Clinica Chimica Acta最新文献

{"title":"A prospective cohort study on serum PINK1 as a biochemical marker in relation to poor neurological prognosis, stroke-associated pneumonia and early neurological deterioration after acute intracerebral hemorrhage","authors":"Weifang Ni,&nbsp;Si-Hua Chen,&nbsp;Le Dai,&nbsp;Yifu Zhou,&nbsp;Chenjun He","doi":"10.1016/j.cca.2025.120282","DOIUrl":"10.1016/j.cca.2025.120282","url":null,"abstract":"<div><h3>Background</h3><div>PTEN-induced putative kinase 1 (PINK1) may moderate neurodegeneration via sustaining mitochondrial function and integrity. Here, we attempted to determine relationship between serum PINK1 levels, disease severity, poor prognosis, Early Neurological Deterioration (END) and Stroke-Associated Pneumonia (SAP) following acute Intracerebral Hemorrhage (ICH).</div></div><div><h3>Methods</h3><div>Altogether, 175 patients with ICH and 80 controls were encompassed in this prospective cohort study. Serum PINK1 levels were measured at admission of all patients and at study entry of all controls. The National Institutes of Health Stroke Scale (NIHSS) scores and hematoma volumes were applied to determine the severity. SAP, END and post-ICH 6-month poor prognosis (modified Rankin Scale scores: 3–6) were recorded as the three outcome variables of interest.</div></div><div><h3>Results</h3><div>Patients, in contrast to controls, had significantly elevated serum PINK1 levels. Serum PINK1 levels were independently correlated with NIHSS scores, hematoma volumes and 6-month modified Rankin Scale scores. Serum PINK1 levels were linearly correlated with risks of SAP, END and post-ICH 6-month poor prognosis under the restricted cubic spline, as well as along with NIHSS scores and hematoma volumes, became their independent predictors. As demonstrated under receiver operating characteristic curve, serum PINK1 levels displayed effective predictive ability and possessed similar discrimination efficiency, when compared to NIHSS scores and hematoma volumes. Using sensitivity analysis, prognosis association was robust.</div></div><div><h3>Conclusion</h3><div>Serum PINK1 levels are substantially heightened after ICH, and may accurately mirror hemorrhagic intensity and efficaciously forecast END, SAP, and poor neurological prognosis, signifying that PINK1 may be a serological prognosticator of good prospect in ICH.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120282"},"PeriodicalIF":3.2,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810676","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":"Rapid detection of Klebsiella pneumoniae based on one-tube RPA-CRISPR/Cas12a system","authors":"Zhiyun Wu ,&nbsp;Yin Xu ,&nbsp;Wei Zhou ,&nbsp;Luoluo Shi ,&nbsp;Weifeng Shi ,&nbsp;Lei Pu ,&nbsp;Jingting Jiang","doi":"10.1016/j.cca.2025.120281","DOIUrl":"10.1016/j.cca.2025.120281","url":null,"abstract":"<div><div><em>Klebsiella pneumoniae</em> (KP) is a prevalent pathogen implicated in both community-acquired and nosocomial infections, often leading to severe clinical outcomes. The conventional methods for KP identification are characterized by intricacy and suboptimal efficiency. In this research, we have engineered a novel One-Tube RPA- CRISPR/Cas12a system, integrating recombinase polymerase amplification (RPA) method with the CRISPR/Cas12a diagnostic platform, to facilitate the detection of <em>K. pneumoniae</em>. To minimize the likelihood of aerosol-based contamination, the RPA components are positioned at the base of the tube, while the CRISPR/Cas12a components are placed at the tube’s cap. The systems are combined post-RPA amplification through a brief centrifugation step, ensuring that RPA reactions are conducted independently to produce an adequate amount of target DNA before interaction with the CRISPR/Cas12a system. This method was validated using both fluorescent and lateral flow strip assays, achieving a limit of detection (LOD) of 10⁰ copies/μL and 10¹ copies/μL respectively. The specificity for KP detection was found to be 100 %. Furthermore, the system demonstrated a positivity rate of 78 % (18/23) when directly extracting DNA from sputum samples, corroborated by culture and Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS). The simplicity and rapidity of the assay are augmented by a straightforward sample processing without extraction. The complete assay duration from specimen receipt to result is approximately 40 min, significantly reducing the turnaround time (TAT). Collectively, this system presents a streamlined, expeditious, and highly specific diagnostic approach for the detection of <em>Klebsiella pneumoniae</em> strains.