Journal of Clinical Laboratory Analysis最新文献_第9页

The Role of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as an Early Indicator of Mortality in Pediatric Septic Shock 可溶性尿激酶凝血活酶原受体（suPAR）作为小儿败血症休克死亡率早期指标的作用。

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-05-06 DOI: 10.1002/jcla.25040

Caner Turan, Ali Yurtseven, Pinar Yazici Ozkaya, Elif Azarsiz, Eylem Ulas Saz

Background

Despite advancements in antibiotic therapy and resuscitation protocols, sepsis and septic shock remain major contributors to morbidity and mortality in children. We aimed to investigate the utility of soluble urokinase plasminogen activator receptor (suPAR) for the early detection of septic shock and to evaluate its accuracy in predicting mortality.

Methods

A prospective study was conducted in a tertiary pediatric emergency department (ED), enrolling patients diagnosed with the sepsis, severe sepsis, or septic shock. In addition to assessing infection biomarkers such as C-reactive protein and procalcitonin, suPAR levels were quantified upon admission using enzyme-linked immunosorbent assay. The primary outcome measure was 30-day mortality.

Results

Overall 72 patients and 80 healthy children included. Plasma suPAR levels demonstrated a statistically significant elevation in the sepsis, severe sepsis, and septic shock groups compared with the control group (p < 0.001 for all). The septic shock group exhibited the highest suPAR levels upon admission, surpassing both the sepsis and severe sepsis groups (p = 0.009 and 0.042). ROC analysis underscored the promising potential of suPAR with an AUC of 0.832 for septic shock. Analysis of mortality prediction revealed significantly higher suPAR levels in nonsurvivors than survivors (9.7 ng/mL vs. 4.2 ng/mL; p < 0.001). Employing plasma suPAR levels to discriminate between mortality and survival, a threshold of ≥7.0 ng/mL demonstrated a sensitivity of 90.9% and specificity of 71.0%.

Conclusion

Plasma suPAR levels have the potential as a biomarker for predicting mortality in children with septic shock. In pediatric septic shock, the presence of plasma suPAR ≥7 ng/mL along with an underlying disease significantly increases the risk of mortality.

背景：尽管抗生素治疗和复苏方案取得了进步，但败血症和脓毒性休克仍是导致儿童发病和死亡的主要原因。我们旨在研究可溶性尿激酶纤溶酶原激活物受体（suPAR）对早期检测脓毒性休克的作用，并评估其预测死亡率的准确性：在一家三级儿科急诊科（ED）开展了一项前瞻性研究，纳入了被诊断为脓毒症、严重脓毒症或脓毒性休克的患者。除了评估 C 反应蛋白和降钙素原等感染生物标志物外，还在患者入院时使用酶联免疫吸附试验对 suPAR 水平进行了量化。主要结果指标为 30 天死亡率：结果：共纳入 72 名患者和 80 名健康儿童。与对照组相比，脓毒症组、严重脓毒症组和脓毒性休克组的血浆 suPAR 水平有统计学意义的显著升高（p 结论：血浆 suPAR 水平对脓毒症、严重脓毒症和脓毒性休克有显著的抑制作用：血浆 suPAR 水平有可能成为预测脓毒性休克患儿死亡率的生物标志物。在小儿脓毒性休克中，血浆 suPAR≥7 纳克/毫升并伴有潜在疾病会显著增加死亡风险。

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引用次数: 0

Comparison Evaluation of Automated Nucleated Red Blood Cell Enumeration by Sysmex XN 1000 in Comparison With Microscopic Reference in Children Under 1 Year 用 Sysmex XN 1000 对一岁以下儿童进行有核红细胞自动计数与显微镜参照的比较评估

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-04-15 DOI: 10.1002/jcla.25037

Sophie Brunner-Ziegler, Bernd Jilma, Gabriele Grimm, Petra Jilma-Stohlawetz

Background

In newborns, elevated nucleated red blood cell (NRBC) levels can be associated with enhanced erythropoietic stress and might be predictive for adverse outcome. Also, the presence of NRBC in peripheral blood might lead to erroneous enumeration results of white blood cells in automated hematology analyzers. We aimed to assess the comparability of the Sysmex XN 1000 to manual slide reviews and correlation of NRBC with inflammation markers.

