.5、97.1/98.5、97.8/97.3 和 97.6%。基于 cfb 和基于 sip 的 qPCR 检测方法的 GBS 感染率分别为 24.7% 和 25.5%，与培养方法（25.5%）一致。结论两种直接实时 PCR 检测方法在诊断 GBS 方面都具有很高的准确性，与色原培养法不相上下。

{"title":"Comparison of qPCR and chromogenic culture methods for rapid detection of group B streptococcus colonization in Vietnamese pregnant women","authors":"Manh-Tuan Ha , Huyen Tran-Thi-Bich , Thao Bui-Thi-Kim , My-Linh Nguyen-Thi , Thanh Vu-Tri , Thuy-Duong Ho-Huynh , Tuan-Anh Nguyen","doi":"10.1016/j.plabm.2024.e00435","DOIUrl":"10.1016/j.plabm.2024.e00435","url":null,"abstract":"<div><h3>Introduction</h3><div>Neonatal infections can rapidly become severe, with delays in treatment often proving fatal. <em>Streptococcus agalactiae</em> (Group B <em>Streptococcus</em>, GBS) is a common cause, typically transmitted from colonized pregnant women to neonates during childbirth. In Vietnam, routine prenatal care lacks standardized GBS screening protocols. This study aims to compare enhanced qPCR methods with the culture method, evaluate the diagnostic accuracy of these qPCR procedures, and assess the frequency of GBS infection in pregnant Vietnamese women during their final trimester.</div></div><div><h3>Materials and methods</h3><div>Pregnant women aged 35 weeks gestation or more were recruited. Rectovaginal swabs were collected and analyzed for GBS using chromogenic culture, a commercial real-time PCR kit, and in-house real-time PCR assays targeting the <em>cfb</em> and <em>sip</em> genes. Clinical diagnostic values were calculated, and GBS prevalence was determined.</div></div><div><h3>Results</h3><div>The study included 259 pregnant women with a mean age of 30.2 ± 5.0 years. Of these, 96.6 % had gestational ages of 37 weeks or more at delivery. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the <em>cfb</em>-based and sip-based qPCR assays were 94.1/92.7, 99.0/99.5, 97.1/98.5, 97.8/97.3, and 97.6 %, respectively. The Kappa values were excellent (0.940 and 0.939), with results available in under 2 h. GBS prevalence was 24.7 % and 25.5 % by <em>cfb</em>-based and <em>sip</em>-based qPCR assays, aligning with the culture method (25.5 %).</div></div><div><h3>Conclusions</h3><div>Both direct real-time PCR assays demonstrated high accuracy and were comparable to chromogenic culture in diagnosing GBS. A significant prevalence of GBS colonization was found among Vietnamese pregnant women in their final trimester.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00435"},"PeriodicalIF":1.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142445068","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

Validation of a LC-MS/MS assay for citric acid, cysteine and oxalic acid determination and its application to explore pre-analytical sample storage 验证测定柠檬酸、半胱氨酸和草酸的 LC-MS/MS 分析法及其在探索分析前样品储存中的应用

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI: 10.1016/j.plabm.2024.e00433

Ying Shen , Xia Luo , Qing Guan , Wenjie Lou , Liming Cheng

Objectives

Citrate, oxalate and cystine in 24-h urine are considered to be associated with the incidence and recurrence risk of urinary stone disease (USD). An evaluation of the LC-MS/MS kit for simultaneous quantification of the three analytes was undertaken.

Design

& Methods: The analytical performance of the kit was investigated based on FDA, EMA and CLSI guidelines. To promote the standardization of sample storage, this kit has been applied to perform systematic pre-analytical stability study of these analytes in urine.

Results

This method was validated with good linearity with accuracy of 93.1%–104 %. Intra-day and inter-day imprecision were ≤5.55 % and 5.34 %, respectively. Recoveries of citrate, oxalate and cystine added to clinical samples were in the range of 92.0–103 %, 94.8–100 % and 99.0–107 % with CV ≤ 5.52 %. It was recommended that urine preserved with hydrochloric acid could be preferable in consideration of both reliable test results and neglected sample heterogeneity.

Conclusions

This kit is suitable for measurement of citrate, oxalate and cystine for understanding the etiology of urinary stones, and the proper storage of urine samples is crucial for the correctness of the test results.