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120281"},"PeriodicalIF":3.2,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802726","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":"Prospective multicenter comparison of the diagnostic value of IgG and IgGAM antibodies for heparin-induced thrombocytopenia","authors":"Wenjie Zhang ,&nbsp;Rui Feng ,&nbsp;Yu Su ,&nbsp;Jia Kang ,&nbsp;Yong Yao ,&nbsp;Huiru Zhao ,&nbsp;Xiangyu Cao ,&nbsp;Qingkun Fan ,&nbsp;Jun Wu","doi":"10.1016/j.cca.2025.120279","DOIUrl":"10.1016/j.cca.2025.120279","url":null,"abstract":"<div><h3>Background and aims</h3><div>Heparin-induced thrombocytopenia (HIT) is a critical complication of heparin therapy. Immune antibodies are involved in the development of HIT. The purpose of this study was to explore the diagnostic value of IgGAM and IgG antibodies.</div></div><div><h3>Materials and methods</h3><div>This prospective multicenter cohort study enrolled 170 patients with suspected HIT and 120 healthy volunteers. HIT was suspected when the complete blood count indicated a reduced platelet count. The presence of HIT was determined according to the clinical condition and laboratory results of patients. Parameters examined included conventional coagulation tests and IgG and IgGAM antibodies.</div></div><div><h3>Results</h3><div>Among 170 patients with suspected HIT, 69 were PF4/H-antibody-positive (Ab+ patients), and 12 were diagnosed with HIT. Ab+ patients had higher levels of 4T score, D-dimer, and platelet reduction ratio than Ab- patients (<em>P</em> &lt; 0.001 for all). We defined a HIT antibody risk index (HARI) as 0.807 × 4T score+ 0.028 × platelet reduction ratio (%)+ 0.114 × D-dimer (mg/l FEU), and found that the area under the curve (AUC) for HARI was greatest (0.857). Furthermore, the levels of IgGAM and IgG antibodies were higher in patients with HIT than without (<em>P</em> = 0.003 and <em>P</em> &lt; 0.001, respectively). The AUC for IgG antibody was significantly greater than that for IgGAM antibody (0.870 vs. 0.775).</div></div><div><h3>Conclusions</h3><div>HARI can serve as a potential predictor for the risk of PF4/H-antibody positivity in patients with suspected HIT pre-test. For high-risk patients, IgG antibody testing may be used as a potential exclusion diagnostic indicator for patients with suspected HIT.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120279"},"PeriodicalIF":3.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787902","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":"Considerations for enhancing the clinical validation and comparative analysis of RPA-CRISPR-Cas12a in Mycoplasma pneumoniae detection","authors":"Shanshan Yuan,&nbsp;Congcong Cheng","doi":"10.1016/j.cca.2025.120274","DOIUrl":"10.1016/j.cca.2025.120274","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"572 ","pages":"Article 120274"},"PeriodicalIF":3.2,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143785749","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":"Vascular calcification inhibitors in chronic kidney disease","authors":"Annika Adoberg ,&nbsp;Liisi Leis ,&nbsp;Merike Luman ,&nbsp;Fredrik Uhlin ,&nbsp;Ivo Fridolin ,&nbsp;Margus Viigimaa ,&nbsp;Jana Holmar","doi":"10.1016/j.cca.2025.120271","DOIUrl":"10.1016/j.cca.2025.120271","url":null,"abstract":"<div><h3>Background</h3><div>Increased cardiovascular mortality due to multifactorial progressive arterial stiffness in chronic kidney disease is influenced by the disturbed balance between inducers and inhibitors of vascular calcification. The potential to enhance the protective effects of vascular calcification inhibitors through effective therapy could stimulate further research and collaboration. This systematic review aims to give a grounded overview of vascular calcification inhibitors and their serum levels in different stages of chronic kidney disease to demonstrate the dynamics during stages of declining kidney function and renal replacement therapy.</div></div><div><h3>Methods</h3><div>The systematic review was registered in the PROSPERO database on August 30th, 2023 (CRD42023459169). and conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA).