Annals of Laboratory Medicine最新文献

Analytical Interference of Exemestane With Androstenedione Immunoassays. 依西美坦与雄烯二酮免疫分析法的干扰分析。

IF 4 2区医学

Annals of Laboratory Medicine Pub Date : 2025-07-01 Epub Date: 2025-03-21 DOI: 10.3343/alm.2024.0362

Marina Giralt, Roser Ferrer, Noelia Díaz-Troyano, Belén Vega, Manuel Luque-Ramírez, Sílvia Martínez, Bárbara Fernández, Irene Martínez, Aleix Fabregat, Eulalia Urgell, Ignacio Cardona, Gregori Casals, Héctor F Escobar-Morreale

{"title":"Analytical Interference of Exemestane With Androstenedione Immunoassays.","authors":"Marina Giralt, Roser Ferrer, Noelia Díaz-Troyano, Belén Vega, Manuel Luque-Ramírez, Sílvia Martínez, Bárbara Fernández, Irene Martínez, Aleix Fabregat, Eulalia Urgell, Ignacio Cardona, Gregori Casals, Héctor F Escobar-Morreale","doi":"10.3343/alm.2024.0362","DOIUrl":"10.3343/alm.2024.0362","url":null,"abstract":"Background: Exemestane, an aromatase inhibitor commonly used for breast cancer treatment, shares structural similarities with sex steroids analyzed in clinical laboratories. We aimed to investigate the influence of exemestane cross-reactivity in the measurement of sex steroids across various immunoassays.Methods: We conducted a multicenter study involving measurements of androstenedione, testosterone, estradiol, progesterone, and 17-hydroxyprogesterone in serum samples from women undergoing exemestane therapy (N=15; 25 mg/day). Measurements were performed using liquid chromatography-mass spectrometry (LC-MS) and various commercially available chemiluminescence immunoassays, ELISA, and radioimmunoassay. In-vitro cross-reactivity was assessed by adding exemestane and 17-hydroexemestane to serum samples.Results: Patients undergoing exemestane therapy had markedly falsely elevated androstenedione results in all immunoassays evaluated (N=4), which correlated with serum exemestane levels. In-vitro experiments confirmed this interference to be caused by cross-reactivity with exemestane. Additionally, one immunoassay yielded falsely elevated estradiol results in 20% of patients. However, in-vitro experiments did not confirm this to be caused by cross-reactivity with exemestane or 17-hydroexemestane.Conclusions: Exemestane cross-reacts with androstenedione immunoassays, causing falsely elevated results in treated patients. This analytical interference may raise unnecessary concerns, leading to expensive diagnostic workups.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"410-419"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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

Tuberous Sclerosis Complex Caused by TSC2 Inversion and Deletions Identified Using Whole-genome Sequencing: A Case Study. 使用全基因组测序鉴定由TSC2倒置和缺失引起的结节性硬化症：一个案例研究。

IF 4 2区医学

Annals of Laboratory Medicine Pub Date : 2025-07-01 Epub Date: 2025-06-17 DOI: 10.3343/alm.2025.0063

DongJu Yoon, Jung Ah Kwon, Soo-Young Yoon, Baik-Lin Eun, Jung Yoon

引用次数: 0

Standards and Practice Guidelines for Venous Blood Collection: Consensus Recommendations from the Korean Society for Laboratory Medicine. 静脉血采集的标准和实践指南：韩国检验医学学会的一致建议。

IF 4 2区医学

Annals of Laboratory Medicine Pub Date : 2025-07-01 Epub Date: 2025-06-17 DOI: 10.3343/alm.2025.0022

Jeonghyun Chang, Sooin Choi, Hanwool Cho, Sollip Kim, Jae-Woo Chung, Soo Jin Yoo, Eun Young Song, Sail Chun

