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Comparison of the accuracy of procalcitonin, neutrophil CD64, and C-reactive protein for the diagnosis and prognosis of septic patients after antibiotic therapy
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-01-01 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.
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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 Pub Date : 2025-01-01 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 Pub Date : 2025-01-01 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
Enhancing laboratory test consistency through linear transformation: A multi-center study
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-12-24 DOI: 10.1016/j.plabm.2024.e00445
Shitong Cheng , Dongliang Man , Zhiwei Zhou , Hui Kang

Objectives

China is promoting the mutual recognition of clinical laboratory test results to reduce redundant testing, provide more convenient medical services, and lower economic burdens. This study aimed to enhance the consistency of test results across laboratories using a linear transformation method, focusing on five representative biochemical parameters: ALP, CA, TBIL, TC, and TG.

Methods

Five ISO 15189 accredited laboratories participated in this study. We established inter-laboratory and intra-laboratory conversion relationships using patient sample comparisons and daily quality control (QC) data. These relationships were used to develop a web-based tool enabling real-time conversion and mutual recognition of laboratory test results.

Results

The study found that the linear transformation method effectively improved the consistency of test results. After three stages of conversion, most test results showed deviations within ±1/2 TEa when compared to a reference laboratory. However, some parameters in the low-value range exhibited less significant conversion effects, likely due to the sensitivity of percentage deviation measurements in this range.

Conclusions

The developed approach and web-based tool show potential for enhancing result consistency and facilitating mutual recognition across laboratories. Despite its effectiveness, the study's limitations, such as a small sample size and a narrow focus on five biochemical parameters, indicate the need for further research and broader application.
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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 Pub Date : 2024-11-01 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
Assay precision, 99th percentile reference value and proportion of detected healthy european adults for VIDAS® high-sensitive troponin I VIDAS®高敏感肌钙蛋白I的检测精度、99百分位参考值和检测到的健康欧洲成年人比例。
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00441
Nathalie Auberger , Isabelle Coin , Laure Marillet , Frédérique Raymond , Sandrine Michel-Busseret , Pierre-Géraud Claret , Camille Pease

Introduction/objectives

Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.

Methods

High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples.

Results

One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays.

Conclusion

VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.
简介/目的:根据IFCC(国际临床化学和检验医学联合会)关于高灵敏度心肌肌钙蛋白检测的指南,我们对VIDAS®高灵敏度肌钙蛋白I (TNHS)检测进行了评估。评估了该测试至少检测50%健康个体的能力,并在第99个百分位数检查变异系数小于10%。方法:通过检查检测限、测定第99百分位值、在该值处的评价不精确度和检测结果高于检测限(LoD)对欧洲健康人群进行高灵敏度评价。在总共808份血浆样本上验证了VIDAS®TNHS在健康人群中的检测能力。结果:共纳入1619个值,其中男性样本888个,女性样本731个。VIDAS®高敏感肌钙蛋白I检测在第99百分位的总不精确性为5.2%,57.4%的健康个体的肌钙蛋白I值超过LoD。由于该测试检测到超过50%的健康个体,并且在第99百分位数的变异系数小于10%,因此它符合高灵敏度心肌肌钙蛋白检测的标准。结论:VIDAS®高灵敏度肌钙蛋白I检测是一种高灵敏度心肌肌钙蛋白检测,符合IFCC指南提供的定义。
{"title":"Assay precision, 99th percentile reference value and proportion of detected healthy european adults for VIDAS® high-sensitive troponin I","authors":"Nathalie Auberger ,&nbsp;Isabelle Coin ,&nbsp;Laure Marillet ,&nbsp;Frédérique Raymond ,&nbsp;Sandrine Michel-Busseret ,&nbsp;Pierre-Géraud Claret ,&nbsp;Camille Pease","doi":"10.1016/j.plabm.2024.e00441","DOIUrl":"10.1016/j.plabm.2024.e00441","url":null,"abstract":"<div><h3>Introduction/objectives</h3><div>Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.</div></div><div><h3>Methods</h3><div>High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples.</div></div><div><h3>Results</h3><div>One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays.</div></div><div><h3>Conclusion</h3><div>VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00441"},"PeriodicalIF":1.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11665417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882823","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
The measurement of immunosuppressive drugs by mass spectrometry and immunoassay in a South African transplant setting 在南非移植环境中通过质谱法和免疫测定法测量免疫抑制药物
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00440
Amy Strydom, Doreen Jacob, Taryn Pillay, Refeletse Malahlela, Sean Currin

