Clinical biochemistry最新文献

{"title":"Sustainable healthcare and medical laboratories: The impact of global collaborations between frameworks and initiatives.","authors":"Fikriye Uras","doi":"10.1016/j.clinbiochem.2025.110945","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.110945","url":null,"abstract":"<p><p>Climate change is a pressing global challenge that requires urgent action. The Paris Agreement and the 2030 Agenda of United Nations (UN) set clear global targets for emission reduction and sustainability to limit warming to 1.5 °C. Partnerships between standardization organizations are crucial in accelerating climate action. The Geneva Sustainability Centre (GSC) is at the forefront of healthcare sustainability, launching the Sustainability Accelerator Tool (SAT) in 2023 to help hospitals assess their environmental impact. In partnership with GSC, Joint Commission International (JCI) has integrated sustainability into its accreditation standards and will introduce the JCI-GSC Healthcare Sustainability Certification in 2025, built on the SAT. To accelerate the achievement of the Sustainable Development Goals (SDGs), ISO and the UN formed a strategic partnership in 2023 to create the first global SDG standard. ISO has published the IWA 42:2022 Net Zero Guidelines and is developing its first global Standard on Net Zero, set for release in 2025. Additionally, ISO introduced the Climate Change Amendments, embedding climate considerations into over 30 existing management system standards, including ISO 9001. With these amendments now shaping all newly developed or revised standards, future updates to ISO 15189 will likely incorporate sustainability requirements, especially as ISO 9001 is an essential part of ISO 15189. Reducing operational emissions from healthcare and medical laboratories alone will not achieve net zero. A sector-wide approach is essential, tackling supply chain emissions from energy, pharmaceuticals, and medical devices. Combating climate change requires a coordinated, cross-sector effort, making international collaboration indispensable. This review highlights key global frameworks, standards, guidelines, and initiatives that have evolved through collaboration to help healthcare organizations, including medical laboratories, to advance sustainability and climate resilience.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110945"},"PeriodicalIF":2.5,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The comparison of miRNA expression levels in Type 2 diabetes and diabetic peripheral neuropathy patients.","authors":"Aleyna Ayaz, Sibel Kuras, Bekir Erdogan, Hanife Serife Aktas, Mahmud Esad Pence, Halime Hanim Pence","doi":"10.1016/j.clinbiochem.2025.110946","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.110946","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to investigate the correlation between miRNA expression levels in patients with type 2 diabetes mellitus (T2DM) and diabetic peripheral neuropathy (DPN) and determine their potential functions in DPN.</p><p><strong>Material and methods: </strong>The study participants were between 30 and 75 years old and divided into three groups: 30 patients with Type 2 T2DM without DPN (group 1), 30 patients with DPN (group 2), and 30 healthy controls (group 3). Whole blood samples were obtained from the individuals forming the groups, and the expression of the miR-128a, miR-146a, miR-155, and miR-375 genes in these samples was determined by real-time polymerase chain reaction (PCR). RNU6 was used as the housekeeping gene.</p><p><strong>Results: </strong>No significant differences were observed in the expression levels of miR-128a, miR-146a, and miR-155 among all groups (p > 0.05). However, miR-375 expression levels differed significantly between the group 2 and the group 3 (p < 0.05). No significant differences in miR-375 expression levels were found between the group 1 and the group 3, nor between the group 1 and the group 2 (p > 0.05).</p><p><strong>Conclusions: </strong>miR-375 may be linked to the progression of diabetic peripheral neuropathy (DPN).