Diagnostic microbiology and infectious disease最新文献

{"title":"Non-Invasive molecular dengue virus 1 diagnosis in saliva is possible","authors":"Carolina Gracia Poitevin ,&nbsp;Carla Adriane Royer ,&nbsp;Ana Claudia Bonatto ,&nbsp;Cristina de Oliveira Rodrigues ,&nbsp;Gabrielle Caroline Peiter ,&nbsp;Ana Paula Carneiro Brandalize ,&nbsp;Alexia Cristine Oliveira Rocha ,&nbsp;Carolina Langaro Brockmann ,&nbsp;Gabriela Bravim de Araujo ,&nbsp;Giovanna Lourenço Cavagnoli ,&nbsp;Ingrid Vitória Simardo ,&nbsp;Valentina Miotto Gasparim ,&nbsp;Regiane Stafim da Cunha ,&nbsp;Vanessa Crocetti Pereira ,&nbsp;Edneia Amancio de Souza Ramos ,&nbsp;Pedro Henrique Cardoso ,&nbsp;Monica Barcellos Arruda ,&nbsp;Patrícia Alvarez da Silva Baptista ,&nbsp;Emanuel Maltempi de Souza ,&nbsp;Daniela Fiori Gradia ,&nbsp;Jaqueline Carvalho de Oliveira","doi":"10.1016/j.diagmicrobio.2025.116935","DOIUrl":"10.1016/j.diagmicrobio.2025.116935","url":null,"abstract":"<div><h3>Objectives</h3><div>Dengue is a systemic virus infection, endemic in tropical/subtropical regions and of increasing global importance. The diagnostic gold standard for acute infection is the detection of viral RNA through reverse transcription quantitative polymerase chain reaction (RT-qPCR) in blood. Regrettably, venous collection requires specialized professionals, and dengue tests may be avoided by those who afraid of needles. Therefore, the aim of the present study is to evaluate the feasibility of using saliva in DENV-1 detection.</div></div><div><h3>Methods</h3><div>RT-qPCR was performed to detect DENV-1 in 201 paired saliva and plasma samples, from individuals with up to five days from the onset of symptoms.</div></div><div><h3>Results</h3><div>140 (69.65 %) patients had DENV-1 positive detection in plasma and 115 (57.21 %) positive in saliva samples. Those values rendered a sensitivity of 82.14 % and 100 % of specificity (agreement kappa index 0.736 [0.69 - 0.77].</div></div><div><h3>Conclusions</h3><div>Despite reduced sensitivity, we demonstrated the feasibility of DENV-1 diagnosis in saliva samples, presenting a valuable alternative, particularly in outbreak scenario.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116935"},"PeriodicalIF":2.1,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interlaboratory study to assess precision and reproducibility of the meningococcal antigen surface expression (MEASURE) assay to quantify factor H binding protein expression at the surface of meningococcal serogroup B strains","authors":"Jakob Loschko ,&nbsp;Paul Liberator ,&nbsp;Jamie Findlow ,&nbsp;Jason Yip ,&nbsp;Charles Tan ,&nbsp;Karen Garcia ,&nbsp;MaryAnn Murillo ,&nbsp;Yamini Gorantla ,&nbsp;Kimberly M. Moss ,&nbsp;Panagiotis Maniatis ,&nbsp;Stephen A. Clark ,&nbsp;Ray Borrow","doi":"10.1016/j.diagmicrobio.2025.116920","DOIUrl":"10.1016/j.diagmicrobio.2025.116920","url":null,"abstract":"<div><h3>Background</h3><div>The serum bactericidal antibody using human complement (hSBA) assay, the accepted surrogate measure of meningococcal vaccine efficacy, is limited by human sera and complement requirements. Pfizer developed and validated the flow-cytometry−based Meningococcal Antigen Surface Expression (MEASURE) assay to quantify surface-expressed factor H binding protein (fHbp) levels on intact meningococci. Surface expression of fHbp is correlated with hSBA assay killing by MenB-fHbp (Trumenba^Ⓡ)–induced antibody, meaning the MEASURE assay can be used to predict meningococcal serogroup B (MenB) strain susceptibility to antibodies elicited by MenB-fHbp. This study aimed to evaluate interlaboratory precision and reproducibility of the MEASURE assay.</div></div><div><h3>Methods</h3><div>The MEASURE assay was transferred to UK Health Security Agency (UKHSA) and US Centers for Disease Control and Prevention (CDC) laboratories. MEASURE assay results from 42 MenB strains encoding sequence-diverse fHbp variants that express fHbp at different levels were compared between the UKHSA, CDC, and Pfizer laboratories. Intermediate precision within each laboratory was determined.