Clinical biochemistry最新文献_第4页

A survey of Canadian neurologists’ perspectives and preferences for laboratory reporting of CSF oligoclonal banding 加拿大神经科医生对实验室报告 CSF 少克隆条带的观点和偏好调查。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-21 DOI: 10.1016/j.clinbiochem.2024.110855

Victoria Higgins , Michelle L. Parker , Daniel R. Beriault , Ahmed Mostafa , Mathew P. Estey , Terence Agbor , Ola Z. Ismail

Introduction

Cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis aids in the diagnosis of multiple sclerosis (MS). Despite its clinical importance, there is profound variation in processes, reporting, and interpretation of CSF OCB and associated tests/indices across Canadian laboratories. This is likely due to the lack of clear, evidence-based recommendations on CSF OCB analysis processes and reporting. Here, we assessed the CSF OCB reporting needs and preferences of Canadian neurologists as a first step in clinical stakeholder engagement to aid in the development of CSF OCB reporting recommendations.

Methods

A 16-question survey was sent to neurologists across Canada in January 2022, and it closed in March 2022. The survey included questions regarding location and length of clinical practice; preferred maximum time limit for paired CSF and serum samples; reporting preferences for CSF-specific OCB, banding patterns, and associated tests/indices; as well as the clinical utility of CSF OCB and associated tests/indices.

Results

Twenty-two neurologists from nine provinces participated, with a median practice length of 13 years. Most (64 %) preferred a 24-hour limit for paired serum and CSF sample collection. The majority (73 %) favored a cutoff of ≥ 2 CSF-specific bands for positivity, aligning with the 2017 McDonald criteria. Opinions varied on reporting the number of bands and listing specific conditions in the interpretive comments. Some highlighted the need for further research on band count interpretation and its clinical implications. All respondents found CSF OCB results useful, with 64 % valuing it more than other CSF tests for MS evaluation.

Conclusions

Our survey reveals diverse preferences among Canadian neurologists for CSF OCB reporting. Stakeholder engagement and further research are crucial for standardized, improved MS diagnostic practices.

简介：脑脊液（CSF）寡克隆带（OCB）分析有助于诊断多发性硬化症（MS）。尽管其临床重要性不言而喻，但加拿大各实验室在脑脊液寡克隆带分析及相关检测/指标的流程、报告和解释方面却存在很大差异。这可能是由于缺乏关于 CSF OCB 分析流程和报告的明确循证建议。在此，我们对加拿大神经科医生的 CSF OCB 报告需求和偏好进行了评估，作为临床利益相关者参与的第一步，以帮助制定 CSF OCB 报告建议：方法： 2022 年 1 月，我们向加拿大各地的神经科医生发送了一份包含 16 个问题的调查问卷，并于 2022 年 3 月结束。调查内容包括临床实践的地点和时间长短；CSF 和血清样本配对的首选最长时限；CSF 特异性 OCB、分带模式和相关检验/指标的报告偏好；以及 CSF OCB 和相关检验/指标的临床实用性：来自 9 个省的 22 名神经科医生参加了此次调查，他们的执业年限中位数为 13 年。大多数医生（64%）倾向于将血清和脑脊液样本的采集时间限制为 24 小时。大多数人（73%）赞成 CSF 特异性条带阳性的临界值≥ 2，这与 2017 年麦克唐纳标准一致。对于在解释性意见中报告条带数和列出具体条件，意见不一。一些人强调需要进一步研究条带数解释及其临床意义。所有受访者都认为 CSF OCB 结果有用，64% 的受访者认为 CSF OCB 比其他 MS 评估 CSF 检测更有价值：我们的调查揭示了加拿大神经科医生对 CSF OCB 报告的不同偏好。利益相关者的参与和进一步的研究对于标准化和改进 MS 诊断实践至关重要。

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引用次数: 0

Discordance between creatinine and cystatin C-based estimation of glomerular filtration rate (eGFR) in solid organ transplant recipients 基于肌酐和胱抑素 C 的实体器官移植患者肾小球滤过率（eGFR）估算结果不一致。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-20 DOI: 10.1016/j.clinbiochem.2024.110853

Mary Kathryn Bohn , Meshach Asare-Werehene , Felix Leung , Davor Brinc , Rajeevan Selvaratnam

Background

Estimation of glomerular filtration rate is a critical component of assessing kidney function post-solid organ transplantation and in monitoring risk of acute injury. Our objective was to evaluate estimated glomerular filtration rate (eGFR) as derived from creatinine (eGFR_cr), cystatin C (eGFR_cys), and both (eGFR_cr-cys) in a cohort of transplant recipients.

