Practical Laboratory Medicine最新文献_第2页

The interference and elimination of nitrite on determination of total urinary protein by Pyrogallol Red–Molybdate method 焦红-钼酸盐法测定尿总蛋白时亚硝酸盐的干扰与消除

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-10-15 DOI: 10.1016/j.plabm.2024.e00436

Shijian Fan , Jiaqing Liu , Yu Wei , Jie Yao , Juan Cheng , Yang Tong , Qiang Zhou , Yuanhong Xu

Background

Some urine samples showed negative values of total urinary protein by Pyrogallol red–molybdate (PRM) method. Interestingly, these samples showed notably high levels of nitrite in the urine dipstick test.

Methods

A total of 120 urine samples were collected and categorized into four groups (0 - < 100, 100-<500, 500-<1000, ≥1000 mg/L) based on total urinary protein concentration. Various concentrations of nitrite (2, 10, 50, 100, and 200 mg/L) were added to urine samples to investigate potential interference of nitrite in total urinary protein measurement by the PRM method. Additionally, different concentrations of L-ascorbic acid (100, 500, 1000, and 2000 mg/L) were added to urine-nitrite mixtures to explore the possibility of reversing the interference effects.

Results

2 mg/L nitrite had no impact on the test results.10 mg/L nitrite only showed significant effects on the detection results among the groups with 0 - < 100 and 100-<500 mg/L (P < 0.05). 200 mg/L nitrite caused a noticeable decrease in the urinary protein detection results of the four groups (0 - < 100, 100-<500, 500-<1000, ≥1000 mg/L), and the concentrations were reduced to 2.7 %, 26.85 %, 75.22 %, and 89.33 % of their original levels, respectively. 500 mg/L L-ascorbic acid effectively eliminated the interference from 200 mg/L nitrite and almost had no effect on detection.

Conclusions

Nitrite had negative effect on the detection of total urinary protein by PRM method and L-ascorbic acid was effective in counteracting the interference caused by nitrite.

背景部分尿样经焦聚醇红钼酸盐（PRM）法检测显示尿总蛋白呈阴性。方法共收集了 120 份尿液样本，并根据尿液总蛋白浓度分为四组（0 - 100、100-500、500-1000、≥1000 mg/L）。在尿样中加入不同浓度的亚硝酸盐（2、10、50、100 和 200 mg/L），以研究亚硝酸盐对 PRM 方法测定尿蛋白总量的潜在干扰。结果2 毫克/升亚硝酸盐对检测结果没有影响。10 毫克/升亚硝酸盐只对 0 - < 100 和 100 - < 500 毫克/升组的检测结果有显著影响（P < 0.05）。200 mg/L 亚硝酸盐使四组（0 - <100、100-<500、500-<1000、≥1000 mg/L）的尿蛋白检测结果明显下降，浓度分别降至原来的 2.7 %、26.85 %、75.22 % 和 89.33 %。结论亚硝酸盐对 PRM 法检测尿总蛋白有负面影响，L-抗坏血酸能有效抵消亚硝酸盐的干扰。

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引用次数: 0

Validation of a LC-MS/MS assay for citric acid, cysteine and oxalic acid determination and its application to explore pre-analytical sample storage 验证测定柠檬酸、半胱氨酸和草酸的 LC-MS/MS 分析法及其在探索分析前样品储存中的应用

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-30 DOI: 10.1016/j.plabm.2024.e00433

Ying Shen , Xia Luo , Qing Guan , Wenjie Lou , Liming Cheng

Objectives

Citrate, oxalate and cystine in 24-h urine are considered to be associated with the incidence and recurrence risk of urinary stone disease (USD). An evaluation of the LC-MS/MS kit for simultaneous quantification of the three analytes was undertaken.

Design

& Methods: The analytical performance of the kit was investigated based on FDA, EMA and CLSI guidelines. To promote the standardization of sample storage, this kit has been applied to perform systematic pre-analytical stability study of these analytes in urine.

