Journal of Clinical Laboratory Analysis最新文献

{"title":"Performance Evaluation of the VISITECT CD4 Lateral Flow Point-Of-Care Assay for Identifying Advanced HIV Disease","authors":"Mariana Andreani,&nbsp;Claudia E. Frola,&nbsp;Liliana Guelfand,&nbsp;Fabiana C. Chaile,&nbsp;José Barletta,&nbsp;María J. Rolón,&nbsp;Mariana Erbin,&nbsp;Juan L. Rodriguez-Tudela","doi":"10.1002/jcla.70340","DOIUrl":"10.1002/jcla.70340","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To evaluate the performance and reader-dependent variability of the VISITECT CD4 lateral flow assay (LFA) as a screening tool for identifying advanced HIV disease (AHD; CD4 ≤ 200 cells/μL) during routine programmatic implementation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted a two-phase diagnostic evaluation in Argentina, including a training phase (<i>n</i> = 100) and a validation phase (<i>n</i> = 249), for a total of 349 participants, comparing VISITECT CD4-LFA with flow cytometry. Diagnostic performance was assessed using the manufacturer-recommended cut-off. Sensitivity, specificity, and accuracy were calculated with 95% confidence intervals (CI). Receiver operating characteristic (ROC) analysis was used to estimate the implicit CD4 thresholds applied by readers.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The VISITECT CD4-LFA showed 100% sensitivity (95% CI 94–100) in both phases. Specificity improved from 19% (95% CI 8–35) to 40% (95% CI 31–49) after training, with accuracy increasing from 42% (95% CI 33–53) to 57% (95% CI 51–63). ROC analysis demonstrated a shift in the implicit reader threshold from 363 to 270 cells/μL, indicating improved interpretation with experience.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The VISITECT CD4-LFA is a highly sensitive point-of-care (POC) tool for AHD screening, though its visual design limits specificity, highlighting the need for reader-independent technologies.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 19","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13490773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148793920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preliminary Development and Assessment of a Multiplex Assay for Human Papillomavirus Antibody Detection Using Commercial L1 Proteins","authors":"Arash Aslanabadi,&nbsp;Maryam Karimi,&nbsp;Laura Powell,&nbsp;Lisa Schumaker,&nbsp;Ashley Shutt,&nbsp;Mahsa Hojabri,&nbsp;Rahim Abbasi,&nbsp;Søren M. Bentzen,&nbsp;Kevin J. Cullen,&nbsp;Trevor A. Crowell,&nbsp;Rebecca G. Nowak,&nbsp;Mohammad M. Sajadi","doi":"10.1002/jcla.70343","DOIUrl":"10.1002/jcla.70343","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Human papillomavirus (HPV)-associated cancers are preventable with vaccination. Serologic assays monitor antibody responses, but their complexity and cost pose limitations when evaluating population level immunity. We developed an L1-based assay for the detection of multiple type-specific HPV antibodies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The Luminex-based assay used recombinant L1 proteins from seven HPVs (HPV-6/11/16/18/35/45/58) for the detection of type-specific immunoglobulin (Ig)G and IgA. Cutoffs were established using plasma from infants and children. The assay was optimized and qualified using a sample set from a blinded proficiency panel developed at the Frederick National Laboratory for Cancer Research.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Sensitivity and specificity for anti-HPV-6/11/16/18/58 IgG were 100% at the Mean + 3 standard deviation [SD] and Mean + 5 SD thresholds. Sensitivity for HPV-45 was 100% and 92.9% at the +3 SD and +5 SD thresholds, respectively. IgA detection showed moderate positivity among vaccinated individuals, with peak estimates of 96.4% (HPV-11) and 85.7% (HPV-58) at the +3 SD threshold. IgA was correlated with IgG (Spearman's <i>ρ</i> = 0.74). The L1-assay differentiated high, intermediate, low, and negative response groups from the blinded samples for all HPV genotypes (<i>p</i> &lt; 0.0001).