Methods

A total of 47 unique post-solid organ transplant patients receiving tacrolimus were included. Residual specimens were assayed for creatinine (Jaffe and enzymatic), cystatin C, and tacrolimus. eGFR was estimated using the 2021 CKD-EPI formulae. Results were compared by Deming regression and bias was assessed using non-parametric cumulative distribution plots. Percent agreement in chronic kidney disease (CKD) by stage was evaluated across equations.

Results

eGFR_c_ys relative to eGFR_c_r estimates demonstrated a median bias of –22 mL/min/1.73 m² and an overall 21.3 % [95 % CI: 12.1, 35.0] agreement in CKD staging. eGFR_cr-cys demonstrated a median bias of −14 mL/min/1.73 m² and overall agreement of 34.0 % [95 % CI: 22.3, 48.4] relative to eGFR_cr (enzymatic). Discordance increased proportionally with eGFR and did not differ by creatinine assay (Jaffe or enzymatic).

Conclusion

Cystatin C incorporation leads to markedly negative biases between eGFR estimates in patients with solid organ transplant, implying lack of applicability of eGFR_cys or GFR_cr-cys in the transplant setting. This highlights the dependency of patient characteristics on equation performance and the need to consider confounding factors in interpretation and utilization of cystatin C based equations.

背景：估算肾小球滤过率是评估实体器官移植后肾功能和监测急性损伤风险的重要组成部分。我们的目的是在一组移植受者中评估根据肌酐（eGFRcr）、胱抑素 C（eGFRcys）和两者（eGFRcr-cys）得出的估计肾小球滤过率（eGFR）：方法：共纳入 47 名接受他克莫司治疗的独特的实体器官移植后患者。采用 2021 年慢性肾脏病 (CKD) -EPI 公式估算 eGFR。通过戴明回归比较结果，并使用非参数累积分布图评估偏差。结果：eGFRcr 相对于 eGFRcys 估计值的中位偏差为 -22 mL/min/1.73 m2，在 CKD 分期中的总体一致性为 21.3% [95 % CI: 12.1, 35.0]。不一致性随 eGFR 成比例增加，但肌酐测定（雅法或酶法）并无差异：结论：胱抑素 C 的加入会导致实体器官移植患者的 eGFR 估计值之间出现明显的负偏差，这意味着胱抑素 C 在移植环境中缺乏适用性。这凸显了患者特征对方程性能的依赖性，以及在解释和使用基于胱抑素 C 的方程时考虑混杂因素的必要性。

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引用次数: 0

Evaluation of the applicability of urine lateral flow immunochromatography tests for the detection of cocaine in plasma samples 评估尿液侧流免疫层析检测法检测血浆样本中可卡因的适用性。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-17 DOI: 10.1016/j.clinbiochem.2024.110854

Isabella Almeida Millan de Souza , Bruno Pereira dos Santos , Sabrina Nunes do Nascimento , Letícia Birk , Viviane Cristina Sebben , Sarah Eller , Tiago Franco de Oliveira

Introduction

Qualitative analysis of cocaine in urine is a common practice in emergency settings. However, positive results from urine screening tests do not necessarily indicate recent exposure. In this context, plasma is considered a more appropriate option due to its shorter detection window and better correlation with symptomatology. Therefore, the availability of rapid tests for this biological matrix is extremely relevant in the clinical and emergency context.