Results

This method was validated with good linearity with accuracy of 93.1%–104 %. Intra-day and inter-day imprecision were ≤5.55 % and 5.34 %, respectively. Recoveries of citrate, oxalate and cystine added to clinical samples were in the range of 92.0–103 %, 94.8–100 % and 99.0–107 % with CV ≤ 5.52 %. It was recommended that urine preserved with hydrochloric acid could be preferable in consideration of both reliable test results and neglected sample heterogeneity.

Conclusions

This kit is suitable for measurement of citrate, oxalate and cystine for understanding the etiology of urinary stones, and the proper storage of urine samples is crucial for the correctness of the test results.

目的 24 小时尿液中的柠檬酸盐、草酸盐和胱氨酸被认为与尿石症（USD）的发病率和复发风险有关。我们对 LC-MS/MS 试剂盒进行了评估，以同时定量分析这三种分析物：根据 FDA、EMA 和 CLSI 指南对试剂盒的分析性能进行了调查。结果：该方法线性关系良好，准确度为 93.1%-104%。日内和日间误差分别小于5.55%和5.34%。临床样本中柠檬酸盐、草酸盐和胱氨酸的回收率分别为 92.0%-103%、94.8%-100% 和 99.0%-107%，CV ≤ 5.52%。结论：该试剂盒适用于测定枸橼酸盐、草酸盐和胱氨酸，可用于了解尿路结石的病因，尿样的妥善保存对检测结果的正确性至关重要。

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引用次数: 0

Performance evaluation of Eu3+-based CRP/SAA and PCT/IL-6 lateral flow immunoassay kits and their diagnostic value in respiratory tract infections 基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定试剂盒的性能评估及其在呼吸道感染中的诊断价值

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-27 DOI: 10.1016/j.plabm.2024.e00432

Mingxin Lin , Jing Zhang , Jianxing Cai , Jumei Liu , Min Zhu , Ke Li , Miaoyun Hu , Chenxi Li , Huiming Ye

Objectives

Respiratory infections are among the most common infectious diseases, resulting in significant morbidity and mortality. C-reactive protein (CRP), serum amyloid A (SAA), procalcitonin (PCT), and interleukin-6 (IL-6) are advantageous for diagnosing respiratory tract infections. This study assessed the analytical performance and accuracy of new kits for Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay and its diagnostic value in respiratory tract infections.

Methods

This study evaluated the detection performance of a test kit using guidelines from the Center for Medical Device Evaluation (CMDE) and the Clinical and Laboratory Standards Institute (CLSI). The test results were compared to those of the commercial kits (CRP: Mindray; SAA: Norman; PCT: Shanghai Upper; IL-6: Wantai BioPharm). A total of 156 patients with respiratory tract infections (53 with bacterial infections (Bac group); 50 with viral infections (Vir group); and 53 with co-infections (Bac + Vir group)) were enrolled, along with 50 healthy controls (HC group). Venous blood samples were collected to measure levels of SAA, PCT, CRP, and IL-6 using both the test and commercial kits. The diagnostic value of these biomarkers was assessed using receiver operating characteristic (ROC) curves.

Results

Correlation analysis demonstrated a strong concordance between the test kits and commercial kits (CRP: r = 0.9396, P < 0.0001; SAA: r = 0.8986, P < 0.0001; PCT: r = 0.9594, P < 0.0001; IL-6: r = 0.9009, P < 0.0001). The diagnostic performance of the test kits in identifying bacterial, viral, and co-infections was highly consistent with that of the commercial kit.

Conclusions

The Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay test kits demonstrated high levels of consistency with commercial kits in terms of quantitative outcomes and diagnostic performance for respiratory tract infections.