</div></div><div><h3>Results</h3><div>Pairwise comparisons of fHbp expression levels for all 42 MenB test strains showed &gt;97 % agreement across the 3 laboratories when strains were grouped above or below a mean fluorescence intensity level of 1000, the threshold previously established as indicative of susceptibility to MenB-fHbp–induced antibodies in the hSBA assay. Each laboratory met assay precision criteria of ≤30 % total relative standard deviation.</div></div><div><h3>Conclusions</h3><div>Quantification of fHbp surface expression using the MEASURE assay is robust and reproducible across different laboratories. Previously determined cutoffs corresponding to predicted susceptibility to vaccine-induced antibodies can be applied to MEASURE data generated across laboratories.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116920"},"PeriodicalIF":2.1,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144279514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pooled testing strategy for enterovirus D68 to facilitate local, resource-conserving surveillance","authors":"Madeline E. Spradley ,&nbsp;Timothy Williams ,&nbsp;Rendie McHenry ,&nbsp;Laura L. Short ,&nbsp;Dalton J. Nelson ,&nbsp;James D. Chappell ,&nbsp;Natasha Halasa ,&nbsp;Frederick R. Haselton ,&nbsp;Jonathan E. Schmitz","doi":"10.1016/j.diagmicrobio.2025.116934","DOIUrl":"10.1016/j.diagmicrobio.2025.116934","url":null,"abstract":"<div><div>Pooled testing represents a resource-conserving diagnostic strategy, and we propose enterovirus-D68 (EV-D68) as an attractive target for pooling (especially locally). To validate an RT-qPCR-based approach, retrospective pools were contrived from EV-D68-positive nasopharyngeal specimens and non-EV-D68-enterovirus-positive specimens. Five/nine-fold pools demonstrated 90.9 %/88.6 % sensitivity versus-unpooled testing (no false-positives), with commensurate results observed prospectively.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116934"},"PeriodicalIF":2.1,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The accuracy of Mycobacterium tuberculosis complex identification using cording observation with mpt64 antigen as the reference standard","authors":"Mutiah Nurul Jihadah ,&nbsp;Jessi Annisa ,&nbsp;Dyshelly Nurkartika Pascapurnama ,&nbsp;Nabilla Ghina Zavitri ,&nbsp;Yoopie Setiawan ,&nbsp;Raspati Cundarani Koesoemadinata ,&nbsp;Ida Parwati ,&nbsp;Intan Mauli Warma Dewi ,&nbsp;Lidya Chaidir","doi":"10.1016/j.diagmicrobio.2025.116927","DOIUrl":"10.1016/j.diagmicrobio.2025.116927","url":null,"abstract":"<div><div>Serpentine cording is a <em>Mycobacterium tuberculosis</em> complex (MTBC) specific colony morphology in liquid culture formed by outer mycomembrane component intracolonic interaction. This structure has the potential to streamline tuberculosis microbiology detection and potentially be used as a solo identification biomarker. This study assessed the sensitivity and specificity of cording-based identification compared to the presence of MPT64 antigen, by immunochromatography test or gene sequencing, as the reference standard for MTBC identification from culture. Direct cording observation by Microscopic Observation Drug Susceptibility (MODS) Assay was performed on 3426 screened TB suspects. As many as 1694 isolates were confirmed as MTBC and forty isolates as NTM (Non-Tuberculous Mycobacteria) only by cording visibility. Twelve pseudo-cording isolates were observed. Cording-based identification yields 100 % sensitivity and 76.9 % (95 % CI: 65.5 - 88.4) specificity. This study highlights the possibility of using cording as an MTBC identification biomarker after overcoming the pseudo-cording and mutation in MPT64 antigen.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116927"},"PeriodicalIF":2.1,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144253755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-pandemic surveillance of seven key respiratory pathogens using targeted next-generation sequencing (tNGS): A regional epidemiological study from Shandong, China","authors":"Jue Wang ,&nbsp;Shiliang Cheng ,&nbsp;Yufei Zhang ,&nbsp;Jingrong Qian ,&nbsp;Yanli Zhang ,&nbsp;Xuewei Zhuang","doi":"10.1016/j.diagmicrobio.2025.116931","DOIUrl":"10.1016/j.diagmicrobio.2025.116931","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory tract infections (RTIs) represent a substantial public health concern, particularly as the circulation patterns of pathogens undergo changes. This research utilized targeted next-generation sequencing (tNGS) to examine the epidemiological distribution of seven key RTI-associated pathogens, among patients hospitalized with RTI-indicative symptoms from February 2023 to February 2024.