Methods

A lateral flow immunochromatography test designed for analyzing cocaine in urine was evaluated for use with plasma samples. A total of 412 samples from suspected cases of intoxication were processed and tested. Concurrently, the samples were analyzed for cocaine and its metabolites, benzoylecgonine and ecgonine methyl ester, using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Reliability parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and efficiency, were calculated considering different cutoff values.

Results

Approximately 8.3 % of the samples tested positive in the immunoassay, while 10.2 % had a concentration greater than 5 ng/mL for at least one analyte in the LC-MS/MS analysis. Using benzoylecgonine as the target analyte with a cutoff of 40 ng/mL yielded the best reliability results, with 96.3 % sensitivity and 97.9 % specificity. Cocaine did not show satisfactory results, whereas ecgonine methyl ester, despite having 92.9 % sensitivity and 94.7 % specificity at its best cutoff (20 ng/mL), had a positive predictive value of only 38.2 %.

Conclusions

The study evaluated the suitability of using rapid urine tests for cocaine detection in plasma, offering a simple and quick drug screening method that is particularly useful in toxicological emergencies.

导言：对尿液中的可卡因进行定性分析是急诊环境中的常见做法。然而，尿液筛查试验的阳性结果并不一定表明最近接触过可卡因。在这种情况下，血浆被认为是更合适的选择，因为它的检测时间更短，与症状的相关性更好。因此，提供这种生物基质的快速检测方法对临床和急救工作极为重要：方法：评估了用于分析尿液中可卡因的侧流免疫层析检测法在血浆样本中的应用。共处理和检测了 412 份疑似中毒病例的样本。同时，利用液相色谱-串联质谱法（LC-MS/MS）对样本中的可卡因及其代谢物苯甲酰可待因和可待因甲酯进行了分析。根据不同的临界值计算了灵敏度、特异性、阳性预测值、阴性预测值和效率等可靠性参数：约 8.3% 的样本在免疫测定中呈阳性，而 10.2% 的样本在 LC-MS/MS 分析中至少有一种分析物的浓度超过 5 纳克/毫升。以苯甲酰可待因为目标分析物，以 40 纳克/毫升为临界值，结果可靠性最佳，灵敏度为 96.3%，特异性为 97.9%。可卡因的结果并不令人满意，而蜕皮激素甲酯尽管在最佳临界值（20 纳克/毫升）下具有 92.9 % 的灵敏度和 94.7 % 的特异性，但其阳性预测值仅为 38.2 %：该研究评估了使用快速尿检检测血浆中可卡因的适用性，提供了一种简单、快速的药物筛查方法，尤其适用于毒理学紧急情况。

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引用次数: 0

The potential of anti-glutamic acid decarboxylase antibodies to support a diagnosis of autoimmune diabetes mellitus 抗谷氨酸脱羧酶抗体支持自身免疫性糖尿病诊断的潜力。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-17 DOI: 10.1016/j.clinbiochem.2024.110842

Maryah Liepert , Shamayel Alhaqqan , Alaa Husain , Heather Lochnan , Ronald A. Booth , Julie Shaw , Cathy J. Sun

Objective

Anti-glutamic acid decarboxylase (anti-GAD) antibodies are a frequently used diagnostic marker for autoimmune forms of diabetes mellitus (DM), namely, type 1 diabetes mellitus (T1DM) and latent autoimmune diabetes in adults (LADA). We sought to provide insight into a unique diagnostic application of anti-GAD antibodies in patients potentially misdiagnosed with type 2 diabetes mellitus (T2DM).

Methods

We present a case series of patients who had a change in diagnosis from T2DM to autoimmune DM that was supported by positive anti-GAD antibodies. Patients were identified via a retrospective chart review of all anti-GAD antibodies tests ordered between 1 January 2020 and 31 December 2021 at a tertiary care academic hospital.

Results

Of the 23 patients with previous diagnosis of T2DM, positive anti-GAD antibodies supported the clinician’s decision to change the diagnosis to autoimmune DM. The prominent clinical reasons for ordering anti-GAD antibodies in patients previously diagnosed as T2DM were patient presentation with diabetic ketoacidosis, features of insulin insufficiency, inadequate effect of oral diabetes mellitus medications, young age at diagnosis, and a family history of autoimmune conditions.