目的呼吸道感染是最常见的传染病之一，会导致严重的发病率和死亡率。C反应蛋白（CRP）、血清淀粉样蛋白A（SAA）、降钙素原（PCT）和白细胞介素-6（IL-6）是诊断呼吸道感染的有利指标。本研究评估了基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定新试剂盒的分析性能和准确性及其在呼吸道感染中的诊断价值。检测结果与商用试剂盒（CRP：Mindray；SAA：Norman；PCT：Shanghai Upper；IL-6：Wantai BioPharm）的检测结果进行了比较。共招募了 156 名呼吸道感染患者（53 名细菌感染患者（Bac 组）；50 名病毒感染患者（Vir 组）；53 名合并感染患者（Bac + Vir 组））和 50 名健康对照组（HC 组）。采集静脉血样本，使用检测试剂盒和商业试剂盒测量 SAA、PCT、CRP 和 IL-6 的水平。结果相关性分析表明，检测试剂盒与商用试剂盒之间具有很强的一致性（CRP：r = 0.9396，P <；0.0001；SAA：r = 0.8986，P <；0.0001；PCT：r = 0.9594，P <；0.0001；IL-6：r = 0.9009，P <；0.0001）。结论基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定试剂盒在呼吸道感染的定量结果和诊断性能方面与商业试剂盒具有高度的一致性。

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引用次数: 0

The potential relationship between EasyNAT system Tt values and Cobas z480 Ct values in the detection of SARS-Cov-2 EasyNAT 系统 Tt 值与 Cobas z480 Ct 值在检测 SARS-Cov-2 中的潜在关系

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-26 DOI: 10.1016/j.plabm.2024.e00431

Lu-Qing Zheng, Qing-Yong Wang

Objectives

This study aimed to evaluate the potential relationship between the time threshold (Tt) values of a commercial EasyNAT system, which is based on cross priming amplification (CPA) technology, and the cycle threshold (Ct) values of the Cobas z480 analyzer, which is based on a real-time fluorescence polymerase chain reaction (PCR) method, in the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) from oropharyngeal swabs. Design and Methods: Data were retrospectively collected from a clinical laboratory between December 4, 2022 and July 1, 2024.

Results

A total of 277 EasyNAT-positive samples (Tt values from 3.83 to 29.5) were simultaneously investigated using the Cobas z480 analyzer (Ct values from 10.74 to 38.78). The concordance rate between the two systems was 100 %. Among the positive samples, the mean and maximum PCR Ct values of O and N genes increased in line with increasing Tt values of the left and right amplification areas of the EasyNAT system. The maximum Ct values of the O or N gene determined by the Cobas z480 analyzer were no more than 29.52 when the Tt values of the left or right amplification areas of the UC0116 analyzer were no more than 6.

Conclusions

The safe, simple, fast, accurate, and automatic EasyNAT system used in conjunction with a PCR system might be a better choice for the detection of SARS-CoV-2 in hospitals, especially in settings without sophisticated PCR facilities. The Tt value (≤6) of the EasyNAT system can be a reference index for estimating the maximum Ct value (29.52) in SARS-CoV-2-positive samples.

目的本研究旨在评估基于交叉引物扩增（CPA）技术的商用 EasyNAT 系统的时间阈值（Tt）与基于实时荧光聚合酶链反应（PCR）方法的 Cobas z480 分析仪的周期阈值（Ct）之间在检测口咽拭子中的严重急性呼吸系统综合征冠状病毒-2（SARS-CoV-2）方面的潜在关系。设计与方法：结果使用 Cobas z480 分析仪同时检测了 277 份 EasyNAT 阳性样本（Tt 值从 3.83 到 29.5 不等）（Ct 值从 10.74 到 38.78 不等）。两个系统的吻合率为 100%。在阳性样本中，O 和 N 基因的平均 PCR Ct 值和最大 PCR Ct 值随着 EasyNAT 系统左右扩增区 Tt 值的增加而增加。当 UC0116 分析仪左右扩增区的 Tt 值不超过 6 时，Cobas z480 分析仪测定的 O 或 N 基因的最大 Ct 值不超过 29.52。EasyNAT 系统的 Tt 值（≤6）可以作为估计 SARS-CoV-2 阳性样本中最大 Ct 值（29.52）的参考指标。

