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Practical application of the patient data-based quality control method: the potassium example. 基于患者数据的质量控制方法的实际应用:以钾为例。
Pub Date : 2024-02-15 DOI: 10.11613/BM.2024.010901
Yan Zhang, Hua-Li Wang, Ye-Hong Xie, Da-Hai He, Chao-Qiong Zhou, Li-Rui Kong

Introduction: Internal quality control (IQC) is a core pillar of laboratory quality control strategies. Internal quality control commercial materials lack the same characteristics as patient samples and IQC contributes to the costs of laboratory testing. Patient data-based quality control (PDB-QC) may be a valuable supplement to IQC; the smaller the biological variation, the stronger the ability to detect errors. Using the potassium concentration in serum as an example study compared error detection effectiveness between PDB-QC and IQC.

Materials and methods: Serum potassium concentrations were measured by using an indirect ion-selective electrode method. For the training database, 23,772 patient-generated data and 366 IQC data from April 2022 to September 2022 were used; 15,351 patient-generated data and 246 IQC data from October 2022 to January 2023 were used as the testing database. For both PDB-QC and IQC, average values and standard deviations were calculated, and z-score charts were plotted for comparison purposes.

Results: Five systematic and three random errors were detected using IQC. Nine systematic errors but no random errors were detected in PDB-QC. The PDB-QC showed systematic error warnings earlier than the IQC.

Conclusions: The daily average value of patient-generated data was superior to IQC in terms of the efficiency and timeliness of detecting systematic errors but inferior to IQC in detecting random errors.

简介:内部质量控制(IQC)是实验室质量控制战略的核心支柱:内部质量控制(IQC)是实验室质量控制战略的核心支柱。内部质量控制的商业材料缺乏与患者样本相同的特性,因此 IQC 增加了实验室检测的成本。基于患者数据的质量控制(PDB-QC)可能是 IQC 的重要补充;生物变异越小,发现错误的能力就越强。研究以血清中的钾浓度为例,比较了 PDB-QC 和 IQC 的错误检测效果:使用间接离子选择电极法测定血清钾浓度。在训练数据库中,使用了 2022 年 4 月至 2022 年 9 月的 23772 个患者生成的数据和 366 个 IQC 数据;在测试数据库中,使用了 2022 年 10 月至 2023 年 1 月的 15351 个患者生成的数据和 246 个 IQC 数据。计算了PDB-QC和IQC的平均值和标准偏差,并绘制了z-分数图进行比较:结果:使用 IQC 检测出了 5 个系统误差和 3 个随机误差。PDB-QC 检测出 9 个系统误差,但没有随机误差。PDB-QC 比 IQC 更早显示出系统误差警告:患者生成数据的日平均值在检测系统性错误的效率和及时性方面优于 IQC,但在检测随机错误方面则逊于 IQC。
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引用次数: 0
The nuclear factor erythroid 2-related factor 2/p53 axis in breast cancer. 核因子红细胞2型相关因子2/p53轴在癌症中的表达。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030504
Lei Xia, Wenbiao Ma, Ahmad Afrashteh, Mir Amirhossein Sajadi, Hadi Fakheri, Mohammad Valilo

One of the most important factors involved in the response to oxidative stress (OS) is the nuclear factor erythroid 2-related factor 2 (Nrf2), which regulates the expression of components such as antioxidative stress proteins and enzymes. Under normal conditions, Kelch-like ECH-associated protein 1 (Keap1) keeps Nrf2 in the cytoplasm, thus preventing its translocation to the nucleus and inhibiting its role. It has been established that Nrf2 has a dual function; on the one hand, it promotes angiogenesis and cancer cell metastasis while causing resistance to drugs and chemotherapy. On the other hand, Nrf2 increases expression and proliferation of glutathione to protect cells against OS. p53 is a tumour suppressor that activates the apoptosis pathway in aging and cancer cells in addition to stimulating the glutaminolysis and antioxidant pathways. Cancer cells use the antioxidant ability of p53 against OS. Therefore, in the present study, we discussed function of Nrf2 and p53 in breast cancer (BC) cells to elucidate their role in protection or destruction of cancer cells as well as their drug resistance or antioxidant properties.