Conclusion

Anti-GAD antibodies’ positivity can support a change in diagnosis from T2DM to autoimmune DM, which has substantial impact on patient care. Timely and reliable clinical laboratory reporting of anti-GAD antibodies is highly recommended.

目的：抗谷氨酸脱羧酶（anti-GAD）抗体是自身免疫性糖尿病（DM），即1型糖尿病（T1DM）和成人潜伏自身免疫性糖尿病（LADA）的常用诊断标志物。我们试图深入了解抗GAD抗体在可能被误诊为2型糖尿病（T2DM）患者中的独特诊断应用：我们展示了一系列病例，这些患者的诊断由T2DM转变为自身免疫性DM，抗GAD抗体阳性支持了诊断结果。我们对一家三级医疗学术医院在 2020 年 1 月 1 日至 2021 年 12 月 31 日期间开具的所有抗 GAD 抗体检测单进行了回顾性病历审查，从而确定了患者：结果：在23名先前诊断为T2DM的患者中，抗GAD抗体阳性支持临床医生将诊断改为自身免疫性DM的决定。先前被诊断为T2DM的患者订购抗-GAD抗体的主要临床原因是患者出现糖尿病酮症酸中毒、胰岛素分泌不足、口服糖尿病药物效果不佳、诊断时年龄较小、有自身免疫性疾病家族史：抗-GAD抗体阳性可支持从T2DM到自身免疫性DM的诊断改变，这对患者护理有重大影响。我们强烈建议临床实验室及时、可靠地报告抗-GAD抗体。

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引用次数: 0

Decreased monocytic HLA-DR in patients with sepsis: Prediction of diagnosis, severity and prognosis 败血症患者单核细胞 HLA-DR 减少：预测诊断、严重程度和预后。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-15 DOI: 10.1016/j.clinbiochem.2024.110851

Juanjuan Cui , Wen Cai , Li Zhang , Yueyuan Wu , Yan Huang , Weifeng Zhao

Objective

Sepsis is characterized by high incidence and mortality rates, making early recognition and risk stratification critical for preventing delayed treatment and overtreatment. This study investigated the potential of monocytic (m) HLA-DR as a diagnostic and prognostic biomarker of sepsis.

Methods

In this prospective study, we collected blood in EDTA-anticoagulated tubes within 48 h from patients diagnosed with sepsis or infection and analyzed the percentage of mHLA-DR in peripheral blood mononuclear cells, C-reactive protein, and procalcitonin within 2 h of collection. We gathered clinical and laboratory data, including sex, age, and comorbidities, calculated the number of dysfunctional organs and sequential organ failure assessment (SOFA) score, and recorded the survival status of patients with sepsis on the 30th day after admission.

Results

mHLA-DR levels were lower in patients with sepsis (median 46.60 [interquartile range 23.86–66.51]%) than infection (75.44 [52.13–91.50]%). mHLA-DR could distinguish sepsis from infection with an area under the curve (AUC) of 0.724 (95 %CI 0.624–0.824). Decreased mHLA-DR levels have been found in septic patients with shock or secondary infections. mHLA-DR expression decreased with an increasing number of dysfunctional organs and higher SOFA score. In 30-day non-survivors, mHLA-DR levels were 26.94 (12.06–44.45)%, significantly lower than in survivors (55.20 [24.83–72.37]%). mHLA-DR predicted sepsis prognosis with an AUC of 0.750 (95 %CI 0.623–0.877). When the cut-off value was <52.29 %, the sensitivity and specificity of mHLA-DR for prognosis were 100 % and 52.83 %, respectively. The 30-day survival rate of septic patients with mHLA-DR ≥ 52.29 % was 6.798 (95 %CI 2.075–22.27) times higher than that of patients with mHLA-DR < 52.29 %.

Conclusion

mHLA-DR negatively correlates with the severity of sepsis and could be used as a diagnostic and prognostic biomarker for sepsis.