{"title":"Standards and Practice Guidelines for Venous Blood Collection: Consensus Recommendations from the Korean Society for Laboratory Medicine.","authors":"Jeonghyun Chang, Sooin Choi, Hanwool Cho, Sollip Kim, Jae-Woo Chung, Soo Jin Yoo, Eun Young Song, Sail Chun","doi":"10.3343/alm.2025.0022","DOIUrl":"10.3343/alm.2025.0022","url":null,"abstract":"High-quality specimens are essential for accurate laboratory results. Preanalytical errors due to issues, such as hemolysis, microclotting, and insufficient specimen volume, account for 60%-70% of laboratory errors and frequently result from improper blood collection techniques or negligence during the collection process. Therefore, standardized blood collection guidelines and continuous education are required. In Korea, standardized venous blood collection procedures have not yet been fully established, highlighting the need for an evidence-based protocol tailored to local requirements. The venous blood collection guideline presented here was adapted from international standards to conform to globally recognized practices and address the Korean clinical context. The guideline, developed by the Korean Society for Laboratory Medicine, outlines the critical steps in venous blood collection, from patient identification and consent to post-collection handling. Practical recommendations are provided for medical students, doctors, nurses, and medical technologists. The guideline addresses specific considerations for pediatric and older patients, as well as individuals undergoing blood culture tests, with an emphasis on minimizing errors and promoting the safety of patients and medical staff. The guideline includes practical tools, such as checklists and detailed information on sampling devices, to facilitate implementation. This initiative would help standardize blood collection practices, improve specimen quality, and enhance patient care by ensuring accurate laboratory results in clinical settings.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"343-357"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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

XN-1000 Hematology Analyzer as an Alternative to Flow Cytometry for Measuring Residual Cells in Blood Components. XN-1000血液学分析仪作为流式细胞术的替代，用于测量血液成分中的残留细胞。

IF 4 2区医学

Annals of Laboratory Medicine Pub Date : 2025-07-01 Epub Date: 2025-02-12 DOI: 10.3343/alm.2024.0448

Anita Siller, Lisa Seekircher, Daniela Schmidt, Lena Tschiderer, Peter Willeit, Harald Schennach, Marco Amato

{"title":"XN-1000 Hematology Analyzer as an Alternative to Flow Cytometry for Measuring Residual Cells in Blood Components.","authors":"Anita Siller, Lisa Seekircher, Daniela Schmidt, Lena Tschiderer, Peter Willeit, Harald Schennach, Marco Amato","doi":"10.3343/alm.2024.0448","DOIUrl":"10.3343/alm.2024.0448","url":null,"abstract":"Background: Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies.Methods: Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytometry (fluorescence-activated cell sorting; FACS).Results: rWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15-0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correlation coefficients of 0.82-0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33-0.84) and rRBCs (0.61, 0.35-0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in >90% of RBC concentrates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively.Conclusions: Sysmex XN-1000 is suitable for residual cell measurements in RBC concentrates and plasma, with some limitations for PLT concentrates.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"437-449"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143397926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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

Pancreatic Cancer Detection and Differentiation from Chronic Pancreatitis: Potential Biomarkers Identified through a High-Throughput Multiplex Proteomic Assay and Machine Learning-Based Analysis. 胰腺癌的检测和慢性胰腺炎的分化：通过高通量多重蛋白质组学分析和基于机器学习的分析确定的潜在生物标志物。

IF 4 2区医学

Annals of Laboratory Medicine Pub Date : 2025-07-01 Epub Date: 2025-04-02 DOI: 10.3343/alm.2024.0492