参与氧化应激反应的最重要因素之一是核因子红系2相关因子2(Nrf2),它调节抗氧化应激蛋白和酶等成分的表达。在正常条件下,Kelch样ECH相关蛋白1(Keap1)将Nrf2保持在细胞质中,从而阻止其易位到细胞核并抑制其作用。已经证实Nrf2具有双重功能;一方面,它促进血管生成和癌症细胞转移,同时引起对药物和化疗的耐药性。另一方面,Nrf2增加谷胱甘肽的表达和增殖,以保护细胞免受OS的侵害。p53是一种肿瘤抑制因子,除了刺激谷氨酸解和抗氧化途径外,它还能激活衰老和癌症细胞的凋亡途径。癌症细胞利用p53对OS的抗氧化能力。因此,在本研究中,我们讨论了Nrf2和p53在癌症(BC)细胞中的功能,以阐明它们在保护或破坏癌症细胞中的作用以及它们的耐药性或抗氧化特性。
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引用次数: 0
Establishment of age- and -gender specific reference intervals for amino acids and acylcarnitines by tandem mass spectrometry in Turkish paediatric population. 通过串联质谱法在土耳其儿科人群中建立氨基酸和酰基肉毒碱的年龄和性别特异性参考区间。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030704
Özlem Çakır Madenci, Soner Erdin, Ayşe Kestane, Müge Kutnu

Introduction: We determined age- and gender-specific reference intervals (RIs) for acylcarnitines and amino acids by tandem mass spectrometry (MS/MS) in the Turkish paediatric population by using laboratory information system (LIS) data.

Materials and methods: A total of 9156 MS/MS results of children between 0-18 years of age, were downloaded from the LIS. Premature infants and newborns followed in the intensive care unit were excluded and only the first result of each patient attending outpatient clinics was included. Children with a known or suspected diagnosis of metabolic disease, malignancy, epilepsy, mental retardation, or genetic disorder were excluded. Laboratory results were evaluated and children with any pathological laboratory finding were excluded, resulting in a final sample size of 3357 (2029 boys and 1328 girls). Blood was collected by capillary puncture and spotted on Whatman 903 filter paper cards and analysed by MS/MS (Shimadzu LCMS-8050, Shimadzu Corporation, Kyoto, Japan). Data were evaluated for age and gender differences and age partitioning was performed according to the literature and visual evaluation of the data. Age subgroups were: ≤ 1 month, 2 months-1 year, 2-5 years, 6-10 years, and 11-18 years.

Results: There were significant age-related differences for the majority of amino acids and acylcarnitines thus age dependent RIs were established. Gender-specific RIs were established for tyrosine, leucine-isoleucine, isovalerylcarnitine (C5) and hexadecanoylcarnitine (C16).

Conclusions: Establishing age-related RIs can enhance the quality of medical care by facilitating early diagnosis and therapy, especially in certain metabolic disorders presenting with mild biochemical abnormalities and subtle clinical manifestations.

引言:我们使用实验室信息系统(LIS)数据,通过串联质谱法(MS/MS)在土耳其儿科人群中确定了酰基肉毒碱和氨基酸的年龄和性别特异性参考区间(RIs)。材料和方法:从LIS下载0~18岁儿童的9156份MS/MS结果。在重症监护室随访的早产儿和新生儿被排除在外,只包括每个门诊患者的第一个结果。排除已知或疑似诊断为代谢性疾病、恶性肿瘤、癫痫、智力迟钝或遗传性疾病的儿童。对实验室结果进行了评估,排除了有任何病理实验室发现的儿童,最终样本量为3357人(2029名男孩和1328名女孩)。通过毛细管穿刺收集血液,并在Whatman 903滤纸卡上进行斑点,并通过MS/MS(Shimadzu LCMS-8050,ShimadzuCorporation,Kyoto,Japan)进行分析。评估数据的年龄和性别差异,并根据文献和数据的视觉评估进行年龄划分。年龄亚组为:≤1个月、2个月-1年、2-5年、6-10年和11-18年。结果:大多数氨基酸和酰基肉毒碱存在显著的年龄相关性差异,因此建立了年龄依赖性RIs。针对酪氨酸、亮氨酸-异亮氨酸、异戊酰基肉碱(C5)和十六烷酰基肉碱(C16)建立了性别特异性RIs。结论:建立与年龄相关的RIs可以通过促进早期诊断和治疗来提高医疗质量,尤其是在某些表现为轻度生化异常和细微临床表现的代谢紊乱中。
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引用次数: 0
Association of smoking cigarettes, age, and sex with serum concentrations of olanzapine in patients with schizophrenia. 精神分裂症患者吸烟、年龄和性别与血清奥氮平浓度的关系。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030702
Mihovil Horvat, Mate Kadija, Andrijana Ščavničar, Maja Živković, Marina Šagud, Mila Lovrić

Introduction: Olanzapine is an atypical antipsychotic drug which is effective in the treatment of schizophrenia. Cigarette smoking, age, and sex could be related to the pharmacokinetics and serum concentrations of olanzapine in patients with schizophrenia. The aim of the study was to examine whether there was a significant difference in the serum olanzapine concentrations with regard to the mentioned factors.