目的：败血症具有高发病率和高死亡率的特点，因此早期识别和风险分层对于防止延误治疗和过度治疗至关重要。本研究探讨了单核细胞（m）HLA-DR 作为败血症诊断和预后生物标志物的潜力：在这项前瞻性研究中，我们在 48 小时内用 EDTA 抗凝管采集了确诊为败血症或感染患者的血液，并在采集后 2 小时内分析了外周血单核细胞中 mHLA-DR 的百分比、C 反应蛋白和降钙素原。我们收集了包括性别、年龄和合并症在内的临床和实验室数据，计算了功能障碍器官的数量和序贯器官衰竭评估（SOFA）评分，并记录了脓毒症患者入院后第 30 天的生存状况。结果：与感染（75.44 [52.13-91.50] %）相比，脓毒症患者的 mHLA-DR 水平较低（中位数 46.60 [四分位距 23.86-66.51]%）。随着功能障碍器官数量的增加和 SOFA 评分的提高，mHLA-DR 的表达也会降低。在 30 天内未存活的患者中，mHLA-DR 水平为 26.94 (12.06-44.45)%，明显低于存活者（55.20 [24.83-72.37]%）。mHLA-DR 预测脓毒症预后的 AUC 为 0.750 (95 %CI 0.623-0.877)。结论：mHLA-DR与脓毒症的严重程度呈负相关，可用作脓毒症的诊断和预后生物标志物。

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引用次数: 0

Malignant pleural effusion risk based on a novel tool using homocysteine and carcinoembryonic antigen in pleural fluid: A multicenter study 基于胸腔积液中同型半胱氨酸和癌胚抗原的新型工具的恶性胸腔积液风险：一项多中心研究。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-13 DOI: 10.1016/j.clinbiochem.2024.110841

Jose D. Santotoribio , Juan Corral-Pérez , David Nuñez-Jurado , Daniel Fatela-Cantillo , Ángela García-De La Torre , Gabriel Orantes-Maroto , Luis Del Valle-Vázquez , Daniel Del Castillo-Otero , Nieves Maira-Gonzalez , Andrés Cobos-Díaz , Juan M. Guerrero , Juan-Bosco Lopez-Saez

Introduction

This multicenter study aimed to evaluate the Malignant Pleural Effusion Risk (MPER) diagnostic accuracy in distinguishing between benign and malign pleural effusion. Methods: MPER is based on pleural fluid Homocysteine (HCY) and carcinoembryonic antigen (CEA) that were measured using three different methods. MPER was calculated by assessing a previously published probabilistic model: Probability (%) = 100× (1 + e-z)-1, where Z = 0.5471 × [HCY] + 0.3846 × [CEA]–8.2671.

Results

A total of 301 patients were included (140 MPE). MPER demonstrated a high AUC (0.891), sensitivity (84.3 %), and specificity (80.7 %) with a cut-off > 35.3 %.

Conclusions

The MPER model demonstrated a high diagnostic accuracy supporting its use as a novel and powerful tool.

简介：这项多中心研究旨在评估恶性胸腔积液风险（MPER）诊断良性和恶性胸腔积液的准确性：这项多中心研究旨在评估恶性胸腔积液风险（MPER）在区分良性和恶性胸腔积液方面的诊断准确性：MPER基于胸腔积液中的高半胱氨酸（HCY）和癌胚抗原（CEA），采用三种不同的方法进行测量。MPER 是通过评估之前公布的概率模型计算得出的：概率 (%) = 100× (1 + e-z)-1，其中 Z = 0.5471 × [HCY] + 0.3846 × [CEA]-8.2671：共纳入 301 例患者（140 例 MPE）。MPER 的 AUC（0.891）、灵敏度（84.3%）和特异度（80.7%）都很高，临界值大于 35.3%：MPER 模型显示出很高的诊断准确性，支持将其用作一种新颖而强大的工具。

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引用次数: 0

ROC of SII and FIB-4 index for predicting mortality in idiopathic pulmonary fibrosis patients 预测特发性肺纤维化患者死亡率的 SII 和 FIB-4 指数的 ROC。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-07 DOI: 10.1016/j.clinbiochem.2024.110836

