Clinical Microbiology and Infection最新文献

{"title":"Pre- and postapproval diagnostic test accuracy of FDA-authorized rapid antigen SARS-CoV-2 tests used according to instruction: A systematic review and meta-analysis.","authors":"Mathias Damkjær, David Ruben Teindl Laursen, Mia Elkjær, Oke Gerke, Andreas Lundh, Asbjørn Hróbjartsson, Jeppe B Schroll","doi":"10.1016/j.cmi.2025.07.009","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.009","url":null,"abstract":"<p><strong>Background: </strong>Manufacturers claim high sensitivity for rapid antigen SARS-CoV-2 tests on product labels, yet systematic reviews report considerably lower sensitivity.</p><p><strong>Objectives: </strong>To describe study characteristics and compare the sensitivity and specificity United States Food and Drug Administration (FDA)-approved rapid antigen SARS-CoV-2 tests in pre-versus postapproval studies.</p><p><strong>Methods: </strong>Systematic review and meta-analysis.</p><p><strong>Data sources: </strong>FDA website, Medline, Embase, and Google Scholar.</p><p><strong>Study eligibility criteria: </strong>Diagnostic test accuracy studies according to instruction for use.</p><p><strong>Participants: </strong>Patients with symptoms of COVID-19.</p><p><strong>Test(s): </strong>Rapid antigen SARS-CoV-2 tests.</p><p><strong>Reference standard: </strong>Reverse transcriptase polymerase chain reaction.</p><p><strong>Assessment of risk of bias: </strong>QUADAS-2 tool.</p><p><strong>Methods of data synthesis: </strong>Bivariate binomial-normal restricted maximum likelihood random-effects meta-analysis and meta-regressions applying the delta method and likelihood ratio tests.</p><p><strong>Results: </strong>We identified postapproval studies for 13 of 61 (21%) rapid antigen tests, of which nine tests had eligible studies. The analysis incorporated 13 preapproval studies (591 COVID-19 cases, 3,155 participants) and 26 postapproval studies (2,765 cases, 12,444 participants). The pooled sensitivity for pre- and postapproval studies was 86.5% (95% CI: 83.3-89.1) and 84.5% (95% CI: 81.2-87.3), respectively. The absolute difference was 2.0% (95% CI: -1.9 to 6.2) and (0%, 95% CI: -0.6 to 0.6) for sensitivity and specificity, respectively. Two of the nine tests had lower sensitivity in postapproval studies.</p><p><strong>Discussion: </strong>Our study found that sensitivity estimates from postapproval studies on FDA-approved rapid antigen tests are largely consistent with manufacturers' estimates. However, for two of the nine tests, postapproval sensitivity was lower than the manufacturers' high estimates. Differences in sensitivity observed in prior systematic reviews likely result from variations in study populations, not bias in study conduct. Given that 79% of FDA-approved rapid antigen tests lacked postapproval studies, ongoing evaluations are needed to ensure alignment with clinical expectations.</p><p><strong>Registration: </strong>The study was preregistered, and the protocol is available at https://osf.io/97cft.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical performance of a genotyping assay based on hybrid capture technique in cervical cancer screening in China: a prospective population-based multicenter cohort study.","authors":"Jian Yin, Sumeng Wang, Shaokai Zhang, Wen Chen, Qinjing Pan, Xun Zhang, Xiaodong Cheng, Xibin Sun, Fanghui Zhao, Youlin Qiao","doi":"10.1016/j.cmi.2025.07.004","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.004","url":null,"abstract":"<p><strong>Objectives: </strong>We aimed to assess the clinical performance of DH3, a hybrid capture method that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines.</p><p><strong>Methods: </strong>A total of 9,379 eligible women aged 21-64 years from 3 centers underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for three years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.</p><p><strong>Results: </strong>At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared to LBC with reflex HR-HPV, primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI, 91.33-98.10%] vs. 84.93% [95% CI, 78.24-89.83%], P_McNemar = 0.004), and a marginally lower specificity (89.65% [95% CI, 89.01-90.25%] vs. 91.61% [95% CI, 91.02-92.15%], P_McNemar < 0.001) for detecting CIN2+. 