Materials and methods: A total of 58 outpatients with schizophrenia (37 smokers, 42 men, 35 older than 40 years) participated in the study. Blood was sampled in serum tubes just before taking the next dose of olanzapine. Olanzapine was extracted by liquid-liquid extraction and was measured by an in-house high-performance liquid chromatography method on Shimadzu Prominence HPLC System with diode array detector SPD-M20A (Shimadzu, Kyoto, Japan). The results were expressed as the ratio of concentration to the daily dose of olanzapine (C/D). Non-parametric statistical tests were used to analyse differences between variables.

Results: The median C/D of olanzapine (interquartile range) in smokers was 6.0 (3.4-10.2) nmol/L/mg and in non-smokers 10.1 (5.9-17.6) nmol/L/mg; P = 0.007. The median C/D of olanzapine in patients younger than 40 years was 5.6 (4.5-10.2) nmol/L/mg and in patients older than 40 years 8.4 (5.6-13.0) nmol/L/mg; P = 0.105. The median C/D of olanzapine in male patients was 6.6 (4.6-10.4) nmol/L/mg and in female patients 9.0 (5.9-15.3) nmol/L/mg; P = 0.064.

Conclusions: The serum olanzapine concentration was significantly lower in smoking than in non-smoking patients with schizophrenia. No significant difference was demonstrated with regard to age and sex.

奥氮平是一种非典型抗精神病药物,可有效治疗精神分裂症。精神分裂症患者的吸烟、年龄和性别可能与奥氮平的药代动力学和血清浓度有关。本研究的目的是检查血清奥氮平浓度是否与上述因素存在显著差异。材料和方法:共有58名门诊精神分裂症患者(37名吸烟者,42名男性,35名40岁以上)参与了这项研究。在服用下一剂奥氮平之前,在血清管中进行血液采样。奥氮平通过液-液萃取进行提取,并通过内部高效液相色谱法在岛津Prominence HPLC系统上使用二极管阵列检测器SPD-M20A(岛津,京都,日本)进行测量。结果表示为奥氮平的浓度与每日剂量的比率(C/D)。使用非参数统计检验来分析变量之间的差异。结果:吸烟者奥氮平的中位C/D(四分位间距)为6.0(3.4-10.2)nmol/L/mg,非吸烟者为10.1(5.9-17.6)nmol/L/min;P=0.007。40岁以下患者奥氮平的中位C/D为5.6(4.5-10.2)nmol/L/mg,40岁以上患者为8.4(5.6-13.0)nmol/L/min;P=0.105。奥氮平在男性患者中的中位C/D为6.6(4.6-10.4)nmol/L/mg,在女性患者中为9.0(5.9-15.3)nmol/L/min;P=0.064。结论:吸烟组精神分裂症患者血清奥氮平浓度明显低于非吸烟组。年龄和性别方面没有显著差异。
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引用次数: 0
Clinical importance of serum and pleural fluid prominin-1 and hypoxia-inducible factor-1α concentration in the evaluation of lymph node involvement in patients with malignant pleural effusion. 血清和胸水促肽-1和缺氧诱导因子-1α浓度在评估恶性胸腔积液患者淋巴结受累中的临床意义。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030701
Zeliha Cansel Ozmen, Mustafa Kupeli

Introduction: Malignant pleural effusion (MPE) and lymph node metastasis (LNM) presence are poor prognostic factors that have importance for cancer patients. The study objective was to determine whether hypoxia-inducible factor-1α (HIF-1α) and prominin-1 (CD133) in pleural fluid (P) and serum (S) could be used as biomarkers for diagnosis of lymph node involvement in patients with MPE.