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The L1-binding assay has the potential to be a scalable option for high-throughput detection of broad-spectrum HPV immunoglobulins, but further standardization and validation are needed.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 19","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13534992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148874281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RETRACTION: Circular RNA_0001946 is Insufficiently Expressed in Tumor Tissues, While its Higher Expression Correlates With Less Lymph Node Metastasis, Lower TNM Stage, and Improved Prognosis in NSCLC Patients","authors":"","doi":"10.1002/jcla.70360","DOIUrl":"10.1002/jcla.70360","url":null,"abstract":"<p><b>RETRACTION</b>: M. Zhang, F. Wen, and K. Zhao, “Circular RNA_0001946 is Insufficiently Expressed in Tumor Tissues, While its Higher Expression Correlates With Less Lymph Node Metastasis, Lower TNM Stage, and Improved Prognosis in NSCLC Patients,” <i>Journal of Clinical and Laboratory Analysis</i> 35, no. 8 (2020): e23625, https://doi.org/10.1002/jcla.23625.</p><p>The above article, published online on 03 July 2021 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor-in-Chief, Rong Fu; and Wiley Periodicals, LLC. The retraction has been agreed due to concerns raised by a third party that identified indications of compromised data and systematic issues within the published article, including inconsistencies related to patient recruitment. The authors did not provide the requested documentation relating to ethics approval, patient informed consent, or the underlying raw data. Accordingly, the article is retracted as the editors have lost trust in the reliability of the data and the results presented. The authors have been informed of this decision but were not available for final confirmation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":"40 19","pages":""},"PeriodicalIF":2.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13598381/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149025065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Different Methods of Haemoglobin Estimation Among Malaria-Infected Patients.","authors":"Mina Ofosu, Jessica Ntiamoah, Patricia Sam Barko, Prince Elikem Torli","doi":"10.1002/jcla.70377","DOIUrl":"10.1002/jcla.70377","url":null,"abstract":"<p><strong>Background: </strong>Haemoglobin (Hb) estimation is essential for assessing anaemia, particularly in malaria-endemic settings. Automated Full Blood Count (FBC) analysers, cyanmethemoglobin spectrophotometry, and portable Hb meters are commonly used, but differences in analytical performance may affect measurements.</p><p><strong>Methods: </strong>This cross-sectional study compared Hb measurements obtained using an automated FBC analyser, the cyanmethemoglobin method, and a portable Hb meter among 100 malaria-infected patients aged 16-65 years at Kumasi South Hospital, Ghana. Measurements were compared using Pearson's correlation coefficient, intraclass correlation coefficient (ICC), Lin's concordance correlation coefficient (CCC), Bland-Altman analysis, percentage error, and Passing-Bablok regression.</p><p><strong>Results: </strong>The three methods showed very strong correlations (r = 0.955-0.992, p < 0.001), excellent ICC (single measures = 0.969; average measures = 0.990), and high concordance (CCC = 0.95-0.99). Mean biases were -0.06 g/dL for FBC analyser versus portable Hb meter, -0.25 g/dL for FBC analyser versus cyanmethemoglobin, and -0.20 g/dL for portable Hb meter versus cyanmethemoglobin. The corresponding 95% limits of agreement were -0.59 to 0.47, -1.48 to 0.98, and -1.35 to 0.95 g/dL, respectively. Passing-Bablok slopes were 1.00 for all comparisons. The FBC analyser and portable Hb meter showed the closest agreement.