Clinica Chimica Acta最新文献

{"title":"Interval-specific likelihood ratios and probability-based models for interpreting combined CSF biomarkers for Alzheimer’s disease","authors":"Jonas Dubin ,&nbsp;Rik Vandenberghe ,&nbsp;Koen Poesen","doi":"10.1016/j.cca.2024.119941","DOIUrl":"10.1016/j.cca.2024.119941","url":null,"abstract":"<div><h3>Background</h3><p>In Alzheimer’s disease (AD) diagnosis, a cerebrospinal fluid (CSF) biomarker panel is commonly interpreted with binary cutoff values. However, these values are not generic and do not reflect the disease continuum. We explored the use of interval-specific likelihood ratios (LRs) and probability-based models for AD using a CSF biomarker panel.</p></div><div><h3>Methods</h3><p>CSF biomarker (Aβ_1-42, tTau and pTau₁₈₁) data for both a clinical discovery cohort of 241 patients (measured with INNOTEST) and a clinical validation cohort of 129 patients (measured with EUROIMMUN), both including AD and non-AD dementia/cognitive complaints were retrospectively retrieved in a single-center study. Interval-specific LRs for AD were calculated and validated for univariate and combined (Aβ_1-42/tTau and pTau₁₈₁) biomarkers, and a continuous bivariate probability-based model for AD, plotting Aβ_1-42/tTau versus pTau₁₈₁ was constructed and validated.</p></div><div><h3>Results</h3><p>LR for AD increased as individual CSF biomarker values deviated from normal. Interval-specific LRs of a combined biomarker model showed that once one biomarker became abnormal, LRs increased even further when another biomarker largely deviated from normal, as replicated in the validation cohort. A bivariate probability-based model predicted AD with a validated accuracy of 88% on a continuous scale.</p></div><div><h3>Conclusions</h3><p>Interval-specific LRs in a combined biomarker model and prediction of AD using a continuous bivariate biomarker probability-based model, offer a more meaningful interpretation of CSF AD biomarkers on a (semi-)continuous scale with respect to the post-test probability of AD across different assays and cohorts.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009898124021946/pdfft?md5=05e0ecf9d219f9e140dab945711e40ca&pid=1-s2.0-S0009898124021946-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055110","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":"Irisin in thyroid diseases","authors":"Qi Chen ,&nbsp;Jing Wang ,&nbsp;Kang Li ,&nbsp;Jun-Qin Luan ,&nbsp;Jing-Mei Li ,&nbsp;Ya-Ting Wang","doi":"10.1016/j.cca.2024.119929","DOIUrl":"10.1016/j.cca.2024.119929","url":null,"abstract":"<div><p>Irisin, a hormone-like adipo-myokine, has garnered considerable attention in recent years for its potential impact in metabolic diseases. Its physiological effects are similar to those of thyroid hormones, prompting numerous investigations into potential correlations and interactions between irisin and thyroid function through various <em>in vitro</em> and animal experiments. However, existing studies suggest that the relationship between irisin and thyroid diseases is highly complex and multifaceted. In this paper, we have summarized the research results on serum irisin and thyroid function, providing an overview of advancements and constraints in current research on irisin and thyroid hormones. The aim is to offer insights and directions for future clinical trials in this field.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999487","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":"Copeptin associates with major adverse cardiovascular events in patients on maintenance hemodialysis","authors":"Zhen Zhang ,&nbsp;Lin Zhang ,&nbsp;Xinyue Dong ,&nbsp;Bo Shen ,&nbsp;Fangfang Xiang ,&nbsp;Xuesen Cao ,&nbsp;Jinbo Yu ,&nbsp;Yaqiong Wang ,&nbsp;Xiaoqiang Ding ,&nbsp;Yuxin Nie","doi":"10.1016/j.cca.2024.119937","DOIUrl":"10.1016/j.cca.2024.119937","url":null,"abstract":"<div><h3>Background</h3><p>End-stage renal disease (ESRD) necessitating hemodialysis pose substantial cardiovascular risks, with cardiovascular disease (CVD) as a leading cause of mortality. Biomarkers like copeptin have emerged as potential indicators of cardiovascular stress and prognosis in CKD populations.