Objectives

Liquid chromatography tandem mass spectrometry (LC-MS/MS) is the gold standard for measurement of immunosuppressive drugs (ISDs), but is technically demanding and less accessible in resource-limited countries. Immunoassays can also measure ISD concentrations, but may be limited by cross-reactivity. We evaluated the performance of the Roche electrochemiluminescence immunoassay (ECLIA) for cyclosporine, everolimus and sirolimus against LC-MS/MS in an African population for the first time.

Methods

Bias for ECLIA was estimated by comparing ECLIA-measured ISD concentrations to those obtained by LC-MS/MS in 42, 43 and 47 patient samples for cyclosporine, everolimus and sirolimus, respectively. Precision was assessed by performing replicate measurements of quality control materials.

Results

Deming regression analysis for all ISDs showed strong correlation between ECLIA and LC-MS/MS with a Pearson's r of >0.94. The slopes for cyclosporine, everolimus and sirolimus were 0.94 [95 % CI: 0.87–1.03], 1.35 [95 % CI: 1.23–1.44] and 0.96 [95 % CI: 0.85–1.15] with y-intercepts of 31.60 μg/L [95 % CI: 2.02–57.63], 0.23 μg/L [95 % CI: 0.21 – 0.72] and 2.61 μg/L [95 % CI: 1.30–3.56], respectively. Difference plots showed a median bias of 2.07 % [95 % CI: 1.42 – 6.99 %], 41.2 % [95 % CI: 34.9–51.8 %] and 34.9 % [95 % CI: 28.4–47.3 %] for cyclosporine, everolimus and sirolimus, respectively.

