Annals of Clinical Biochemistry最新文献

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Decrease in the internal quality control intermediate reproducibility imprecision of Cystatin C results in China in the years from 2014 to 2023. 2014 - 2023年国内胱抑素C检测结果内部质控中间重现性不精确度的降低
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-03-14 DOI: 10.1177/00045632251329182
Zhixin Zhang, Jie Zeng, Wei Wang, Yuxuan Du, Shuai Yuan, Na Dong, Chuanbao Zhang, Zhiguo Wang
{"title":"Decrease in the internal quality control intermediate reproducibility imprecision of Cystatin C results in China in the years from 2014 to 2023.","authors":"Zhixin Zhang, Jie Zeng, Wei Wang, Yuxuan Du, Shuai Yuan, Na Dong, Chuanbao Zhang, Zhiguo Wang","doi":"10.1177/00045632251329182","DOIUrl":"10.1177/00045632251329182","url":null,"abstract":"<p><p>ObjectivesWe evaluated the intermediate reproducibility imprecision of cystatin C results based on internal quality control (IQC) data.MethodsIQC data for cystatin C analyte were collected each year from 2014 to 2023. We used the coefficient of variation (CV) to evaluate the level of laboratory imprecision. Five performance specifications [1/3 total allowable error (TEa), 1/4TEa and three levels performance specifications based on biological variation] were used to calculate the proportion of laboratories with CVs less than or equal to the performance specifications, namely, the pass rate. Based on the reference interval of Chinese adult serum cystatin C (0.59-1.03 mg/L), the concentration of quality control materials was divided into two levels for CV analysis: Level 1 (≤1.03 mg/L) and Level 2 (>1.03 mg/L). Additionally, group analysis was conducted according to the reagent manufacturer. Peer groups were further divided based on instruments to study differences between instruments. Boxplots were drawn to analyze trends in CVs, and differences in CVs among different groups were assessed using the Kruskal-Wallis test and Mann-Whitney U test.ResultsThe number of participating laboratories increased significantly from 255 in 2014 to 1814 in 2023. The intermediate reproducibility imprecision of Cystatin C IQC results in China had decreased from 5.1% (CV%) in 2014 to 3.3% in 2023. The pass rates based on 1/3 TEa showed upward trends increasing from 67% in 2014 to 88% in 2023. The pass rates for the other four performance specifications were all below 80%. The CVs of two concentration levels showed significant differences in most years. Roche Diagnostics reagent manufacturer exhibited low intermediate reproducibility imprecision. The BSBE-Abbott Architect series platform achieved a 100% pass rate based on 1/3 TEa in 2023.ConclusionsThe intermediate reproducibility imprecision of cystatin C has been a continuous overall improvement in China. However, the performance specifications of Cystatin C based on BV are currently not applicable to some laboratories in China. In addition, attention should be paid to the differences in intermediate reproducibility imprecision between various analysis systems.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"387-394"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Falsely elevated type IV collagen caused in part by heterophilic antibodies: A case report. 部分由嗜异性抗体引起的IV型胶原蛋白错误升高1例报告。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-02-20 DOI: 10.1177/00045632251322316
Xian-Min Lv, Long Xiao, Hong-Lei Yu, Lu-Wei Yan
{"title":"Falsely elevated type IV collagen caused in part by heterophilic antibodies: A case report.","authors":"Xian-Min Lv, Long Xiao, Hong-Lei Yu, Lu-Wei Yan","doi":"10.1177/00045632251322316","DOIUrl":"10.1177/00045632251322316","url":null,"abstract":"<p><p>Immunoassays, which are used ubiquitously in clinical practice, are inherently vulnerable to distortions arising from endogenous immunoglobulins, particularly heterophilic antibodies. While many studies have explored interference in substances measured using chemiluminescence or electrochemiluminescence methods based on the double-antibody sandwich principle, there are limited data on interference in immunoturbidimetric assays, particularly for type IV collagen. This article presents the first report of a noteworthy increase in serum type IV collagen levels stemming from heterophilic antibody