7,747 (82.6% follow-up rate) women completed the three-year follow-up, during which 236 (3.00%) were cumulatively diagnosed with CIN2+. HR-HPV with reflex LBC demonstrated significantly higher sensitivity than LBC with reflex HR-HPV (91.95% [95% CI, 87.77-94.79%] vs. 63.56% [95% CI, 57.25-69.44%], P_McNemar < 0.001), while both methods exhibited similar specificity (90.57% [95% CI, 89.89-91.21%] vs. 91.37% [95% CI, 90.72-91.99%], P_McNemar = 0.062) for CIN2+. The colposcopy referral rates for the two algorithms were also comparable (5.77% (447/7747) vs. 5.38% (417/7747), P = 0.294). In addition, individuals positive for HPV16/18 had a three-year absolute risk of CIN2+ exceeding 48%. In comparison, the risk was only 0.28% (19/6822) in the HPV-negative population, markedly lower than the 1.24% (86/6949) risk observed in individuals with normal cytology. Limiting the analysis to women aged 30 and older yielded similar results.</p><p><strong>Conclusions: </strong>Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methenamine hippurate as prophylaxis for recurrent urinary tract infections in older women - a triple-blind, randomised, placebo-controlled, phase IV trial (ImpresU).","authors":"Silje Rebekka Heltveit-Olsen, Egill Snaebjörnsson Arnljots, Pär-Daniel Sundvall, Ronny Gunnarsson, Anna Kowalczyk, Maciej Godycki-Cwirko, Tamara N Platteel, Wim G Groen, Sara Sofia Lithén, Sofia Sundvall, Christina Åhren, Nils Grude, Theo J M Verheij, Cees M P M Hertogh, Morten Lindbæk, Sigurd Høye","doi":"10.1016/j.cmi.2025.07.006","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.006","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the preventive effect of the antiseptic methenamine hippurate on recurrent urinary tract infections (rUTIs) in older women.</p><p><strong>Methods: </strong>Triple-blind, randomised, placebo-controlled phase IV trial with a six-month treatment period and a six-month follow-up. Women ≥ 70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started December 2019, with follow-up completed at the end of June 2023. Participants were randomised to methenamine hippurate 1g x 2 or placebo 1 tablet x 2 for six months. The primary outcome was number of antibiotic treatments for UTIs during the treatment period. Secondary outcomes included number of antibiotic treatments for UTIs during the follow-up period, UTI symptom severity and episode duration. Differences in complications were measured as safety outcomes.</p><p><strong>Results: </strong>Of 289 recruited women, 281 (97%) were included in the main analysis (140 in the methenamine hippurate group, 141 in the placebo group). During the treatment period, the methenamine hippurate group had a lower incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 0.75 (95% CI 0.57-1.0, p= 0.049). In the follow-up period, the ratio was reversed: The methenamine hippurate group had a higher incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 1.7 (95% CI 1.3-2.3, p<0.001). There were no important differences in UTI symptom severity/duration or complications between the groups.</p><p><strong>Conclusion: </strong>Methenamine hippurate reduces the frequency of rUTIs in older women with a point estimate of a 25% reduction, suggesting advantages over low-dose antibiotic prophylaxis due to its low potential for selection for antimicrobial resistance and mild side effects. However, discontinuation after six-month treatment duration seems to increase the risk of UTI relapses, and physicians should be aware of this risk when initiating or discontinuing treatment.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Registry (NCT04077580); EudraCT: 2018-002235.