Clinica Chimica Acta最新文献

{"title":"Development and evaluation of a novel non-competitive MAGLUMI estradiol chemiluminescence immunoassay","authors":"Yueying Wang ,&nbsp;Yun Zhang ,&nbsp;Zhonggang Fang ,&nbsp;Ran Xu ,&nbsp;Qiang Luo ,&nbsp;Jian Liu ,&nbsp;Yixiong Yao ,&nbsp;Wenhai Liang ,&nbsp;Ruiwei Gan ,&nbsp;Tinghua Li ,&nbsp;Zhifang Lin","doi":"10.1016/j.cca.2025.120356","DOIUrl":"10.1016/j.cca.2025.120356","url":null,"abstract":"<div><div>Estradiol is a key estrogen, and measuring its circulating levels is essential for evaluating ovarian function, monitoring follicular development, and assessing reproductive health. In several patient samples, estradiol levels can be extremely low, surpassing the detection capabilities of current competitive immunoassays. This research introduces a non-competitive MAGLUMI estradiol chemiluminescence immunoassay (CLIA) that utilizes a two-step sandwich approach to quantify estradiol levels. The sandwich-based detection system for estradiol was established by preparing monoclonal antibodies for estradiol-primary antibody immune complexes. To optimize the performance of the reagents, we screened the ideal feeding ratios of the primary antibody to magnetic beads and the secondary antibody to ABEI, and then determined the best reaction system. The novel system exhibited higher sensitivity and precision compared to competitive assays. Besides superiority in limit of blank (LoB, 1.0 × 10⁻³ μg/L), limit of detection (LoD, 5.0 × 10⁻³ μg/L), limit of quantification (LoQ, 9.3 × 10⁻³ μg/L) and coefficient of variation for reproducibility (CV, 3.15 %∼9.47 %). The cross-reactivity with estrone, estriol, fulvestrant, abemaciclib and estradiol valerate is notably minimized. Meanwhile, the quantification result of this system strongly correlates with LC-MS/MS (y = 1.008x + 0.8949, R² = 0.981). In conclusion, the non-competitive reagents developed in this study for estradiol detection outperform existing competitive reagents, providing more reliable results for clinical applications.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"575 ","pages":"Article 120356"},"PeriodicalIF":3.2,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068623","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":"Evaluating monocyte distribution width in pediatric emergency care","authors":"Luisa Agnello ,&nbsp;Caterina Maria Gambino ,&nbsp;Fabio Del Ben ,&nbsp;Concetta Scazzone ,&nbsp;Carmelinda Cavallaro ,&nbsp;Claudia Colomba ,&nbsp;Marcello Ciaccio","doi":"10.1016/j.cca.2025.120357","DOIUrl":"10.1016/j.cca.2025.120357","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric sepsis remains a major global health challenge, complicated by age-related variability in presentation and diagnostic uncertainty. Monocyte Distribution Width (MDW), a measure of monocyte anisocytosis automatically reported with complete blood count, has shown promise as an early biomarker for sepsis in adults. However, its clinical utility in pediatric patients remains unclear. In this study, we explored the usefulness of MDW in pediatric patients presenting to the emergency department (ED).</div></div><div><h3>Methods</h3><div>We conducted a retrospective observational study of pediatric patients (&lt;18 years) who presented to the ED for any cause. Patients were categorized into four groups: controls (no infection), infection, sepsis, and shock. MDW values were compared across groups and stratified by age (≤6 years and &gt; 6 years). A receiver operating characteristic (ROC) curve analysis was performed to assess MDW diagnostic performance.</div></div><div><h3>Results</h3><div>A total of 393 patients were enrolled: 117 controls, 183 with infection, 88 with sepsis, and 5 with shock. Overall, MDW values increased with disease severity, peaking in patients with shock. However, significant overlap was observed between infection and sepsis groups, particularly in children ≤ 6 years, where MDW was elevated even in controls. In children &gt; 6 years, MDW showed a clearer stepwise increase across disease categories. ROC analysis revealed an AUC of 0.73 for distinguishing infected from non-infected patients at a cutoff of 24.