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引用次数: 0

Laboratory considerations in the assessment of 25-hydroxyvitamin D in pregnant women by automated immunoassays 使用自动免疫测定法评估孕妇体内 25- 羟维生素 D 的实验室注意事项

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-25 DOI: 10.1016/j.plabm.2024.e00430

Darya Ayad Khalid , Bijan Nouri , Shakhawan Abdulrahman Mustafa , Mohammad Abdi

Background

Because of the pathophysiological role of vitamin D in health, there is an increased interest to check the clinical status of this vitamin. Immunochemical assays are commonly employed to determine 25-hydroxyvitamin D (25 (OH) D) in clinical laboratories and its testing could be influenced by pre-analytic and analytic issues. The aim of this study was to compare the 25(OH)D results obtained from three commonly used immunoassays in pregnant women to check a possible discrepancy between tests.

Material and methods

A group of 50 pregnant women who were in their third trimester were included in this study. The quantification of serum vitamin D was performed utilizing three immunochemistry-based assays including Elecsys, VIDAS and Alegria. We also involved 21 non-pregnant volunteers to clinically assess the vitamin D status in this group of people.

Results

Our findings revealed a significant inconsistency between the obtained results from three assays for serum 25(OH)D. The 25(OH)D showed higher values when measured by the Elecsys assay while the VIDAS assay had lower values compared to the other immunoassays. More notably, the 25(OH)D testing in non-pregnant subjects showed consistent results in all three immunoassays.

Conclusions

The results of the 25(OH)D measurements in pregnant women should be interpreted carefully due to a great inaccuracy in immunoassay testing. There is no such disagreement in non-pregnant people. Standardization of vitamin D testing in various settings is a crucial matter for clinical laboratories.

背景由于维生素 D 在健康中的病理生理作用，人们对检查这种维生素的临床状态越来越感兴趣。临床实验室通常采用免疫化学方法来测定 25- 羟基维生素 D（25 (OH) D），其检测结果可能会受到分析前和分析过程中问题的影响。本研究的目的是比较三种常用免疫测定法测定孕妇 25（OH）D 的结果，以检查不同检测方法之间可能存在的差异。使用三种基于免疫化学的检测方法（包括 Elecsys、VIDAS 和 Alegria）对血清维生素 D 进行定量。我们还邀请了 21 名非孕妇志愿者对这部分人群的维生素 D 状态进行临床评估。与其他免疫测定法相比，Elecsys 法测定的 25（OH）D 值较高，而 VIDAS 法测定的 25（OH）D 值较低。更值得注意的是，在对非孕妇进行 25（OH）D 检测时，所有三种免疫测定法的结果都是一致的。在非孕妇中则没有这种分歧。对临床实验室来说，在不同环境中进行维生素 D 检测的标准化至关重要。