</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110946"},"PeriodicalIF":2.5,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biomarker profiling for infection diagnosis in emergency departments: A diagnostic study evaluating C-reactive protein, procalcitonin, Club Cell Protein 16, interleukin-6, chitinase-like protein, and soluble urokinase-type plasminogen activator receptor.","authors":"Rasmus Bruhn, Helene Skjøt-Arkil, Thor Aage Skovsted, Claus Lohman Brasen, Eline Sandvig Andersen, Anne Heltborg, Mathias Amdi Hertz, Eva Rabing Brix Petersen, Christian Backer Mogensen, Antoni Torres, Mariana Bichuette Cartuliares","doi":"10.1016/j.clinbiochem.2025.110943","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.110943","url":null,"abstract":"<p><strong>Introduction: </strong>Diagnosing infections in emergency departments (EDs) is vital for prompt and effective treatment. This study evaluates the diagnostic accuracy of six inflammatory biomarkers-CC16, CRP, IL-6, PCT, suPAR, and YKL-40-in ED patients with suspected infections.</p><p><strong>Materials and methods: </strong>This was a multicenter diagnostic accuracy study. Adult patients suspected of infections at four Danish EDs were included. We measured biomarker levels at admission and analyzed their diagnostic performance.</p><p><strong>Results: </strong>The study included 966 patients, with 789 (81.7%) confirmed infections. CRP, IL-6, and PCT demonstrated the highest positive predictive values, recorded at 93% (95% CI, 91-95), 92% (95% CI, 90-94), and 91% (95% CI, 88-93), respectively. However, the negative predictive values of these markers were low, at 35.5 (95% CI, 30.8-40.5), 38.3 (95% CI, 32.5-44.3) and 34.2 (95% CI, 28.9-39.9) respectively at Youden Index. CRP, IL-6, and PCT were the most predictive, with CRP demonstrating an area under the curve (AUC) of 0.79. IL-6 and PCT showed similar levels of accuracy. CC16, suPAR, and YKL-40 displayed AUCs in the range of 0.53-0.64. CRP levels peaked three days after symptoms appeared, whereas PCT levels were highest upon symptom onset and admission. The influence of fever enhanced the sensitivity of IL-6 and PCT.</p><p><strong>Conclusion: </strong>CRP, IL-6, and PCT showed the best diagnostic accuracy among the biomarkers tested but are influenced by the timing of symptom onset and fever presence. CC16, suPAR, and YKL-40 had poor diagnostic accuracy and were considered poor discriminators. Overall, no single biomarker was sufficient to conclusively rule in or rule out infection. These findings support the need for nuanced interpretation when using biomarkers to diagnose infections in ED settings.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110943"},"PeriodicalIF":2.5,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Venous lactate as a tool for the Risk-Stratification of patients with acute pulmonary embolism: A retrospective cohort study","authors":"Eun Sang Lee ,&nbsp;Kyle E. Chang ,&nbsp;Christiana K. Prucnal ,&nbsp;Karsten Stannek ,&nbsp;Paige Koetter ,&nbsp;William B. Stubblefield ,&nbsp;Isabel Dhar ,&nbsp;Drew A. Birrenkott ,&nbsp;Grace Wang ,&nbsp;Timothy M. Matthews ,&nbsp;Nora Horick ,&nbsp;Gregory A. Peters ,&nbsp;Tyleah Brown ,&nbsp;Christopher Kabrhel","doi":"10.1016/j.clinbiochem.2025.110942","DOIUrl":"10.1016/j.clinbiochem.2025.110942","url":null,"abstract":"<div><h3>Introduction</h3><div>Prognostication in pulmonary embolism (PE) is crucial due to the broad range of clinical severity, and biomarkers such as arterial lactate are considered helpful markers for illness severity. Venous lactate is more readily accessible, but its prognostic value in acute PE has not been widely evaluated. We aimed to determine optimal cutoffs for venous lactate in predicting adverse outcomes in patients with PE.</div></div><div><h3>Methods</h3><div>We performed a retrospective study of normotensive (systolic blood pressure &gt; 100 mmHg) patients presenting with imaging-confirmed PE severe enough to require Pulmonary Embolism Response Team (PERT) activation and a venous lactate measured clinically within 24 h of activation. Data were extracted from an ongoing registry of PERT patients at a single, tertiary academic medical center. The primary outcome was clinical deterioration defined by a composite of clinical events occurring within 7 days, including death, catheter-based intervention, systemic thrombolysis, extracorporeal membrane oxygenation (ECMO), or intubation. We performed a receiver operating characteristic (ROC) curve analysis, calculated the area under curve (AUC), and calculated optimal cutoff value using the least distance from (0,1).