目的 24 小时尿液中的柠檬酸盐、草酸盐和胱氨酸被认为与尿石症（USD）的发病率和复发风险有关。我们对 LC-MS/MS 试剂盒进行了评估，以同时定量分析这三种分析物：根据 FDA、EMA 和 CLSI 指南对试剂盒的分析性能进行了调查。结果：该方法线性关系良好，准确度为 93.1%-104%。日内和日间误差分别小于5.55%和5.34%。临床样本中柠檬酸盐、草酸盐和胱氨酸的回收率分别为 92.0%-103%、94.8%-100% 和 99.0%-107%，CV ≤ 5.52%。结论：该试剂盒适用于测定枸橼酸盐、草酸盐和胱氨酸，可用于了解尿路结石的病因，尿样的妥善保存对检测结果的正确性至关重要。

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引用次数: 0

Biochemical indices of patients with enteric fever and pancreatitis: A comparative cross-sectional study 肠炎和胰腺炎患者的生化指标：横断面比较研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 Epub Date: 2024-09-18 DOI: 10.1016/j.plabm.2024.e00429

Nathaniel Ebo Aidoo , Emmanuel Kwaku Ofori , Vincent Boima , Eric Nana Yaw Nyarko , John Cletus Osei , Clement G. Darkwah , Morris O. Gayflor , Seth K. Amponsah , Henry Asare-Anane

Objective

Enteric fever (EF), a potentially fatal febrile illness, is prevalent in developing countries. Elevated levels of lipase and amylase in serum, typically associated with acute pancreatitis (AP), have been observed in patients with EF. The elevated enzymes in both conditions may lead to diagnostic confusion and care delays. This study aimed to determine biochemical indices that are peculiar to EF and AP.

Methods

A cross-sectional comparative study was conducted at the Korle-Bu Teaching Hospital, Ghana. Volunteers were categorized into three groups: EF (n = 32), AP (n = 30) and healthy controls (n = 31). A standard questionnaire was used to collect socio-demographic and clinical information from the participants. Blood and stool samples were obtained, followed by biochemical analysis: total amylase, lipase, pancreatic amylase, serum elastase 1, hepatic enzymes, calcium, magnesium, phosphate, stool colour, stool pH, and stool fat presence.

Results

The AP group displayed higher total amylase, lipase, elastase-1, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyl transferase levels compared to the EF and control groups (p < 0.05 respectively). Elastase 1 levels were found to be high in all AP participants, whereas no elevations were observed in the EF group. Positive associations were observed in the AP and EF groups for lipase vs total amylase (ρ = .543, p = 0.001; ρ = .543, p = 0.001 for both).

Conclusions

Elevated levels of total/pancreatic amylase and lipase were found to be indicative of a patient with AP and EF. Further, elastase-1 was found to be a good biomarker to distinguish between AP and EF.

目的肠胃热（EF）是一种可能致命的发热性疾病，在发展中国家很普遍。在肠炎患者中观察到血清中脂肪酶和淀粉酶水平升高，这通常与急性胰腺炎（AP）有关。这两种情况下的酶升高都可能导致诊断混乱和护理延误。本研究旨在确定 EF 和 AP 所特有的生化指标。志愿者被分为三组：EF 组（32 人）、AP 组（30 人）和健康对照组（31 人）。采用标准问卷收集参与者的社会人口学和临床信息。采集血液和粪便样本，然后进行生化分析：总淀粉酶、脂肪酶、胰淀粉酶、血清弹性蛋白酶 1、肝酶、钙、镁、磷酸盐、粪便颜色、粪便 pH 值和粪便脂肪含量。所有 AP 参与者的弹性蛋白酶 1 水平都很高，而 EF 组则没有发现任何升高。在 AP 组和 EF 组中，脂肪酶与总淀粉酶呈正相关（ρ = .543，p = 0.001；两者均为ρ = .543，p = 0.001）。此外，还发现弹性蛋白酶-1是区分 AP 和 EF 的良好生物标志物。

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引用次数: 0

Development of a rapid LFA test based on direct RT-LAMP for diagnosis of SARS-CoV-2 开发基于直接 RT-LAMP 的快速 LFA 检验，用于诊断 SARS-CoV-2

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 Epub Date: 2024-10-18 DOI: 10.1016/j.plabm.2024.e00437

Negar Sadeghi , Neda Shirazi , Moein Dehbashi , Bahareh Maleki , William C. Cho , Zohreh Hojati

Introduction

In response to the rapid spread of the SARS-CoV-2 virus, we developed a rapid molecular approach to diagnose COVID-19 without the need for RNA extraction.

Methods

The study utilized two molecular methods, RT-qPCR and colorimetric RT-LAMP, to diagnose the RdRp and ORF8 genes, respectively, in oro-nasopharyngeal swabs. Due to the high sequence diversity of ORF8 in SARS-CoV and SARS-CoV-2, it has been identified as a suitable target for virus detection. The RT-LAMP method was also carried out directly on heat-treated swab samples. The strip tests were made using gold nanoparticles and combined with the RT-LAMP for further analysis.