{"title":"Laboratory considerations in the assessment of 25-hydroxyvitamin D in pregnant women by automated immunoassays","authors":"Darya Ayad Khalid , Bijan Nouri , Shakhawan Abdulrahman Mustafa , Mohammad Abdi","doi":"10.1016/j.plabm.2024.e00430","DOIUrl":"10.1016/j.plabm.2024.e00430","url":null,"abstract":"<div><h3>Background</h3><div>Because of the pathophysiological role of vitamin D in health, there is an increased interest to check the clinical status of this vitamin. Immunochemical assays are commonly employed to determine 25-hydroxyvitamin D (25 (OH) D) in clinical laboratories and its testing could be influenced by pre-analytic and analytic issues. The aim of this study was to compare the 25(OH)D results obtained from three commonly used immunoassays in pregnant women to check a possible discrepancy between tests.</div></div><div><h3>Material and methods</h3><div>A group of 50 pregnant women who were in their third trimester were included in this study. The quantification of serum vitamin D was performed utilizing three immunochemistry-based assays including Elecsys, VIDAS and Alegria. We also involved 21 non-pregnant volunteers to clinically assess the vitamin D status in this group of people.</div></div><div><h3>Results</h3><div>Our findings revealed a significant inconsistency between the obtained results from three assays for serum 25(OH)D. The 25(OH)D showed higher values when measured by the Elecsys assay while the VIDAS assay had lower values compared to the other immunoassays. More notably, the 25(OH)D testing in non-pregnant subjects showed consistent results in all three immunoassays.</div></div><div><h3>Conclusions</h3><div>The results of the 25(OH)D measurements in pregnant women should be interpreted carefully due to a great inaccuracy in immunoassay testing. There is no such disagreement in non-pregnant people. Standardization of vitamin D testing in various settings is a crucial matter for clinical laboratories.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00430"},"PeriodicalIF":1.7,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357189","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

Biochemical indices of patients with enteric fever and pancreatitis: A comparative cross-sectional study 肠炎和胰腺炎患者的生化指标：横断面比较研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-18 DOI: 10.1016/j.plabm.2024.e00429

Nathaniel Ebo Aidoo , Emmanuel Kwaku Ofori , Vincent Boima , Eric Nana Yaw Nyarko , John Cletus Osei , Clement G. Darkwah , Morris O. Gayflor , Seth K. Amponsah , Henry Asare-Anane

Objective

Enteric fever (EF), a potentially fatal febrile illness, is prevalent in developing countries. Elevated levels of lipase and amylase in serum, typically associated with acute pancreatitis (AP), have been observed in patients with EF. The elevated enzymes in both conditions may lead to diagnostic confusion and care delays. This study aimed to determine biochemical indices that are peculiar to EF and AP.

Methods

A cross-sectional comparative study was conducted at the Korle-Bu Teaching Hospital, Ghana. Volunteers were categorized into three groups: EF (n = 32), AP (n = 30) and healthy controls (n = 31). A standard questionnaire was used to collect socio-demographic and clinical information from the participants. Blood and stool samples were obtained, followed by biochemical analysis: total amylase, lipase, pancreatic amylase, serum elastase 1, hepatic enzymes, calcium, magnesium, phosphate, stool colour, stool pH, and stool fat presence.

Results

The AP group displayed higher total amylase, lipase, elastase-1, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyl transferase levels compared to the EF and control groups (p < 0.05 respectively). Elastase 1 levels were found to be high in all AP participants, whereas no elevations were observed in the EF group. Positive associations were observed in the AP and EF groups for lipase vs total amylase (ρ = .543, p = 0.001; ρ = .543, p = 0.001 for both).

Conclusions

Elevated levels of total/pancreatic amylase and lipase were found to be indicative of a patient with AP and EF. Further, elastase-1 was found to be a good biomarker to distinguish between AP and EF.

目的肠胃热（EF）是一种可能致命的发热性疾病，在发展中国家很普遍。在肠炎患者中观察到血清中脂肪酶和淀粉酶水平升高，这通常与急性胰腺炎（AP）有关。这两种情况下的酶升高都可能导致诊断混乱和护理延误。本研究旨在确定 EF 和 AP 所特有的生化指标。志愿者被分为三组：EF 组（32 人）、AP 组（30 人）和健康对照组（31 人）。采用标准问卷收集参与者的社会人口学和临床信息。采集血液和粪便样本，然后进行生化分析：总淀粉酶、脂肪酶、胰淀粉酶、血清弹性蛋白酶 1、肝酶、钙、镁、磷酸盐、粪便颜色、粪便 pH 值和粪便脂肪含量。所有 AP 参与者的弹性蛋白酶 1 水平都很高，而 EF 组则没有发现任何升高。在 AP 组和 EF 组中，脂肪酶与总淀粉酶呈正相关（ρ = .543，p = 0.001；两者均为ρ = .543，p = 0.001）。此外，还发现弹性蛋白酶-1是区分 AP 和 EF 的良好生物标志物。