</div></div><div><h3>Results</h3><div>We included 145 patients in the final analysis. Mean age was 64 years and 61 (43 %) were female. 36 patients (26 %) met the composite outcome. The AUC of the ROC curve was 0.56, and the optimal cutoff for venous lactate was 1.8 mmol/L, corresponding to 58 % sensitivity and 61 % specificity.</div></div><div><h3>Conclusion</h3><div>In a cohort of normotensive patients with severe acute PE, venous lactate was not significantly associated with acute deterioration. Our findings do not support the use of venous lactate for prognostication of clinical deterioration in patients with PE severe enough to warrant PERT activation.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110942"},"PeriodicalIF":2.5,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143927385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Shortcoming of serum B-cell maturation antigen measurement by enzyme-linked immunosorbent assay in one laboratory’s experience: Unsatisfactory assay reproducibility","authors":"Ian Cheong ,&nbsp;Christopher Liang ,&nbsp;Vipin Bhayana ,&nbsp;Ivan Stevic ,&nbsp;Martha Louzada ,&nbsp;Ian Chin-Yee ,&nbsp;Angela C. Rutledge","doi":"10.1016/j.clinbiochem.2025.110941","DOIUrl":"10.1016/j.clinbiochem.2025.110941","url":null,"abstract":"<div><h3>Introduction</h3><div>Serum protein electrophoresis and serum free light chain (SFLC) assays are standard methods for monitoring patients with multiple myeloma (MM). However, patients with non-secretory MM often require invasive bone marrow biopsies to monitor treatment response and disease progression. Recently, serum soluble B-cell maturation antigen (sBCMA) has been proposed as an alternative biomarker for monitoring of MM, including non-secretory disease. We aimed to optimize the performance of and validate a serum sBCMA enzyme-linked immunosorbent assay (ELISA) from R&amp;D Systems for research and eventual clinical use.</div></div><div><h3>Methods and Results</h3><div>A total allowable error of 25 % was used, with one-third (8.3 %) budgeted for imprecision, one-third for bias, and one-half (12.5 %) as the allowable deviation from linearity. For imprecision, the repeatability coefficient of variation (CV) was acceptable, but the within-laboratory CV was not. We were limited in our ability to assess accuracy, but recovery of the ELISA standards was acceptable, and the sBCMA concentrations determined in various patient populations compared well to previous publications. The sBCMA concentration also correlated significantly with the M−protein concentration and the involved/uninvolved SFLC ratio. The sBCMA ELISA was verified to be linear within the allowable deviation between 99.04–1179.36 pg/mL. We attempted to confirm stability of serum sBCMA stored at room temperature, 4 °C, and −20 °C for up to 50 weeks, but the assay reproducibility was too poor for this to be assessed adequately.</div></div><div><h3>Conclusion</h3><div>Despite efforts to optimize the performance of the ELISA, the results were not reproducible enough over time to allow us to implement this sBCMA ELISA for clinical use.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110941"},"PeriodicalIF":2.5,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143924128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hook effect although rare, still exists","authors":"Giulia Napoli ,&nbsp;Simone Leggeri ,&nbsp;Carla Lombardi ,&nbsp;Giorgia Mazzuccato ,&nbsp;Andrea Urbani ,&nbsp;Silvia Baroni","doi":"10.1016/j.clinbiochem.2025.110947","DOIUrl":"10.1016/j.clinbiochem.2025.110947","url":null,"abstract":"<div><h3>Background</h3><div>The hook effect occurs when extremely high concentrations of an analyte in the sample, saturate the antibodies used in the method, leading to falsely low results.</div></div><div><h3>Case</h3><div>We describe a case observed with the Atellica IM 1600 (Siemens) analyzer for the measurement of human chorionic gonadotropin (β-HCG) in serum of a pregnant woman at the thirteenth week of pregnancy.</div></div><div><h3>Discussion</h3><div>The β-HCG result was inconsistent with the gestational age and helped us to highlight the hook effect and supported the clinical diagnosis of vesicular mole in the patient. The same sample was also analyzed using the Alinity-i Total β-hCG kit (Abbott), and the authors highlight how differences between diagnostic kits can significantly affect the analytical result.