Methods

Specimens of 3397 children under 1 year were compared by automated and microscopic NRBC enumeration. Additionally, potential correlations between NRBC and age and inflammation markers were examined.

Results

Overall, there was good correlation (r = 0.97) between automated (range: 0%–3883%) and microscopic enumeration (range: 0%–3694%) of NRBC with high comparability up to a NRBC value of 200% and an increase in the variation between the two methods with increasing NRBC numbers. When 94 samples with ≤ 200% NRBC and ≥ 30% divergence between methods were separately reanalyzed with respect to overlapping cell populations in their scattergrams, Sysmex would have generated unrecognized incorrect automated results in 47 samples, corresponding to 1.4% of total study samples. NRBC counts were negatively correlated to age, but not to inflammation markers.

Conclusion

Sysmex XN 1000 is highly precise in the enumeration of NRBC in children under 1 year up to counts of 200% and might replace time-intense manual counting in routine diagnostics. In the setting of neonatal and intensive care diagnostics, microscopic control and supervision of scattergrams are highly recommended for any automated NRBC enumeration processes.

背景在新生儿中，有核红细胞（NRBC）水平升高可能与红细胞生成压力增加有关，并可能预示着不良预后。此外，外周血中 NRBC 的存在可能会导致自动血液分析仪中白细胞计数结果的错误。我们的目的是评估 Sysmex XN 1000 与手动玻片审查的可比性以及 NRBC 与炎症标记物的相关性。结果总体而言，NRBC 的自动计数（范围：0%-3883%）与显微镜计数（范围：0%-3694%）之间具有良好的相关性（r = 0.97），在 NRBC 值达到 200% 时具有很高的可比性，并且随着 NRBC 数量的增加，两种方法之间的差异也在增加。如果对 NRBC 值≤ 200% 且两种方法之间差异≥ 30% 的 94 个样本分别重新分析其散点图中重叠的细胞群，Sysmex 会在 47 个样本中生成无法识别的错误自动结果，相当于研究样本总数的 1.4%。NRBC 计数与年龄呈负相关，但与炎症标志物无相关性。在新生儿和重症监护诊断中，强烈建议对任何自动 NRBC计数流程进行显微镜控制和散点图监督。

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引用次数: 0

Reliability of a Screening Method Using Antibiotic Disks to Detect Carbapenemases in Glucose-Nonfermenting Gram-Negative Microorganisms From Clinical Samples of a Regional Hospital in Southeastern Spain 使用抗生素药盘检测西班牙东南部一家地区医院临床样本中葡萄糖不发酵革兰氏阴性微生物碳青霉烯酶的筛查方法的可靠性

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-04-15 DOI: 10.1002/jcla.25036

Itahisa Hernández-Chico, Enrique Rodríguez-Guerrero, Manuela Expósito-Ruiz, José María Navarro-Marí, José Gutiérrez-Fernández

Background

Infections by glucose-nonfermenting gram-negative bacilli (NFGNB) pose a major public health problem due to multiresistance to beta-lactam antibiotics, especially plasmid-borne carbapenemases. Their detection by microbiology laboratories is challenging, and there is a need for easy-to-use and reliable diagnostic techniques. Our objective was to evaluate an in-house screening method to presumptively detect carbapenemases in NFGNB in a simple and clinically useful manner.

Methods

The study included 175 NFGNB isolates from urinary, respiratory, and rectal samples. In a triple assay, isolates were incubated at 37°C for 24 h on three solid-culture media: MacConkey II Agar, 5% Sheep Blood Columbia Agar and Mueller Hinton II Agar; meropenem (MEM) and cefepime (FEP) disks were employed for screening. Studies were then performed on the inhibition halo diameter, scanning effects, and the appearance of mutant colonies, which were compared with those observed using the colorimetric Neo-Rapid CARB Kit and immunochromatography (NG5-Test Carba and K-Set for OXA-23). Receiver operating characteristic curves were constructed for these data.

Results

Carbapenemases were expressed by 79/175 (45.1%): 19 Pseudomonas aeruginosa and 60 Acinetobacter baumannii. Optimal inhibition halo diameter cutoffs to detect this resistance on 5% sheep blood agar were as follows: 6 mm (MEM) and 6.5 mm (FEP) for P. aeruginosa (in the absence of scanning effects and mutations) and 10.5 mm (MEM) and 16 mm (FEP) for A. baumannii (even in the presence of scanning effects).

