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The neutrophil-lymphocyte ratio to predict poor prognosis of critical acute myocardial infarction patients: a retrospective cohort study. 中性粒细胞-淋巴细胞比值预测急性心肌梗死危重患者预后不良:一项回顾性队列研究。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010702
Wenhui Wang, Linlin Liu, Zhongping Ning, Lin Che, Xinming Li

Introduction: Inflammation is closely related to adverse outcomes of acute myocardial infarction (AMI). This study aimed to evaluate whether neutrophil-lymphocyte ratio (NLR) can predict poor prognosis of critical AMI patients.

Materials and methods: We designed a retrospective cohort study and extracted AMI patients from the "Medical Information Mart for Intensive Care-III" database. The primary outcome was 1-year all-cause mortality. The secondary outcomes were 90-day and in-hospital all-cause mortalities, and acute kidney injury (AKI) incidence. The optimal cut-offs of NLR were picked by X-tile software according to the 1-year mortality and patient groups were created: low-NLR (< 4.8), high-NLR (4.8 - 21.1), and very high-NLR (> 21.1). Cox and modified Poisson regression models were used to evaluate the effect of NLR on outcomes in critically AMI patients.

Results: Finally, 782 critical AMI patients were enrolled in this study, and the 1-year mortality was 32% (249/782). The high- and very high-NLR groups had a higher incidence of outcomes than the low-NLR group (P < 0.05). The multivariate regression analyses found that the high- and very high-NLR groups had a higher risk of 1-year mortality (Hazard ratio (HR) = 1.59, 95% CI: 1.12 to 2.24, P = 0.009 and HR = 1.73, 95% CI: 1.09 to 2.73, P = 0.020), 90-day mortality (HR = 1.69, 95% CI: 1.13 to 2.54, P = 0.011 and HR = 1.90, 95% CI: 1.13 to 3.20, P = 0.016), in-hospital mortality (Relative risk (RR) = 1.77, 95% CI: 1.14 to 2.74, P = 0.010 and RR = 2.10, 95% CI: 1.23 to 3.58, P = 0.007), and AKI incidence (RR = 1.44, 95% CI: 1.06 to 1.95, P = 0.018 and RR = 1.34, 95% CI: 0.87 to 2.07, P = 0.180) compared with low-NLR group. NLR retained stable predictive ability in sensitivity analyses.

Conclusion: Baseline NLR is an independent risk factor for 1-year mortality, 90-day mortality, in-hospital mortality, and AKI incidence in AMI patients.

炎症与急性心肌梗死(AMI)的不良结局密切相关。本研究旨在探讨中性粒细胞-淋巴细胞比值(NLR)能否预测急性心肌梗死危重患者的不良预后。材料和方法:我们设计了一项回顾性队列研究,并从“重症监护医疗信息市场- iii”数据库中提取AMI患者。主要终点为1年全因死亡率。次要结局是90天内和院内全因死亡率,以及急性肾损伤(AKI)发生率。采用X-tile软件根据1年病死率选取NLR的最佳临界值,划分低NLR(< 4.8)、高NLR(4.8 ~ 21.1)、极高NLR(> 21.1)患者组。采用Cox和改良泊松回归模型评估NLR对急性心肌梗死危重患者预后的影响。结果:最终纳入782例AMI危重患者,1年死亡率为32%(249/782)。高nlr组和极高nlr组的预后发生率高于低nlr组(P < 0.05)。多元回归分析发现,高收入和非常high-NLR组1年死亡率的风险更高(风险比(人力资源)= 1.59,95% CI: 1.12 ~ 2.24, P = 0.009和HR = 1.73, 95% CI: 1.09 ~ 2.73, P = 0.020), 90天的死亡率(HR = 1.69, 95% CI: 1.13 ~ 2.54, P = 0.011和HR = 1.90, 95% CI: 1.13 ~ 3.20, P = 0.016),住院死亡率(相对危险度(RR) = 1.77, 95% CI: 1.14 ~ 2.74, P = 0.010和RR = 2.10, 95%置信区间CI:1.23 ~ 3.58, P = 0.007), AKI发生率(RR = 1.44, 95% CI: 1.06 ~ 1.95, P = 0.018, RR = 1.34, 95% CI: 0.87 ~ 2.07, P = 0.180)与低nlr组比较。NLR在敏感性分析中保持稳定的预测能力。结论:基线NLR是AMI患者1年死亡率、90天死亡率、住院死亡率和AKI发生率的独立危险因素。
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引用次数: 2
Detection of macroenzymes: establishing upper reference limits for eight enzymes after polyethylene glycol precipitation. 大酶检测:聚乙二醇沉淀后建立8种酶的上参考值。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010705
Lieselot Dedeene, Marie Stockman, Sophie Steels, Pieter Vermeersch, Glynis Frans