Young-Gon Kim, Sang-Mi Kim, Soo-Youn Lee

{"title":"Pancreatic Cancer Detection and Differentiation from Chronic Pancreatitis: Potential Biomarkers Identified through a High-Throughput Multiplex Proteomic Assay and Machine Learning-Based Analysis.","authors":"Young-Gon Kim, Sang-Mi Kim, Soo-Youn Lee","doi":"10.3343/alm.2024.0492","DOIUrl":"10.3343/alm.2024.0492","url":null,"abstract":"Background: Pancreatic cancer (PC)-screening methods have limited accuracy despite their high clinical demand. Differential diagnosis of chronic pancreatitis (CP) poses another challenge for PC diagnosis. Therefore, we aimed to identify blood protein biomarkers for PC diagnosis and differential diagnosis of CP using high-throughput multiplex proteomic analysis.Methods: Two independent cohorts (N=88 and 80) were included, and residual serum samples were collected from all individuals (N=168). Each cohort consisted of four groups: healthy (H) individuals and those with CP, stage I/II PC (PC1), or stage III/IV PC (PC2). Protein expression in the first cohort was quantified using the Olink Immuno-Oncology and Oncology 3 proximity extension assay (PEA) panels and was analyzed using machine-learning (ML)-based analyses. Samples in the second cohort were utilized to verify candidate biomarkers in immunoassays.Results: Both the PEA and immunoassay results confirmed that previously recognized biomarkers, such as the mucin-16 and interleukin-6 proteins, were more highly expressed in the PC (PC1 and PC2) groups than in the non-PC (CP and H) groups. Several novel biomarkers for PC diagnosis were identified via ML-based feature extraction, including C1QA and CDHR2, whereas pro-neuropeptide Y (NPY) appeared to be a promising biomarker for the differential diagnosis of CP. Applying XGBoost classification incorporating the selected features resulted in an area under the curve of 0.92 (0.85-0.98) for differentiating the PC group from the CP and H groups.Conclusions: Promising blood biomarkers for PC diagnosis and differential diagnosis of CP were identified using a PEA platform and ML techniques.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"399-409"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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 Thyroid-Stimulating Hormone Level Due to Macro-TSH Interference: A Case Report. 巨量促甲状腺激素干扰导致促甲状腺激素水平虚高1例报告。

IF 4.9 2区医学

Annals of Laboratory Medicine Pub Date : 2025-06-19 DOI: 10.3343/alm.2025.0006

Jing Jin,Xueqi Zhang,Songwen Wang,Zhongyan Shan,Weiping Teng,Xiaochun Teng

引用次数: 0

Advancing Accuracy in Chronic Kidney Disease Diagnosis and Management: Reference Materials and Reference Measurement Procedures for Clinical Markers. 提高慢性肾脏疾病诊断和管理的准确性：临床标志物的参考材料和参考测量程序。

IF 4.9 2区医学

Annals of Laboratory Medicine Pub Date : 2025-06-18 DOI: 10.3343/alm.2024.0583

Hwee Tong Tan,Qinde Liu,Tang Lin Teo

{"title":"Advancing Accuracy in Chronic Kidney Disease Diagnosis and Management: Reference Materials and Reference Measurement Procedures for Clinical Markers.","authors":"Hwee Tong Tan,Qinde Liu,Tang Lin Teo","doi":"10.3343/alm.2024.0583","DOIUrl":"https://doi.org/10.3343/alm.2024.0583","url":null,"abstract":"Chronic kidney disease (CKD) is a major non-communicable disease and a leading cause of mortality worldwide. With the increasing prevalence of risk factors such as diabetes mellitus, obesity, and hypertension in the 21st century, CKD currently affects over 10% of the global population. The clinical and economic burden of this widespread disease is projected to continue to rise worldwide. Early detection, treatment, and monitoring of this progressive condition through accurate clinical laboratory testing of CKD biomarkers are paramount to mitigate this growing healthcare challenge. The development of reference materials (RMs) and reference measurement procedures (RMPs) for these clinical analytes is pivotal to ensuring accurate measurements using in vitro diagnostics. In this review, we emphasize the importance of establishing RMs and RMPs to standardize the measurements of key clinical markers for CKD, i.e., urine and serum creatinine, urine albumin, serum cystatin C, and urea. Standardizing CKD biomarker measurements based on RMs and RMPs can help support global efforts to reduce CKD-related morbidity and healthcare costs by ensuring reliable diagnostic practices.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"43 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144311416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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

Advances in Circulating Biomarkers for Neurodegenerative Diseases, Traumatic Brain Injuries, and Central Nervous System Tumors. 神经退行性疾病、创伤性脑损伤和中枢神经系统肿瘤循环生物标志物研究进展