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Autochthonous Leishmania major infections in Kabylie, Algeria: A signal of changing epidemiology.","authors":"Nacera Seklaoui, Denis Sereno, Abdelkamel Mouloua, Djamila Kais, Fatiha Kerkouche, Kahina Chekaoui, Sophie Brun, Boussad Hamrioui, Arezki Izri, Mohammad Akhoundi","doi":"10.1016/j.cmi.2025.07.008","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.008","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lyophilized vancomycin-hydrochloride for intravenous use retains full bactericidal activity and molecular stability 20 years post-expiration.","authors":"Jari Verbunt, Freek G Bouwman, Suzan van Mens, Rogier van der Zanden, Frank Stassen, Paul Savelkoul","doi":"10.1016/j.cmi.2025.07.007","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.007","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144648763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Screening clinical Candida albicans isolates for invasiveness by mimicking the human environment.","authors":"Clément Vulin, Julian Sutter, Tiziano A Schweizer, Federica Andreoni, Julian Baer, Willy Isao Steiger, Alexandra Bernasconi, Karl Bulut, Roger D Kouyos, Brunella Posteraro, Maurizio Saunguinetti, Annelies S Zinkernagel","doi":"10.1016/j.cmi.2025.07.003","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.003","url":null,"abstract":"<p><strong>Objectives: </strong>Candida albicans virulence is associated with filamentation, triggered by environmental factors encountered in the host. Here, we monitored the growth behavior of C. albicans isolated from a patient's abscess. We also established an in-vitro screening-framework of filamentation to assess the invasiveness potential of ten clinical isolates.</p><p><strong>Methods: </strong>Routine microbiology testing and convenience sampling were used for patients' selection. We monitored colony appearance time of one abscess isolate ex-vivo using time-lapse imaging. Filamentation patterns of ten isolates were followed over 14 days using 48 variations of growth conditions (glucose and nitrogen concentrations, pH, temperature) to mimic host environment fluctuations. An automated image analysis pipeline was developed to quantify filamentation. Filamentation was also tested by growing isolates on modified filtration membranes, mimicking physical human body barriers.</p><p><strong>Results: </strong>The abscess isolate displayed heterogeneous colony-appearance-times and filamentation morphologies, indicating phenotypic heterogeneity within a growing population. Filamentation of all isolates was growth parameters and isolate-dependent. Based on their filamentation response to environmental changes, the isolates clustered in three distinct groups reflecting their site of isolation in the host. Colony transmigration on modified filtration membranes was a predictor for filamentation on agar.</p><p><strong>Conclusion: </strong>We observed diverse filamentation morphologies in all isolates, indicating a phenotypically heterogeneous behavior. Using our newly established screening framework, we could group isolates based on their isolation site, showing a link between filamentation morphology and invasive potential of C.albicans isolates.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revolution in publication: if not now, when?","authors":"Jean-Philippe Lanoix, Asma Nasim, Elda Righi, Dafna Yahav","doi":"10.1016/j.cmi.2025.07.005","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.005","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How to interpret MICs of amphotericin B, echinocandins and flucytosine against Candida auris (Candidozyma auris) according to the newly established EUCAST breakpoints.","authors":"Maiken Cavling Arendrup, Jesus Guinea, Sevtap Arikan-Akdagli, Eelco F J Meijer, Jacques F Meis, Jochem B Buil, Eric Dannaoui, Christian G Giske, Pavlina Lyskova, Joseph Meletiadis","doi":"10.1016/j.cmi.2025.07.002","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.07.002","url":null,"abstract":"<p><strong>Background: </strong>Candida auris (Candidozyma auris) has emerged as an important pathogen across all continents, with clonal outbreaks and hospital transmissions. Most isolates are fluconazole resistant and variable resistance rates are reported for amphotericin B and echinocandins.</p><p><strong>Objectives: </strong>The aim was to present an overview of the newly established ECOFFs and antifungal breakpoints against C. auris and the supporting evidence.