</div></div><div><h3>Conclusions</h3><div>MDW is a readily accessible biomarker that may aid in identifying pediatric patients with infection in emergency settings.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"575 ","pages":"Article 120357"},"PeriodicalIF":3.2,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143947397","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":"Method comparison and re-calibration of three top-used immunoassays and one LC-MS/MS assay for four core cerebrospinal fluid biomarkers of Alzheimer’s disease: an explorative study for harmonization","authors":"Yutong Zou ,&nbsp;Xiaoli Ma ,&nbsp;Chenhui Mao ,&nbsp;Shanshan Chu ,&nbsp;Tianyi Wang ,&nbsp;Wei Jin ,&nbsp;Yifei Wang ,&nbsp;Songlin Yu ,&nbsp;Jing Gao ,&nbsp;Ling Qiu","doi":"10.1016/j.cca.2025.120352","DOIUrl":"10.1016/j.cca.2025.120352","url":null,"abstract":"<div><h3>Background</h3><div>We aimed to compare the analytical performance of four assays, for measuring β-amyloid 1–42 (Aβ1-42), β-amyloid 1–40 (Aβ1-40), total tau, and p-tau181 in cerebrospinal fluid (CSF) and evaluate the clinical performance for the diagnosis of Alzheimer’s disease (AD).</div></div><div><h3>Methods</h3><div>The measured concentrations and analytical performance, including precision, linearity, and accuracy of four assays were compared. The discriminative accuracy for amyloid positron emission tomography (PET) status based on different assays was evaluated.</div></div><div><h3>Results</h3><div>The measurements of the four biomarkers based on the four assays demonstrated favorable agreement, while still significantly different. For the discrimination of PET status, the ratio of Aβ1-42/p-tau181 showed better diagnostic performance than other biomarkers, with liquid chromatography tandem-mass spectrometry (LC-MS/MS) and Lumipulse G assays performing better when combining all biomarkers for each assay.</div></div><div><h3>Conclusions</h3><div>It is crucial to promote the harmonization and standardization of pre-analytical and measurement procedures to achieve consistent and comparable results in different assays and laboratories.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"575 ","pages":"Article 120352"},"PeriodicalIF":3.2,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984978","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":"Comparability evaluation of serum and plasma cytokine levels by multiplex bead-based flow cytometry","authors":"Xiaoran Feng ,&nbsp;Wenrong Zou ,&nbsp;Pan Li ,&nbsp;Kai Guo ,&nbsp;Yating Ma ,&nbsp;Gaofeng Hu ,&nbsp;Jian Kang ,&nbsp;Xinjian Yu ,&nbsp;Mingting Peng","doi":"10.1016/j.cca.2025.120351","DOIUrl":"10.1016/j.cca.2025.120351","url":null,"abstract":"<div><h3>Background and aims</h3><div>Serum and plasma are the most common matrices for cytokine assays. Nevertheless, there is a lack of comparability evaluation for cytokine levels in two matrices based on multiplex bead-based flow cytometry. The study aimed to evaluate the comparability of IL-6, IL-8, and IL-10 serum- and plasma-based measurement results using flow cytometry.</div></div><div><h3>Materials and methods</h3><div>The serum and EDTA-K₂ plasma were collected from three cohorts of hematologic malignancy patients (n = 66, 75, and 37, respectively) to evaluate comparability of IL-6, IL-8, and IL-10 measurement results using QuantoBio 14-plex cytokine kit on the BeamCyte-1026 flow cytometry. The Passing-Bablok regression was performed between serum- and plasma-based levels of cytokines. Additionally, the relative deviation of cytokine measurement results from the two matrices was compared with the allowable limits from the China National External Quality Assessment cytokine program.</div></div><div><h3>Results</h3><div>The results revealed a relatively high correlation in IL-6, IL-8, and IL-10 levels between serum and plasma, with correlation coefficients of 0.966, 0.924, and 0.985, respectively. However, the comparability in the two matrices was unsatisfactory. Compared to plasma, the relative deviation of IL-6, IL-8, and IL-10 in serum was 74.8 %, −29.3 %, and 46.5 %, respectively, and only 20 % (IL-6), 31 % (IL-8), and 38 % (IL-10) of samples met allowable limits.