Conclusion

The combined utilization of MEM and FEP antibiotic disks in 5% sheep blood agar, measuring their inhibition haloes, offers an effective method to predict the presence of carbapenemases as resistance mechanism in P. aeruginosa and A. baumannii.

背景由于葡萄糖不发酵革兰氏阴性杆菌（NFGNB）对β-内酰胺类抗生素（尤其是质粒携带的碳青霉烯酶）具有多重耐药性，因此葡萄糖不发酵革兰氏阴性杆菌感染已成为一个重大的公共卫生问题。微生物实验室对它们的检测具有挑战性，因此需要易于使用且可靠的诊断技术。我们的目标是评估一种内部筛查方法，该方法能以简单、临床实用的方式推定检测出 NFGNB 中的碳青霉烯酶。在三重试验中，分离物在 37°C 下在三种固体培养基上培养 24 小时：采用美罗培南（MEM）和头孢吡肟（FEP）盘进行筛选。然后对抑制光晕直径、扫描效应和突变菌落的出现进行了研究，并与使用比色法 Neo-Rapid CARB 试剂盒和免疫层析法（NG5-Test Carba 和 K-Set for OXA-23）观察到的结果进行了比较。结果79/175（45.1%）种细菌表达了碳青霉烯酶：19个铜绿假单胞菌和60个鲍曼不动杆菌表达了碳青霉烯酶。在 5%绵羊血琼脂上检测这种抗药性的最佳抑制光环直径临界值如下：6 毫米（MEM）和 6 毫米（MEM）：结论在 5%绵羊血琼脂中结合使用 MEM 和 FEP 抗生素盘，测量其抑制光晕，是预测铜绿假单胞菌和鲍曼不动杆菌中碳青霉烯酶耐药机制的有效方法。

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引用次数: 0

The dilution evaluation as a corrective measure for interference in the white blood cell scattergram in Beckman Coulter DxH 900 稀释评估作为贝克曼库尔特 DxH 900 中白细胞散点图干扰的纠正措施

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-04-09 DOI: 10.1002/jcla.25007

Filipa P. Freitas, Jorge Reis, Joana Oliveira, Pedro Mota Veiga, Ana Raquel Paiva, Rui Soares

Background

The Beckman Coulter DxH 900 is a haematological analyser capable of counting and sizing blood cells, and obtaining a complete blood cell count (CBC). This analyses different parameters of red blood cells (RBC), platelets and white blood cells/leukocytes. Some automated CBC counters present limitations due to specimen characteristics, abnormal cells or both factors. In the presence of abnormalities, the DxH 900 has a flagging system, warning the laboratory technician that something needs to be verified. In the present work, we evaluated samples from oncologic patients, presenting a population erroneously perceived as being lymphocytes. The most common explanations for this situation are RBC resistant to lysis or serum hyperbilirubinaemia.

Methods

In an attempt to solve and understand what the cause of this problem might be, we diluted our samples (1:3) and analysed the serum total bilirubin. To identify cells' abnormalities, the samples were also analysed by manual DLC counts. During the study, we also checked the different flags presented by the equipment.

Results

The results evidenced that the major interference was due to RBC lysis resistance, corresponding to 94.7% of the cases, while hyperbilirubinaemia was only present in 73.4%. Besides, we determined that some samples with normal bilirubin levels also presented interference, suggesting that hyperbilirubinaemia was not the main cause of the error. The most recurrent flag observed was “High event rate”.

Conclusion

The dilution solved all of the observed interferences. The results between diluted and manual counts showed a strong correlation, leading us to introduce dilution in our laboratory routine.