</p><p><strong>Sources: </strong>This document is based on the recently updated EUCAST rationale documents, clinical breakpoint and ECOFF documents.</p><p><strong>Content: </strong>An alternative approach was adopted for ECOFF setting of C. auris to avoid MIC distributions dominated by isogenic outbreak strains. A carefully selected strain collection of 30 isolates from 11 countries, representing five clades and 21 unique genotypes, was shared among five individual laboratories. MICs were determined with the EUCAST E.Def 7.4 methodology providing five non-clonal datasets well above the required ≥100 total MICs per drug. Available PK-PD and clinical data were reviewed. The following ECOFFs and breakpoints were established for C. auris: amphotericin B: ECOFF: 2 mg/L, S: ≤ 0.001 mg/L, R: >2 mg/L; implying that the entire wild-type distribution is \"susceptible, Increased exposure\" (I) (increased dose: 5 mg/kg liposomal amphotericin B daily); anidulafungin and micafungin: ECOFFs: 0.25 mg/L, S: ≤ 0.25; R: >0.25; rezafungin: ECOFF: 0.125 mg/L; and flucytosine: ECOFF: 0.5 mg/L. Importantly, notable MIC variations have been reported for C. auris and some agents across commercial tests. Consequently, important detailed guidance is provided on how to validate your MIC test in house before adopting the EUCAST breakpoints for MIC interpretation.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unexpected natural cefiderocol resistance in Stenotrophomonas maltophilia associated to the genogroup 4 genetic background.","authors":"Céline Sakr, Maxime Danjean, Florence Cizeau, David Ducellier, Melissa N Debi, Guilhem Royer, Laurent Poirel, Jean-Winoc Decousser","doi":"10.1016/j.cmi.2025.07.001","DOIUrl":"10.1016/j.cmi.2025.07.001","url":null,"abstract":"<p><strong>Objectives: </strong>Stenotrophomonas maltophilia (Sm) is responsible for infections in immunocompromised and hospitalized patients. Its genomic diversity has led to the description of a large complex including numerous genogroups. Regarding acquired resistances, cefiderocol (CeFiDeroCol, CFDC) is a promising therapeutic option. We aimed to evaluate the CFDC susceptibility of a large panel of Sm strains and explored the genetic support and background of resistance.</p><p><strong>Methods: </strong>We prospectively collected 154 non-duplicated clinical and environmental strains from five university hospitals between January 2023 and April 2024. All the strains were whole-genome sequenced and their genetic background studied using multi-locus sequence typing , core genome multi-locus sequence typing, and genogroup determination. CFDC susceptibility was tested using a two-step approach with a marketed product (screening step) and the broth microdilution method (confirmation step). Strains exhibiting an MIC >1 mg/L were considered as non-susceptible (ns). We used a national 2013 strain collection to confirm the resistance in a particular genogroup. The genetic support of CFDC non-susceptibility was studied according to a collection of previously selected CFDC mutants.</p><p><strong>Results: </strong>Six of 154 Sm strains (4%) were non-susceptible to CFDC, including one environmental strain and five clinical strains. None of the patients was exposed to CFDC. The strains belonged to four different sequence type (ST) (ST87, n = 2; ST39, n = 2; ST18, n = 1; and unknown, n = 1) but to the same genogroup (genogroup 4). All seven 2013 genogroup 4 strains were also non-susceptible to CFDC. None of the previously published mutations/deletions were identified, but common non-synonymous mutations were found in tonB and tolQ; a common polymorphism was identified in the promoter region of smet.</p><p><strong>Discussion: </strong>The natural intrinsic non-susceptibility of the genogroup 4 could hamper the contribution of CFDC for the empiric treatment of Sm infections.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mimicry of Malignancy: Peritoneal Nodule Caused by Ectopic Enterobius vermicularis.","authors":"Alicia Moreno-Sabater, Vénus Tostivint, Adrien Pecriaux, Yann Parc","doi":"10.1016/j.cmi.2025.06.034","DOIUrl":"https://doi.org/10.1016/j.cmi.2025.06.034","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}