Materials and methods: Fifty-six patients with MPE and 30 healthy control subjects were included. Computerized tomography (CT) and positron emission tomography (PET) were used to diagnose pleural effusion. Patients with malignant cells in pleural fluid cytological examination were included in the MPE group. Thirty-five patients with lymph node metastases on CT were included in the LNM-positive MPE group. Serum and pleural fluid HIF-1α and CD-133 concentrations were measured manually via enzyme-linked immunosorbent assay (ELISA).

Results: Serum concentrations of HIF-1α and CD133 were higher in MPE patients. It was found that CD133/HIF-1α (S) ratio was higher in the malignant patient group with positive lymph node involvement than in the negative group, while concentrations of HIF-1α (P) were lower. Pleural fluid HIF-1α and CD133/HIF-1α (S) ratio had sufficient performance in diagnosing lymphatic metastases in patients with MPE (AUC = 0.90 and 0.83, respectively).

Conclusions: In conclusion, serum HIF-1α and CD133 concentrations were higher in patients with MPE, consistent with our hypothesis. Concentrations of HIF-1α (P) and CD133/HIF-1α (S) ratio can be used as biomarkers in diagnosing lymph node involvement in MPE patients, according to this experiment.

简介:恶性胸腔积液(MPE)和淋巴结转移(LNM)是预后不良的因素,对癌症患者具有重要意义。本研究的目的是确定胸水(P)和血清(S)中的缺氧诱导因子-1α(HIF-1α)和促敏素-1(CD133)是否可以作为诊断MPE患者淋巴结受累的生物标志物。材料和方法:56名MPE患者和30名健康对照受试者。应用计算机断层扫描(CT)和正电子发射断层扫描(PET)对胸腔积液进行诊断。在胸水细胞学检查中有恶性细胞的患者被纳入MPE组。35名CT上有淋巴结转移的患者被纳入LNM阳性MPE组。采用酶联免疫吸附法(ELISA)测定MPE患者血清和胸水HIF-1α和CD133的浓度。结果发现,淋巴结转移阳性的恶性患者组CD133/HIF-1α(S)比值高于淋巴结转移阴性组,而HIF-1α浓度较低。胸水HIF-1α和CD133/HIF-1α(S)比值对MPE患者的淋巴结转移有足够的诊断作用(AUC=0.90和0.83)。根据本实验,HIF-1α(P)和CD133/HIF-1α比率的浓度可作为诊断MPE患者淋巴结受累的生物标志物。
{"title":"Clinical importance of serum and pleural fluid prominin-1 and hypoxia-inducible factor-1α concentration in the evaluation of lymph node involvement in patients with malignant pleural effusion.","authors":"Zeliha Cansel Ozmen,&nbsp;Mustafa Kupeli","doi":"10.11613/BM.2023.030701","DOIUrl":"10.11613/BM.2023.030701","url":null,"abstract":"<p><strong>Introduction: </strong>Malignant pleural effusion (MPE) and lymph node metastasis (LNM) presence are poor prognostic factors that have importance for cancer patients. The study objective was to determine whether hypoxia-inducible factor-1α (HIF-1α) and prominin-1 (CD133) in pleural fluid (P) and serum (S) could be used as biomarkers for diagnosis of lymph node involvement in patients with MPE.</p><p><strong>Materials and methods: </strong>Fifty-six patients with MPE and 30 healthy control subjects were included. Computerized tomography (CT) and positron emission tomography (PET) were used to diagnose pleural effusion. Patients with malignant cells in pleural fluid cytological examination were included in the MPE group. Thirty-five patients with lymph node metastases on CT were included in the LNM-positive MPE group. Serum and pleural fluid HIF-1α and CD-133 concentrations were measured manually <i>via</i> enzyme-linked immunosorbent assay (ELISA).</p><p><strong>Results: </strong>Serum concentrations of HIF-1α and CD133 were higher in MPE patients. It was found that CD133/HIF-1α (S) ratio was higher in the malignant patient group with positive lymph node involvement than in the negative group, while concentrations of HIF-1α (P) were lower. Pleural fluid HIF-1α and CD133/HIF-1α (S) ratio had sufficient performance in diagnosing lymphatic metastases in patients with MPE (AUC = 0.90 and 0.83, respectively).</p><p><strong>Conclusions: </strong>In conclusion, serum HIF-1α and CD133 concentrations were higher in patients with MPE, consistent with our hypothesis. Concentrations of HIF-1α (P) and CD133/HIF-1α (S) ratio can be used as biomarkers in diagnosing lymph node involvement in MPE patients, according to this experiment.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10564156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41242942","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
Corrigendum to: Post-treatment neutrophil to lymphocyte ratio as a prognostic tool in patients treated with tocilizumab for severe COVID-19 pneumonia - a single center experience. 更正:治疗后中性粒细胞与淋巴细胞比率作为接受托西珠单抗治疗的严重新冠肺炎肺炎患者的预后工具-单中心经验。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.031201
Marija Gomerčić Palčić, Hana Matijaca, Ivan Kruljac, Lucija Vusić, Vedran Hostić, Luka Vrbanić, Fanika Mrsić, Radovan Zrilić, Ivana Ćelap, Petar Gaćina

