Journal of Clinical Laboratory Analysis最新文献

{"title":"Performance Evaluation of Dry Chemical Colorimetry for Plasma Ammonia Detection on the VITROS 350 Chemistry System.","authors":"Jia Liu, Lin Wang, Yue Tang, Peiran Li, Lili Zhao, Wenwen Yuan, Bo Li, Boan Li","doi":"10.1002/jcla.70347","DOIUrl":"10.1002/jcla.70347","url":null,"abstract":"<p><strong>Objective: </strong>Plasma ammonia quantitation is one of the most valuable laboratory tests for assessing hepatic function. Accurate measurement is clinically imperative for the diagnosis and management of severe hepatobiliary diseases. This study aimed to comprehensively evaluate the analytical performance of the VITROS dry chemistry system with dry chemical colorimetry for plasma ammonia detection.</p><p><strong>Methods: </strong>A full performance validation was conducted on the VITROS 350 Chemistry System in accordance with the guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the China National Accreditation Service for Conformity Assessment (CNAS). Comparability was performed using the VITROS 350 Chemistry System and VITROS 5600 Integrated System across our center and four external laboratories.</p><p><strong>Results: </strong>The VITROS 350 platform demonstrated robust analytical performance for plasma ammonia testing. Precision, accuracy, upper limit of the reportable interval, linearity, and carryover rates were all compliant with both clinical requirements and manufacturer specifications. Comparative analysis revealed strong inter-platform concordance, with results from five concentration levels across five laboratories remaining within predefined allowable limits. Regarding interference, only high concentrations of hemoglobin exerted a clinically significant impact on test results, a finding consistent with established clinical experience and diagnostic expectations.</p><p><strong>Conclusion: </strong>This study validates the reliability of the VITROS dry chemistry system for routine plasma ammonia testing. It provides clinical laboratories with a robust framework for method selection and establishes a framework for future external quality assessment (EQA) based on dry chemistry colorimetry.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70347"},"PeriodicalIF":2.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13662657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149182315","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":"Clinical and Cytogenomic Characterization of Three Patients With Distal 1q43q44 Deletion: Twin Sisters With a de novo Deletion and a Patient With der(1)t(1;21)(q43;q22.3)mat","authors":"Ma. Guadalupe Domínguez-Quezada,&nbsp;Horacio Rivera,&nbsp;Luis E. Figuera,&nbsp;Patricio Barros-Núñez,&nbsp;José Luis Castrillo,&nbsp;Carlos Córdova-Fletes,&nbsp;Thania Alejandra Aguayo-Orozco","doi":"10.1002/jcla.70338","DOIUrl":"10.1002/jcla.70338","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Deletions involving the 1q43q44 region are among the most recurrent terminal chromosomal imbalances and are associated with a recognizable neurodevelopmental phenotype. These deletions may occur as isolated events or in the context of more complex rearrangements.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Case Presentation</h3>\u0000 \u0000 <p>We describe presumed monozygotic twin sisters (patients 1 and 2) with a <i>de novo</i> 1q43q44 deletion and an unrelated patient (patient 3) carrying a similar deletion combined with a 21q22.3 duplication derived from a t(1;21)(q43;q22.3)mat. All three patients exhibited features consistent with the distal 1q43q44 deletion syndrome, including microcephaly, corpus callosum abnormalities, developmental delay, intellectual disability, language impairment, hypotonia, micro−/retrognathia, and congenital heart defects.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Cytogenetics and FISH analyses confirmed distal 1q deletions in all patients. Chromosomal microarray analysis identified a ~9.5 Mb deletion in patient 1 (her twin was not tested) and a ~12.1 Mb deletion in patient 3. Despite differences in deletion size and genomic context, both rearrangements disrupted a largely overlapping interval containing 171 genes, including the dosage-sensitive neurodevelopmental genes <i>AKT3</i>, <i>HNRNPU</i>, and <i>ZBTB18</i> as well as other monoallelic expressed genes (<i>GREM2</i> and <i>NLRP3</i>) and, in patient 3 only, <i>RYR2</i>. Functional enrichment analyses highlighted pathways related to neurodevelopment, epilepsy, and cardiac function. Although the twins showed similar congenital manifestations, patient 1 later developed seizures whose origin could not be assessed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>These findings further support the role of haploinsufficient genes within the distal 1q43q44 region, particularly <i>AKT3</i>, <i>HNRNPU</i>, and <i>ZBTB18</i>, to the core neurodevelopmental phenotype and highlight the value of high-resolution genomic analysis for patient characterization.