</div></div><div><h3>Conclusions</h3><div>In cases of discrepancies between laboratory data and clinical findings, it is essential to consult with laboratory specialists to rule out analytical interferences. To minimize the risk of the hook effect, we modified the analytical procedure and submitted a report to Siemens European Support.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"138 ","pages":"Article 110947"},"PeriodicalIF":2.5,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143917658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determining susceptibility of routine clinical biochemistry assays to methylene blue interference","authors":"Ivan Stevic ,&nbsp;Tina Kllapi ,&nbsp;Vipin Bhayana ,&nbsp;Arish Jasani ,&nbsp;Angela C. Rutledge","doi":"10.1016/j.clinbiochem.2025.110940","DOIUrl":"10.1016/j.clinbiochem.2025.110940","url":null,"abstract":"<div><h3>Introduction</h3><div>Methylene blue (MB) is a blue-coloured treatment for multiple indications, including methemoglobinemia. Its interference potential with spectrophotometric and/or colorimetric clinical assays has not been well studied.</div></div><div><h3>Objective and methods</h3><div>We determined an MB absorbance spectrum and identified spectrophotometric assays in our core laboratory with interference potential based on their wavelengths. We identified twelve Roche cobas c502/c702 chemistry assays and co-oximetry on the Werfen GEM Premier 4000 blood gas analyzers as potentially susceptible. We also tested colorimetric urinalysis performed on a Roche cobas u601 urine analyzer. For Roche cobas c502/c702 assays or urinalysis, we performed an initial study with MB mostly at concentrations of 10 or 100 mg/L (or water as a control) in leftover patient specimens with relevant analyte concentrations. For co-oximetry, venous whole blood from healthy donors was spiked with MB. For assays with differences between MB-spiked samples and controls exceeding total allowable error, dose–response studies were performed to better characterize the MB concentrations causing interference.</div></div><div><h3>Results</h3><div>MB &gt;0.1, &gt;0.01, and &gt;0.08 mg/L, respectively, caused negative interference with the cobas c502 hemolysis index, positive interference with the cobas c502 lipemia index, and positive interference with the cobas c702 urine amphetamines assay. MB at ≥50–70 mg/L in venous whole blood yielded incalculable co-oximetry results on the GEM Premier 4000. These interferences were not felt to be clinically concerning. However, a urine MB concentration of ≥5 mg/L interfered with most urinalysis parameters on the cobas u601 analyzer. Automated comments based on colour detection were introduced to make clinicians aware of potential MB interference with urinalysis.</div></div><div><h3>Conclusion</h3><div>We identified the assays in our core laboratory susceptible to MB interference and addressed them where clinically indicated.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110940"},"PeriodicalIF":2.5,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143900042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Green laboratory practice: Top 2 environmental recommendations for clinical laboratories.","authors":"Saranya Arnoldo, Dana Bailey, Felix Leung, Ihssan Bouhtiauy, Mohamed Abou El Hassan, Curtis Oleschuk, Daniel R Beriault","doi":"10.1016/j.clinbiochem.2025.110944","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2025.110944","url":null,"abstract":"<p><p>Choosing Wisely Canada has made significant contributions to diagnostic stewardship and appropriate test ordering. Given that laboratories play a crucial role in advancing healthcare efficiency and sustainability, it is imperative to continue advocating for Choosing Wisely laboratory initiatives to minimize unnecessary testing and mitigate the associated environmental impact. Herein, we recommend the focus on two environmental impacts associated with the overuse of diagnostic laboratory tests. Firstly, collaboration with healthcare providers is essential to raise public awareness about the waste generated by performing lab tests in the absence of a clear clinical indication. Not only does unnecessary testing come with clinical and financial costs, but it also contributes significantly to a substantial carbon footprint. Patients also