[This corrects the article DOI: 10.11613/BM.2023.020704.].

[这更正了文章DOI:10.11613/BM.2023020704.]。
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引用次数: 0
Negligible effect of vitamin D supplementation on exacerbation in patients with chronic obstructive pulmonary disease: meta-analysis. 补充维生素D对慢性阻塞性肺病患者病情恶化的可忽略影响:荟萃分析。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030703
Ye Hua, Ting Jiang, Jiangyi Feng, Mi Zou

Introduction: The focus of this meta-analysis was how vitamin D supplementation influences exacerbations in patients with chronic obstructive pulmonary disease (COPD) and vitamin D deficiency (VDD).

Materials and methods: Cochrane Library, Web of Science, Embase, and PubMed databases have been systematically searched in an attempt to collect randomized controlled trials related to vitamin D supplementation in COPD patients with VDD published in English available by July 2022. Primary outcome indicators included the mean number of exacerbation and rate of exacerbation. Secondary outcome indicators included forced expiratory volume in the first second (FEV1), FEV1/forced vital capacity (FVC) ratio, and serum 25-hydroxyvitamin D (25(OH)D) concentration.

Results: Five studies involving 522 COPD patients with VDD (defined as 25(OH)D < 50 nmol/L) were included, among them 61 were severely deficient in vitamin D (25(OH)D < 25 nmol/L). The results showed that vitamin D supplementation did not decrease the mean number of exacerbation (standardized mean difference (SMD): - 0.10, 95% CI: - 0.29 to 0.09) and the rate of exacerbation (relative risk (RR): 0.89, 95% CI: 0.76 to 1.04, P = 0.179). Also, its effect on FEV1 (SMD: - 0.06, 95% CI: - 0.30 to 0.17) and FEV1/FVC (SMD: -0.10, 95% CI: - 0.48 to 0.27) remained negligible. However, it could increase the serum 25(OH)D concentration (SMD: 2.44, 95 CI%: 2.20 to 2.68, P < 0.001).

Conclusions: The effects of vitamin D supplementation on decreasing exacerbation and improving pulmonary function were not significant.