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引用次数: 0

Exploring free pregnancy associated plasma protein a (fPAPP-A) as a biomarker in early pregnancy 将游离妊娠相关血浆蛋白 a（fPAPP-A）作为孕早期生物标志物的探索

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-16 DOI: 10.1016/j.plabm.2024.e00428

Jesper Friis Petersen , Vilma Tiittanen , Saara Wittfooth , Ellen Løkkegaard , Lennart Jan Friis-Hansen

Objectives

In combined first trimester screening for Down syndrome, Pregnancy-Associated Plasma Protein A (PAPP-A) is pivotal. PAPP-A tests evaluate total PAPP-A, consisting of the biologically active free PAPP-A (fPAPP-A) and PAPP-A complexed with eosinophil major basic protein's proform (proMBP). While PAPP-A is well-researched, limited understanding persists regarding fPAPP-A's first trimester concentrations and diagnostic utility.

Design

and methods: PAPP-A and fPAPP-A levels were gauged in 602 serum samples at 2-week intervals (gestational weeks 4–14) from 159 women with delivery of a healthy neonate and 80 samples from 37 miscarriages. The final sample at the time of diagnosis from women who miscarried was included in analyses.

Results

During the first trimester, PAPP-A and fPAPP-A levels displayed significant and strong correlation (r = 0.94), with median values doubling weekly. Free PAPP-A constituted only 3.0 % of PAPP-A over gestational weeks. Low fPAPP-A linked to miscarriage (p < 0.001), maternal weight (p < 0.001), and smoking (p = 0.02). For miscarriage prediction fPAPP-A was equal to PAPP-A (area under the receiver operating characteristics curve 0.79 vs. 0.81, p = 0.44).

Conclusions

Investigating fPAPP-A presence and concentration directly in first trimester serum has not been done previously. This study report lower fPAPP-A values than anticipated from prior enzymatic studies of fPAPP-A. fPAPP-A was not superior to PAPP-A as a first trimester biomarker in this dataset.

目标在唐氏综合征的首胎联合筛查中，妊娠相关血浆蛋白 A (PAPP-A) 至关重要。PAPP-A 检测可评估总 PAPP-A，包括具有生物活性的游离 PAPP-A（fPAPP-A）和与嗜酸性粒细胞主要碱性蛋白原形（proMBP）复合物的 PAPP-A。虽然对 PAPP-A 的研究较多，但对 fPAPP-A 在妊娠头三个月的浓度和诊断作用的了解仍然有限：设计与方法：对 159 名分娩健康新生儿的妇女和 37 名流产妇女的 80 份血清样本中的 602 份血清样本进行了 PAPP-A 和 fPAPP-A 水平测定，每隔 2 周（孕周 4-14）测定一次。结果在妊娠头三个月，PAPP-A 和 fPAPP-A 水平显示出显著的强相关性（r = 0.94），中位值每周翻一番。游离 PAPP-A 仅占孕周 PAPP-A 的 3.0%。低 fPAPP-A 与流产（p < 0.001）、产妇体重（p < 0.001）和吸烟（p = 0.02）有关。在预测流产方面，fPAPP-A 与 PAPP-A（接收者操作特征曲线下面积 0.79 vs. 0.81，p = 0.44）相当。本研究报告的 fPAPP-A 值低于之前对 fPAPP-A 进行酶学研究的预期值。

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引用次数: 0

Analytical performance evaluation of a new integrated clinical chemistry and immunoassay analyzer 新型集成临床化学和免疫测定分析仪的分析性能评估

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-08-01 DOI: 10.1016/j.plabm.2024.e00427

Ulla Ruffing, Sabrina Mickeler, Michaela Kraft, Peter Findeisen

Background

Clinical laboratories perform a wide range of tests that are used by healthcare professionals to guide medical decision making. Use of automated analyzers in the clinical laboratory can improve patient care by not only reducing the turn-around-time (TAT) of results but also improving accuracy of the reported results by reducing human error. The aim of this study was to evaluate the performance characteristics of a new automated laboratory instrument, the Atellica® CI Analyzer, Model 1900, over a 3-month period in a European laboratory setting.