Conclusions

The cyclosporine ECLIA yielded results comparable to LC-MS/MS while poorly comparable results were obtained for everolimus and sirolimus, which may be explained by ISD metabolite cross-reactivity, amongst other factors. The poor comparability, although not unique, is noteworthy and the clinical consequences of these differences require further investigation.
目标液相色谱串联质谱法(LC-MS/MS)是测量免疫抑制剂(ISD)的黄金标准,但技术要求高,在资源有限的国家较难获得。免疫测定也可以测量 ISD 的浓度,但可能会受到交叉反应的限制。我们首次在非洲人群中评估了罗氏电化学发光免疫分析法(ECLIA)与液相色谱-质谱联用法(LC-MS/MS)在环孢素、依维莫司和西罗莫司方面的性能。结果对所有 ISD 进行的回归分析表明,ECLIA 与 LC-MS/MS 之间具有很强的相关性,Pearson's r 为 0.94。环孢素、依维莫司和西罗莫司的斜率分别为 0.94 [95 % CI: 0.87-1.03]、1.35 [95 % CI: 1.23-1.44]和 0.96 [95 % CI: 0.85-1.15],Y-截距分别为 0.15、0.15 和 0.15。15],Y-截距分别为 31.60 μg/L [95 % CI:2.02-57.63]、0.23 μg/L [95 % CI:0.21-0.72] 和 2.61 μg/L [95 % CI:1.30-3.56]。差异图显示,环孢素、依维莫司和西罗莫司的中位偏差分别为 2.07 % [95 % CI: 1.42 - 6.99 %]、41.2 % [95 % CI: 34.9 - 51.8 %]和 34.9 % [95 % CI: 28.4 - 47.3 %]。结论 环孢素 ECLIA 的检测结果可与 LC-MS/MS 相媲美,而依维莫司和西罗莫司的检测结果可比性较差,这可能与 ISD 代谢物交叉反应等因素有关。可比性差虽然不是独一无二的,但值得注意,这些差异的临床后果需要进一步研究。
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引用次数: 0
Corrigendum to “Unified calibration of D-dimer can improve the uniformity of different detection systems” [Practical Laboratory Medicine 40 (2024) e00413] 对 "统一校准 D-二聚体可提高不同检测系统的一致性 "的更正 [Practical Laboratory Medicine 40 (2024) e00413]。
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00442
Kun Wang , Xinwei Zang , Wenjie Zhang , Xiangyu Cao , Huiru Zhao , Chunyan Li , Cuiying Liang , Jun Wu
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引用次数: 0
Falsely abnormal serum protein electrophoresis after administration of intravenous immunoglobulins (IVIG): A retrospective cohort study 静脉注射免疫球蛋白(IVIG)后血清蛋白电泳异常:回顾性队列研究
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00434
Andrew Sulaiman, Patrizio Caturegli
Intravenous immunoglobulin (IVIG) therapy, used in several neurologic, hematologic, immunologic and dermatologic conditions, is known to interfere with the results of some serum laboratory tests. We analyzed the potential interference of IVIG on serum protein electrophoresis (SPEP) by reviewing more than a decade of SPEP studies performed by the clinical immunology laboratory of the Johns Hopkins Hospital. Of the total 100,350 SPEP performed between January 1, 2013 and December 31, 2023, 395 contained the keyword IVIG in the pathologist report, contributed by 348 patients confirmed to have received IVIG by chart review. Of the 348 patients, 20 (6 %) had a M-spike on SPEP suggestive of monoclonal gammopathy, while 328 (94 %) did not have it. Of the 20 patients, 14 received IVIG within 30 days from the SPEP collection date, while 6 received beyond 30 days. Serum immunofixation electrophoresis (SIFE) and clinical follow up showed no evidence of monoclonal gammopathy in 5 of the 14 patients. Overall, this 11-year retrospective cohort study showed that 5 of 348 (1.4 %) patients treated with IVIG and tested by SPEP had a false M-spike, that is a spike not confirmed to be caused by a monoclonal gammopathy by subsequent studies. Although small, the false positive rate of 1.4 % suggests that integrating knowledge of recent IVIG administration into the pathologist report would reduce SPEP misdiagnosis.
众所周知,静脉注射免疫球蛋白(IVIG)疗法会干扰某些血清实验室检测的结果,该疗法可用于多种神经、血液、免疫和皮肤病的治疗。我们通过回顾约翰霍普金斯医院临床免疫学实验室十多年来进行的 SPEP 研究,分析了 IVIG 对血清蛋白电泳(SPEP)的潜在干扰。在 2013 年 1 月 1 日至 2023 年 12 月 31 日期间进行的总共 100,350 例 SPEP 中,有 395 例病理学家报告中包含 IVIG 关键字,其中 348 例患者通过病历审查确认接受了 IVIG 治疗。在这 348 名患者中,有 20 人(6%)在 SPEP 中出现了提示单克隆性腺病的 M 峰,而 328 人(94%)没有出现 M 峰。在这 20 名患者中,14 人在 SPEP 采集日期后 30 天内接受了 IVIG 治疗,6 人在 30 天后接受了 IVIG 治疗。血清免疫固定电泳(SIFE)和临床随访显示,14 名患者中有 5 人未发现单克隆抗体病。总体而言,这项为期 11 年的回顾性队列研究显示,在 348 例接受 IVIG 治疗并接受 SPEP 检测的患者中,有 5 例(1.4%)出现了假 M-棘波,即后续研究未证实是由单克隆丙种球蛋白病引起的棘波。1.4% 的假阳性率虽然很小,但表明将近期 IVIG 用药知识纳入病理学家报告可减少 SPEP 误诊。
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引用次数: 0
Glycated albumin in pregnancy correlates negatively with body mass index and contributes to the risk of gestational diabetes mellitus 孕期糖化白蛋白与体重指数呈负相关,并增加妊娠糖尿病的风险
IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-23 DOI: 10.1016/j.plabm.2024.e00439
Toril Ø. Osestad , Kristin Lilleholt , Øyvind Skadberg , Linda R. Sagedal , Ingvild Vistad , Thomas Hundhausen

Objectives

The aims of our study were to establish a reference interval for glycated albumin (GA) in gestational week 30, to investigate whether GA can replace or reduce the need for oral glucose tolerance test (OGTT) in pregnancy, and to reassess the usefulness of body mass-index (BMI), age and fasting glucose in detection of gestational diabetes (GDM).