</p><p><strong>Conclusion: </strong>The three methods demonstrated good agreement and broadly comparable Hb measurements. The findings support the practical use of portable Hb meters where point-of-care testing is required, while recognising that agreement does not establish diagnostic accuracy or analytical validation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70377"},"PeriodicalIF":2.5,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149166041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comments on: Flow Cytometric Profiling Reveals Platelet Dysfunction and Impaired Immune Communication in Acute and Chronic Cerebrovascular Disease.","authors":"Rajesh Prasad Jayaswal, Azeem Rizvi, Javed Siddiqui, Maajid Mohi Ud Din Malik","doi":"10.1002/jcla.70383","DOIUrl":"10.1002/jcla.70383","url":null,"abstract":"","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70383"},"PeriodicalIF":2.5,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149166978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Diagnostic Performance of Three Commercial Real-Time PCR Assays for the Detection of Mycobacterium tuberculosis Complex in Bronchial Washing Specimens: A Large Retrospective Study.","authors":"Jimyung Kim, Yumi Park","doi":"10.1002/jcla.70380","DOIUrl":"10.1002/jcla.70380","url":null,"abstract":"<p><strong>Background: </strong>Molecular assays are essential for the rapid detection of Mycobacterium tuberculosis complex (MTBC). However, head-to-head comparisons of widely used commercial assays remain limited. This study compared the diagnostic performance of three real-time PCR assays-AdvanSure TB/NTM, Cobas MTB, and Xpert MTB/RIF-using bronchial washing specimens.</p><p><strong>Methods: </strong>We retrospectively analyzed molecular assay results from 3348 bronchial washing specimens obtained between January 2021 and May 2024. Among them, 740 specimens were included in a head-to-head comparison of the three assays. Diagnostic performance was evaluated using culture-confirmed MTBC as the reference standard.</p><p><strong>Results: </strong>In the head-to-head comparison (n = 740), the overall concordance rate was 93.6%. Using culture-confirmed MTBC as the reference standard, the sensitivities of the AdvanSure, Cobas, and Xpert assays were 49.1%, 96.2%, and 90.6%, respectively. In smear-negative cases (n = 713), AdvanSure showed markedly lower sensitivity (30.8%) than the Cobas (94.9%) and Xpert (87.2%). AdvanSure showed the highest overall specificity (98.7%), followed by Cobas (96.9%) and Xpert (96.4%). The Xpert MTB/RIF assay demonstrated complete concordance with drug susceptibility testing for detecting rifampicin resistance, with a sensitivity of 100% (95% CI, 59.0%-100.0%) and a specificity of 100% (95% CI, 97.3%-100.0%).</p><p><strong>Conclusion: </strong>In this real-world cohort with a high proportion of smear-negative cases, the Cobas and Xpert assays exhibited significantly higher sensitivity for MTBC detection than the AdvanSure assay. These findings highlight the importance of highly sensitive molecular assays for the early diagnosis of pulmonary tuberculosis, particularly in patients with low bacillary burden.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70380"},"PeriodicalIF":2.5,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149172199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phenotypic and Genotypic Analysis of Two Rare Cases of --^SEA/-α^4.3 HbH Disease.","authors":"Weijia Yang, Xiaoyan Huang, Li Zhang, Xiaoqin Yang, Yaya Guo, Qingping Kang, Min Dou, Guijun Huang","doi":"10.1002/jcla.70379","DOIUrl":"10.1002/jcla.70379","url":null,"abstract":"<p><strong>Background: </strong>To report two cases of hemoglobin H (HbH) disease with routine genetic testing missed rare variants, where the phenotype was inconsistent with routine genetic testing results, explore their true genotypes and clinical characteristics, and evaluate the application value of single-molecule nanopore sequencing (CycloneSEQ platform) in detecting rare thalassemia variants.</p><p><strong>Methods: </strong>Common thalassemia gene testing was performed on two adult male patients who presented with different complications. The results showed --^SEA/αα, which was significantly inconsistent with their hematological parameters. Subsequently, long-read sequencing of the α-globin gene cluster was conducted using the CycloneSEQ platform (single-molecule nanopore sequencing technology), and specific primers were designed based on the results for PCR verification.