</div></div><div><h3>Conclusions</h3><div>Poor comparability was found between serum- and plasma-based measurement results. Moreover, given the great potential of cytokine profiling in diagnosing and treating diseases, there is an urgent need to develop accurate and consistent processing of samples of cytokine assays to improve the accuracy and reproducibility of results and ensure the specimen’s fitness for purpose.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"575 ","pages":"Article 120351"},"PeriodicalIF":3.2,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143947396","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":"Limitations of hemolysis-based correction for potassium measurement in hemolyzed whole blood samples","authors":"Laura Pighi,&nbsp;Gian Luca Salvagno,&nbsp;Giuseppe Lippi","doi":"10.1016/j.cca.2025.120353","DOIUrl":"10.1016/j.cca.2025.120353","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120353"},"PeriodicalIF":3.2,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935812","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":"Euthyroid hyperthyroxinemia: relevance of albumin and transthyretin genetic variations in a single centre experience","authors":"Ilaria Piva ,&nbsp;Barollo Susi ,&nbsp;Censi Simona ,&nbsp;Bertazza Loris ,&nbsp;Ruggeri Edoardo ,&nbsp;Cristina Clausi ,&nbsp;Alfonso Massimiliano Ferrara ,&nbsp;Annalisa Stefani ,&nbsp;Monica Maria Mion ,&nbsp;Martina Montagnana ,&nbsp;Caterina Mian","doi":"10.1016/j.cca.2025.120354","DOIUrl":"10.1016/j.cca.2025.120354","url":null,"abstract":"<div><h3>Objectives</h3><div>Euthyroid Hyperthyroxinemia (EH) is a condition consisting of high total T4 (TT4), variable total T3 (TT3), endogenous free T4 (fT4) and free T3 (fT3) within the reference interval, normal TSH, absence of thyroid disease. EH may be due to genetic alterations of <em>albumin (ALB)</em>, <em>transthyretin (TTR)</em> and <em>thyroxine binding globulin (TBG)</em> genes. Our study aimed to evaluate the frequency of inherited conditions affecting thyroid hormones transport proteins, associated with EH.</div></div><div><h3>Methods</h3><div>We retrospectively enrolled 42 patients with EH who underwent genetic testing for <em>ALB</em> and <em>TTR</em> mutations. A control group of 58 patients, having normal thyroid function tests, negative for <em>ALB</em> and <em>TTR</em> mutations, was selected. Direct sequencing of exons 1,2,3,4 of <em>TTR</em> gene (NM_000371.4), exon 7 of <em>ALB</em> gene (NM_000477.7) was performed.</div></div><div><h3>Results</h3><div>In 42 patients with EH, <em>ALB</em> p.R218H (c.653G &gt; A) variant was found in 20 subjects (47.6 %); 7 subjects (16.7 %) had <em>TTR</em> gene variants; 15 patients (35.7 %) were wild-type for <em>ALB</em> and <em>TTR</em> genetic testing. FT4 concentration was not dependent on the presence of sequence variants. We compared thyroid hormones levels of all carriers of <em>ALB</em> and <em>TTR</em> variants, including relatives positive for <em>ALB</em> and <em>TTR</em> variants, with 58 controls negative for <em>ALB</em> and <em>TTR</em> mutation. We observed a statistically significant difference between fT4 levels according to mutational status, being fT4 in <em>ALB</em>-mutated: 24.47 ± 2.58 pmol/L, in <em>TTR</em>-mutated: 20.65 ± 3.75 pmol/L; in controls: 14.50 ± 1.65 pmol/L (mean ± 1 standard deviation) (p &lt; 0.000001).</div></div><div><h3>Conclusions</h3><div>After exclusion of secondary causes, genetic variation in thyroid hormones transport proteins is a common cause of EH.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120354"},"PeriodicalIF":3.2,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143943464","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":"Reference ranges for select elements and metals in healthy biomatrices","authors":"Mohammad Hassan Emami ,&nbsp;Safoora Mohammadzadeh ,&nbsp;Nasrin Zare ,&nbsp;Farideh Saberi ,&nbsp;Alireza Fahim ,&nbsp;Owais Yousuf ,&nbsp;Zakieh Keshavarzi ,&nbsp;Pouria Samadi ,&nbsp;Samane Mohammadzadeh ,&nbsp;Fatemeh Maghool","doi":"10.1016/j.cca.2025.120331","DOIUrl":"10.1016/j.cca.2025.120331","url":null,"abstract":"<div><h3>Introduction/Objective</h3><div>This review aimed to consolidate and compare reference values (RVs) for various elements and metals in biological samples from healthy populations worldwide.