Guo-Ming Zhang , Xu-Xiao Guo

引用次数: 0

Reply to Letter to the Editor “The importance of SII and FIB-4 scores in predicting mortality in idiopathic pulmonary fibrosis patients” 回复致编辑的信 "SII 和 FIB-4 评分在预测特发性肺纤维化患者死亡率方面的重要性"。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-07 DOI: 10.1016/j.clinbiochem.2024.110837

Gorkem Berna Koyun, Serdar Berk, Omer Tamer Dogan

引用次数: 0

Carrier frequency and molecular basis of hemoglobinopathies among blood donors in eastern Morocco: Implications for blood donation and genetic diagnosis 摩洛哥东部献血者中血红蛋白病的携带者频率和分子基础：对献血和基因诊断的影响。

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-06 DOI: 10.1016/j.clinbiochem.2024.110840

Ihab Belmokhtar , Karam Yahya Belmokhtar , Saida Lhousni , Majida Charif , Zaina Sidqi , Rachid Seddik , Mohammed Choukri , Mohammed Bellaoui , Redouane Boulouiz

Background

Hemoglobinopathies represent the most commonly inherited autosomal recessive blood disorders in the world. The aim of this study was to determine the carrier frequency and molecular basis of hemoglobinopathies among blood donors in eastern Morocco. This is the first study of its kind for this country.

Methods

Healthy blood donors of the BRO Biobank were included in this study. Blood samples were analyzed using an automatic blood cell analyzer for complete blood counts. Hemoglobin fractions were analyzed by capillary electrophoresis and serum ferritin was measured on a chemical and immunological analyzer. Suspected hemoglobinopathy carriers were further characterized by Sanger sequencing, Gap PCR and PCR-RFLP.

Results

The study involved 2013 blood donors, of whom 1063 were male and 950 were female (sex ratio male-to-female of 1.1). The median age of these donors was 35 years. The overall carrier frequency of hemoglobinopathies was 1.84 %, with β-thalassemia carriers being the most prevalent (0.65 %) followed by HbAC (0.55 %), α-thalassemia carriers (0.30 %), HbAS (0.1 %), HbAG-Philadelphia (0.1 %), HbAD-Ouled Rabah (0.05 %) and HbAO-Arab (0.05 %). Additionally, novel β-thalassemia variants (C6(−G) and −83(A > G)) and a structural variant (Hb D-Ouled Rabah) were discovered for the first time in Morocco.

Conclusions

This study provided the first report on carrier frequency and molecular basis of hemoglobinopathies among healthy donors in Morocco. These findings are valuable for the implementation of carrier screening and genetic diagnosis for hemoglobinopathies. Furthermore, these results justify the need to introduce pre-donation screening for hemoglobinopathy carriers in Morocco, particularly in areas with a high prevalence of carriers to enhance the overall quality of the national blood supply.

背景：血红蛋白病是世界上最常见的常染色体隐性遗传血液病。这项研究的目的是确定摩洛哥东部献血者中血红蛋白病的携带者频率和分子基础。方法：本研究纳入了 BRO 生物库的健康献血者。使用自动血细胞分析仪对血样进行全血细胞计数分析。用毛细管电泳分析血红蛋白组分，用化学和免疫分析仪测量血清铁蛋白。通过桑格测序、Gap PCR 和 PCR-RFLP 对疑似血红蛋白病携带者进行进一步鉴定：研究涉及 2013 名献血者，其中男性 1063 人，女性 950 人（男女性别比为 1.1）。这些献血者的年龄中位数为 35 岁。血红蛋白病的总携带率为 1.84%，其中β-地中海贫血携带者最多（0.65%），其次是 HbAC（0.55%）、α-地中海贫血携带者（0.30%）、HbAS（0.1%）、HbAG-费城（0.1%）、HbAD-Ouled Rabah（0.05%）和 HbAO-阿拉伯（0.05%）。此外，摩洛哥还首次发现了新型β地中海贫血变异体（C6(-G)和-83(A > G)）和一种结构变异体（Hb D-Ouled Rabah）：本研究首次报告了摩洛哥健康捐献者中血红蛋白病的携带者频率和分子基础。这些发现对实施血红蛋白病的携带者筛查和基因诊断很有价值。此外，这些结果证明有必要在摩洛哥对血红蛋白病携带者进行献血前筛查，尤其是在携带者高发地区，以提高全国血液供应的整体质量。