</div></div><div><h3>Results</h3><div>We screened 463 articles, of which 192 were eligible, and investigated vascular calcification inhibitors or included values of their serum levels. Serum levels of fetuin-A, vitamin D, FGF-23, Klotho, osteopontin, matrix GLA protein, osteoprotegerin, magnesium, and sclerostin are demonstrated in tables and sparingly studied substances with a perspective towards better treatment options are found in <span><span>Supplementary Table</span></span>.</div></div><div><h3>Conclusion</h3><div>Endogenous vascular calcification inhibitors could serve the role of valuable biomarkers to detect the process earlier and estimate the effect of treatment. The serum levels presented demonstrate the dynamics in different stages in chronic kidney disease and propose practical feedback for personalized treatment strategies. Manifold possible vascular calcification inhibitors under research set a promising starting point for more effective therapeutic interventions.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"572 ","pages":"Article 120271"},"PeriodicalIF":3.2,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143783209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosensors and lateral flow immunoassays: Current state and future prospects","authors":"Raveena Udhani ,&nbsp;Charmy Kothari ,&nbsp;Sunny Kumar","doi":"10.1016/j.cca.2025.120272","DOIUrl":"10.1016/j.cca.2025.120272","url":null,"abstract":"<div><div>The advent of paper-based biosensors represents a novel paradigm in point-of-care (POC) diagnostics, emerging as versatile tools. However, the broad term “biosensors” can be misleading, encompassing a range of techniques such as dipstick assays, electrochemical, microfluidics and immunoassay-based biosensors (including lateral flow (LFA), vertical flow and nucleic acid-based immunoassays). This narrative review aims to consolidate the vast and dispersed information on biosensors into a systematically organized resource addressing both practical and theoretical aspects for researchers developing paper-based biosensors. It offers a comprehensive classification of biorecognition elements and labels, insights into various conjugation techniques, and characterization methods for both labels and conjugates. Following the development and optimization of biological reactions, this review emphasizes the careful selection of membranes and reagents to effectively reproduce molecular reactions on paper. Membranes are critical to biosensor efficacy, with fluid dynamics influenced by factors such as pore size, protein holding capacity and wicking rate. While POC diagnostics have traditionally provided binary (yes/no) results, advancements now allow for semi-quantitative and quantitative results. Technologies such as in-text, printers, various software’s and smartphone can be used as colour analysis utilizing colour models beyond RGB like XYZ, grey intensity, CMY, CMYK, HSV and HSL that can analyse and process the colour intensity. AI integration further simplifies result analysis through image analysis, interpretation, predictive modelling, clinical decision support, enhancing detection, data integration and management. This review also emphasizes validation and stability studies in accordance with regulatory guidelines, ensuring the reliability of biosensors. The review ultimately covers: (i) A foundational understanding of various biosensor techniques, focusing on the self-sufficient LFA technique. (ii) Strategies to enhance sensitivity through pre- and post-assay modifications. (iii) A comprehensive troubleshooting section addressing common challenges in bioassay and fabrication. (iv) Multiplexing approaches enabling the simultaneous detection of multiple analytes for enhanced biomarker confirmation. By amalgamating knowledge from these approaches, this review offers the potential to elevate a basic traditional LFA strip into a highly sensitive diagnostic tool. It serves not only as a repository of knowledge but also as a roadmap for researchers and practitioners navigating the burgeoning field of paper-based biosensors.