have a role in reducing waste by understanding when tests are truly necessary and when they might be redundant or even harmful. Secondly, laboratories should partner with in vitro diagnostic device manufacturers to prioritize environmentally conscientious solutions. This includes minimizing the use of single-use consumables, toxic chemicals, and high-energy consumption processes. Laboratories should adopt a holistic, \"environmental lens\" approach, scrutinizing every stage of the laboratory total testing workflow- from sample collection and transportation, to testing, reporting, and disposal-to identify areas where waste reduction and process efficiencies can be achieved. The optimization of testing workflows to eliminate unnecessary steps can lead to both environmentally sound and cost-effective operations. In summary, laboratories are in a unique position to lead the way in both improving clinical care and driving eco-friendliness in healthcare. By aligning with Choosing Wisely initiatives and focusing on greener practices, laboratories can lead the way in improving both patient care and environmental sustainability.</p>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":" ","pages":"110944"},"PeriodicalIF":2.5,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Critical appraisal of the MPER model: Validation rigor and clinical translation considerations","authors":"Shanshan Yuan ,&nbsp;Wenya Han","doi":"10.1016/j.clinbiochem.2025.110939","DOIUrl":"10.1016/j.clinbiochem.2025.110939","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110939"},"PeriodicalIF":2.5,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143878583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance of the Siemens’ thyroid stimulating immunoglobulin assay in the diagnosis of hyperthyroidism: Prospective cohort study","authors":"Gregory A. Kline ,&nbsp;Dustin T. Proctor ,&nbsp;Nadia Moledina ,&nbsp;Heather A. Paul ,&nbsp;Jason L. Robinson ,&nbsp;Cody Lewis ,&nbsp;Lois Donovan ,&nbsp;Hossein S.M. Sadrzadeh","doi":"10.1016/j.clinbiochem.2025.110938","DOIUrl":"10.1016/j.clinbiochem.2025.110938","url":null,"abstract":"<div><h3>Background</h3><div>Auto-antibody testing is recommended for Graves’ Disease (GD). The thyroid-stimulating-immunoglobulin (TSI) bridge method is designed to provide specificity for stimulatory antibodies to the TSH receptor which may translate to differences in performance in diagnosis of GD compared to TSH-receptor-antibody (TRAb) assays that don’t distinguish between TSH-receptor antibody subclasses. The objective of this study was to prospectively compare the performance of a TSI assay to a TRAb assay for diagnosis of GD.</div></div><div><h3>Methods</h3><div>A total of 158 non-pregnant patients with new-onset hyperthyroidism were recruited into the study by endocrinologists. Final diagnosis of GD or non-GD was made by endocrinologists after clinical assessment and diagnostic work-up (TSH, free T4, TRAb and imaging). TSI results were blinded. Sensitivity/specificity of TRAb and TSI were determined; receiver operating characteristic (ROC) curve analysis was used to compare overall accuracy and optimal diagnostic thresholds for each assay.</div></div><div><h3>Results</h3><div>Complete assessment was available for 131/158 patients (95 GD and 36 non-GD). A strong correlation between TRAb and TSI existed (r = 0.92 (0.89–0.94), p &lt; 0.0001). There was no significant difference between tests, area under the curve (AUC) (0.935 vs 0.929, p = 0.86) using manufacturer’s recommended thresholds. Both assays had sensitivity around 88 % and specificity 80–90 %. The ROC-determined threshold for 95 % GD specificity was 3.63 IU/L (TRAb) and 0.98 IU/L (TSI) with corresponding sensitivities 77.5 % and 86.2 %. Assuming nuclear tracer thyroid scanning for results below 95 % specificity, 14 (14.7 %) GD patients would require a scan after TRAb, and 7 (7.4 %) after TSI.</div></div><div><h3>Conclusions</h3><div>TRAb and TSI performed similarly in the work up of hyperthyroidism; an optimized specificity threshold might permit TSI testing to reduce nuclear tracer thyroid scan requirements, without losing diagnostic sensitivity.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110938"},"PeriodicalIF":2.5,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143874943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}