引言:这项荟萃分析的重点是补充维生素D如何影响慢性阻塞性肺病(COPD)和维生素D缺乏症(VDD)患者的病情恶化。材料和方法:Cochrane Library,Web of Science,Embase,和PubMed数据库已被系统搜索,试图收集2022年7月以英文发表的与COPD VDD患者补充维生素D相关的随机对照试验。主要转归指标包括平均加重次数和加重率。次要转归指标包括第一秒用力呼气量(FEV1)、FEV1/用力肺活量(FVC)比率和血清25-羟基维生素D(25(OH)D)浓度。结果:纳入了5项研究,涉及522名患有VDD(定义为25(OH)D<50nmol/L)的COPD患者,其中61名患者严重缺乏维生素D(25(OH。结果表明,补充维生素D并没有降低平均加重次数(标准化平均差(SMD):-0.10,95%CI:-0.29-0.09)和加重率(相对风险(RR):0.89,95%CI:0.76-1.04,P=0.179)。此外,维生素D对FEV1(SMD:-0.06,95%CI:0.30-0.17)和FEV1/FVC(SMD:-0.10,95%CI:-0.48-0.27)的影响仍然可以忽略不计。结论:补充维生素D对减轻急性加重和改善肺功能的作用不显著。
{"title":"Negligible effect of vitamin D supplementation on exacerbation in patients with chronic obstructive pulmonary disease: meta-analysis.","authors":"Ye Hua, Ting Jiang, Jiangyi Feng, Mi Zou","doi":"10.11613/BM.2023.030703","DOIUrl":"10.11613/BM.2023.030703","url":null,"abstract":"<p><strong>Introduction: </strong>The focus of this meta-analysis was how vitamin D supplementation influences exacerbations in patients with chronic obstructive pulmonary disease (COPD) and vitamin D deficiency (VDD).</p><p><strong>Materials and methods: </strong>Cochrane Library, Web of Science, Embase, and PubMed databases have been systematically searched in an attempt to collect randomized controlled trials related to vitamin D supplementation in COPD patients with VDD published in English available by July 2022. Primary outcome indicators included the mean number of exacerbation and rate of exacerbation. Secondary outcome indicators included forced expiratory volume in the first second (FEV1), FEV1/forced vital capacity (FVC) ratio, and serum 25-hydroxyvitamin D (25(OH)D) concentration.</p><p><strong>Results: </strong>Five studies involving 522 COPD patients with VDD (defined as 25(OH)D < 50 nmol/L) were included, among them 61 were severely deficient in vitamin D (25(OH)D < 25 nmol/L). The results showed that vitamin D supplementation did not decrease the mean number of exacerbation (standardized mean difference (SMD): - 0.10, 95% CI: - 0.29 to 0.09) and the rate of exacerbation (relative risk (RR): 0.89, 95% CI: 0.76 to 1.04, P = 0.179). Also, its effect on FEV1 (SMD: - 0.06, 95% CI: - 0.30 to 0.17) and FEV1/FVC (SMD: -0.10, 95% CI: - 0.48 to 0.27) remained negligible. However, it could increase the serum 25(OH)D concentration (SMD: 2.44, 95 CI%: 2.20 to 2.68, P < 0.001).</p><p><strong>Conclusions: </strong>The effects of vitamin D supplementation on decreasing exacerbation and improving pulmonary function were not significant.</p>","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10564157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41242945","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
Reporting LDL cholesterol results by clinical biochemistry laboratories in Czechia and Slovakia to improve the detection rate of familial hypercholesterolemia. 捷克和斯洛伐克临床生物化学实验室报告LDL胆固醇结果,以提高家族性高胆固醇血症的检出率。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030705
Tomáš Šálek, Vladimír Soška, Marek Budina, Marek Vecka, Veronika Šálková, Michal Vrablík

Introduction: This survey aims to assess the implementation of recommendations from the European Atherosclerosis Society (EAS) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) by clinical biochemistry laboratories in Czechia and Slovakia in their policies for reporting low-density lipoprotein cholesterol (LDL-C) concentrations.

Materials and methods: The web-based survey was distributed to all 383 Czech and Slovak clinical biochemistry laboratories that measure lipids by external quality assessment provider SEKK. A total of 17 single-answer questions were included. The questionnaire was focused on the detection and decision points in familial hypercholesterolemia (FH). All survey answers were taken into account. The laboratories followed the EFLM and EAS guidelines when they reported an interpretative comment considering FH diagnosis in adults.

Results: A total of 203 (53%) laboratories answered. Only 5% of laboratories added interpretative comments considering FH diagnosis when LDL-C concentrations are above 5.0 mmol/L in adults, and 3% of laboratories added interpretative comments considering FH diagnosis when LDL-C concentrations are above 4.0 mmol/L in children. Only 7% of laboratories reported goals for all cardiovascular risk categories (low, moderate, high, very high). Non-HDL cholesterol concentrations were calculated by 74% of responders. A significant number (51%) of participants did not measure apolipoprotein B, and 59% of laboratories did not measure lipoprotein(a).

Conclusions: Only a small portion of laboratories from Czechia and Slovakia reported high LDL-C results with interpretative comments considering FH diagnosis in adults, the laboratories did not follow the guidelines.