Design

and methods: We measured GA in 486 healthy pregnant women. Reference interval was calculated using the central 95 % of the results. ROC curves were created to assess the ability of GA, fasting glucose and BMI separately to detect GDM, and logistic regression analysis was used to estimate risk of developing GDM given the level of the same markers. Finally, multiple logistic regression analysis based on GA, fasting glucose and BMI was used to find a strategy of predicting a patient's risk of GDM.

Results

The reference interval for GA at week 30 of gestation is 6.8–10.3 %. The analysis has a low AUC (0.53) with respect to detecting GDM. It increases slightly to 0.64 when corrected for BMI, as GA is inversely correlated to BMI. Combining GA with fasting glucose and BMI at gestational weeks 16–20 could raise the AUC to 0.80.

Conclusion

GA cannot be recommended to replace OGTT for the diagnosis of GDM. Nor can it be used to identify women at risk of developing GDM. GA combined with fasting glucose and BMI in early pregnancy could be a useful model to estimate risk of GDM.
目的 我们的研究旨在确定妊娠 30 周糖化白蛋白(GA)的参考区间,研究 GA 是否可以取代或减少妊娠期口服葡萄糖耐量试验(OGTT),并重新评估体重指数(BMI)、年龄和空腹血糖在检测妊娠糖尿病(GDM)中的作用:我们测量了 486 名健康孕妇的妊娠期糖尿病。以结果的 95% 为中心计算参考区间。绘制了 ROC 曲线,分别评估 GA、空腹血糖和体重指数检测 GDM 的能力,并使用逻辑回归分析估算在相同指标水平下罹患 GDM 的风险。最后,基于 GA、空腹血糖和 BMI 的多重逻辑回归分析被用来寻找预测患者 GDM 风险的策略。该分析在检测 GDM 方面的 AUC 较低(0.53)。由于 GA 与体重指数成反比,因此在对体重指数进行校正后,AUC 略微上升至 0.64。将 GA 与空腹血糖和孕 16-20 周时的 BMI 相结合,可将 AUC 提高到 0.80。GA不能取代OGTT用于诊断GDM,也不能用于识别有患GDM风险的妇女。GA与孕早期空腹血糖和体重指数相结合,可作为估计GDM风险的有用模型。
{"title":"Glycated albumin in pregnancy correlates negatively with body mass index and contributes to the risk of gestational diabetes mellitus","authors":"Toril Ø. Osestad ,&nbsp;Kristin Lilleholt ,&nbsp;Øyvind Skadberg ,&nbsp;Linda R. Sagedal ,&nbsp;Ingvild Vistad ,&nbsp;Thomas Hundhausen","doi":"10.1016/j.plabm.2024.e00439","DOIUrl":"10.1016/j.plabm.2024.e00439","url":null,"abstract":"<div><h3>Objectives</h3><div>The aims of our study were to establish a reference interval for glycated albumin (GA) in gestational week 30, to investigate whether GA can replace or reduce the need for oral glucose tolerance test (OGTT) in pregnancy, and to reassess the usefulness of body mass-index (BMI), age and fasting glucose in detection of gestational diabetes (GDM).</div></div><div><h3>Design</h3><div>and methods: We measured GA in 486 healthy pregnant women. Reference interval was calculated using the central 95 % of the results. ROC curves were created to assess the ability of GA, fasting glucose and BMI separately to detect GDM, and logistic regression analysis was used to estimate risk of developing GDM given the level of the same markers. Finally, multiple logistic regression analysis based on GA, fasting glucose and BMI was used to find a strategy of predicting a patient's risk of GDM.</div></div><div><h3>Results</h3><div>The reference interval for GA at week 30 of gestation is 6.8–10.3 %. The analysis has a low AUC (0.53) with respect to detecting GDM. It increases slightly to 0.64 when corrected for BMI, as GA is inversely correlated to BMI. Combining GA with fasting glucose and BMI at gestational weeks 16–20 could raise the AUC to 0.80.</div></div><div><h3>Conclusion</h3><div>GA cannot be recommended to replace OGTT for the diagnosis of GDM. Nor can it be used to identify women at risk of developing GDM. GA combined with fasting glucose and BMI in early pregnancy could be a useful model to estimate risk of GDM.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00439"},"PeriodicalIF":1.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142533309","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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