</p></div><div><h3>Objective</h3><p>This study aimed to assess the prognostic value of copeptin in predicting major adverse cardiovascular events (MACEs) among hemodialysis patients, alongside traditional cardiac biomarkers.</p></div><div><h3>Methods</h3><p>ESRD patients undergoing maintenance hemodialysis were enrolled. Copeptin levels were measured, and patients were followed for MACEs, defined as cardiovascular deaths, myocardial infarction, stroke, or heart failure-related hospitalizations. Cox proportional-hazards models were used to evaluate the association between copeptin and outcomes, adjusting for relevant covariates.</p></div><div><h3>Results</h3><p>Among 351 patients followed for a median of 22.7 months, elevated copeptin levels were significantly associated with an increased risk of MACEs (HR 1.519, 95 % CI 1.140 to 2.023; p = 0.00425). Copeptin demonstrated predictive capability across multiple statistical tests (Log-rank p = 0.024; Gehan p &lt; 0.001; Tarone-Ware p &lt; 0.001; Peto-Peto p = 0.027), although significance was attenuated in pairwise comparisons post-adjustment for multiple testing. Combining copeptin with NT-proBNP or hs-cTnT further enhanced risk stratification for MACEs.</p></div><div><h3>Conclusion</h3><p>Elevated copeptin levels independently predict adverse cardiovascular outcomes in hemodialysis patients. Integrating copeptin with traditional cardiac biomarkers may refine risk stratification and guide personalized therapeutic strategies in this high-risk population.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035431","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":"Integrating pretest probability for rheumatoid arthritis with likelihood ratios of RF and ACPA to improve clinical utility of rheumatoid arthritis autoantibody testing","authors":"Daphné Vandebeek ,&nbsp;Elke Lodewijckx ,&nbsp;Lieve Van Hoovels ,&nbsp;Patrick Verschueren ,&nbsp;Xavier Bossuyt","doi":"10.1016/j.cca.2024.119928","DOIUrl":"10.1016/j.cca.2024.119928","url":null,"abstract":"<div><h3>Background and aims</h3><p>Rheumatoid arthritis (RA) manifests through various symptoms and systemic manifestations. Diagnosis involves serological markers like rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). Past studies have shown the added value of likelihood ratios (LRs) in result interpretation. LRs can be combined with pretest probability to estimate posttest probability for RA. There is a lack of information on pretest probability. This study aimed to estimate pretest probabilities for RA.</p></div><div><h3>Materials and methods</h3><p>This retrospective study included 133 consecutive RA patients and 651 consecutive disease controls presenting at a rheumatology outpatient clinic. Disease characteristics, risk factors associated with RA and laboratory parameters were documented for calculating pretest probabilities and LRs.</p></div><div><h3>Results</h3><p>Joint involvement, erosions, morning stiffness, and positive CRP, ESR tests significantly correlated with RA. Based on these factors, probabilities for RA were estimated. Besides, LRs for RA were established for RF and ACPA and combinations thereof. LRs increased with antibody levels and were highest for double high positivity. Posttest probabilities were estimated based on pretest probability and LR.</p></div><div><h3>Conclusion</h3><p>By utilizing pretest probabilities for RA and LRs for RF and ACPA, posttest probabilities were estimated. Such approach enhances diagnostic accuracy, offering laboratory professionals and clinicians insights in the value of serological testing during the diagnostic process.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008322","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 novel stoploss mutation CYB5R3 c.906A>G(p.