引言:本调查旨在评估捷克和斯洛伐克的临床生物化学实验室在报告低密度脂蛋白胆固醇(LDL-C)浓度的政策中对欧洲动脉粥样硬化学会(EAS)和欧洲临床化学与实验室医学联合会(EFLM)建议的执行情况。材料和方法:这项基于网络的调查由外部质量评估提供商SEKK分发给捷克和斯洛伐克所有383个测量脂质的临床生物化学实验室。共包括17个单项回答问题。调查问卷主要针对家族性高胆固醇血症(FH)的检测和决策要点。所有的调查答案都被考虑在内。实验室在报告考虑成人FH诊断的解释性意见时,遵循了EFLM和EAS指南。结果:共有203个(53%)实验室回答了问题。当成人LDL-C浓度高于5.0 mmol/L时,只有5%的实验室添加了考虑FH诊断的解释性意见,当儿童LDL-C水平高于4.0 mmol/L时有3%的实验室添加添加了考虑到FH诊断。只有7%的实验室报告了所有心血管风险类别(低、中、高、极高)的目标。74%的应答者计算了非高密度脂蛋白胆固醇浓度。相当多的参与者(51%)没有测量载脂蛋白B,59%的实验室没有测量脂蛋白(A)。结论:只有捷克和斯洛伐克的一小部分实验室报告了高LDL-C结果,并对成人FH诊断提出了解释性意见,实验室没有遵循指南。
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引用次数: 0
The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures. LEAP检查表,用于临床测量程序的实验室评估和分析性能特征报告。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030505
Tze Ping Loh, Brian R Cooke, Thi Chi Mai Tran, Corey Markus, Rosita Zakaria, Chung Shun Ho, Elvar Theodorsson, Ronda F Greaves

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

在同行评审期刊上报告方法评估后的测量程序及其分析性能是临床实验室从业者分享他们的发现的重要手段。它也是一个重要的证据基础来源,可以帮助其他人对自己的做法做出明智的决定。目前,实验室医学期刊出版物中描述测量程序分析性能的信息存在显著差异。这些变化也对作者、读者、审稿人和编辑在决定提交稿件的质量方面提出了挑战。国际临床化学和实验医学联合会方法评估协议工作组(IFCC WG-MEP)制定了一份检查表,并建议采用该检查表,以便在实验医学期刊上报告方法评估和测量程序的分析性能特征。据设想,实验室评估和分析性能特征(LEAP)检查表将提高描述方法评估和分析绩效特征的期刊出版物的标准化,提高从业者所依赖的证据库的质量。
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引用次数: 0
Undetectable high-performance liquid chromatography haemoglobin A1c on variant haemoglobin E phenotype: a case report. 变异型血红蛋白E表型上检测不到的高效液相色谱法血红蛋白A1c:一例报告。
Pub Date : 2023-10-15 DOI: 10.11613/BM.2023.030801
Nadia Sadriani, Ferdy Royland Marpaung

The gold standard for long-term monitoring of diabetic patients is glycated haemoglobin (HbA1c), which is routinely tested for glycaemic control. Furthermore, the National glycohemoglobin standardization program (NGSP) has designated high-performance liquid chromatography (HPLC) as the reference method for HbA1c measurement. A woman from the Sumba tribe, Indonesia, aged 52, visited the Internal Medicine Clinic for a routine check-up. She had been taking diabetic and hypertension medicines on a regular basis for over 10 years. The HPLC procedure yielded "no result" for the patient's HbA1c assessment and there was no peak on the HPLC graphic. However, there was a discrepancy between the data history of HbA1c measured by turbidimetric method (average of 51 mmol/mol, reference range < 48 mmol/mol), fasting blood glucose (average of 7.7 mmol/L, reference range < 7.0 mmol/L) and 2-hour plasma glucose (average of 13 mmol/L, reference range < 11.1 mmol/L). Glycated albumin was 3.1 mmol/L (reference range 1.8-2.4 mmol/L). Haemoglobin electrophoresis identified homozygote haemoglobinopathy E (HbE). Patients with haemoglobin variants are proposed to utilize glycated albumin.

糖尿病患者长期监测的金标准是糖化血红蛋白(HbA1c),它是血糖控制的常规测试。此外,国家糖化血红蛋白标准化计划(NGSP)已指定高效液相色谱法(HPLC)作为HbA1c测量的参考方法。一名来自印度尼西亚Sumba部落的52岁妇女前往内科诊所进行常规检查。10多年来,她一直定期服用糖尿病和高血压药物。HPLC程序对患者的HbA1c评估“没有结果”,HPLC图上也没有峰值。然而,浊度法测得的HbA1c数据史(平均值51 mmol/mol,参考范围<48 mmol/mol)、空腹血糖(平均值7.7 mmol/L,参考范围<7.0 mmol/L)和2小时血糖(平均13 mmol/L,参照范围<11.1 mmol/L)之间存在差异。糖化白蛋白为3.1 mmol/L(参考范围1.8-2.4 mmol/L)。血红蛋白电泳鉴定纯合血红蛋白病E(HbE)。有血红蛋白变体的患者被建议使用糖化白蛋白。
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