Practical Laboratory Medicine最新文献_第2页

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

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

Lu-Qing Zheng, Qing-Yong Wang

{"title":"The potential relationship between EasyNAT system Tt values and Cobas z480 Ct values in the detection of SARS-Cov-2","authors":"Lu-Qing Zheng, Qing-Yong Wang","doi":"10.1016/j.plabm.2024.e00431","DOIUrl":"10.1016/j.plabm.2024.e00431","url":null,"abstract":"<div><h3>Objectives</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00431"},"PeriodicalIF":1.7,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142425000","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

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

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

{"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

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

{"title":"Biochemical indices of patients with enteric fever and pancreatitis: A comparative cross-sectional study","authors":"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","doi":"10.1016/j.plabm.2024.e00429","DOIUrl":"10.1016/j.plabm.2024.e00429","url":null,"abstract":"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 (<em>p</em> < 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, <em>p</em> = 0.001; ρ = .543, <em>p</em> = 0.001 for both).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00429"},"PeriodicalIF":1.7,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142320182","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

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

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

{"title":"Exploring free pregnancy associated plasma protein a (fPAPP-A) as a biomarker in early pregnancy","authors":"Jesper Friis Petersen , Vilma Tiittanen , Saara Wittfooth , Ellen Løkkegaard , Lennart Jan Friis-Hansen","doi":"10.1016/j.plabm.2024.e00428","DOIUrl":"10.1016/j.plabm.2024.e00428","url":null,"abstract":"<div><h3>Objectives</h3><div>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.</div></div><div><h3>Design</h3><div>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.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00428"},"PeriodicalIF":1.7,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424976","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

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

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

Ulla Ruffing, Sabrina Mickeler, Michaela Kraft, Peter Findeisen

{"title":"Analytical performance evaluation of a new integrated clinical chemistry and immunoassay analyzer","authors":"Ulla Ruffing, Sabrina Mickeler, Michaela Kraft, Peter Findeisen","doi":"10.1016/j.plabm.2024.e00427","DOIUrl":"10.1016/j.plabm.2024.e00427","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00427"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000738/pdfft?md5=7ddf564e23e32bba0c10890fee87712a&pid=1-s2.0-S2352551724000738-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142163636","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

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

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

{"title":"Evaluation of the EUROIMMUN automated chemiluminescence immunoassays for measurement of four core biomarkers for Alzheimer’s disease in cerebrospinal fluid","authors":"Katharina Römpler , Philipp Arendt , Britta Brix , Viola Borchardt-Lohölter , Anette Schulz , Mandy Busse , Stefan Busse","doi":"10.1016/j.plabm.2024.e00425","DOIUrl":"10.1016/j.plabm.2024.e00425","url":null,"abstract":"<div><h3>Introduction</h3><p>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<sub>1-40</sub>, Aβ<sub>1-42</sub>, tTau, and pTau(181) in human cerebrospinal fluid (CSF).</p></div><div><h3>Methods</h3><p>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).</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Discussion</h3><p>EUROIMMUN ChLIAs showed good analytical performances and represent new valuable tools for diagnostics of AD.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00425"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000714/pdfft?md5=97eaafe39fae3e30f93e744afd267114&pid=1-s2.0-S2352551724000714-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230684","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

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

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

{"title":"An assessment of analytical performance using the six sigma scale in second-trimester maternal prenatal screening practices in China","authors":"Jinming Zhang , Xingtong Chen , Jiaming Wu , Penghui Feng , Wei Wang , Kun Zhong , Shuai Yuan , Yuxuan Du , Chuanbao Zhang , Falin He","doi":"10.1016/j.plabm.2024.e00422","DOIUrl":"10.1016/j.plabm.2024.e00422","url":null,"abstract":"<div><h3>Objectives</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00422"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000684/pdfft?md5=94fce0bc72c07b868b95e4af86aeb411&pid=1-s2.0-S2352551724000684-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141960300","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

Analytical performance of publicly dispensed glucometers in primary health care in a southern Brazilian city 巴西南部城市初级卫生保健中公共配发血糖仪的分析性能

IF 1.7

Practical Laboratory Medicine Pub Date : 2024-08-01 DOI: 10.1016/j.plabm.2024.e00421

Isabelle L. Silva, Flávia Martinello

{"title":"Analytical performance of publicly dispensed glucometers in primary health care in a southern Brazilian city","authors":"Isabelle L. Silva, Flávia Martinello","doi":"10.1016/j.plabm.2024.e00421","DOIUrl":"10.1016/j.plabm.2024.e00421","url":null,"abstract":"<div><h3>Aims</h3><p>This study aimed to assess the use of glucometers by patients and the analytical performance of glucometers provided by the primary care services.</p></div><div><h3>Methods</h3><p>The analytical performance of 48 glucometers Accu-Chek® Active, was assessed through quintuplicate analyses of one Roche and one PNCQ (National Quality Control Program) control sample at different concentrations; 31 were also evaluated by a single proficiency testing sample. The evaluation metrics included imprecision, bias, and total error and were measured according to quality specifications based on biological variation (QSBV). Glucometer users answered a questionnaire regarding their experience.</p></div><div><h3>Results</h3><p>Among the 48 glucometers evaluated with internal control samples, 17 met precision criteria at both control levels according to QSBV, while 24 met the criteria at only one control level. Of the 31 glucometers further evaluated through proficiency test, 11 met accuracy criteria according to QSBV, and only one device showed an unacceptable result. Out of these 31, only 15 demonstrated a total error within the acceptable maximum limits based on QSBV.</p></div><div><h3>Conclusions</h3><p>Overall, our findings showed that patients had a good understanding of glucometer usage and suggested that some glucometers should be replaced, as they sometimes failed to meet even the manufacturer’s acceptable variation limits, and/or did not meet QSBV.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00421"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000672/pdfft?md5=4da41e980a7e2125105f74c43088cc49&pid=1-s2.0-S2352551724000672-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141846706","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