Introduction: The presence of macroenzymes in blood can cause diagnostic confusion. Therefore, confirming the presence of macroenzymes is important to reduce unnecessary (non-)invasive investigations. Polyethylene glycol (PEG) precipitation is a simple and fast first-line method for the detection of macroenzymes. However, there is no consensus on the upper reference limit for the PEG-precipitable activity (%PPA) of monomeric enzymes. The aim of this study was to verify a PEG precipitation protocol for the detection of macroenzymes in our laboratory by establishing upper reference limits (URLs) and determining imprecision for eight enzymes after PEG precipitation. In addition, we aimed to clinically verify the URLs using samples containing macroenzymes as identified by electrophoresis.

Materials and methods: Per enzyme, at least 40 leftover blood samples from adult patients with either normal or increased enzyme activities were diluted 1:1 with 25% PEG 6000 and 1:1 with 0.9% NaCl. Mixtures were incubated for 10 min at 37°C and centrifuged. Supernatant enzyme activity was measured on Cobas c702 and the %PPA was calculated.

Results: The following URLs were obtained: 26% PPA for amylase, 29% PPA for alkaline phosphatase (ALP), 61% PPA for alanine aminotransferase, 48% PPA for aspartate aminotransferase, 24% PPA for creatine kinase (CK), 55% PPA for gamma-glutamyltransferase, 65% PPA for lactate dehydrogenase, and 56% PPA for lipase. The within-lab imprecision was < 15%. Regarding the clinical verification, the two historical samples with proven macroCK showed a %PPA of 69% and 43%, respectively, and a sample with proven macroALP had a %PPA of 52%.

Conclusion: In this study, URLs for monomeric enzyme activities after PEG precipitation for eight different enzymes were established. The URLs are suitable for clinical use, but are only partially in line with other studies. Therefore, our data highlight the importance of establishing laboratory-specific upper reference limits for %PPA to allow a correct interpretation.

血液中巨酶的存在会导致诊断混乱。因此,确认大酶的存在对于减少不必要的(非)侵入性检查是很重要的。聚乙二醇(PEG)沉淀法是一种简便、快速的检测大型酶的一线方法。然而,对于单体酶的聚乙二醇可沉淀活性(%PPA)的参考上限尚无共识。本研究的目的是通过建立PEG沉淀后8种酶的上参考限(url)和测定不精确度,验证我们实验室中用于检测大型酶的PEG沉淀方案。此外,我们的目的是使用电泳鉴定的含有大酶的样品对url进行临床验证。材料和方法:每种酶,至少40份酶活性正常或升高的成年患者剩余血液样本,用25% PEG 6000 1:1稀释,0.9% NaCl 1:1稀释。混合物在37℃下孵育10分钟并离心。测定Cobas c702上清酶活性,计算PPA %。结果:获得了淀粉酶的26% PPA、碱性磷酸酶(ALP)的29% PPA、丙氨酸转氨酶的61% PPA、天冬氨酸转氨酶的48% PPA、肌酸激酶的24% PPA、γ -谷氨酰转移酶的55% PPA、乳酸脱氢酶的65% PPA、脂肪酶的56% PPA。实验室内不精确性< 15%。在临床验证方面,两个经证实的macroCK历史样品的PPA分别为69%和43%,经证实的macroALP样品的PPA为52%。结论:本研究建立了聚乙二醇沉淀后8种不同酶的单体酶活性url。url适合临床使用,但与其他研究只有部分一致。因此,我们的数据强调了建立实验室特定的%PPA上限的重要性,以允许正确的解释。
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引用次数: 0
Association of serum ADMA, SDMA and L-NMMA concentrations with disease progression in COVID-19 patients. 血清ADMA、SDMA和L-NMMA浓度与COVID-19患者疾病进展的关系
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010701
Adnan Haşimi, Özlem Doğan, Ceyhan Ceran Serdar, Muhittin A Serdar

Introduction: This study determines and compares the concentrations of arginine and methylated arginine products ((asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), n-monomethyl-1-arginine (L-NMMA) and homoarginine (HA)) for assessment of their association with disease severity in serum samples of COVID-19 patients.

Materials and methods: Serum arginine and methylated arginine products of 57 mild-moderate and 29 severe (N = 86) COVID-19 patients and 21 controls were determined by tandem mass spectrometry. Moreover, the concentrations of some of the routine clinical laboratory parameters -neutrophil lymphocyte ratio (NLR), C-reactive protein, ferritin, D-dimer, and fibrinogen measured during COVID-19 follow-up were also taken into consideration and compared with the concentrations of arginine and methylated arginine products.