背景贝克曼库尔特 DxH 900 是一款血液分析仪，能够对血细胞进行计数和定型，并获得全血细胞计数 (CBC)。它能分析红细胞 (RBC)、血小板和白细胞/白血球的不同参数。一些自动全血细胞计数器会因样本特征、异常细胞或这两种因素而受到限制。在出现异常时，DxH 900 有一个标记系统，提醒实验室技术人员需要对某些情况进行核实。在本次工作中，我们对肿瘤患者的样本进行了评估，结果发现样本中的细胞被误认为是淋巴细胞。这种情况最常见的解释是抗溶解的红细胞或血清高胆红素血症。为了解决和了解造成这一问题的原因，我们将样本稀释（1:3）并分析血清总胆红素。为了确定细胞是否异常，我们还对样本进行了人工 DLC 计数分析。研究期间，我们还检查了设备发出的不同信号。结果结果表明，主要干扰是由于红细胞溶解抵抗，占 94.7%，而高胆红素血症仅占 73.4%。此外，我们还发现一些胆红素水平正常的样本也出现了干扰，这表明高胆红素血症并不是造成误差的主要原因。最常出现的标记是 "事件发生率高"。稀释计数和人工计数的结果显示出很强的相关性，这促使我们在实验室常规工作中引入稀释计数。

{"title":"The dilution evaluation as a corrective measure for interference in the white blood cell scattergram in Beckman Coulter DxH 900","authors":"Filipa P. Freitas, Jorge Reis, Joana Oliveira, Pedro Mota Veiga, Ana Raquel Paiva, Rui Soares","doi":"10.1002/jcla.25007","DOIUrl":"10.1002/jcla.25007","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The Beckman Coulter DxH 900 is a haematological analyser capable of counting and sizing blood cells, and obtaining a complete blood cell count (CBC). This analyses different parameters of red blood cells (RBC), platelets and white blood cells/leukocytes. Some automated CBC counters present limitations due to specimen characteristics, abnormal cells or both factors. In the presence of abnormalities, the DxH 900 has a flagging system, warning the laboratory technician that something needs to be verified. In the present work, we evaluated samples from oncologic patients, presenting a population erroneously perceived as being lymphocytes. The most common explanations for this situation are RBC resistant to lysis or serum hyperbilirubinaemia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In an attempt to solve and understand what the cause of this problem might be, we diluted our samples (1:3) and analysed the serum total bilirubin. To identify cells' abnormalities, the samples were also analysed by manual DLC counts. During the study, we also checked the different flags presented by the equipment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The results evidenced that the major interference was due to RBC lysis resistance, corresponding to 94.7% of the cases, while hyperbilirubinaemia was only present in 73.4%. Besides, we determined that some samples with normal bilirubin levels also presented interference, suggesting that hyperbilirubinaemia was not the main cause of the error. The most recurrent flag observed was “High event rate”.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The dilution solved all of the observed interferences. The results between diluted and manual counts showed a strong correlation, leading us to introduce dilution in our laboratory routine.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"38 8","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25007","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140575187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Multiplex Recombinase-Aided qPCR Assay for Highly Sensitive and Rapid Detection of khe, blaKPC-2, and blaNDM-1 Genes in Klebsiella pneumoniae 高灵敏、快速检测肺炎克雷伯菌中 khe、blaKPC-2 和 blaNDM-1 基因的多重重组酶辅助 qPCR 分析法

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-04-08 DOI: 10.1002/jcla.25038

Shao-wei Hua, Jie Wang, Zi-jin Zhao, Feng-yu Tian, Meng Zhao, Yu-xin Wang, Rui-qing Zhang, Zhi-qiang Han, Shi-jue Gao, Xiao-na Lv, Hong-yi Li, Xin-xin Shen, Xue-jun Ma, Zhi-shan Feng

Objective

This study aimed to establish a highly sensitive and rapid single-tube, two-stage, multiplex recombinase-aided qPCR (mRAP) assay to specifically detect the khe, bla_KPC-2, and bla_NDM-1 genes in Klebsiella pneumoniae.

Methods

mRAP was carried out in a qPCR instrument within 1 h. The analytical sensitivities of mRAP for khe, bla_KPC-2, and bla_NDM-1 genes were tested using recombinant plasmids and dilutions of reference strains. A total of 137 clinical isolates and 86 sputum samples were used to validate the clinical performance of mRAP.

Results

mRAP achieved the sensitivities of 10, 8, and 14 copies/reaction for khe, bla_KPC-2, and bla_NDM-1 genes, respectively, superior to qPCR. The Kappa value of qPCR and mRAP for detecting khe, bla_KPC-2, and bla_NDM-1 genes was 1, 0.855, and 1, respectively (p < 0.05).