Methods

Analytical performance of 17 analytes (13 chemistry and four immunochemistry) was assessed by evaluating repeatability and within-laboratory precision using anonymized remnant serum samples. Method comparison studies were performed on the Atellica CI Analyzer and the Roche cobas® 6000.

Results

Excellent precision was observed with coefficients of variation (CVs) less than 2 % for repeatability and less than 3 % within-laboratory imprecision for most analytes. Comparison of select assays with the cobas 6000 system resulted in correlation coefficients ranging from 0.980 to 1.000.

Conclusion

This is the first reported evaluation of the Atellica CI Analyzer in a clinical laboratory setting. The strong analytical performance of the Atellica CI Analyzer demonstrates that this instrument is suitable for routine clinical use.

背景临床实验室进行各种检验，医护人员利用这些检验来指导医疗决策。在临床实验室中使用自动分析仪不仅能缩短结果的周转时间（TAT），还能通过减少人为错误提高报告结果的准确性，从而改善患者护理。本研究的目的是在欧洲实验室环境中对新型自动实验室仪器 Atellica® CI 分析仪（1900 型）的性能特点进行为期 3 个月的评估。方法使用匿名残留血清样本评估重复性和实验室内精确度，从而评估 17 种分析物（13 种化学和 4 种免疫化学）的分析性能。结果表明，大多数分析物的重复性变异系数（CV）小于2%，实验室内不精密度小于3%，具有极佳的精密度。将某些测定与 cobas 6000 系统进行比较，得出的相关系数从 0.980 到 1.000 不等。Atellica CI 分析仪强大的分析性能表明该仪器适合常规临床使用。

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引用次数: 0

Evaluation of the EUROIMMUN automated chemiluminescence immunoassays for measurement of four core biomarkers for Alzheimer’s disease in cerebrospinal fluid 评估 EUROIMMUN 自动化学发光免疫测定法，用于测量脑脊液中阿尔茨海默病的四种核心生物标记物

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-08-01 DOI: 10.1016/j.plabm.2024.e00425

Katharina Römpler , Philipp Arendt , Britta Brix , Viola Borchardt-Lohölter , Anette Schulz , Mandy Busse , Stefan Busse

Introduction

Robust immunoassays for quantification of Alzheimer's disease (AD)-specific biomarkers are required for routine diagnostics. We report analytical performance characteristics of four new chemiluminescence immunoassays (ChLIA, EUROIMMUN) running on closed, fully automated random-access instruments for quantification of Aβ_1-40, Aβ_1-42, tTau, and pTau(181) in human cerebrospinal fluid (CSF).

Methods

ChLIAs were validated according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI). Optimal cut-offs for biomarkers and biomarker ratios were determined using samples from 219 AD patients and 220 patients with AD-related symptoms. For performance comparison, biomarker concentrations were measured in 110 diagnostic leftover samples using the ChLIAs and established Lumipulse G assays (Fujirebio).

Results

All ChLIAs met CLSI criteria. Overall agreement between assays was 89.0%–97.3 % with highly correlating results (Pearson's correlation coefficients: 0.82–0.99). Passing-Bablok regression analysis revealed systematic differences.

Discussion

EUROIMMUN ChLIAs showed good analytical performances and represent new valuable tools for diagnostics of AD.