IF 4.9 2区医学

Annals of Laboratory Medicine Pub Date : 2025-06-18 DOI: 10.3343/alm.2024.0611

Ming Yang,Allison Zhang,Meng Chen,Jing Cao

{"title":"Advances in Circulating Biomarkers for Neurodegenerative Diseases, Traumatic Brain Injuries, and Central Nervous System Tumors.","authors":"Ming Yang,Allison Zhang,Meng Chen,Jing Cao","doi":"10.3343/alm.2024.0611","DOIUrl":"https://doi.org/10.3343/alm.2024.0611","url":null,"abstract":"Neurological disorders, including neurodegenerative diseases, traumatic brain injuries (TBI), and central nervous system (CNS) tumors, are complex conditions that significantly impact patients globally. Timely diagnosis and monitoring are critical for improving outcomes, driving the need for reliable biomarkers. Specifically, biomarkers detectable in cerebrospinal fluid (CSF) and blood offer important insights into disease presence and progression. This review explores the evolution of circulating blood biomarkers for neurodegenerative diseases, TBI, and CNS tumors, highlighting advanced detection technologies from enzyme-linked immunosorbent assays (ELISAs) to electrochemiluminescence (ECL) assays, single-molecule arrays (Simoa), and mass spectrometry. Advanced technologies with enhanced sensitivity and specificity, particularly in detecting low-abundance analytes, facilitate the investigation of CSF biomarkers for various neurological disorders. We also describe the progress in blood-based biomarkers for , emerging as less invasive alternatives to CSF sampling. Clinically, the implementation of Alzheimer's disease (AD) blood biomarkers Aβ42/Aβ40 ratio and Apolipoprotein E isoform-specific peptide can aid the diagnosis, while p-tau181 and p-tau217 differentiates AD dementia from non-AD neurodegenerative diseases. Blood glial fibrillary acidic protein and ubiquitin C-terminal hydrolase-L1 are used in ruling out mild TBI. Despite these innovations, challenges remain, including assay standardization, sensitivity/specificity trade-offs, and the requirement for longitudinal studies to understand biomarker utility over time. Future research should focus on addressing these challenges to fully realize the potential of blood-based biomarkers in neurological disorder diagnostics and patient care.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"23 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144311422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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 Utility of Monitoring Circulating Tumor DNA Using a Targeted Next-generation Sequencing Panel in Patients with Colorectal Cancer. 使用靶向新一代测序面板监测结直肠癌患者循环肿瘤DNA的临床应用

IF 4.9 2区医学

Annals of Laboratory Medicine Pub Date : 2025-06-18 DOI: 10.3343/alm.2024.0598

Hyoeun Shim,Soobeen Heo,Jiyu Sun,Moon Ki Choi,Sung Chan Park,Chang Won Hong,Seong Hoon Kim,Seog-Yun Park,Sun-Young Kong,Ji Yeon Baek

{"title":"Clinical Utility of Monitoring Circulating Tumor DNA Using a Targeted Next-generation Sequencing Panel in Patients with Colorectal Cancer.","authors":"Hyoeun Shim,Soobeen Heo,Jiyu Sun,Moon Ki Choi,Sung Chan Park,Chang Won Hong,Seong Hoon Kim,Seog-Yun Park,Sun-Young Kong,Ji Yeon Baek","doi":"10.3343/alm.2024.0598","DOIUrl":"https://doi.org/10.3343/alm.2024.0598","url":null,"abstract":"BackgroundCirculating tumor DNA (ctDNA) profiling from peripheral blood allows relatively noninvasive monitoring of solid tumors; however, its utility post-surgery or chemotherapy in colorectal cancer remains underexplored. We evaluated the clinical implications of a ctDNA next-generation sequencing (NGS) panel post-surgery or chemotherapy in patients with colorectal cancer.MethodsWe collected samples from 23 patients with colorectal cancer (17 men, median age 65 yrs) at baseline and post-surgery or chemotherapy at the National Cancer Center, Korea, between January 2021 and September 2023. ctDNA was analyzed using an NGS panel including 46 genes, and variant allele frequencies (VAFs) were determined. Follow-up samples were analyzed using the NGS panel or droplet digital PCR (ddPCR) when probes were available. Clinical status was compared with ctDNA results, and survival was analyzed using a time-dependent Cox model.ResultsMutations were identified in 13 out of 14 patients (92.8%) with stage II/III cancer and in all nine patients (100%) with stage IV cancer. Mutations were detected in KRAS (N=15, 65%), APC (N=8, 35%), TP53 (N=7, 30%), PIK3CA (N=5, 22%), and RET (N=4, 17%). A 1% increase in KRAS and TP53 VAFs was associated with 48% and 32% increased mortality risk, respectively. Changes in VAF correlated well with clinical findings.ConclusionsThe detection of and an increase in KRAS and TP53 VAFs were associated with poor prognosis. ddPCR-based ctDNA monitoring results were comparable to those obtained with the NGS panel. ctDNA monitoring during treatment is clinically informative in managing colorectal cancer.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":"12 1","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144311425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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