Results: Serum ADMA, SDMA and L-NMMA were found to be significantly higher in severe COVID-19 patients, than in both mild-moderate patients and the control group (P < 0.001 for each). In addition, multiple logistic regression analysis indicated L-NMMA (cut-off =120 nmol/L OR = 34, 95% confidence interval (CI) = 3.5-302.0, P= 0.002), CRP (cut-off = 32 mg/L, OR = 37, 95% CI = 4.8-287.0, P < 0.001), and NLR (cut-off = 7, OR = 22, 95% CI = 1.4-335.0, P = 0.020) as independent risk factors for identification of severe patients.

Conclusions: The concentration of methylated arginine metabolites are significantly altered in COVID-19 disease. The results of this study indicate a significant correlation between the severity of COVID-19 disease and concentrations of CRP, NLR and L-NMMA.

前言:本研究测定并比较了COVID-19患者血清样本中精氨酸和甲基化精氨酸产物(不对称二甲基精氨酸(ADMA)、对称二甲基精氨酸(SDMA)、n-单甲基-1-精氨酸(L-NMMA)和同型精氨酸(HA))的浓度,以评估其与疾病严重程度的相关性。材料与方法:采用串联质谱法测定57例轻中度、29例重度(N = 86) COVID-19患者及21例对照组的血清精氨酸和甲基化精氨酸产物。此外,还考虑了在COVID-19随访期间测量的一些常规临床实验室参数-中性粒细胞淋巴细胞比率(NLR)、c反应蛋白、铁蛋白、d -二聚体和纤维蛋白原的浓度,并与精氨酸和甲基化精氨酸产物的浓度进行了比较。结果:重症患者血清ADMA、SDMA、L-NMMA均显著高于轻、中度患者和对照组(P < 0.001)。此外,多元logistic回归分析显示,L- nmma (cut- cut =120 nmol/L OR = 34, 95%可信区间(CI) = 3.5 ~ 302.0, P= 0.002)、CRP (cut- cut = 32 mg/L OR = 37, 95% CI = 4.8 ~ 287.0, P < 0.001)和NLR (cut- cut = 7, OR = 22, 95% CI = 1.4 ~ 335.0, P= 0.020)是鉴定重症患者的独立危险因素。结论:甲基化精氨酸代谢物浓度在COVID-19疾病中发生显著改变。本研究结果表明,COVID-19疾病严重程度与CRP、NLR和L-NMMA浓度存在显著相关性。
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引用次数: 1
Undefilled blood tube containing EDTA: Is it an inappropriate sample for HbA1c assay? 含EDTA的未灌注血管:是否不适合用于糖化血红蛋白检测?
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010901
Berrak Guven, Ismail Benice, Murat Can

Introduction: Blood samples having inappropriate volume are a substantial part of preanalytical errors. Inadequate sample volume for glycated haemoglobin (HbA1c) test may be a common problem of patients with diabetes mellitus having vascular changes. In this study, we compared HbA1c concentrations of underfilled and appropriately filled blood collection tubes.

Materials and methods: To compare HbA1c concentrations, blood samples were collected into 2 mL tubes containing K3-EDTA from 109 subjects. Two blood samples (underfilled and appropriately filled) were drawn from a patient by the same personnel and materials. HbA1c measurements were assayed on a Cobas 6000 analyser module c 501 (Roche Diagnostics, Mannheim, Germany). The HbA1c% results were compared by t-test and Wilcoxon's signed-rank statistical methods (SPSS Inc., Chicago, USA). Bias analysis was performed using Microsoft Excel 4.0.

Results: Underfilled samples were classified three groups (group 1, N = 44; group 2, N = 36; and group 3, N = 29) according to the filling ratio of the samples; 0.5 mL and below (< 25%), 0.5-1.0 mL (25-50%), and 1.0-2.0 mL (> 50%), respectively. When we compared underfilled tubes with pairing filled tubes, there was a statistically significant difference only with tubes filled less than 25% (P = 0.030). Furthermore, we have done bias analysis between paired tubes according to the diagnostic cut-off value of 6.5%. The bias was more prominent in up to 50% underfilled blood tubes (1.1%), when HbA1c concentrations were below the diagnostic cut-off of 6.5%.

Conclusions: We suggest that the blood tubes with EDTA for HbA1c measurement should be filled with at least 50% to avoid clinical variations.