Analytical performances of a novel fluorescent immunoassay of anti-Müllerian hormone and establishment of the reference intervals in Chinese children 抗缪勒氏管激素新型荧光免疫测定在中国儿童中的分析性能及参考区间的确定

IF 1.7

Practical Laboratory Medicine Pub Date : 2024-08-01 DOI: 10.1016/j.plabm.2024.e00419

Li Li , Mingyi Li , Wenqian Zhu, Lisong Shen, Limin Jiang

{"title":"Analytical performances of a novel fluorescent immunoassay of anti-Müllerian hormone and establishment of the reference intervals in Chinese children","authors":"Li Li , Mingyi Li , Wenqian Zhu, Lisong Shen, Limin Jiang","doi":"10.1016/j.plabm.2024.e00419","DOIUrl":"10.1016/j.plabm.2024.e00419","url":null,"abstract":"<div><h3>Background</h3><p>AMH is important in child growth and the concentrations change with age and gender. This study aimed to evaluate the performance of the Pylon AMH assays and establish pediatric reference intervals.</p></div><div><h3>Methods</h3><p>The experiments on imprecision, sensitivity, linearity, reportable range, interference and comparison were carried out to evaluate the analytical performance. The AMH reference ranges were calculated in 238 females and 346 males aged 0–18 years using robust methods.</p></div><div><h3>Results</h3><p>The repeatability and the within-laboratory imprecision CVs of the assay were 3.7 % and 6.4 % at 2.25 ng/mL, and 4.6 % and 6.4 % at 15.49 ng/mL, respectively. The sensitivity (LoB = 0.05 ng/mL, LoD = 0.1 ng/mL and LoQ = 0.3 ng/mL) was verified. The linearity was 0.1–19.55 ng/mL and report up to 391 ng/mL with 20x pre-dilution. There was no significant interference from hemoglobin (500 mg/dL), triglyceride (500 mg/dL), bilirubin (10 mg/dL), cholesterol (800 mg/dL) and biotin (3000 ng/mL). The AMH measured by the Pylon assays correlated to those measured by the Elecsys assays. In males, the AMH levels were high at birth (0 d-1 m: median 95.10 ng/mL) and increased to a peak (7 m-1y: median 158.80 ng/mL) before they decreased with age (15–18 y: median 6.31 ng/mL). In females, the AMH concentrations were low at birth (0 d-1 m: median 0.20 ng/mL) and increased with age (15–18 y: median 3.03 ng/mL).</p></div><div><h3>Conclusion</h3><p>The Pylon AMH assays showed good analytical performance and the AMH reference intervals in chinese children determined may provide a basis in clinical diagnosis and treatment of related diseases.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00419"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000659/pdfft?md5=42c6a900de6eb50328f578096f7c7513&pid=1-s2.0-S2352551724000659-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141715239","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

Accidental bufotoxin intoxication: Arenobufagin identification by liquid chromatography coupled to mass spectrometry 意外布福毒素中毒：液相色谱-质谱法鉴定阿伦布法金

IF 1.7

Practical Laboratory Medicine Pub Date : 2024-08-01 DOI: 10.1016/j.plabm.2024.e00424

Alessandro Bonari , Mauro Leucio Mattei , Giovanni Cappelli , Francesca Romano , Nicoletta Cini , Francesca Luceri , Donato Squillaci , Stefano Dugheri , Alessandra Fanelli , Nicola Mucci

{"title":"Accidental bufotoxin intoxication: Arenobufagin identification by liquid chromatography coupled to mass spectrometry","authors":"Alessandro Bonari , Mauro Leucio Mattei , Giovanni Cappelli , Francesca Romano , Nicoletta Cini , Francesca Luceri , Donato Squillaci , Stefano Dugheri , Alessandra Fanelli , Nicola Mucci","doi":"10.1016/j.plabm.2024.e00424","DOIUrl":"10.1016/j.plabm.2024.e00424","url":null,"abstract":"<div><p>Background: Since ancient times, poisoning, even serious poisoning, has been known to occur during nature walks. Intentional or unintentional ingestion of toxins of animal origin is one of the possible causes of poisoning. Bufadienolide poisoning is a critical case. This is because of its high potency and its ability to cross the blood-brain barrier. Due to the rarity of these poisonings in humans in Central Europe, their identification is often difficult. The following is a case report of a poisoning by toad eggs in an Italina child, that presented vertigo, fussiness and sleepiness. A method of toxin identification using the prince of pharmacotoxicology, liquid chromatography (LC) coupled with tandem mass spectrometry (MS/MS), and an innovative reasoning were used. This method can be applied to other poisoning cases.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00424"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000702/pdfft?md5=e5a24c523b354e3bf3163d696432eabb&pid=1-s2.0-S2352551724000702-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997278","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}

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