A Novel Fibrinogen Assay Using Recombinant Batroxobin and Carboxymethyl Chitosan: Carboxymethyl Chitosan Stimulates the Enzymatic Activity of Recombinant Batroxobin. 重组Batroxobin和羧甲基壳聚糖的新型纤维蛋白原测定：羧甲基壳聚糖刺激重组Batroxobin的酶活性。

IF 4 2区医学

Annals of Laboratory Medicine Pub Date : 2025-06-12 DOI: 10.3343/alm.2024.0688

Jung-Ah Kim, Eunhye Ko, Yongje Woo, Young-Doug Sohn, Jong-Tak Kim, Jaewoo Song, Rojin Park

{"title":"A Novel Fibrinogen Assay Using Recombinant Batroxobin and Carboxymethyl Chitosan: Carboxymethyl Chitosan Stimulates the Enzymatic Activity of Recombinant Batroxobin.","authors":"Jung-Ah Kim, Eunhye Ko, Yongje Woo, Young-Doug Sohn, Jong-Tak Kim, Jaewoo Song, Rojin Park","doi":"10.3343/alm.2024.0688","DOIUrl":"https://doi.org/10.3343/alm.2024.0688","url":null,"abstract":"Background: The Clauss assay is widely used to quantify blood fibrinogen levels in clinical laboratories. However, by relying on thrombin as the main reagent, the Clauss assay is susceptible to interference from thrombin inhibitors, such as heparin or direct thrombin inhibitors. Here, we developed an innovative fibrinogen assay utilizing both recombinant batroxobin (rBat) and carboxymethyl chitosan (CMCS).Methods: Various biopolymers were tested to identify a suitable candidate that could enhance rBat-induced fibrin clot formation. Chromogenic substrate hydrolysis and sodium dodecyl sulfate-polyacrylamide gel electrophoresis analysis showed that CMCS potentiated rBat activity. Consequently, we formulated a novel fibrinogen assay reagent, ANYFIB.C, comprising rBat and CMCS. We compared ANYFIB.C fibrinogen with an established reagent (HemosIL fibrinogen-C) with 96 clinical samples using an ACL-TOP 700 coagulation analyzer. We also evaluated the interfering effects of thrombin inhibitors on fibrinogen measurements.Results: CMCS significantly enhanced the enzymatic activity of rBat and dose-dependently reduced plasma clotting times. ANYFIB.C fibrinogen levels were comparable with those of HemosIL fibrinogen-C, with the 95% confidence intervals of the Passing-Bablok regression intercept and slope being -7.4797 to 6.0185 and 0.9581 to 1.0116, respectively. No significant interference was observed with heparin concentrations up to 10 U/mL or dabigatran concentrations up to 600 μg/L in the ANYFIB.C fibrinogen assays. In contrast, the HemosIL fibrinogen-C reagent demonstrated inhibitory interference at dabigatran concentrations as low as 150 μg/L.Conclusions: Our results suggest that ANYFIB.C (a mixture of CMCS and rBat) can be used to measure blood fibrinogen levels effectively and protect from thrombin inhibitor interference.","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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