*302Trpext*42) involved in the pathogenesis of hereditary methemoglobinemia","authors":"Kai-ying He ,&nbsp;Hong-ping Yu ,&nbsp;Jing Zou ,&nbsp;Xiang Chen ,&nbsp;Li Chen ,&nbsp;Dan-dan Ruan ,&nbsp;Ting Chen ,&nbsp;Qian Chen ,&nbsp;Li Zhang ,&nbsp;Mei-zhu Gao ,&nbsp;Xin-fu Lin ,&nbsp;Hong Li ,&nbsp;Zhu-ting Fang ,&nbsp;Jing Wu ,&nbsp;Jie-wei Luo ,&nbsp;Li-sheng Liao","doi":"10.1016/j.cca.2024.119930","DOIUrl":"10.1016/j.cca.2024.119930","url":null,"abstract":"<div><p>Recessive congenital methemoglobinemia (RCM) is a hereditary autosomal disorder with an extremely low incidence rate. Here, we report a case of methemoglobinemia type I in a patient with congenital persistent cyanosis. The condition was attributed to a novel compound heterozygous mutation in CYB5R3, characterized by elevated methemoglobin levels (13.4 % of total hemoglobin) and undetectable NADH cytochrome b5 reductase (CYB5R3) activity. Whole-exome sequencing (WES) revealed two heterozygous mutations in CYB5R3: a previously reported pathogenic missense mutation c.611G&gt;A(p.Cys204Tyr) inherited from the father, and a novel stop codon mutation c.906A&gt;G(p.*302Trpext*42) from the mother, the latter mutation assessed as likely pathogenic according to ACMG guidelines. In cells overexpressing the CYB5R3 c.906A&gt;G mutant construct, the CYB5R3 mRNA level was significantly lower than in cells overexpressing the wild-type (WT) CYB5R3 construct. However, there was no significant difference in protein expression levels between the mutant and WT constructs. Notably, an additional protein band of approximately 55 kDa was detected in the mutant cells. Immunofluorescence localization showed that, compared to wild-type CYB5R3, the subcellular localization of the CYB5R3 p.*302Trpext*42 mutant protein did not show significant changes and remained distributed in the endoplasmic reticulum and mitochondria. However, the c.906A&gt;G(p.*302Trpext*42) mutation resulted in increased intracellular reactive oxygen species (ROS) levels and decreased NAD⁺/NADH ratio, suggesting impaired CYB5R3 function and implicating this novel mutation as likely pathogenic.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999486","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":"Accuracy study of Angiotensin 1–7 composite index test to predict pulmonary fibrosis and guide treatment","authors":"Nathalie De Vos ,&nbsp;Marie Bruyneel ,&nbsp;Alain Roman ,&nbsp;Mathieu Antoine ,&nbsp;Anne-Violette Bruyneel ,&nbsp;Stephane Alard ,&nbsp;Stéphanie André ,&nbsp;Hafid Dahma ,&nbsp;Audrey Chirumberro ,&nbsp;Frédéric Cotton","doi":"10.1016/j.cca.2024.119926","DOIUrl":"10.1016/j.cca.2024.119926","url":null,"abstract":"<div><h3>Background</h3><p>Pulmonary fibrosis can develop after acute respiratory distress syndrome (ARDS). The hypothesis is we are able to measure phenotypes that lie at the origin of ARDS severity and fibrosis development. The aim is an accuracy study of prognostic circulating biomarkers.</p></div><div><h3>Methods</h3><p>A longitudinal study followed COVID-related ARDS patients with medical imaging, pulmonary function tests and biomarker analysis, generating 444 laboratory data. Comparison to controls used non-parametrical statistics; <em>p &lt; 0·05</em> was considered significant. Cut-offs were obtained through receiver operating curve. Contingency tables revealed predictive values. Odds ratio was calculated through logistic regression.</p></div><div><h3>Results</h3><p>Angiotensin 1–7 beneath 138 pg/mL defined Angiotensin imbalance phenotype. Hyper-inflammatory phenotype showed a composite index test above 34, based on high Angiotensin 1–7, C-Reactive Protein, Ferritin and Transforming Growth Factor-β. Analytical study showed conformity to predefined goals. Clinical performance gave a positive predictive value of 95 % (95 % confidence interval, 82 %–99 %), and a negative predictive value of 100 % (95 % confidence interval, 65 %–100 %). Those severe ARDS phenotypes represented 34 (Odds 95 % confidence interval, 3–355) times higher risk for pulmonary fibrosis development (<em>p &lt; 0·001</em>).</p></div><div><h3>Conclusions</h3><p>Angiotensin 1–7 composite index is an early and objective predictor of ARDS evolving to pulmonary fibrosis. It may guide therapeutic decisions in targeted phenotypes.