Conclusion

mRAP is a rapid and highly sensitive assay for potential clinical identification of khe, bla_KPC-2, and bla_NDM-1 genes in K. pneumoniae.

本研究旨在建立一种高灵敏度、快速的单管、两阶段、多重重组酶辅助qPCR（mRAP）检测方法，以特异性检测肺炎克雷伯菌中的khe、blaKPC-2和blaNDM-1基因。结果mRAP对khe、blaKPC-2和blaNDM-1基因的灵敏度分别为10、8和14拷贝/反应，优于qPCR。在检测 khe、blaKPC-2 和 blaNDM-1 基因方面，qPCR 和 mRAP 的 Kappa 值分别为 1、0.855 和 1（p < 0.05）。

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引用次数: 0

Clinical Performance of Immunonephelometric Assay and Chemiluminescent Immunoassay for Detection of IgG Subclasses in Chinese 用于检测中国人 IgG 亚类的免疫浮肿测定法和化学发光免疫测定法的临床表现

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-04-02 DOI: 10.1002/jcla.25033

Yan Qin, Yuhan Jia, Congcong Liang, Rui Fu, Zhaojun Liang, Yanlin Wang, Min Feng, Chong Gao, Jing Luo

Background

Detection of IgG subclasses (IgGSc) is vital for the diagnosis and management of disease, especially IgG4-related diseases (IgG4-RD). This study aimed to evaluate the performances of the chemiluminescent immunoassay (CLIA) for detecting IgGSc and diagnosing IgG4-RD by IgGSc.

Methods

A total of 40 individuals with IgG4-RD, 40 with primary Sjogren's syndrome (pSS), and 40 healthy controls (HCs) were enrolled. Serum samples were collected for the simultaneous detection of IgG1, IgG2, IgG3, and IgG4 by the Siemens immunonephelometric assay and the CLIA. The correlation analysis was performed, and diagnostic value was analyzed by the receiver operating characteristic (ROC) curve.

Results

Patients with IgG4-RD had higher IgG4 (p < 0.001) and lower IgG1 (p < 0.001) than those with pSS, and HC. The results by the Siemens immunonephelometric assay and the CLIA showed a strong correlation in detecting IgG1, IgG2, IgG3, and IgG4 (r = 0.937, r = 0.847, r = 0.871, r = 0.990, all p < 0.001, respectively). The sum of IgG1, IgG2, IgG3, and IgG4 using two assays strongly correlated with total IgG by the IMMAGE 800 (r = 0.866, r = 0.811, both p < 0.001, respectively). For discriminating IgG4-RD from pSS and HC, no significant differences were observed in CLIA IgG4 and Siemens immunonephelometric assay IgG4 (z = 0.138, p = 0.891), which provided the area under the curves (AUCs) of 0.951 (p < 0.001) and 0.950 (p < 0.001), respectively. The AUCs of CLIA IgG1 and Siemens immunonephelometric assay IgG1 in distinguishing pSS from IgG4-RD and HC were 0.761 (p < 0.001) and 0.765 (p < 0.001), respectively, with no significant differences (z = 0.228, p = 0.820).

Conclusions

The CLIA and the Siemens immunonephelometric assay appeared to have good consistency with comparable diagnostic value in detecting IgGSc, especially IgG4, and IgG1 that can accurately identify IgG4-RD or pSS in clinical practice.

背景：IgG亚类（IgGSc）的检测对于疾病的诊断和管理至关重要，尤其是IgG4相关疾病（IgG4-RD）。本研究旨在评估化学发光免疫测定（CLIA）检测 IgGSc 和通过 IgGSc 诊断 IgG4-RD 的性能：方法：共招募了 40 名 IgG4-RD 患者、40 名原发性 Sjogren's 综合征（pSS）患者和 40 名健康对照者（HCs）。采集血清样本，用西门子免疫测定法和 CLIA 法同时检测 IgG1、IgG2、IgG3 和 IgG4。结果显示，IgG4-RD 患者的血清 IgG1、IgG2、IgG3 和 IgG4 均高于正常值：结果：IgG4-RD 患者的 IgG4 较高（p 结论：IgG4-RD 患者的 IgG4 较低：CLIA 和西门子免疫测定在检测 IgGSc（尤其是 IgG4）和 IgG1 方面具有良好的一致性和可比诊断价值，可在临床实践中准确识别 IgG4-RD 或 pSS。