导言：常规诊断需要可靠的免疫测定来量化阿尔茨海默病（AD）特异性生物标记物。我们报告了在封闭式全自动随机接入仪器上运行的四种新型化学发光免疫测定（ChLIA，EUROIMMUN）的分析性能特点，它们可用于定量检测人脑脊液（CSF）中的Aβ1-40、Aβ1-42、tTau和pTau(181)。使用 219 例 AD 患者和 220 例 AD 相关症状患者的样本确定了生物标记物和生物标记物比率的最佳临界值。为了进行性能比较，使用 ChLIA 和现有的 Lumipulse G 检测方法（Fujirebio）测量了 110 份诊断残留样本中的生物标记物浓度。各检测方法之间的总体一致性为 89.0%-97.3 %，结果高度相关（皮尔逊相关系数：0.82-0.99）。Passing-Bablok 回归分析显示存在系统性差异。

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引用次数: 0

An assessment of analytical performance using the six sigma scale in second-trimester maternal prenatal screening practices in China 使用六西格玛量表评估中国孕产妇第二胎产前筛查实践中的分析绩效

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-08-01 DOI: 10.1016/j.plabm.2024.e00422

Jinming Zhang , Xingtong Chen , Jiaming Wu , Penghui Feng , Wei Wang , Kun Zhong , Shuai Yuan , Yuxuan Du , Chuanbao Zhang , Falin He

Objectives

We aimed to evaluate the analytical performance of second-trimester maternal serum screening in China, and to compare if there are differences in sigma levels across different methods and months.

Methods

A retrospective study was conducted to assess the analytical quality levels of laboratories by calculating the Sigma metrics with prenatal screening biomarkers: AFP, Total β-hCG, free β-hCG, uE3. Data from 591 laboratories were selected. Sigma metrics were computed using the formula: Sigma metrics(σ) = (%TEa - |%Bias|)/%CV. The Friedman test and Mann-Whitney test were used to compare differences across various methods and different months. The Hodges–Lehmann was used for determining 95 % confidence intervals of pseudo-medians.

Results

Only uE3 showed significant monthly variations in sigma calculations. However, around 8 % of laboratories across all four analytes demonstrated sigma levels both above 6 and below 3 in different months. Laboratories utilizing time-resolved fluorescence methods significantly outperformed those using chemiluminescence in sigma level. For AFP, the pseudo-median difference between these methods lies within a 95 % confidence interval of (−3.22, −1.93), while for uE3, it is at (−2.30, −1.40). Notably, the median sigma levels for all analytes reached the 4-sigma threshold, with free β-hCG even attaining the 6-sigma level.

Conclusion

With current standards, China's second-trimester maternal serum screening is of relatively high analytical quality, and variations in sigma levels exist across different months and methods.

目的我们旨在评估中国第二胎孕产妇血清筛查的分析性能，并比较不同方法和月份的西格玛水平是否存在差异。方法我们进行了一项回顾性研究，通过计算产前筛查生物标志物的西格玛指标来评估实验室的分析质量水平：AFP、总β-hCG、游离β-hCG、uE3。选取了 591 个实验室的数据。西格玛指标的计算公式为Sigma metrics(σ) = (%TEa - |%Bias|)/%CV。弗里德曼检验和曼-惠特尼检验用于比较不同方法和不同月份之间的差异。结果只有 uE3 在西格玛计算中显示出显著的月度差异。然而，在所有四种分析物中，约有 8% 的实验室在不同月份的西格玛水平高于 6 和低于 3。使用时间分辨荧光方法的实验室在西格玛水平上明显优于使用化学发光方法的实验室。就甲胎蛋白而言，这些方法之间的假中值差异在 95 % 置信区间（-3.22，-1.93）内，而就 uE3 而言，则在 95 % 置信区间（-2.30，-1.40）内。值得注意的是，所有分析物的中位数西格玛水平都达到了 4 西格玛阈值，游离β-hCG 甚至达到了 6 西格玛水平。

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