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S000989812402179X/pdfft?md5=72bbcf0bab422ea7ac9ec449c174363a&pid=1-s2.0-S000989812402179X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995420","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":"Corrigendum to “Differences in bile acid profiles between cholestatic diseases – Development of a high throughput assay for dried bloodspots” [Clin. Chim. Acta 562 (2024) 119864]","authors":"Anders Ziegler ,&nbsp;Ingjerd Sæves ,&nbsp;Runar Almaas","doi":"10.1016/j.cca.2024.119882","DOIUrl":"10.1016/j.cca.2024.119882","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009898124021351/pdfft?md5=095bafbffd9633853fbf233bedeaba9a&pid=1-s2.0-S0009898124021351-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757446","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":"A missense variant in SLC12A3 gene enhances aberrant splicing causing Gitelman syndrome","authors":"Chun Yiu Law ,&nbsp;David Tak Wai Lui ,&nbsp;Eunice Lau ,&nbsp;Chariene Shao Lin Woo ,&nbsp;Johnny Yau Cheung Chang ,&nbsp;Eunice Ka Hong Leung ,&nbsp;Alan Chun Hong Lee ,&nbsp;Chi Ho Lee ,&nbsp;Yu Cho Woo ,&nbsp;Wing Sun Chow ,&nbsp;Karen Siu Ling Lam ,&nbsp;Kathryn Choon Beng Tan ,&nbsp;Tsz Ki Ling ,&nbsp;Ching Wan Lam","doi":"10.1016/j.cca.2024.119924","DOIUrl":"10.1016/j.cca.2024.119924","url":null,"abstract":"<div><p>Gitelman syndrome (GS) is the most prevalent genetic tubulopathy characterized by several electrolyte abnormalities, including hypokalemia, hypomagnesemia, hypocalciuria, metabolic alkalosis, and hyperreninemic hyperaldosteronism. These features are caused by a bi-allelic mutation in the <em>SLC12A3</em> gene. In this report, we present a case of GS in an asymptomatic woman who incidentally exhibited hypokalemia during an antenatal check-up. Her biochemical profile was consistent with GS. Genetic analysis revealed two heterozygous variants <em>in trans</em>, namely, NM_001126108.2:c.625C&gt;T; p.(Arg209Trp) and c.965C&gt;T; p.(Ala322Val). The c.625C&gt;T; p.(Arg209Trp) variant has previously been experimentally confirmed as a loss-of-function (LOF) variant. However, the functional impact of the c.965C&gt;T variant, located at the 5 prime end of exon 8, has not been fully elucidated. Through the utilization of both complementary DNA (cDNA) and minigene analysis, we confirmed that the c.965C&gt;T variant can generate two distinct cDNA transcripts. The first transcript carries a missense mutation, p.(Ala322Val) in the full <em>SLC12A3</em> transcript, while the second transcript consists of an in-frame deletion of both exons 7 and 8 in the <em>SLC25A13</em> transcript, in which may result in the loss of transmembrane regions 5 – 6 involved in chloride transport. Our findings provide insights into the intricate mechanisms of splicing, highlighting how a variant in one exon can remotely influence the transcription of an upstream exon, as observed with the variant in exon 8 impacting the transcription of exon 7.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995419","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 breast cancer","authors":"Pouria Kiani ,&nbsp;Hamid Vatankhahan ,&nbsp;Alireza Zare-Hoseinabadi ,&nbsp;Felora Ferdosi ,&nbsp;Sajad Ehtiati ,&nbsp;Parasta Heidari ,&nbsp;Zahra Dorostgou ,&nbsp;Ahmad Movahedpour ,&nbsp;Aria Baktash ,&nbsp;Mansour Rajabivahid ,&nbsp;Seyyed Hossein Khatami","doi":"10.1016/j.cca.2024.119923","DOIUrl":"10.1016/j.cca.2024.119923","url":null,"abstract":"<div><p>Breast cancer continues to be a significant contributor to global cancer deaths, particularly among women. This highlights the critical role of early detection and treatment in boosting survival rates. While conventional diagnostic methods like mammograms, biopsies, ultrasounds, and MRIs are valuable tools, limitations exist in terms of cost, invasiveness, and the requirement for specialized equipment and trained personnel. Recent shifts towards biosensor technologies offer a promising alternative for monitoring biological processes and providing accurate health diagnostics in a cost-effective, non-invasive manner. These biosensors are particularly advantageous for early detection of primary tumors, metastases, and recurrent diseases, contributing to more effective breast cancer management. The integration of biosensor technology into medical devices has led to the development of low-cost, adaptable, and efficient diagnostic tools. In this framework, electrochemical screening platforms have garnered significant attention due to their selectivity, affordability, and ease of result interpretation. The current review discusses various breast cancer biomarkers and the potential of electrochemical biosensors to revolutionize early cancer detection, making provision for new diagnostic platforms and personalized healthcare solutions.