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引用次数: 0

Effect of a Declined Plasma Concentration of Valproic Acid Induced by Meropenem on the Antiepileptic Efficacy of Valproic Acid 美罗培南导致丙戊酸血浆浓度下降对丙戊酸抗癫痫药效的影响

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-04-02 DOI: 10.1002/jcla.25025

Chunping Gu, Yongfang Zhang, Fumiao Yuan, Kaibin Huang, Zhenzhou Lin, Qiong Chen, Yan Chen, Yongming Wu, Dongmei Wang, Shengnan Wang

Objective

This study aimed to indicate whether a declined plasma concentration of valproic acid (VPA) induced by co-administration of meropenem (MEPM) could affect the antiepileptic efficacy of VPA.

Methods

We retrospectively reviewed data of hospitalized patients who were diagnosed with status epilepticus or epilepsy between 2010 and 2019. Patients co-administered VPA and MEPM during hospitalization were screened and assigned to the exposure group, while those co-administerd VPA and other broad-spectrum antibiotics were allocated to the control group.

Results

The exposure group and control group included 50 and 11 patients, respectively. With a similar dosage of VPA, the plasma concentration of VPA significantly decreased during co-administration (24.6 ± 4.3 μg/mL) compared with that before co-administration (88.8 ± 13.6 μg/mL, p < 0.0001), and it was partly recovered with the termination of co-administration (39.8 ± 13.2 μg/mL, p = 0.163) in the exposure group. The inverse probability of treatment weighting estimated the treatment efficacy via changes in seizure frequency, seizure duration, and concomitant use of antiepileptic drugs, which were not significantly different between the exposure and control groups. In the exposure group, there was no significant differences in seizure frequency between the periods of before-during and before-after (p = 0.074 and 0.153, respectively). Seizure duration during VPA–MEPM co-administration was not significantly different from that before co-administration (p = 0.291).

Conclusions

In this study, the reduced plasma concentration of VPA induced by the co-administration of MEPM did not affect the antiepileptic efficacy of VPA. This conclusion should be interpreted with caution, and more research is warranted.

Trial Registration

Chinese Clinical Trial Registry: ChiCTR2000034567. Registered on 10 July 2020

研究目的本研究旨在说明联合应用美罗培南（MEPM）引起的丙戊酸（VPA）血浆浓度下降是否会影响VPA的抗癫痫疗效：我们回顾性研究了2010年至2019年期间被诊断为癫痫状态或癫痫的住院患者的数据。筛选住院期间联合使用 VPA 和 MEPM 的患者并将其分配到暴露组，而联合使用 VPA 和其他广谱抗生素的患者则分配到对照组：暴露组和对照组分别包括 50 名和 11 名患者。结果：暴露组和对照组分别有 50 名和 11 名患者，在使用类似剂量的 VPA 时，VPA 的血浆浓度（24.6 ± 4.3 μg/mL）与联合用药前（88.8 ± 13.6 μg/mL，P）相比明显下降：在本研究中，合用 MEPM 导致的 VPA 血浆浓度降低并未影响 VPA 的抗癫痫疗效。对这一结论的解释应谨慎，还需要更多的研究：试验注册：中国临床试验注册中心：ChiCTR2000034567。注册日期：2020年7月10日。

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引用次数: 0

Assessment of Faecal Microbiota Transplant Stability in Deep-Freeze Conditions: A 12-Month Ex Vivo Viability Analysis 粪便微生物群移植在深冷条件下的稳定性评估：为期 12 个月的体外存活率分析

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-03-27 DOI: 10.1002/jcla.25023

Hana Soukupova, Veronika Rehorova, Ivana Cibulkova, Frantisek Duska

Background

Faecal microbiota transplantation (FMT) is an established treatment for Clostridioides difficile infection and is under investigation for other conditions. The availability of suitable donors and the logistics of fresh stool preparation present challenges, making frozen, biobanked stools an attractive alternative.