</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/PMC13478828/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148760231","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 of a Machine Learning Algorithm for Differential Diagnosis Between Primary Immune Thrombocytopenia and Connective Tissue Disease-Related Thrombocytopenia in Pediatric Patients","authors":"Furong Kang,&nbsp;Mei Yan,&nbsp;Yingbin Yue,&nbsp;Xuemei Wang,&nbsp;Yu Liu","doi":"10.1002/jcla.70337","DOIUrl":"10.1002/jcla.70337","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>To develop a machine learning model for early differentiation of primary immune thrombocytopenia (pITP) from connective tissue disease-related thrombocytopenia (CTD-TP) in children presenting with thrombocytopenia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>A retrospective study was conducted on 387 newly diagnosed children with thrombocytopenia. All patients were clinically diagnosed and divided into a training set and a test set in a 7:3 ratio. Six machine learning algorithms, including XGboost, RF, SVM, LR, GBDT, BPNN, were used to establish differential diagnostic models for pITP and CTD-TP. The model performance was evaluated by accuracy, precision, recall, F1 score, and area under the receiver operating characteristic curve (AUC). Explain the importance and contribution of model feature variables through the Shapley Additive Explanations (SHAP) method.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Result</h3>\u0000 \u0000 <p>A total of 387 patients were included in the study, including 347 cases of pITP and 40 cases of CTD-TP. Based on the above evaluation indicators, the BPNN model had the best performance, with an F1 score of 0.95, an accuracy rate of 94.87%, and an AUC of 0.9738. According to the SHAP value, the top 10 influencing factors were selected as age, erythrocyte sedimentation rate, antinuclear antibodies, IgM, Complement C3, T + B + NK%, B cells, body weight, complement C4, lymphocyte count.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The successful construction of the pITP and CTD-TP identification models shows that BPNN has the best performance and can provide clinical strategies for early disease identification based on the importance of its variables.</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/PMC13539337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148879922","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":"Novel Target for Pathogenic Leptospira Detection via Colorimetric Loop-Mediated Isothermal Amplification (LAMP): Development, Validation, and Comparative Analysis.","authors":"Peyman Ghoraishizadeh, Benjie Clemente, Kween Saimuang, Sakaorat Lertjuthaporn, Sukhonta Limsampan, Patcharapan Suwannin, Mongkol Techakasikornpanich, Galayanee Doungchawee, Edilberto Manahan, Kulachart Jangpatarapongsa","doi":"10.1002/jcla.70277","DOIUrl":"10.1002/jcla.70277","url":null,"abstract":"<p><strong>Background: </strong>Leptospirosis is a globally prevalent zoonotic disease that remains challenging to diagnose due to its nonspecific symptoms and the limitations of current diagnostic methods and targets. To address these challenges, we developed and validated a naked-eye loop-mediated isothermal amplification (LAMP) assay targeting the newly identified orpH region for the rapid detection of pathogenic Leptospira species.</p><p><strong>Methods: </strong>Comparative genomic analysis identified orpH as a conserved sequence among pathogenic Leptospira. A colorimetric LAMP assay (LAMP-orpH) was developed and evaluated using reference strains and serum samples obtained from patients with suspected leptospirosis. The diagnostic performance of the assay on these serum samples was evaluated in comparison with conventional PCR and the microscopic agglutination test (MAT), with the real-time PCR assay targeting lipL32 designated as the reference standard.</p><p><strong>Results: </strong>The LAMP-orpH assay demonstrated 87.2% sensitivity and 94.8% specificity among 76 suspected cases and 29 controls, showing strong agreement with real-time PCR (κ = 0.826). It outperformed MAT (63.8% sensitivity) and conventional PCR (23.4% sensitivity), achieving a detection limit of 10² cells/mL in spiked serum.</p><p><strong>Conclusion: </strong>The LAMP-orpH assay offers a rapid, sensitive, and specific tool for early leptospirosis diagnosis. Its simple colorimetric readout and minimal equipment requirements make it ideal for use in rural and resource-limited settings, providing a practical alternative to MAT, conventional PCR, and qPCR.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70277"},"PeriodicalIF":2.5,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13669682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149182296","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":"Establishment Reference Intervals Using the Kosmic Algorithm for Hemoglobin Levels and Platelet, Red Blood Cell, and White Blood Cell Counts","authors":"Chunyan Liu,&nbsp;Zhaohui Deng,&nbsp;Yingbo Song,&nbsp;Wenli Wu,&nbsp;Yan Li,&nbsp;Fang Yang,&nbsp;Huimin Liu,&nbsp;Xin Zhang","doi":"10.1002/jcla.70341","DOIUrl":"10.1002/jcla.70341","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Reference intervals (RIs) for complete blood count (CBC) are crucial for assessment of overall health status and effective diagnosis of diseases. However, the RI data for CBC currently used in clinical practice in China are mainly derived from the Han Chinese population and are not stratified by ethnicity. This study aimed to calculate RIs for red blood cell count (RBC), hemoglobin (HGB), white blood cell count (WBC), and platelet count (PLT) among local populations based on ethnicity and sex in Xinjiang, China, using an indirect method to help clinicians better explain patient status in multiethnic populations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We analyzed data from 5679 individuals. We used Tukey's test to eliminate outliers based on ethnicity, sex, and age. Subgroup stratification of RIs for RBC, WBC, PLT, and HGB was determined according to a standard deviation ratio threshold. Total RIs and ethnicity- and sex-specific RIs for these parameters were calculated using the kosmic algorithm.