Results

The results showed that the isothermal amplification method had a sensitivity of 95 % (95 % C.I.: 86.08 %–98.96 %) and a specificity of 75 % (95 % C.I.: 19.41 %–99.37 %). The RT-LAMP-LFA method was able to distinguish positive and negative samples with 100 % sensitivity (95 % C.I.: 91.96–100) and 77.27 % specificity (95 % C.I.: 54.63–92.18). This method only required heating swab samples for 10 min at 65 °C before the RT-LAMP reaction.

Conclusion

By utilizing the RT-LAMP in combination with the LFA, it is possible to diagnose SARS-CoV-2 rapidly without the need for RNA extraction. The entire process from sample collection to test interpretation takes only 75–90 min, and the results can be interpreted by untrained individuals with the naked eye. By employing the ORF8 gene as a diagnostic target and eliminating the need for RNA extraction, the direct RT-LAMP-LFA method achieves a significant breakthrough that was not previously reported.

方法该研究利用 RT-qPCR 和比色 RT-LAMP 两种分子方法分别诊断口鼻咽拭子中的 RdRp 和 ORF8 基因。由于 ORF8 在 SARS-CoV 和 SARS-CoV-2 中具有高度序列多样性，因此被确定为检测病毒的合适目标。RT-LAMP 方法也是直接在经过热处理的咽拭子样本上进行的。结果表明，等温扩增法的灵敏度为 95 %（95 % C.I.：86.08 %-98.96 %），特异性为 75 %（95 % C.I.：19.41 %-99.37 %）。RT-LAMP-LFA 方法能够区分阳性和阴性样本，灵敏度为 100 %（95 % C.I.：91.96-100），特异度为 77.27 %（95 % C.I.：54.63-92.18）。该方法只需在 RT-LAMP 反应前将拭子样本在 65 °C 下加热 10 分钟即可。从样本采集到检验结果判读的整个过程只需 75-90 分钟，未经训练的人也能用肉眼判读结果。直接 RT-LAMP-LFA 方法采用 ORF8 基因作为诊断靶标，无需提取 RNA，实现了前所未有的重大突破。

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引用次数: 0

Laboratory considerations in the assessment of 25-hydroxyvitamin D in pregnant women by automated immunoassays 使用自动免疫测定法评估孕妇体内 25- 羟维生素 D 的实验室注意事项

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 Epub Date: 2024-09-25 DOI: 10.1016/j.plabm.2024.e00430

Darya Ayad Khalid , Bijan Nouri , Shakhawan Abdulrahman Mustafa , Mohammad Abdi

Background

Because of the pathophysiological role of vitamin D in health, there is an increased interest to check the clinical status of this vitamin. Immunochemical assays are commonly employed to determine 25-hydroxyvitamin D (25 (OH) D) in clinical laboratories and its testing could be influenced by pre-analytic and analytic issues. The aim of this study was to compare the 25(OH)D results obtained from three commonly used immunoassays in pregnant women to check a possible discrepancy between tests.

Material and methods

A group of 50 pregnant women who were in their third trimester were included in this study. The quantification of serum vitamin D was performed utilizing three immunochemistry-based assays including Elecsys, VIDAS and Alegria. We also involved 21 non-pregnant volunteers to clinically assess the vitamin D status in this group of people.

Results

Our findings revealed a significant inconsistency between the obtained results from three assays for serum 25(OH)D. The 25(OH)D showed higher values when measured by the Elecsys assay while the VIDAS assay had lower values compared to the other immunoassays. More notably, the 25(OH)D testing in non-pregnant subjects showed consistent results in all three immunoassays.

Conclusions

The results of the 25(OH)D measurements in pregnant women should be interpreted carefully due to a great inaccuracy in immunoassay testing. There is no such disagreement in non-pregnant people. Standardization of vitamin D testing in various settings is a crucial matter for clinical laboratories.

背景由于维生素 D 在健康中的病理生理作用，人们对检查这种维生素的临床状态越来越感兴趣。临床实验室通常采用免疫化学方法来测定 25- 羟基维生素 D（25 (OH) D），其检测结果可能会受到分析前和分析过程中问题的影响。本研究的目的是比较三种常用免疫测定法测定孕妇 25（OH）D 的结果，以检查不同检测方法之间可能存在的差异。使用三种基于免疫化学的检测方法（包括 Elecsys、VIDAS 和 Alegria）对血清维生素 D 进行定量。我们还邀请了 21 名非孕妇志愿者对这部分人群的维生素 D 状态进行临床评估。与其他免疫测定法相比，Elecsys 法测定的 25（OH）D 值较高，而 VIDAS 法测定的 25（OH）D 值较低。更值得注意的是，在对非孕妇进行 25（OH）D 检测时，所有三种免疫测定法的结果都是一致的。在非孕妇中则没有这种分歧。对临床实验室来说，在不同环境中进行维生素 D 检测的标准化至关重要。

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引用次数: 0