血液样本容量不合适是分析前错误的重要组成部分。糖化血红蛋白(HbA1c)检测样本量不足可能是伴有血管改变的糖尿病患者的常见问题。在本研究中,我们比较了未充血和充血适当的采集管的HbA1c浓度。材料与方法:为比较HbA1c浓度,109例受试者采集血样至2ml含K3-EDTA管中。由相同的人员和材料从患者身上抽取两份血液样本(未充分填充和适当填充)。HbA1c测量在Cobas 6000分析仪模块c501(罗氏诊断,曼海姆,德国)上进行分析。HbA1c%结果采用t检验和Wilcoxon's signed-rank统计方法(SPSS Inc., Chicago, USA)进行比较。使用Microsoft Excel 4.0进行偏倚分析。结果:未充份标本分为3组(1组,N = 44;第二组,N = 36;第3组,N = 29);0.5 mL及以下(< 25%),0.5-1.0 mL (25-50%), 1.0-2.0 mL(> 50%)。当我们比较未充液管与配对充液管时,只有充液管小于25%时,差异才有统计学意义(P = 0.030)。此外,我们根据6.5%的诊断临界值对配对管进行了偏倚分析。当HbA1c浓度低于6.5%的诊断临界值时,这种偏差在高达50%的未充血管(1.1%)中更为突出。结论:我们建议使用EDTA检测HbA1c的血管应至少填充50%,以避免临床变异。
{"title":"Undefilled blood tube containing EDTA: Is it an inappropriate sample for HbA1c assay?","authors":"Berrak Guven,&nbsp;Ismail Benice,&nbsp;Murat Can","doi":"10.11613/BM.2023.010901","DOIUrl":"https://doi.org/10.11613/BM.2023.010901","url":null,"abstract":"<p><strong>Introduction: </strong>Blood samples having inappropriate volume are a substantial part of preanalytical errors. Inadequate sample volume for glycated haemoglobin (HbA1c) test may be a common problem of patients with diabetes mellitus having vascular changes. In this study, we compared HbA1c concentrations of underfilled and appropriately filled blood collection tubes.</p><p><strong>Materials and methods: </strong>To compare HbA1c concentrations, blood samples were collected into 2 mL tubes containing K3-EDTA from 109 subjects. Two blood samples (underfilled and appropriately filled) were drawn from a patient by the same personnel and materials. HbA1c measurements were assayed on a Cobas 6000 analyser module c 501 (Roche Diagnostics, Mannheim, Germany). The HbA1c% results were compared by t-test and Wilcoxon's signed-rank statistical methods (SPSS Inc., Chicago, USA). Bias analysis was performed using Microsoft Excel 4.0.</p><p><strong>Results: </strong>Underfilled samples were classified three groups (group 1, N = 44; group 2, N = 36; and group 3, N = 29) according to the filling ratio of the samples; 0.5 mL and below (< 25%), 0.5-1.0 mL (25-50%), and 1.0-2.0 mL (> 50%), respectively. When we compared underfilled tubes with pairing filled tubes, there was a statistically significant difference only with tubes filled less than 25% (P = 0.030). Furthermore, we have done bias analysis between paired tubes according to the diagnostic cut-off value of 6.5%. The bias was more prominent in up to 50% underfilled blood tubes (1.1%), when HbA1c concentrations were below the diagnostic cut-off of 6.5%.</p><p><strong>Conclusions: </strong>We suggest that the blood tubes with EDTA for HbA1c measurement should be filled with at least 50% to avoid clinical variations.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010901"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9927728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9663357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Reversible atransferrinemia in a patient with chronic enteropathy: is transferrin mandatory for iron transport? 慢性肠病患者可逆转铁蛋白血症:转铁蛋白是铁运输必需的吗?
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010801
Alexandre Raynor, Carmen Stefanescu, Arnaud Bruneel, Hervé Puy, Katell Peoc'h, Hana Manceau

Herein, we report the case of a 42-year-old woman, hospitalized in a French tertiary hospital for a relapse of a chronic enteropathy, who was found on admission to have no detectable serum transferrin. Surprisingly, she only exhibited mild anaemia. This atransferrinemia persisted for two months throughout her hospitalization, during which her haemoglobin concentration remained broadly stable. Based on her clinical history and evolution, we concluded to an acquired atransferrinemia secondary to chronic undernutrition, inflammation and liver failure. We discuss the investigations performed in this patient, and hypotheses regarding the relative stability of her haemoglobin concentration despite the absence of detectable transferrin.