interference detected through an immunoturbidimetric assay. The present study investigated the mechanisms of this interference and the differences introduced by heterophilic antibodies between the two methodologies. Additionally, it outlines strategies for identifying and mitigating such interference, and discusses the principles, limitations, and considerations of each corrective approach. The objective is to raise awareness among clinical laboratory professionals concerning the potential interference of heterophilic antibodies in immunoturbidimetric assays. Increased awareness will aid in the prompt detection and correction of this issue, ensuring the provision of accurate and reliable laboratory data for informed clinical decision-making and the prevention of adverse medical outcomes.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"420-425"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
LabMedUK25 Conference Manchester - Editorial. LabMedUK25曼彻斯特会议-编辑。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-09-08 DOI: 10.1177/00045632251361348
{"title":"LabMedUK25 Conference Manchester - Editorial.","authors":"","doi":"10.1177/00045632251361348","DOIUrl":"https://doi.org/10.1177/00045632251361348","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":"62 5","pages":"339-341"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145013721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Metronidazole is a chromatographic interference on a routine HPLC-UV assay for thiopurine metabolites. 甲硝唑是常规HPLC-UV测定硫嘌呤代谢物的色谱干扰物。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-02-21 DOI: 10.1177/00045632251319917
Andrew A Wood, Sophie Rothwell Mason, Anna F Robson
{"title":"Metronidazole is a chromatographic interference on a routine HPLC-UV assay for thiopurine metabolites.","authors":"Andrew A Wood, Sophie Rothwell Mason, Anna F Robson","doi":"10.1177/00045632251319917","DOIUrl":"10.1177/00045632251319917","url":null,"abstract":"<p><p>BackgroundThiopurine metabolites, 6-thioguanine (6TG) and 6-methylmercaptopurine (6MMP), are monitored to aid therapeutic management of thiopurine drugs. At Manchester University NHS Foundation Trust (MFT), thiopurine metabolites are measured by high performance liquid chromatography with ultraviolet detection (HPLC-UV). Whole blood samples are lysed and subjected to hydrolysis with derivatisation of 6MMP before HPLC-UV detection at 304 nm for the 6MMP-derivative and 342 nm for 6TG. For some samples, 6MMP cannot be reported due to a chromatographic interference at 304 nm co-eluting with the 6MMP peak. An investigation was performed to identify the interfering compound.MethodsPatient medication histories were examined to identify candidate compounds for the interference. Candidate compounds were spiked into blood at supraphysiological concentrations and tested on the assay.ResultsMetronidazole was identified as being prescribed to all patients whose samples demonstrated the interference. Metronidazole and its metabolite, hydroxymetronidazole, were spiked into blood. HPLC-UV analysis of spiked blood demonstrated similar UV absorbance patterns to those seen in patient samples with the interference. Hydroxymetronidazole co-eluted with 6MMP causing interference in the measurement.ConclusionMetronidazole and its major metabolite can interfere with 6MMP measurement by HPLC-UV analysis at 304 nm.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"408-411"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143057759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Metamizole (dipyrone) as an interferent in biochemical assays. 甲基咪唑(双吡咯酮)在生化检测中的干扰作用。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-03-04 DOI: 10.1177/00045632251328131
David Ceacero-Marín, Lídia Martínez-Zamorano, Adrían Gisbert-Alonso, Isabel Cachón-Suárez, Karla Gabriela Mendoza-Javier, María José Castro-Castro