</p><p><strong>Results: </strong>The two patients were ultimately diagnosed with rare deletional HbH disease with the genotype --^SEA/-α^4.3 (NC_000016.10:g.176935-181274DEL). The deletion range includes the α1 gene and is accompanied by an X-Y-Z segment recombination, which is reported here for the first time. Both patients exhibited varying degrees of anemia and complications, suggesting that the same genotype can manifest significant phenotypic heterogeneity.</p><p><strong>Conclusion: </strong>Conventional thalassemia testing fails to identify rare deletional HbH disease, frequently causing genotype-phenotype discordance and diagnostic bias. The newly reported --^SEA/-α^4.3 genotype with X-Y-Z recombination expands the HbH disease genotypic spectrum and confirms obvious phenotypic heterogeneity. CycloneSEQ nanopore sequencing effectively detects rare complex variants undetectable by routine methods, supporting precise diagnosis of atypical thalassemia with favorable clinical prospects.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70379"},"PeriodicalIF":2.5,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is Geenius HCV Supplemental Assay an Alternative to HCV Confirmatory Western Blot INNO-LIA HCV Score in Repeatedly Reactive Blood Donations After First Line Screening?","authors":"Zorana P Kozić, Irina S Maslovarić, Ivana T Drvenica, Marijana V Kovačić, Dragana C Marković, Vesna Lj Ilić, Dušan D Vučetić","doi":"10.1002/jcla.70367","DOIUrl":"10.1002/jcla.70367","url":null,"abstract":"<p><strong>Background: </strong>The objective of this study is to evaluate whether the rapid lateral flow immunochromatography Geenius HCV Supplemental Assay (ICH) can serve as an alternative to INNO-LIA HCV Score Confirmatory western blot (WB) assay in a population of blood donors.</p><p><strong>Methods: </strong>Sera of 60 blood donors, anti-HCV antibodies repeatedly reactive after first line screening with Architect anti-HCV chemiluminescent immunoassay, (ABBOTT, Wiesbaden, Germany) (ICL) were evaluated for anti-HCV antibodies with Geenius HCV Supplemental assay (Bio-Rad. Marnes-la-Coquette-France) (ICH) and Inno-LIA HCV Score (Inogenetics NV. Gent. Belgium) (Inno-LIA WB). The level of agreement between ICH and WB results was determined by kappa statistics.</p><p><strong>Results: </strong>Out of 60 samples identified as anti-HCV antibodies repeatedly reactive by ICL, ICH identified 32% samples as reactive and 2% as indeterminate. WB identified 35% samples as positive and 20% as indeterminate. Kappa analysis detected moderate agreement between ICH and WB in detecting anti-HCV antibodies (kappa = 0.60). Moderate to almost very good agreement is acknowledged between ICH and WB in reactivity with individual HCV antigens.</p><p><strong>Conclusion: </strong>Given the limited number of samples analyzed in this study we can summarize that Geenius HCV Supplemental and Inno-LIA WB assays are comparable pertaining to anti-HCV positive samples, but with discrepancy in results occurring in the area of samples classified with WB assay as indeterminate. However, there is very good agreement between Inno-LIA WB and Geenius ICH positivity/reactivity with individual HCV antigens. Our findings indicate that Geenius ICH Supplemental test cannot replace anti-HCV Inno-LIA WB in confirming anti-HCV antibodies.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70367"},"PeriodicalIF":2.5,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13650667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149137034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CHAPLE-Like Enteropathy and Renal Microangiopathy in an Adult Patient With CD46 Deficiency.","authors":"Bircan Erden, Pelin Korkmaz, Halil Yazici, Ahmet Burak Dirim, Fatih Beşışık, Nevzat Kahveci, Zeynep Kilinc, Derya Unal, Osman Ozan Yegit, Tuğba Kalaycı, Özge Hürdoğan, Yasemin Özlük, Melek Büyük, Asli Gelincik, Semra Demir","doi":"10.1002/jcla.70370","DOIUrl":"10.1002/jcla.70370","url":null,"abstract":"<p><strong>Background: </strong>Protein-losing enteropathy is a rarely reported feature of CD46-associated disease and may resemble CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy (CHAPLE) syndrome. Associated hypogammaglobulinemia may be mistaken for primary antibody deficiency.