在此,我们报告一名42岁的女性,在法国三级医院住院治疗慢性肠病复发,入院时发现血清转铁蛋白未检出。令人惊讶的是,她只表现出轻度贫血。这种转移铁血症在住院期间持续了两个月,在此期间她的血红蛋白浓度基本保持稳定。根据她的临床病史和病情发展,我们认为她是继发于慢性营养不良、炎症和肝功能衰竭的获得性转铁蛋白血症。我们讨论了在该患者中进行的调查,以及关于她的血红蛋白浓度相对稳定性的假设,尽管没有检测到转铁蛋白。
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引用次数: 1
Reference intervals for thyroid disorders calculated by indirect method and comparison with reference change values. 采用间接法计算甲状腺疾病的参考区间,并与参考变化值进行比较。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010704
Zeynep Yildiz, Lale Köroğlu Dağdelen

Introduction: The aim of the study was to calculate reference intervals (RIs) for thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) and evaluate the clinical significance of these intervals by use of reference change values (RCV) of the analytes.

Materials and methods: Laboratory patient data between August and December 2021 were evaluated for the study. A total of 188,912 patients with TSH, fT4, fT3, anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-Tg) results were evaluated. All measurements were performed on Cobas c801 (Roche Diagnostics, Penzberg, Germany) using electrochemiluminescence immunoassay technology. Estimated RIs were compared with manufacturer's by means of RCVs of analytes.

Results: Thyroid stimulating hormone values didn't differ significantly by gender and age. The combined RIs for whole group (N = 28,437) was found as 0.41-4.37 mIU/mL. Free T4 values (11.6-20.1 pmol/L, N = 13,479 in male; 10.5-19.5 pmol/L, N = 17,634 female) and fT3 values (3.38-6.35 pmol/L, N = 2,516 in male; 3.39-5.99 pmol/L, N = 3,348 pmol/L in female) significantly differed by gender (P < 0.050). Both fT4 and fT3 values also showed significant differences in age subgroups comparisons. So, male and female RIs were represented separately for age subgroups. When compared with manufacturer's RIs, TSH whole group and fT4 subgroups RIs didn't exceed the analytes' RCVs, but this difference was greater for fT3.

Conclusions: Reference interval estimation by use of indirect method out of laboratory data may be more accurate than manufacturer provided RIs. This population based RIs evaluated using RCV of analytes may provide useful information in clinical interpretation of laboratory results.

本研究的目的是计算促甲状腺激素(TSH)、游离甲状腺素(fT4)和游离三碘甲状腺原氨酸(fT3)的参考区间(RIs),并利用分析物的参考变化值(RCV)评价这些区间的临床意义。材料和方法:对2021年8月至12月的实验室患者数据进行评估。共评价188,912例患者TSH、fT4、fT3、抗甲状腺过氧化物酶抗体(Anti-TPO)和抗甲状腺球蛋白抗体(Anti-Tg)结果。所有测量均采用电化学发光免疫分析技术在Cobas c801 (Roche Diagnostics, Penzberg, Germany)上进行。通过分析物的rcv将估计的RIs与制造商的RIs进行比较。结果:促甲状腺激素值在性别、年龄上无显著差异。全组(N = 28,437)的综合RIs为0.41 ~ 4.37 mIU/mL。游离T4值(11.6 ~ 20.1 pmol/L, N = 13,479);10.5 ~ 19.5 pmol/L,女性N = 17,634)和fT3值(3.38 ~ 6.35 pmol/L,男性N = 2,516;3.39 ~ 5.99 pmol/L,女性N = 3348 pmol/L),性别差异显著(P < 0.050)。fT4和fT3值在年龄亚组比较中也显示出显著差异。因此,男性和女性RIs分别代表年龄亚组。与制造商的RIs相比,TSH全组和fT4亚组的RIs没有超过分析者的rcv,但fT3的差异更大。结论:利用实验室数据外的间接方法估计参考区间可能比制造商提供的RIs更准确。使用分析物的RCV评估基于人群的RIs可能为实验室结果的临床解释提供有用的信息。
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引用次数: 1
Utility of serum indices in a particular case of serum protein electrophoresis. 血清指标在血清蛋白电泳的特殊情况下的应用。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-10-01 Epub Date: 2022-08-05 DOI: 10.11613/BM.2022.030802
Massimo Daves, Andrea Piccin, Cristina Vicidomini, Antonia De Luisi, Andrea Mega

Screening and measurement of monoclonal (M) proteins are commonly performed using capillary zone electrophoresis (CZE). The identification of M-protein or monoclonal component (CM) is an essential requirement for diagnosis and monitoring of monoclonal gammopathies. The detection of CM has been largely improved by CZE. Capillary electrophoresis estimates CM more accurately, because absence of variation due to different dye binding affinities of proteins as instead seen with agarose gel electrophoresis. However, interferences can be present in CZE. This occurs because all substances absorbing at 200 nm can be identified. Recognition and handling of specimens exhibiting such interferences is essential to ensure accurate diagnostic and patient safety. We herein report on an unusual case of serum protein electrophoresis, to highlight that laboratory staff must be aware of and familiarise with the information provided by laboratory instruments. For example, in the case of serum indices, about specimen quality.