</div></div><div><h3>Methods</h3><div>The clinical and demographic information of 5,556 RTI-affected individuals was subjected to retrospective analysis. Pharyngeal swab samples were gathered, and tNGS was implemented to concurrently identify multiple pathogens. The positivity rates were contrasted based on age, sex, and season, and variations in infection patterns across different demographic categories and seasonal periods.</div></div><div><h3>Results</h3><div>Among the analyzed samples, 55.74 % were found to be positive for at least one pathogen. Flu-A had the highest prevalence rate of 16.45 %, succeeded by HRV at 13.48 % and SARS-CoV-2 at 10.89 %. Mixed infections were detected in 7.9 % of instances, with the combination of Flu-A and HRV being the most frequently observed dual-pathogen scenario. An age-stratified examination showed a higher overall positivity rate among children in the 4-18-year-old age group and a considerably greater RSV positivity rate among children aged 0-3 years. Season based analysis demonstrated peak infection rates in the winter season (61.09 %). Female patients were found to have a significantly higher positivity rate for influenza B compared to male patients.</div></div><div><h3>Conclusions</h3><div>tNGS is a valuable tool for comprehensive pathogen detection, supporting more effective and timely public health responses and clinical management strategies tailored to age and seasonal infection trends in the post-pandemic period.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116931"},"PeriodicalIF":2.1,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Off-label use of the BIOFIRE® Blood Culture Identification 2 Panel for multidrug-resistant bacteria colonization surveillance in critical care unit patients: A retrospective study","authors":"Sofía Cano ,&nbsp;María Ángeles Clari ,&nbsp;Javier Colomina ,&nbsp;Laura García ,&nbsp;Cristina Sanchís- Piqueras ,&nbsp;Ignacio Torres ,&nbsp;Gerardo Aguilar ,&nbsp;Nieves Carbonell ,&nbsp;David Navarro","doi":"10.1016/j.diagmicrobio.2025.116930","DOIUrl":"10.1016/j.diagmicrobio.2025.116930","url":null,"abstract":"<div><div>In this retrospective, single-center, observational study we assessed the performance of the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel for the identification of multidrug-resistant bacteria (MDRB)-colonized critical care unit patients compared with a standard culture and antimicrobial susceptibility testing (AST)-based approach. A total of 146 rectal/pharyngeal/nasal combined specimens from 130 patients were tested by using the BCID2 panel. MDRB were detected in 40/146 (27.3%) specimens from 39 patients (30%) by the BCID2 panel; MDRB were recovered by culture in 32/146 (21.9%) specimens from 30 patients (23%). Concordance between the MDRB detected by the BCID2 panel and those recovered by culture was observed in 29/43 cases; MDRB were more frequently extended-spectrum beta-lactamase-harboring Enterobacterales or <em>van</em>A/B-carrying <em>Enterococcus faecium</em>. The per specimen positive and negative percentage agreement values were 90.6% and 90.3%, respectively (Kappa value: 0.73). The BCID2 panel shows promise as a tool for the rapid identification of MDRB carriers in critical care units. Its use may lead to prescription of more refined empirical antimicrobial therapies on an individual basis and allow timely isolation of patients to prevent MDRB spreading. Nevertheless, larger, multicenter, prospective, and Next-generation sequencing-validated studies are needed to corroborate our findings.