</p><p><strong>Methods: </strong>We describe a 23-year-old woman with childhood-onset enteropathy and hypogammaglobulinemia who had received immunoglobulin replacement for presumed common variable immunodeficiency since age 5. Multidisciplinary reassessment incorporated intestinal and renal histopathology, whole-exome sequencing, family segregation, and longitudinal evaluation of the response to eculizumab.</p><p><strong>Results: </strong>Duodenal biopsy demonstrated intestinal lymphangiectasia, whereas kidney biopsy revealed chronic thrombotic microangiopathy with concurrent PLA2R-negative membranous nephropathy. Serum C3 and C4 were within reference ranges. Sequencing identified homozygous CD46 c.565T>G (p.Tyr189Asp), with no pathogenic CD55 variant. The diagnostic laboratory reported the CD46 finding as a variant of uncertain significance. Family segregation and published functional evidence supported its clinical relevance, although patient-specific functional confirmation was unavailable. Eculizumab promptly improved abdominal pain, vomiting, and oral intake. By April 2026, following dose escalation, serum albumin reached 4.3 g/dL and IgG 554 mg/dL, whereas proteinuria decreased from 5.95 to 2.4 g/day.</p><p><strong>Conclusion: </strong>This case supports considering CD46-associated disease in adults with a CHAPLE-like phenotype, particularly when enteric protein loss and hypogammaglobulinemia coexist with renal microangiopathy despite normal C3 and C4. The response to complement blockade supports a complement-mediated disease process. Documented protein loss should prompt reassessment of a presumptive diagnosis of primary antibody deficiency.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70370"},"PeriodicalIF":2.5,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13643092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Analytical Validation of a Smartphone-Based Quantitative Lateral Flow Immunoassay for Serum Cystatin-C.","authors":"Ye Lian, Ruiying Zheng, Chenqi Yang, Yueyang Luo, Na Zhang, Guojun Lian, Baoqing Li","doi":"10.1002/jcla.70372","DOIUrl":"10.1002/jcla.70372","url":null,"abstract":"<p><strong>Background: </strong>Cystatin-C is an important renal function biomarker, but conventional quantification requires centralized laboratory analyzers, limiting timely testing in primary care and resource-limited settings.</p><p><strong>Methods: </strong>We developed and validated a quantitative smartphone-based lateral flow immunoassay (SP-LFIA) comprising a colorimetric strip, a Redmi Note 12R smartphone, a fixed-geometry macro-lens module with integrated LED illumination, and an Android application. The application directly converted background-corrected test/control-line (T/C) ratios into concentrations using a batch-specific third-order polynomial calibration model. Analytical validation followed relevant Clinical and Laboratory Standards Institute guidelines.</p><p><strong>Results: </strong>The assay showed a quantitative range of 0.32-8.00 mg/L and a limit of detection of 0.15 mg/L. Intra- and inter-assay coefficients of variation were below 10%. No significant interference was observed from bilirubin, triglycerides, hemoglobin, rheumatoid factor, gentamicin sulfate, norvancomycin hydrochloride, or cisplatin at the tested concentrations. Accelerated testing supported strip performance after storage at 50°C for 28 days. In 120 clinical serum samples, SP-LFIA agreed closely with the commercial particle-enhanced turbidimetric immunoassay reference method (R² = 0.9946), with a mean bias of -0.01 mg/L.</p><p><strong>Conclusion: </strong>The smartphone-based LFIA provides a reliable, rapid, low-cost, and practical approach to quantitative Cystatin-C testing in point-of-care settings where serum preparation is available.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70372"},"PeriodicalIF":2.5,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13639760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}