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995422","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 visual detection of Helicobacter pylori and vacA subtypes by Dual-Target RAA-LFD assay","authors":"Sijie Yin ,&nbsp;Yanghe Liu ,&nbsp;Xinyi Yang ,&nbsp;Nasifu Lubanga ,&nbsp;Ping Tai ,&nbsp;Mengqiu Xiong ,&nbsp;Boyue Fan ,&nbsp;Xincheng Yang ,&nbsp;Zhenlin Nie ,&nbsp;Qingsong Zhang ,&nbsp;Bangshun He","doi":"10.1016/j.cca.2024.119927","DOIUrl":"10.1016/j.cca.2024.119927","url":null,"abstract":"<div><h3>Background</h3><p><em>Helicobacter pylori</em> (<em>H. pylori</em>) infects over 50% of the global population and is a significant risk factor for gastric cancer. The pathogenicity of <em>H. pylori</em> is primarily attributed to virulence factors such as <em>vacA</em>. Timely and accurate identification, along with genotyping of <em>H. pylori</em> virulence genes, are essential for effective clinical management and controlling its prevalence.</p></div><div><h3>Methods</h3><p>In this study, we developed a dual-target RAA-LFD assay for the rapid, visual detection of <em>H. pylori</em> genes (<em>16s rRNA</em>, <em>ureA</em>, <em>vacA m1</em>/<em>m2</em>), using recombinase aided amplification (RAA) combined with lateral flow dipstick (LFD) methods. Both <em>16s rRNA</em> and <em>ureA</em> were selected as identification genes to ensure reliable detection accuracy.</p></div><div><h3>Results</h3><p>A RAA-LFD assay was developed to achieve dual-target amplification at a stable 37 °C within 20 min, followed by visualization using the lateral flow dipstick (LFD). The whole process, from amplification to results, took less than 30 min. The 95 % limit of detection (LOD) for <em>16 s rRNA</em> and <em>ureA</em>, <em>vacA m1</em>, <em>vacA m2</em> were determined as 3.8 × 10^-2 ng/μL, 5.8 × 10^-2 ng/μL and 1.4 × 10^-2 ng/μL, respectively. No cross-reaction was observed in the detection of common pathogens including <em>Escherichia coli</em>, <em>Klebsiella pneumoniae</em>, <em>Enterococcus faecalis</em>, <em>Staphylococcus aureus</em>, <em>Pseudomonas aeruginosa</em>, and <em>Bacillus subtilis</em>, showing the assay’s high specificity. In the evaluation of the clinical performance of the RAA-LFD assay. A total of 44 gastric juice samples were analyzed, immunofluorescence staining (IFS) and quantitative polymerase chain reaction (qPCR) were used as reference methods. The RAA-LFD results for the <em>16s rRNA</em> and <em>ureA</em> genes showed complete agreement with qPCR findings, accurately identifying <em>H. pylori</em> infection as confirmed by IFS in 10 out of the 44 patients. Furthermore, the assay successfully genotyped <em>vacA m1</em>/<em>m2</em> among the positive samples, showing complete agreement with qPCR results and achieving a kappa (κ) value of 1.00.</p></div><div><h3>Conclusion</h3><p>The dual-target RAA-LFD assay developed in this study provides a rapid and reliable method for detecting and genotyping <em>H. pylori</em> within 30 min, minimizing dependency on sophisticated laboratory equipment and specialized personnel. Clinical validation confirms its efficacy as a promising tool for effectively control of its prevalence and aiding in the precise treatment of <em>H. pylori</em>-associated diseases.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009898124021806/pdfft?md5=38159736cb5b2a7cd5ff1b39bb95eefc&pid=1-s2.0-S0009898124021806-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995424","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}