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120272"},"PeriodicalIF":3.2,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787900","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":"Data independent acquisition proteomics and machine learning reveals that proteins associated with immunity are potential molecular markers for early diagnosis of autism","authors":"Erlin Hu ,&nbsp;Xiaoni Kuang ,&nbsp;Sun Zhaohui ,&nbsp;Sifeng Wang ,&nbsp;Tuoyu Gan ,&nbsp;Wenjuan zhou ,&nbsp;Zhu Ming ,&nbsp;Yuxia Cheng ,&nbsp;Chunhua Ye ,&nbsp;Kang Yan ,&nbsp;Xiaohui Gong ,&nbsp;Tuanmei Wang ,&nbsp;Xiangwen Peng","doi":"10.1016/j.cca.2025.120238","DOIUrl":"10.1016/j.cca.2025.120238","url":null,"abstract":"<div><h3>Background</h3><div>Early diagnosis of autism is critical to its treatment, but so far, there is no clear molecular marker for early diagnosis in children.</div></div><div><h3>Methods</h3><div>We used data independent acquisition (DIA) mass spectrometry to compare protein expression in serum from 99 Chinese children with autism spectrum disorders with 70 healthy children.</div></div><div><h3>Results</h3><div>We identified 347 downregulated and 394 upregulated proteins. Based on bioinformatics analysis, differential proteins were enriched in the immune system, immune disease, cell motility, and focal adhesion. Machine learning revealed a model with eight proteins (IGH c1898_heavy_IGHV3-33_IGHD3-9_IGHJ4, LYZ, IGL c1860_light_IGLV8-61_IGLJ2, SERPINA10, IG c1421_light_IGKV1-27_IGKJ4, rheumatoid factor RF-ET1, IGL c600_light_IGKV4-1_IGKJ4, and SELL) that were mostly associated with immunity, and accurate for diagnosis of autism. The protein family was verified by a logic-regression leave-one cross-validation method with bidirectional feature screening. The accuracy of this model was 0.9527, and the kappa coefficient was 0.9025.</div></div><div><h3>Conclusions</h3><div>Our study showed that immunity is closely related to the onset of autism and can be used for early screening of patients. A model with eight proteins (IGH c1898_heavy_IGHV3-33_IGHD3-9_IGHJ4, LYZ, IGL c1860_light_IGLV8-61_IGLJ2, SERPINA10, IG c1421_light_IGKV1-27_IGKJ4, rheumatoid factor RF-ET1, IGL c600_light_IGKV4-1_IGKJ4, and SELL), which are mostly associated with immunity, is accurate for diagnosis of autism.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"573 ","pages":"Article 120238"},"PeriodicalIF":3.2,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787901","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":"Electrochemical biosensors for early detection of Alzheimer’s disease","authors":"Sanoeva Matlyuba Jakhonkulovna ,&nbsp;Gulnoz Bahodirova Kamolovna ,&nbsp;Muzaffar Zokirov ,&nbsp;Babajanova Umida Tajimuratovna ,&nbsp;Alexey Yumashev ,&nbsp;Rustem Shichiyakh ,&nbsp;Nasiba I. Safarova ,&nbsp;Aripova Nargiza Nusratovna ,&nbsp;Nilufar Esanmuradova ,&nbsp;Tadjibaeva Muyassar Karimbaevna ,&nbsp;Alidjanova Lazizakhon ,&nbsp;Alisher Ishankulov","doi":"10.1016/j.cca.2025.120278","DOIUrl":"10.1016/j.cca.2025.120278","url":null,"abstract":"<div><div>In recent years, electrochemical biosensors have shown great promise as innovative tools for the early identification of Alzheimer’s disease (AD), a neurodegenerative disorder that severely affects cognitive ability and overall quality of life. This comprehensive review aims to consolidate the latest research on the creation and implementation of electrochemical biosensors designed to detect AD-related biomarkers. We examine cutting-edge approaches to surface modification that enhance the attachment of biorecognition molecules, thus enabling the simultaneous identification of multiple biomarkers. This review emphasizes the crucial role that electrochemical biosensors play in the early diagnosis of Alzheimer’s disease, highlighting their potential to revolutionize clinical practices by facilitating timely interventions. In the future, research efforts should concentrate on refining these technologies for widespread clinical adoption, ensuring that they meet the needs of both healthcare professionals and patients.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"572 ","pages":"Article 120278"},"PeriodicalIF":3.2,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776772","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 new optimization combination used in the exponentially weighted moving average quality control of electrolyte programs","authors":"Mindong Mi ,&nbsp;Jiyong Gong ,&nbsp;Weijie Sun ,&nbsp;Tunguang Xu ,&nbsp;Qifeng Jiang ,&nbsp;Danqing Zhang ,&nbsp;Axiang Han ,&nbsp;Wei Liang","doi":"10.1016/j.cca.2025.120280","DOIUrl":"10.1016/j.cca.2025.120280","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to optimize and validate the EWMA QC procedure for potassium (K), sodium (Na), and chloride (Cl) by selecting optimal exponential weighting factors (λ), quality control limits (CLs), and truncation limits (TLs).