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引用次数: 0

Quantitative evaluation of adalimumab and anti-adalimumab antibodies in sera using a surface plasmon resonance biosensor 利用表面等离子体共振生物传感器定量评估血清中的阿达木单抗和抗阿达木单抗抗体

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry

Pub Date : 2024-11-01 DOI: 10.1016/j.clinbiochem.2024.110838

Andrea Di Santo , Matteo Accinno , Fosca Errante , Manuela Capone , Alessandra Vultaggio , Eleonora Simoncini , Giuditta Zipoli , Lorenzo Cosmi , Francesco Annunziato , Paolo Rovero , Feliciana Real Fernandez

Objectives

Monitoring of therapeutic antibody adalimumab (ADL) and of anti-adalimumab antibodies (AAA) in autoimmune diseases patients' sera has achieved increased attention since several studies showed a correlation between AAA levels and treatment failure. We evaluated a new surface plasmon resonance (SPR)-based method that, with slight changes in the analysis condition and in the ligand immobilized on the chip surface, allows to monitor both AAA and ADL. This new label-free method does not require sample pretreatments, and it is fully automated, only requiring the preparation of the chip, which can be used for multiple analysis, and the preparation of the sample sets.

Design & Methods

Sera from ADL-treated patients (n = 47) and controls (n = 13) were included in this study. Quantitative analysis of AAA and ADL were performed separately using a new SPR-biosensor, and a commercially available ELISA kit. Agreement was defined by overall, positive, and negative agreement. Wilson Score was used to calculate confidence intervals (CI) on binomial probability and Spearman’s rho and Bland-Altman test were used to assess correlations.

Results

ELISA and SPR-based assay were able to identify circulating AAA in ADL-treated patients, with the percentage of positivity varying among the methods, with an overall agreement of 79%. AAA were detected in 18 (38 %) out of the 47 treated patients by the ELISA whereas SPR-based assay detected 10 (21 %) out of 47 samples.

Conclusions

Real-time label free SPR-based protocol for both AAA and ADL quantification has been set-up. Although quantitative differences were observed when compared with ELISA, the agreement among methodologies was high, particularly for ADL quantification within the therapeutic window of the drug.

目的：自从几项研究表明阿达木单抗抗体水平与治疗失败之间存在相关性以来，对自身免疫性疾病患者血清中的治疗抗体阿达木单抗（ADL）和抗阿达木单抗抗体（AAA）进行监测就受到了越来越多的关注。我们评估了一种基于表面等离子体共振（SPR）的新方法，只要稍微改变分析条件和固定在芯片表面的配体，就能同时监测 AAA 和 ADL。这种新的无标记方法不需要对样品进行预处理，而且是全自动的，只需要准备芯片（可用于多次分析）和准备样品集：本研究纳入了ADL治疗患者（47人）和对照组（13人）的血清。使用新型 SPR 生物传感器和市售 ELISA 试剂盒分别对 AAA 和 ADL 进行定量分析。一致性由总体、阳性和阴性一致性定义。结果：ELISA和基于SPR的检测方法能够识别ADL治疗患者体内的循环AAA，不同方法的阳性率不同，总体一致性为79%。ELISA法检测出47名接受治疗的患者中有18人（38%）体内存在AAA，而SPR法检测出47份样本中有10人（21%）体内存在AAA：结论：基于实时无标记 SPR 法的 AAA 和 ADL 定量方案已经建立。尽管与酶联免疫吸附法相比在定量方面存在差异，但各种方法之间的一致性很高，特别是在药物治疗窗内的 ADL 定量方面。

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引用次数: 0