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The RIs for RBC and HGB must be stratified by sex, while those for PLT must be stratified by ethnicity. However, the RI for WBC does not require stratification. Sex-stratified RIs for RBC and HGB in men showed higher upper limits than those in women. The RI for Uyghur individuals had a higher upper limit than that for Han Chinese individuals.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Personalized RIs for CBC provide a laboratory basis for disease diagnosis and treatment and health assessment among adults in Xinjiang.</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/PMC13525422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148850876","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":"Improving the Accuracy of Papillary Thyroid Cancer Pathological Evaluation With Digital PCR Detection of the BRAF V600E Mutation","authors":"Na Yu,&nbsp;Kai Zhang,&nbsp;Ying Jiang,&nbsp;Liang Zheng,&nbsp;Xiu He,&nbsp;Qinglin He,&nbsp;Meng Dai,&nbsp;Tianhua Hu,&nbsp;Dongfang Tang,&nbsp;Jingjing Jin,&nbsp;Xin Huang,&nbsp;Li Xiao","doi":"10.1002/jcla.70323","DOIUrl":"10.1002/jcla.70323","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The <i>BRAF</i> V600E mutation is an important diagnostic factor for papillary thyroid cancer (PTC). Digital PCR (dPCR) is a relatively new technology featured with extremely high sensitivity. This study aims to evaluate the performance of dPCR in detecting <i>BRAF</i> V600E mutations in PTC diagnosis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A total of 252 thyroid samples were collected in this retrospective diagnostic accuracy study. Diagnosis was made by a pathologist following histopathological guidelines. The <i>BRAF</i> V600E mutation was detected by dPCR and the results were compared with calls from amplification refractory mutation system PCR (ARMS-PCR) tests. Discrepant samples were evaluated again by two pathologists, and the presence of mutations was further confirmed by next generation sequencing (NGS). McNemar's test was used for paired categorical data in statistical analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Test results from dPCR and ARMS-PCR assays were in total agreement for PTC tumor and benign thyroid tissues. However, dPCR assays detected <i>BRAF</i> V600E mutations in four tumor-adjacent normal tissues, one lymph node sample, and two fine-needle aspirate (FNA) samples that were negative in ARMS-PCR tests, all with low frequencies of <i>BRAF</i> V600E mutations. When pathology results were used as the standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of dPCR assay were all 100% for tissue and FNA samples, while those of ARMS-PCR assay were 91.2%, 100%, 100%, 96.1%, and 92.9%, 100%, 100%, 95.7% for tissue and FNA samples, respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our data demonstrate that dPCR is a highly valuable tool for PTC molecular pathology.</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/PMC13583474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982625","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 Validation of a Nomogram Based on Red Blood Cell and Reticulocyte Parameters for Differentiating Thalassemia Trait From Iron Deficiency Anemia","authors":"Yong Chen,&nbsp;Yazhen Mao,&nbsp;Jie Liu,&nbsp;Yice Lin,&nbsp;Dandan Chen","doi":"10.1002/jcla.70344","DOIUrl":"10.1002/jcla.70344","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Thalassemia trait (TT) and iron deficiency anemia (IDA) are the most common causes of microcytic hypochromic anemia with overlapping hematological features, complicating differential diagnosis. This study developed and internally validated a nomogram incorporating red blood cell (RBC) and reticulocyte parameters to preliminarily distinguish TT from IDA.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A retrospective cohort of 517 patients (320 IDA, 197 TT) was randomly divided into training (<i>n</i> = 361) and validation (<i>n</i> = 156) cohorts at a 7:3 ratio using stratified random sampling according to diagnostic group. RBC parameters (RBC count, MCV, MCH) and reticulocyte indices (RET%, IRF, LFR, MFR, HFR) were collected. LASSO regression identified key variables, followed by multivariate logistic regression. Model performance was evaluated using ROC curves, calibration plots, and decision curve analysis (DCA).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>LASSO regression selected four predictors: RBC count, MCV, RET%, and HFR. Multivariate analysis showed elevated MCV (<i>p</i> &lt; 0.001), RET% (<i>p</i> &lt; 0.001), and HFR (<i>p</i> &lt; 0.001) were associated with IDA, while elevated RBC count (<i>p</i> &lt; 0.001) predicted TT. The nomogram achieved excellent discrimination with AUC of 0.900 in training and 0.904 in validation cohorts. Calibration plots showed good agreement and DCA suggested potential clinical net benefit across threshold probabilities of 7%–96% (training) and 5%–97% (validation).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This nomogram integrating RBC count, MCV, RET%, and HFR showed promising performance for the preliminary differentiation of TT from IDA and may serve as a practical, noninvasive screening aid for risk stratification and prioritization of confirmatory testing. It should not be used as a substitute for hemoglobin electrophoresis, thalassemia genetic testing, or iron studies.</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/PMC13504082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148813253","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":"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}