</div></div><div><h3>Methods</h3><div>Data from 150,000 serum tests for K, Na, and Cl were obtained from the Laboratory Medicine Department of the First Affiliated Hospital of Ningbo University. The dataset included inpatient, outpatient, and physical examination populations. Using testing times, 400 simulated days with 375 tests each were created. The EWMA QC process was optimized and verified across the three analytes using false positive rate (FPR), true positive rate (TPR), and the median number of patient results affected before error detection (MNped).</div></div><div><h3>Result</h3><div>The EWMA QC procedure with λ = 0.2 outperformed other λ values for Na and Cl, achieving higher sensitivity for errors exceeding the total allowable error (TEa) and better performance with λ = 0.5 for errors below 1/2TEa in K. All three programs maintained FPRs below 5 %. The optimal QC (λ = 0.2) detected 99.93 % of Na errors and 86.30 % of Cl errors. However, K’s QC showed lower sensitivity, with poor performance even at 2TEa.</div></div><div><h3>Conclusion</h3><div>The EWMA QC method demonstrated high sensitivity and specificity for Na and Cl programs with an optimal λ of 0.2. However, its performance for K was suboptimal, indicating limited applicability in this analyte.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"572 ","pages":"Article 120280"},"PeriodicalIF":3.2,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776773","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":"Clinical evaluation, validation and stability testing of a developed paper-based blood grouping diagnostic test device","authors":"Shahila Parween ,&nbsp;K.V.S. Ratnam ,&nbsp;Arjun Jayachandran ,&nbsp;P.R. Raja Ram ,&nbsp;Prajna Arpita ,&nbsp;Harsh Vardhan Shrivastava ,&nbsp;Amit Asthana","doi":"10.1016/j.cca.2025.120276","DOIUrl":"10.1016/j.cca.2025.120276","url":null,"abstract":"<div><div>Blood transfusion necessitates an obligatory test to examine donor-recipient compatibility. Regardless of the typical traditional methods, new blood typing approaches are considered for uncomplicated, correct, and precise testing. In this study, we evaluated the rapid and affordable point-of-care blood typing device and explored new approaches to increase its stability/shelf life. A total of 729 blood samples were validated using this paper-based device. Medical students/staff (total 260) of MNR Medical College &amp; Hospital, Telangana, India, and 57 volunteers from India MedTech Expo 2023 and G20 3rd Health Working Group Meeting organized by Govt. of India, were considered for on-spot testing. The participants were asked to sign the consent form and enter their blood groups, which were later used for confirmation and validation. Out of 260 medical students/staff, this blood typing paper device successfully validated blood groups of 204 samples and tested 45 unknown blood groups. It also provided corrected blood groups to 11, thus having a sensitivity of 100 %. The device tested on MedTech Expo and G20 Health Meeting volunteers showed 100 % specificity. Around 400 blood samples collected from the hospital were tested with the paper device and compared simultaneously with the conventional glass slide method. 12 blood samples were tested via tube method and compared to paper devices. The sensitivity in all cases was superior to that of the traditional method with 100 % specificity. The developed device with a new biofunctionalization strategy exhibited excellent stability for 3 and 6 months at room temperature and 2–8 °C, respectively. This simple and easy diagnostic test device epitomizes a major stride towards enabling comprehensive screening of blood typing both in children and adults. It signifies its feasibility in resource-limited clinical settings towards making a positive diagnosis.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"572 ","pages":"Article 120276"},"PeriodicalIF":3.2,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771638","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}