单克隆(M)蛋白的筛选和测定通常使用毛细管区带电泳(CZE)进行。m蛋白或单克隆成分(CM)的鉴定是单克隆伽玛病诊断和监测的基本要求。CZE大大提高了CM的检出率。毛细管电泳更准确地估计CM,因为不像琼脂糖凝胶电泳那样,由于蛋白质的不同染料结合亲和力而发生变化。然而,干扰可能存在于CZE中。这是因为所有在200nm吸收的物质都能被识别出来。识别和处理显示此类干扰的标本对于确保准确诊断和患者安全至关重要。我们在此报告一个不寻常的血清蛋白电泳病例,以强调实验室工作人员必须了解和熟悉实验室仪器提供的信息。例如,在血清指数的情况下,关于标本质量。
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引用次数: 0
A practical approach example to measurement uncertainty: Evaluation of 26 immunoassay parameters. 测量不确定度的实用方法示例:26个免疫测定参数的评估。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-10-01 Epub Date: 2022-08-05 DOI: 10.11613/BM.2022.030705
Rabia Tan, Mustafa Yilmaz, Yusuf Kurtulmuş

Introduction: Measurement uncertainty is a non-negative parameter that characterizes the distribution of all values appropriate to the measured size and is associated with the measured result. In this study, we aimed to compare the results with various suggestions and produce more qualified results by calculating the measurement uncertainties of the immunoassays like fertility hormones, drug concentration tests, cardiac markers, thyroid function tests and tumour markers.

Materials and methods: Uncertainty calculation was made in accordance with the top-down approach according to Nordtest guide. The 12-month study of internal and external quality assessment results were used. The parameters of drug concentration tests were performed on the Abbott Architect c8000, other hormones/markers on the i2000 of the same brand.

Results: Factors that increased the measurement uncertainty of a test were due to external quality control data. The calculations showed that 13 of 26 parameters satisfied quality requirements. The highest uncertainty value, with 28% belonged to cancer antigen 19-9 test. The lowest value was calculated for prolactin with 8.3%. Dehydroepiandrosterone sulfate and phenytoin performed poorly in terms of measurement uncertainty, although internal and external quality control assessment results were considered favourable for both.

Conclusion: It is recommended that the concept of measurement uncertainty, which plays an important role in the total quality performance of the laboratory, should be followed up by the clinical laboratory experts at certain time intervals and should be increased the awareness of clinicians about the subject.

测量不确定度是一个非负参数,表征所有值与测量尺寸相适应的分布,并与测量结果相关联。在本研究中,我们旨在通过计算生育激素、药物浓度、心脏标志物、甲状腺功能试验和肿瘤标志物等免疫测定的测量不确定度,将结果与各种建议进行比较,得出更合格的结果。材料与方法:根据Nordtest指南,采用自顶向下的方法进行不确定度计算。采用为期12个月的内外部质量评价研究结果。在雅培Architect c8000上进行药物浓度参数测试,在同一品牌的i2000上进行其他激素/标记物测试。结果:增加试验测量不确定度的因素是由于外部质量控制数据。计算结果表明,26个参数中有13个满足质量要求。不确定度值最高,28%属于癌抗原19-9检测。催乳素最低,为8.3%。脱氢表雄酮硫酸盐和苯妥英在测量不确定度方面表现不佳,尽管内部和外部质量控制评估结果都被认为是有利的。结论:建议临床实验室专家每隔一定时间对测量不确定度的概念进行随访,并提高临床医生对该主题的认识,因为测量不确定度对实验室的整体质量表现起着重要作用。
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引用次数: 1
Urinary brain-derived neurotrophic factor and nerve growth factor as noninvasive biomarkers of overactive bladder in children. 尿脑源性神经营养因子和神经生长因子作为儿童膀胱过度活动的无创生物标志物。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-10-01 DOI: 10.11613/BM.2022.030706
Merima Colic, Dunja Rogic, Jasna Lenicek Krleza, Ana Kozmar, Lorna Stemberger Maric, Slaven Abdovic

Introduction: Overactive bladder (OAB) is the most common urinary disorder and the leading cause of functional daytime intermittent urinary incontinence in children. The aim of this study was to determine whether urinary brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) concentrations, normalized to urine creatinine, could be used as biomarkers for diagnosis and treatment monitoring of OAB in children.