</div></div><div><h3>Methods</h3><div>A Web of Science/PubMed/Scopus review was conducted. Original articles in the English language, from January 2012 to February 2022, with at least 120 participants and 3 evaluated elements, and biological samples of whole blood, serum, plasma, umbilical cord, and hair included in this review.</div></div><div><h3>Results</h3><div>Ninety-nine studies were screened and assessed, and eventually, 29 eligible studies from 15 countries and a total recruitment of 26,676 healthy subjects, ages ranging from zero to 80 years were included in this review. The results of evaluating 36 trace/micro/meso/macro/ toxic metals and elements in biological fluids and hair were extracted from eligible studies. Several indicators include reference range (lower, upper), arithmetic and geometric mean, median, percentile (lower, upper), and confidence interval (CI) 95 % of evaluated elements were reported. Due to geographical conditions, different demographic factors, and different analytical methodologies, the results of the analysis were various in different countries.</div></div><div><h3>Conclusions</h3><div>This review points out the necessity for localized RVs and standardized methodologies for accurate clinical evaluations and bio-monitoring. The findings call for extensive studies across diverse populations to develop comprehensive RVs for elements and metals, ensuring effective health assessments and environmental exposure controls.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"575 ","pages":"Article 120331"},"PeriodicalIF":3.2,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986696","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":"Unique motif Sequences for early diagnosis of preeclampsia","authors":"Farizky Martriano Humardani ,&nbsp;Agustina Tri Endharti ,&nbsp;Ratih Asmana Ningrum ,&nbsp;I Wayan Arsana Wiyasa ,&nbsp;Lisa Thalia Mulyanata ,&nbsp;Yulanda Antonius ,&nbsp;Jonathan Jonathan ,&nbsp;Sulistyo Emantoko Dwi Putra","doi":"10.1016/j.cca.2025.120339","DOIUrl":"10.1016/j.cca.2025.120339","url":null,"abstract":"<div><div>Preeclampsia (PE) is a disease that significantly impacts both maternal and infant health with its prevalence varying across different ethnicities. Current diagnostic methods for PE typically identify the condition after 20 weeks of gestation, often when the disease has already manifested and reached an advanced stage. The situation underscores the urgent need for early biomarkers capable of effective screening and diagnosis. Our review addresses this challenge by utilizing bioinformatics approaches as an alternative method prior to preclinical and clinical studies. Specifically, we focus on FRAGmentomics-based Methylation Analysis (FRAGMA), targeting the CGCGCGG sequence motif for methylation studies in cell-free DNA (cfDNA). Since cfDNA is largely derived from the placenta, the FRAGMA approach is particularly promising, given that the primary pathophysiology of PE originates in the placenta, and methylation patterns are unique to specific tissues. In the previous research, we identified 66 genes containing this sequence motif that are implicated in the pathophysiology of PE, and only six genes – FN1, ITGA2, ITGA5, ITGB1, ITGB3, and VWF – show potential as early detection biomarkers for PE. These genes still require further investigation to confirm their utility as biomarkers for PE in the future studies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120339"},"PeriodicalIF":3.2,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143928311","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":"A sample-in- result -out microfluidic system for β-thalassemia diagnostics via direct whole blood PCR-reverse dot blot","authors":"Chao Ye ,&nbsp;Yan Wei ,&nbsp;Yilian Zhao ,&nbsp;Tan Tan ,&nbsp;Youqiong Li ,&nbsp;Xigui Long ,&nbsp;Huiyuan Gao ,&nbsp;Xiaoxing Zhou ,&nbsp;Mengru Xie ,&nbsp;Jilin Qing ,&nbsp;Zhizhong Chen","doi":"10.1016/j.cca.2025.120348","DOIUrl":"10.1016/j.cca.2025.120348","url":null,"abstract":"<div><h3>Objective</h3><div>Existing thalassemia detection methods demand high − end labs and have complex procedures, leading to long testing cycles. This study aims to develop a convenient detection method integrated with a microfluidic platform for a sample − to − result process. Method: First, optimal conditions for the whole blood direct PCR − reverse dot hybridization (dPCR − RDB) system were explored. Then, its performance was evaluated with clinical samples. Finally, the entire process was integrated into a palm − sized microfluidic chip for “sample − in, result − out” detection. Result: A stable dPCR − RDB system was established. Clinical verification on 149 samples showed a 0.1 μl whole − blood minimum detection limit, 100 % specificity, and resistance to high triglyceride and bilirubin levels. It had 100 % positive and negative coincidence rates with traditional methods (kappa = 1). The microfluidic − integrated platform achieved “sample − in, result − out” with 0.5–1 μl blood in 130 min, sans a PCR lab.</div></div><div><h3>Conclusion</h3><div>A “sample − in, result − out” microfluidic gene detection platform using whole blood as the template was successfully established.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120348"},"PeriodicalIF":3.2,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143928312","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":"Tailored pharmacotherapy monitoring in Parkinson’s disease and Schizophrenia using a rapid and sensitive α-Synuclein assay","authors":"Neelam Upadhyay ,&nbsp;Manjari Tripathi ,&nbsp;Rakesh Kumar Chaddha ,&nbsp;Rashmi Ramachandran ,&nbsp;Arunmozhimaran Elavarasi ,&nbsp;Gururao Hariprasad ,&nbsp;Ravikrishnan Elangovan","doi":"10.1016/j.cca.2025.120349","DOIUrl":"10.1016/j.cca.2025.120349","url":null,"abstract":"<div><h3>Background</h3><div>While Parkinson’s disease is a low dopamine neurodegenerative disorder, Schizophrenia is considered a high dopamine psychiatric disorder. Pharmacological interventions that are directed to normalize dopamine concentrations in the mid-brain for an extended duration lead to unintended consequences. Parkinson’s disease patients experience psychosis, and Schizophrenia patients develop extra-pyramidal symptoms due to dopamine levels overshooting their physiological range. An objective monitoring technique is therefore required for better therapeutic efficacy in these two neurological diseases.</div></div><div><h3>Methods</h3><div>A rapid and sensitive assay for α-Synuclein based on magnetic enrichment and enzymatic fluorescent signal generation was developed. This assay has been benchmarked with conventional ELISA and validated in 53 CSF and 36 serum samples.</div></div><div><h3>Results</h3><div>Developed assay from an experimental perspective has a sensitivity of less than 10 pg/mL; requires a turnaround time of 45 mins; and uses 2 µL of CSF/serum fluid samples to quantify alpha synuclein. From a utility perspective, the assay showed (a) a two-fold linearity across clinical phenotypes of Parkinson’s disease, neurological controls, and schizophrenia patients; (b) variation between the naïve and treated patients; (c) correlation with severity of the disease. From a diagnostic perspective, the serum-based assay had a 100 % specificity and a minimum of 67 % sensitivity in differentiating naïve patients from treated patients; the CSF/serum-based assays had a minimum of 91 % specificity and a minimum of 85 % sensitivity in differentiating patients from neurological controls.</div></div><div><h3>Conclusions</h3><div>The developed assay can be used to quantify alpha-synuclein in serum and CSF samples, thereby setting a translational platform for diagnosis, prognosis, and monitoring pharmacotherapy patients with Parkinson’s disease and Schizophrenia.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120349"},"PeriodicalIF":3.2,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143922114","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}