Aims

This study aimed to evaluate the long-term viability of bacterial populations in faecal samples stored at −80°C for up to 12 months, supporting the feasibility of using frozen grafts for FMT.

Methods

Fifteen faecal samples from nine healthy donors were processed, mixed with cryoprotectants and stored at −80°C. Samples were assessed at baseline and after 3, 6 and 12 months using quantitative culturing methods to determine the concentration of live bacteria.

Results

Quantitative analysis showed no significant decrease in bacterial viability over the 12-month period for both aerobic and anaerobic cultures (p = 0.09). At all timepoints, the coefficients of variability in colony-forming unit (CFU) counts were greater between samples (102 ± 21% and 100 ± 13% for aerobic and anaerobic cultures, respectively) than the variability between measurements of the same sample (30 ± 22% and 30 ± 19%).

Conclusions

The study confirmed that faecal microbiota can be preserved with high viability in deep-freeze storage for up to a year, making allogenic FMT from biobanked samples a viable and safer option for patients. However, a multidonor approach may be beneficial to mitigate the risk of viability loss in any single donor sample.

背景：粪便微生物群移植（FMT）是一种治疗艰难梭菌感染的成熟疗法，目前正在对其他疾病进行研究。目的：本研究旨在评估在零下 80 摄氏度下保存长达 12 个月的粪便样本中细菌群的长期存活率，以支持将冷冻移植物用于 FMT 的可行性：方法：对来自 9 名健康捐献者的 15 份粪便样本进行处理，与低温保护剂混合并保存在 -80°C 温度下。在基线和 3、6 和 12 个月后，使用定量培养方法对样本进行评估，以确定活细菌的浓度：结果：定量分析显示，在 12 个月期间，需氧和厌氧培养物的细菌存活率均无明显下降（p = 0.09）。在所有时间点上，样本间菌落形成单位（CFU）计数的变异系数（需氧培养物和厌氧培养物分别为 102 ± 21% 和 100 ± 13%）均大于同一样本测量值之间的变异系数（30 ± 22% 和 30 ± 19%）：该研究证实，粪便微生物群可在深冻储存中以较高的存活率保存长达一年之久，这使得从生物库样本中提取异基因 FMT 对患者来说是一种可行且更安全的选择。不过，多供体方法可能有利于降低任何单一供体样本活力丧失的风险。

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引用次数: 0

A Systematic Literature Review on the Use of Dried Biofluid Microsampling in Patients With Kidney Disease 关于在肾病患者中使用干生物流体微采样的系统性文献综述。

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-03-25 DOI: 10.1002/jcla.25032

Megan K. Lamond, Andrew J. Chetwynd, Alan D. Salama, Louise Oni

Background

Kidney disease is fairly unique due to the lack of symptoms associated with disease activity, and it is therefore dependent on biological monitoring. Dried biofluids, particularly dried capillary blood spots, are an accessible, easy-to-use technology that have seen increased utility in basic science research over the past decade. However, their use is yet to reach the kidney patient population clinically or in large-scale discovery science initiatives. The aim of this study was to systematically evaluate the existing literature surrounding the use of dried biofluids in kidney research.

Methods

A systematic literature review was conducted using three search engines and a predefined search term strategy. Results were summarised according to the collection method, type of biofluid, application to kidney disease, cost, sample stability and patient acceptability.

Results

In total, 404 studies were identified and 67 were eligible. In total, 34,739 patients were recruited to these studies with a skew towards male participants (> 73%). The majority of samples were blood, which was used either for monitoring anti-rejection immunosuppressive drug concentrations or for kidney function. Dried biofluids offered significant cost savings to the patient and healthcare service. The majority of patients preferred home microsampling when compared to conventional monitoring.

Conclusion

There is an unmet need in bringing dried microsampling technology to advance kidney disease despite its advantages. This technology provides an opportunity to upscale patient recruitment and longitudinal sampling, enhance vein preservation and overcome participation bias in research.