Materials and methods: Urine samples of 48 pediatric patients with OAB were collected at the start of anticholinergic therapy (baseline), at follow-up visits (3 and 6 months), and from 48 healthy controls. Urinary BDNF and NGF concentrations were determined by ELISA method (Merck, Darmstadt, Germany) and Luminex method (Thermo Fisher Scientific, Waltham, USA). Differences of frequency between quantifiable analyte concentrations between subject groups were determined using Fisher's exact test.

Results: There was no statistically significant difference between quantifiable analyte concentrations between patients at baseline and the control group for BDNF and NGF by either the ELISA or Luminex method (P = 1.000, P = 0.170, P = 1.000, and P = N/A, respectively). There was a statistically significant difference between quantifiable BDNF by the ELISA method between patients at baseline and complete success follow-up (P = 0.027), while BDNF by Luminex method and NGF by both methods were not statistically significant (P = 0.078, P = 0.519, and P = N/A, respectively).

Conclusions: This study did not demonstrate that urinary BDNF and NGF concentrations, can be used as biomarkers for diagnosis and therapy monitoring of OAB in children.

膀胱过动症(OAB)是最常见的泌尿系统疾病,也是儿童日间功能性间歇性尿失禁的主要原因。本研究的目的是确定尿脑源性神经营养因子(BDNF)和神经生长因子(NGF)浓度与尿肌酐归一化是否可以作为儿童OAB诊断和治疗监测的生物标志物。材料和方法:收集48例OAB患儿在抗胆碱能治疗开始(基线)、随访(3个月和6个月)和48例健康对照者的尿液样本。采用ELISA法(Merck, Darmstadt, Germany)和Luminex法(Thermo Fisher Scientific, Waltham, USA)测定尿液BDNF和NGF浓度。使用Fisher精确检验确定受试者组间可量化分析物浓度之间的频率差异。结果:ELISA法和Luminex法测定基线时患者BDNF和NGF可量化分析物浓度与对照组比较,差异均无统计学意义(P = 1.000, P = 0.170, P = 1.000, P = N/A)。基线时和完全成功随访时,ELISA法可量化BDNF差异有统计学意义(P = 0.027),而Luminex法BDNF和两种方法的NGF均无统计学意义(P = 0.078, P = 0.519, P = N/ a)。结论:本研究并未证明尿BDNF和NGF浓度可作为儿童OAB诊断和治疗监测的生物标志物。
{"title":"Urinary brain-derived neurotrophic factor and nerve growth factor as noninvasive biomarkers of overactive bladder in children.","authors":"Merima Colic,&nbsp;Dunja Rogic,&nbsp;Jasna Lenicek Krleza,&nbsp;Ana Kozmar,&nbsp;Lorna Stemberger Maric,&nbsp;Slaven Abdovic","doi":"10.11613/BM.2022.030706","DOIUrl":"https://doi.org/10.11613/BM.2022.030706","url":null,"abstract":"<p><strong>Introduction: </strong>Overactive bladder (OAB) is the most common urinary disorder and the leading cause of functional daytime intermittent urinary incontinence in children. The aim of this study was to determine whether urinary brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) concentrations, normalized to urine creatinine, could be used as biomarkers for diagnosis and treatment monitoring of OAB in children.</p><p><strong>Materials and methods: </strong>Urine samples of 48 pediatric patients with OAB were collected at the start of anticholinergic therapy (baseline), at follow-up visits (3 and 6 months), and from 48 healthy controls. Urinary BDNF and NGF concentrations were determined by ELISA method (Merck, Darmstadt, Germany) and Luminex method (Thermo Fisher Scientific, Waltham, USA). Differences of frequency between quantifiable analyte concentrations between subject groups were determined using Fisher's exact test.</p><p><strong>Results: </strong>There was no statistically significant difference between quantifiable analyte concentrations between patients at baseline and the control group for BDNF and NGF by either the ELISA or Luminex method (P = 1.000, P = 0.170, P = 1.000, and P = N/A, respectively). There was a statistically significant difference between quantifiable BDNF by the ELISA method between patients at baseline and complete success follow-up (P = 0.027), while BDNF by Luminex method and NGF by both methods were not statistically significant (P = 0.078, P = 0.519, and P = N/A, respectively).</p><p><strong>Conclusions: </strong>This study did not demonstrate that urinary BDNF and NGF concentrations, can be used as biomarkers for diagnosis and therapy monitoring of OAB in children.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"32 3","pages":"030706"},"PeriodicalIF":3.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9562800/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9647504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Inter-rater reliability assessment for the new-born screening quality assurance. 新生儿筛查质量保证的评分者间信度评估。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2022-10-01 DOI: 10.11613/BM.2022.030901
Leonor Guiñón, Anna Soler, Rosa María López, Sonia Pajares, José Manuel González de Aledo, Ana Argudo-Ramírez, José Luis Marín, Judit García-Villoria, Ángeles Sahuquillo, Luisa Alvarez

Introduction: To ensure the quality of the new-born screening (NBS), our laboratory reviewed the analytical procedure to detect subjective steps that may represent a risk to the patient. Two subjective activities were identified in the extra-analytical phases: the classification of dried blood spots (DBS) according to their quality and the assignment of haemoglobin patterns. To keep these activities under control, inter-rater studies were implemented. This study aimed to evaluate the inter-rater reliability and the effectiveness of the measures taken to improve the agreement between observers, to assure NBS results' quality.