{"title":"Metamizole (dipyrone) as an interferent in biochemical assays.","authors":"David Ceacero-Marín, Lídia Martínez-Zamorano, Adrían Gisbert-Alonso, Isabel Cachón-Suárez, Karla Gabriela Mendoza-Javier, María José Castro-Castro","doi":"10.1177/00045632251328131","DOIUrl":"10.1177/00045632251328131","url":null,"abstract":"<p><p>BackgroundMetamizole (MMZ), commonly used as an analgesic/antipyretic in countries like Spain, faces restrictions elsewhere due to side effects. Despite this, its frequent use underscores the critical importance of studying its impact on the accuracy of laboratory tests, particularly when blood samples are obtained shortly after intravenous administration.MethodsTo investigate the in vitro interfering effect of MMZ, 20 serum biochemical assays were selected. The concentrations of biochemical assays were measured in a serum pool spiked with increasing MMZ concentrations. For each assay, the percentage of interference was calculated and compared with our laboratory's quality requirements for bias.ResultsIn vitro interference was observed in some biochemical assays: cholesterol (CHOL), creatinine (CREA), high-density lipoprotein cholesterol (HDL), lactate (LAC), lactate dehydrogenase (LDH), triglycerides (TG) and uric acid (UA), leading to falsely reduced results. All of them, except for the LDH assay, exhibited clinically significant interference with CREA being the first to be affected at a metamizole concentration of 0.31 g/L. No interference was observed in the remaining assays.ConclusionsFalsely decreased and clinically significant CHOL, CREA, HDL, LAC, TG and UA results were observed in serum samples due to in vitro interference caused by MMZ contamination. Serum concentrations in patients receiving intravenous MMZ treatment may be falsely decreased due to interference by MMZ. Knowledge of such interferences in clinical laboratories is crucial for the correct diagnosis and treatment of patients.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"358-365"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
'Tired all the time': What general practitioners request and find in patients with tiredness/fatigue - an audit against NICE clinical knowledge summary of tiredness/fatigue in adults. “一直很累”:全科医生对疲劳/疲劳患者的要求和发现——针对NICE关于成人疲劳/疲劳临床知识总结的审计。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-03-14 DOI: 10.1177/00045632251329175
Sava Handjiev, Jennifer Nobes, Michael J Murphy
{"title":"'Tired all the time': What general practitioners request and find in patients with tiredness/fatigue - an audit against NICE clinical knowledge summary of tiredness/fatigue in adults.","authors":"Sava Handjiev, Jennifer Nobes, Michael J Murphy","doi":"10.1177/00045632251329175","DOIUrl":"10.1177/00045632251329175","url":null,"abstract":"<p><p>BackgroundTiredness/fatigue is a common presenting complaint in primary care. Advice is available from the National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summary (CKS) on its investigation. The application of this guidance has not been reported.AimTo audit the investigation of tiredness/fatigue in adults in primary care against NICE CKS recommendations.MethodsWe reviewed 16,889 primary care requests in 2019, where clinical details included: 'tired all the time' or 'TATT'; 'tired (ness)'; 'fatigue'. We report on how many first-line investigations recommended by the NICE CKS were requested, and, if they were, what the outcome was. We categorised outcomes as normal or abnormal, using relevant laboratory reference intervals.ResultsFirst-line investigations were requested, in decreasing order of frequency, as follows: full blood count (FBC) 89%, renal function (U&Es) 83%, liver function tests (LFTs) 80%, thyroid-stimulating hormone (TSH) 80%, bone profile 70%, C-reactive protein (CRP) 66%, plasma viscosity (PV) 46%, ferritin 9.4%, IgA tissue transglutaminase (TTG) 3.2%, and creatine kinase (CK) 1.4%. Likelihood of abnormal results was 37% for PV, 26% for ferritin, 25% for LFTs, 24% for bone profile, 23% for FBC, 15% for U&Es, 14% for CRP, 10% for TSH, 8% for CK, and 3% for TTG. (Requesting of diagnostic HbA1c (2.8%) was vetted in accordance with a local protocol; 59% of results were in the diabetic range).ConclusionThis is the first study to audit the application in primary care of NICE CKS advice on investigation of tiredness/fatigue in adults. Our findings provide an insight into 'real-world' primary care requesting behaviour, and outcomes of investigations.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"416-419"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Paired copy number variation analysis in siblings discordant for familial Parkinson's disease. 家族性帕金森病兄弟姐妹不一致的配对拷贝数变异分析。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-03-04 DOI: 10.1177/00045632251328130