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116930"},"PeriodicalIF":2.1,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144169110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CMV retinitis in HIV-infected patients: Plasma viral load utility in diagnosis","authors":"Samia Benadda ,&nbsp;Nassima Achour ,&nbsp;Hanifa Ziane ,&nbsp;Kamal Kezzal","doi":"10.1016/j.diagmicrobio.2025.116926","DOIUrl":"10.1016/j.diagmicrobio.2025.116926","url":null,"abstract":"<div><h3>Objectives</h3><div>This study evaluates the role of CMV plasma viral load in diagnosing retinitis among Algerian HIV patients.</div></div><div><h3>Methods</h3><div>Simultaneous ophtalmologic examination and CMV plasma viral load testing were conducted for 40 HIV patients with vision issues. Plasma viral load kinetics was determined during treatment, and in case of persistent viral load, resistance genotyping was performed.</div></div><div><h3>Results</h3><div>Viral load findings correlated with ophtalmic examination results in 75 % of cases. Four (04) retinitis cases had undetectable viral loads. Virological monitoring identified Algeria's first ganciclovir-resistant CMV strain.</div></div><div><h3>Conclusion</h3><div>Plasma viral load testing is a valuable diagnostic tool but cannot replace ophthalmic examination. Quantitative PCR aids in effective virological monitoring and timely treatment initiation.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116926"},"PeriodicalIF":2.1,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144169109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute appendicitis in children: Two microbial states associated with clinical indicators and severity","authors":"Ziyu Liu ,&nbsp;Keqiang Yan ,&nbsp;Jing Li ,&nbsp;Ce Zhang ,&nbsp;Donghao Xu ,&nbsp;Yuhan Wang ,&nbsp;Xiaomei Xie ,&nbsp;Haiyan Li ,&nbsp;Jiarong Qie ,&nbsp;Jinxin Li ,&nbsp;Xiaofei Dong ,&nbsp;Liang Dong ,&nbsp;Hualei Cui","doi":"10.1016/j.diagmicrobio.2025.116925","DOIUrl":"10.1016/j.diagmicrobio.2025.116925","url":null,"abstract":"<div><h3>Background</h3><div>Acute appendicitis (AA) is one of the most common abdominal emergencies worldwide. It is associated with dysbiosis and is usually classified clinically as either simple appendicitis (SA) or complicated appendicitis (CA) . The etiology and pathogenesis of AA remain incompletely understood.</div></div><div><h3>Methods</h3><div>A total of 74 pediatric intra-abdominal pus samples from appendectomy cases (aged 3-15) were collected for AA at Tianjin Children's Hospital (Feb 2022-Sep 2023). The samples were categorised into two groups based on pathological findings: SA (n = 27) and CA (n = 47). Metagenomic profiling was employed to characterized the microbial composition and function in both groups. Additionally, clinical parameters associated with the microbiota were analysed.</div></div><div><h3>Results</h3><div>The SA group exhibited higher levels of <em>Burkholderia, Mycobacterium</em>, and <em>Klebsiella</em>, while the CA group demonstrated higher levels of <em>Porphyromonas, Bacteroides, Fusobacterium, Prevotella</em>, and <em>Tannerella</em>. Additionaly, there were significant differences in clinical parameters, including C-reactive protein (CRP), procalcitonin (PCT), fibrinogen, sodium, potassium, phosphorus, complement C3, and chloride, between two groups. Furthermore, functional profiling revealed alterations in microbial metabolism and antibiotic resistance, highlighting the complex interplay between microbial communities and host inflammatory responses in appendicitis.</div></div><div><h3>Conclusions</h3><div>This study identifies unique microbial and serum biomarkers and their correlates in varying severities of acute appendicitis, highlighting the role of the microbiome in the aetiology of acute appendicitis.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116925"},"PeriodicalIF":2.1,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144138448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A global survey of diagnostic practices in prosthetic joint infections","authors":"Shradha Subedi ,&nbsp;Patrick NA Harris ,&nbsp;Paul Chapman ,&nbsp;Antonia F Chen ,&nbsp;Joshua S Davis ,&nbsp;Po-Yu Liu ,&nbsp;Leonard C Marais ,&nbsp;Mauro J Salles ,&nbsp;Jason A Roberts ,&nbsp;Jesus Rodriguez-Bano ,&nbsp;Marjan Wouthuyzen-Bakker ,&nbsp;David L Paterson ,&nbsp;Natividad