Materials and methods: Dried blood spots specimens were used for the inter-rater studies. Ten studies were performed to assess DBS quality classification, and four to assess the assignment of haemoglobin patterns. Krippendorff's alpha test was used to estimate inter-rater reliability. Causes were investigated when alpha values were below 0.80.

Results: For both activities, the reliability obtained in the first studies was inadequate. After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart's haemoglobin depending on its percentage. Alpha estimates became higher once the training was reinforced and a consensus about the appropriate criteria to be applied was reached.

Conclusion: Inter-rater reliability assessment helped us to ensure the quality of subjective activities that could add variability to NBS results. Furthermore, the evolution of the alpha value over time allowed us to verify the effectiveness of the measures adopted.

为了确保新生儿筛查(NBS)的质量,我们的实验室审查了分析程序,以检测可能对患者构成风险的主观步骤。在分析外阶段确定了两个主观活动:根据其质量对干血斑(DBS)进行分类和分配血红蛋白模式。为了控制这些活动,进行了评价者之间的研究。本研究旨在评估评估者之间的信度和所采取的措施的有效性,以提高观察者之间的一致性,以确保国家统计局结果的质量。材料与方法:采用干燥血斑标本进行鼠间研究。10项研究用于评估DBS质量分类,4项研究用于评估血红蛋白模式的分配。使用Krippendorff的alpha检验来估计评估者之间的信度。当alpha值低于0.80时,调查原因。结果:对于这两种活动,在第一次研究中获得的可靠性是不足的。经过调查,我们发现将DBS分类为缺乏的标准没有得到巩固,并且在是否根据其百分比报告Bart血红蛋白方面缺乏共识。一旦训练得到加强,并就适用的适当标准达成一致意见,阿尔法估计就会更高。结论:评分者间信度评估有助于我们确保主观活动的质量,从而增加NBS结果的可变性。此外,alpha值随时间的演变使我们能够验证所采用措施的有效性。
{"title":"Inter-rater reliability assessment for the new-born screening quality assurance.","authors":"Leonor Guiñón,&nbsp;Anna Soler,&nbsp;Rosa María López,&nbsp;Sonia Pajares,&nbsp;José Manuel González de Aledo,&nbsp;Ana Argudo-Ramírez,&nbsp;José Luis Marín,&nbsp;Judit García-Villoria,&nbsp;Ángeles Sahuquillo,&nbsp;Luisa Alvarez","doi":"10.11613/BM.2022.030901","DOIUrl":"https://doi.org/10.11613/BM.2022.030901","url":null,"abstract":"<p><strong>Introduction: </strong>To ensure the quality of the new-born screening (NBS), our laboratory reviewed the analytical procedure to detect subjective steps that may represent a risk to the patient. Two subjective activities were identified in the extra-analytical phases: the classification of dried blood spots (DBS) according to their quality and the assignment of haemoglobin patterns. To keep these activities under control, inter-rater studies were implemented. This study aimed to evaluate the inter-rater reliability and the effectiveness of the measures taken to improve the agreement between observers, to assure NBS results' quality.</p><p><strong>Materials and methods: </strong>Dried blood spots specimens were used for the inter-rater studies. Ten studies were performed to assess DBS quality classification, and four to assess the assignment of haemoglobin patterns. Krippendorff's alpha test was used to estimate inter-rater reliability. Causes were investigated when alpha values were below 0.80.</p><p><strong>Results: </strong>For both activities, the reliability obtained in the first studies was inadequate. After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart's haemoglobin depending on its percentage. Alpha estimates became higher once the training was reinforced and a consensus about the appropriate criteria to be applied was reached.</p><p><strong>Conclusion: </strong>Inter-rater reliability assessment helped us to ensure the quality of subjective activities that could add variability to NBS results. Furthermore, the evolution of the alpha value over time allowed us to verify the effectiveness of the measures adopted.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"32 3","pages":"030901"},"PeriodicalIF":3.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9284079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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: 2
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Biochemia Medica
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