Sevcan Atay, Ahmet Acarer, Handan Ak, Zafer Colakoglu, Hikmet Hakan Aydin
{"title":"Paired copy number variation analysis in siblings discordant for familial Parkinson's disease.","authors":"Sevcan Atay, Ahmet Acarer, Handan Ak, Zafer Colakoglu, Hikmet Hakan Aydin","doi":"10.1177/00045632251328130","DOIUrl":"10.1177/00045632251328130","url":null,"abstract":"<p><p>ObjectivesNumerous studies on the genetic pathogenesis of familial Parkinson's Disease (PD) have explained the etiology of only a limited percentage of cases. In this study, we aimed to identify copy number variations (CNVs) in patients with familial PD compared to their healthy siblings.MethodsGenomic microarray analysis was performed using the CytoScan HD array platform, and paired copy number variation analysis was performed using Partek Genomics Suite.ResultsA total of 211 CNVs were detected in patients (genomic markers per CNV >10, markers per base pair >0.0005). Genes localized in CNV regions were enriched in the \"<i>Metabolism of xenobiotics by cytochrome P450</i>\" pathway. Subsequently, CNVs located in regions with segmental duplication, large genomic gap or \"dosage sensitivity unlikely,\" with a frequency higher than 0.01%, and found to be \"both amplified and deleted\" in patients were excluded. Genes potentially affected by exonic copy number losses were HPGDS, TUBB8, ZMYND11, FLI-1, THADA, FAM47E, FAM47E-STBD1, AGMO, CYRIB, and MIR5194, while the detected copy number gains included the exons of the PCSK6, MIR4522, WSB1, C8orf44-SGK3, SGK3, and MCMDC2. No copy number variations were detected on chromosomes 13 and 18.ConclusionsHere, we report the results of the first paired CNV analysis in siblings discordant for Familial Parkinson's Disease. Validation and frequency determination of rare and novel CNVs identified in larger familial PD cohorts may reveal novel PD risk genes. The metabolism of xenobiotics by cytochrome P450 pathway deserves further functional and translational studies in familial Parkinson's disease.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"366-376"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Determination of the biological variation and reference change value of lipoprotein (a). 脂蛋白生物学变异及参考变化值的测定(a)。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-09-01 Epub Date: 2025-02-25 DOI: 10.1177/00045632251324063
Kofi Antwi, Paul Downie, Wycliffe Mbagaya
{"title":"Determination of the biological variation and reference change value of lipoprotein (a).","authors":"Kofi Antwi, Paul Downie, Wycliffe Mbagaya","doi":"10.1177/00045632251324063","DOIUrl":"10.1177/00045632251324063","url":null,"abstract":"<p><p>BackgroundUnderstanding lipoprotein (a) [Lp(a)] measurement variability is essential in establishing its coronary heart disease (CHD) association, and optimizing assessment and management of atherosclerotic cardiovascular disease (ASCVD) risk. We established the components of biological variation (BV) and reference change value (RCV) of Lp(a) in a UK cohort.Method22 healthy individuals were recruited to the study. Blood samples were collected for six consecutive weeks and analysed in duplicate using the Lp(a) assay by Sentinel Diagnostics on the Beckman Coulter AU5800. Outlier, heterogeneity, normality, and trend analysis were performed, followed by CV-ANOVA to determine estimates of BV, adhering to the 14 BIVAC quality items. RCV was calculated based on estimated CV<sub>A</sub> and CV<sub>I</sub>.ResultsFour participants were excluded from the analysis as their mean Lp(a) levels fell below the functional sensitivity of the assay. Mean Lp(a) concentration ranged from 14 to 241 nmol/L. The overall estimate of CV<sub>I</sub> for all participants was 10.9% (95% CI of 9.1 - 13.0%). The RCV for Lp(a) was +31.6%/-24.0%.ConclusionOur study obtained a CV<sub>I</sub> estimate for Lp(a) that aligned consistently with recent studies adhering to the quality specifications outlined in the BIVAC checklist. The CV<sub>I</sub> estimate was significantly lower than Lp(a) estimates reported in studies up to 2003. The CV<sub>I</sub> estimate highlights the limitations of relying solely on a single Lp(a) measurement for prognosticating ASCVD risk and identifying candidates for novel Lp(a) therapies, particularly when the measured value is near clinical decision thresholds.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"342-351"},"PeriodicalIF":1.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical impact of current evidence on cardiac troponin structure, function and release mechanisms - An up to date review. 当前证据对心脏肌钙蛋白结构、功能和释放机制的临床影响-最新综述。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-08-28 DOI: 10.1177/00045632251378025