Benito","doi":"10.1016/j.diagmicrobio.2025.116919","DOIUrl":"10.1016/j.diagmicrobio.2025.116919","url":null,"abstract":"<div><div>Prosthetic joint infections (PJIs) lead to significant morbidity, mortality and healthcare costs. A timely and accurate microbiological diagnosis is crucial for administering appropriate antimicrobial therapy. Periprosthetic tissue cultures are considered the ‘gold standard’ for microbiologically diagnosing PJIs. Though International guidelines provide some recommendations for achieving the aetiological diagnosis of PJI, many aspects remain unclear with local practices varying considerably. To better understand these practices, we conducted a global survey to evaluate microbiological diagnostic approaches for PJIs. One hundred and seven hospitals from 24 countries across six continents took part in the survey. Over half of the sites (51.4 %) were from Europe and the majority (79 %) were public hospitals. Nearly half of the sites (49.5 %) reported collecting 5-6 periprosthetic tissue samples for culture; however, 11 % collected fewer than 3 samples. Sonication on explanted joints were done in 46 (43 %) sites. It is noteworthy that 42 % of sites had a culture incubation period of 5 days or less, although 70 % of laboratories extended it under specific circumstances. Matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) was the most used method for bacterial identification (74.8 %), and the European Committee on Antimicrobial Susceptibility Testing (EUCAST) was the preferred method for susceptibility testing (64.5 % of sites), though notable differences were observed between continents. The availability of polymerase chain reaction (PCR) was limited to 46 (43 %) sites. These global variations in diagnostic practices may contribute to discrepancies in the reported aetiology and percentage of culture-negative PJIs reported in the literature.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116919"},"PeriodicalIF":2.1,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methylation testing versus cervical cytology for triage of HPV-positive women: A comparative study","authors":"Mingyang wang ,&nbsp;Ying Ma ,&nbsp;Nina Zhang,&nbsp;Li Li,&nbsp;Yurong Fu,&nbsp;li’an Li,&nbsp;Qingzhi Zhai","doi":"10.1016/j.diagmicrobio.2025.116917","DOIUrl":"10.1016/j.diagmicrobio.2025.116917","url":null,"abstract":"<div><h3>Background</h3><div>In many countries, HPV testing has replaced cervical cytology as the primary screening method for cervical cancer. While HPV testing has high sensitivity, its limited specificity necessitates triage to reduce unnecessary colposcopy referrals. This study evaluates the performance of cervical cytology (TCT) and the GynTect® six-gene methylation test as triage methods for HPV-positive women.</div></div><div><h3>Methods</h3><div>A total of 276 women from China were categorized into four pathological groups: cervical squamous cell carcinoma (CSCC), CIN3, CIN2, and CIN1. The diagnostic performance of TCT and the GynTect test was assessed for detecting CIN3+, with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) calculated for both methods.</div></div><div><h3>Results</h3><div>Abnormal cytology (ASC-US+) had a sensitivity of 71.9% and specificity of 75.0% for detecting CIN3+, with a PPV of 57.5% and NPV of 85.0%. In comparison, the GynTect test demonstrated superior diagnostic accuracy, with a sensitivity of 88.5%, specificity of 87.2%, PPV of 78.7%, and NPV of 93.5%. The GynTect test outperformed cytology in identifying CIN3+ while reducing unnecessary colposcopies in women with CIN2- lesions.</div></div><div><h3>Conclusions</h3><div>The GynTect six-gene methylation test provides higher diagnostic accuracy than cervical cytology in the triage of HPV-positive women. Its superior sensitivity and specificity make it a valuable tool for improving risk stratification in HPV-based cervical cancer screening. These findings support the integration of methylation-based testing into screening programs to enhance diagnostic precision and optimize patient management.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116917"},"PeriodicalIF":2.1,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144169282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}