背景：肾脏疾病相当独特，因为缺乏与疾病活动相关的症状，因此需要依赖生物监测。干燥的生物流体，尤其是干燥的毛细血管血斑，是一种方便易用的技术，过去十年来在基础科学研究中的应用越来越广泛。然而，在临床上或在大规模的发现科学计划中，肾脏病人尚未使用这种技术。本研究旨在系统评估有关在肾脏研究中使用干生物液体的现有文献：方法：使用三个搜索引擎和预定义的搜索词策略进行了系统的文献综述。根据收集方法、生物液体类型、肾脏疾病应用、成本、样本稳定性和患者接受度对结果进行了总结：结果：总共确定了 404 项研究，其中 67 项符合条件。这些研究共招募了 34739 名患者，其中男性参与者占多数（超过 73%）。大部分样本为血液，用于监测抗排斥免疫抑制药物浓度或肾功能。干燥的生物液体可为患者和医疗服务节省大量成本。与传统的监测方法相比，大多数患者更倾向于在家中进行微型采样：结论：尽管干燥微采样技术具有诸多优势，但将其应用于肾脏疾病的需求仍未得到满足。这项技术为扩大患者招募和纵向采样、加强静脉保存和克服研究中的参与偏差提供了机会。

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引用次数: 0

Analytical Performance Evaluation of a Digital Real-Time PCR for Quantifying Major BCR::ABL1 Transcripts 用于定量主要 BCR::ABL1 转录本的数字实时 PCR 的分析性能评估。

IF 2.7 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Journal of Clinical Laboratory Analysis

Pub Date : 2024-03-25 DOI: 10.1002/jcla.25034

Soo Jung Lee, Jong-Mi Lee, Ari Ahn, Sung-Eun Lee, Yuna Hong, Gun Dong Lee, Hyun-Woo Song, Min-Sik Song, Seung-Shick Shin, Myungshin Kim, Yonggoo Kim

Background

Accurate quantification of the BCR::ABL1 transcripts is essential for measurable residual disease (MRD) monitoring in chronic myeloid leukemia (CML) after tyrosine kinase inhibitor (TKI) treatment. This study evaluated the newly developed digital real-time PCR method, Dr. PCR, as an alternative reverse transcription-PCR (qRT-PCR) for MRD detection.

Methods

The performance of Dr. PCR was assessed using reference and clinical materials. Precision, linearity, and correlation with qRT-PCR were evaluated. MRD levels detected by Dr. PCR were compared with qRT-PCR, and practical advantages were investigated.

Results

Dr. PCR detected MRD up to 0.0032%^IS (MR4.5) with excellent precision and linearity and showed a strong correlation with qRT-PCR results. Notably, Dr. PCR identified higher levels of MRD in 12.7% (29/229) of patients than qRT-PCR, including six cases of MR4, which is a critical level for TKI discontinuation. Dr. PCR also allowed for sufficient ABL1 copies in all cases, while qRT-PCR necessitated multiple repeat tests in 3.5% (8/229) of cases.

Conclusion

Our study provides a body of evidence supporting the clinical application of Dr. PCR as a rapid and efficient method for assessing MRD in patients with CML under the current treatment regimen.

背景：酪氨酸激酶抑制剂（TKI）治疗后，BCR::ABL1转录本的精确定量对于监测慢性髓性白血病（CML）的可测量残留疾病（MRD）至关重要。本研究评估了新开发的数字实时 PCR 方法 Dr. PCR，将其作为 MRD 检测的反转录-PCR（qRT-PCR）替代方法：PCR的性能进行了评估。方法：使用参考和临床材料对 Dr. PCR 的性能进行了评估，并对其精确度、线性度以及与 qRT-PCR 的相关性进行了评价。将PCR博士检测到的MRD水平与qRT-PCR进行了比较，并对其实际优势进行了研究：结果：PCR 博士检测到的 MRD 高达 0.0032%IS (MR4.5)，精确度和线性度都非常好，而且与 qRT-PCR 结果有很强的相关性。值得注意的是，与 qRT-PCR 相比，PCR 博士在 12.7% 的患者（29/229）中发现了更高水平的 MRD，其中包括 6 例 MR4，而 MR4 是停用 TKI 的关键水平。PCR博士还在所有病例中检测到了足够的ABL1拷贝，而qRT-PCR在3.5%（8/229）的病例中需要多次重复检测：我们的研究为 Dr. PCR 的临床应用提供了大量证据，它是评估当前治疗方案下 CML 患者 MRD 的一种快速有效的方法。

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引用次数: 0