James Hatherley, Paul Collinson, Eduard Shantsila, David Gaze, Aleem Khand
{"title":"Clinical impact of current evidence on cardiac troponin structure, function and release mechanisms - An up to date review.","authors":"James Hatherley, Paul Collinson, Eduard Shantsila, David Gaze, Aleem Khand","doi":"10.1177/00045632251378025","DOIUrl":"10.1177/00045632251378025","url":null,"abstract":"<p><p>Myocardial infarction remains a significant cause of mortality globally. High-sensitivity cardiac troponin is an essential criterion in the fourth universal definition of myocardial infarction. Our understanding of the structure and release mechanisms of troponin has been updated over the last decade, facilitated by ever more sensitive assays. This review initially outlines the structure and function of the troponin complex, then details the currently proposed mechanisms of release and elimination of troponin. It concludes by using this updated understanding to critique the current universal definition of myocardial infarction and injury.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251378025"},"PeriodicalIF":1.0,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diagnostic accuracy and rapid testing of a novel acute heart failure biomarker: A laboratory evaluation and comparison with natriuretic peptides. 一种新型急性心力衰竭生物标志物的诊断准确性和快速检测:实验室评估和与利钠肽的比较。
IF 1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-08-28 DOI: 10.1177/00045632251378035
Kevin Rouet, Philippe Rouet, François Koukoui, Michel Galinier
{"title":"Diagnostic accuracy and rapid testing of a novel acute heart failure biomarker: A laboratory evaluation and comparison with natriuretic peptides.","authors":"Kevin Rouet, Philippe Rouet, François Koukoui, Michel Galinier","doi":"10.1177/00045632251378035","DOIUrl":"10.1177/00045632251378035","url":null,"abstract":"<p><p>BackgroundDiagnosing acute heart failure in patients presenting with acute dyspnea remains challenging. Current methods, including natriuretic peptide measurement and echocardiography, are time-consuming and not always immediately accessible. A novel biomarker, FILDARIA, may complement natriuretic peptides and enable faster diagnosis.MethodsIn this study (ClinicalTrials.gov: NCT01024049), samples were collected from 235 patients diagnosed via echocardiography: 89 with non-cardiac dyspnea (NCD), 55 with chronic heart failure (CHF), and 91 with acute heart failure (AHF). Levels of BNP and FILDARIA in each patient were measured using both ELISA and lateral flow assay tests.ResultsBNP levels were significantly elevated in AHF and CHF patients compared to NCD patients (905 vs 58 pg/mL, <i>p</i> < .0001; and 447 vs 58 pg/mL, <i>p</i> < .0001, respectively). Similarly, FILDARIA levels were markedly higher in AHF and CHF patients than in NCD patients (1493 vs 223 ng/mL, <i>p</i> < .0001; and 800 vs 223 ng/mL, <i>p</i> < .0001, respectively). The FILDARIA heart failure diagnostic rapid test device accurately identified all 91 AHF patients and correctly excluded 88 of 89 NCD patients, yielding one false positive. Overall diagnostic accuracy was 99.4% (95% CI: 96.9%-99.9%).ConclusionFILDARIA biomarker demonstrates strong potential as a rapid <u>diagnostic</u> tool for AHF in patients with acute dyspnea. Its high accuracy and compatibility with whole blood could make it an excellent solution for point-of-care testing. Further multicentre research could facilitate wider clinical use and clarify its utility in areas such as <u>prognosis</u> (ClinicalTrials.gov: NCT01024049).</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251378035"},"PeriodicalIF":1.0,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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