Open Forum Infectious Diseases最新文献

{"title":"Current Evidence and Gaps for Outpatient Respiratory Tract Infection Diagnostics: A Call to Action.","authors":"Christen J Arena, Holly M Frost, Park Willis, Brian Raux, Minkey Wungwattana, Michael P Veve","doi":"10.1093/ofid/ofaf519","DOIUrl":"https://doi.org/10.1093/ofid/ofaf519","url":null,"abstract":"<p><p>Antimicrobial stewardship programs (ASPs) are underrepresented in outpatient settings, where antibiotic use and overprescribing are common. Upper respiratory tract infections (URIs) account for 30% of outpatient antibiotic prescriptions, highlighting the need for enhanced ASP efforts. Rapid diagnostic testing (RDT) has important value in management of outpatient URIs, such as pharyngitis, and can lead to optimized prescribing practices and significant reductions in unnecessary antimicrobial use by facilitating accurate diagnoses. Implementation of outpatient RDTs is hindered by a lack of streamlined workflows, resources, and ASPs. These gaps often lead to suboptimal use of RDTs and misinterpretation of or failure to act on the results. Future RDT evaluations should include strategies to curtail unnecessary antibiotics and expand point-of-care testing (POCT) to additional settings to enhance antimicrobial stewardship. This paper reviews outpatient RDT initiatives, and specifically POCT, in URIs. Additionally, we highlight the need for more evidence demonstrating the impact on clinical outcomes and antibiotic prescribing with the implementation of RDTs.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 Suppl 2","pages":"S1413-S1417"},"PeriodicalIF":3.8,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12541907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145355598","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":"Navigating and Advancing Market Access for In Vitro Diagnostics: Understanding the Roles of Key Stakeholders and Policy.","authors":"Brandon K Hill, Andrea M Prinzi, J R Kane, Amalia K Corby, Barbara D Powe","doi":"10.1093/ofid/ofaf444","DOIUrl":"https://doi.org/10.1093/ofid/ofaf444","url":null,"abstract":"<p><p>Rapid and accurate infectious diseases diagnostics are essential to guide antimicrobial stewardship, combat antimicrobial resistance, and improve patient outcomes. However, the availability, adoption, and sustainability of in vitro diagnostics (IVDs) are challenged by high upfront costs, inconsistent coverage and reimbursement policies, and an evolving regulatory landscape. Market access, payor and health policy, and advocacy are pivotal in shaping whether these technologies reach the patient. It is essential to understand the key components of the market access process-regulatory pathways, coverage, reimbursement, evidence generation, and stakeholder engagement-and to recognize how healthcare providers, payors, patients, and policymakers influence diagnostic accessibility. Clinicians, pharmacists, and laboratory professionals must actively participate in advocacy efforts, leveraging clinical insight and evidence to inform regulation, reimbursement, and guideline inclusion. This article presents a practical overview for advancing IVDs through policy and market access engagement, emphasizing the need for coordinated, evidence-based communication with regulatory bodies, payors, and professional societies.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 Suppl 2","pages":"S1404-S1412"},"PeriodicalIF":3.8,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12541712/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145355553","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":"Multiplex Polymerase Chain Reaction Panels for Gastrointestinal Infections: Current Evidence, Regulatory Hurdles, and the Way Forward.","authors":"Giannoula S Tansarli, David R Allen, Ferric C Fang","doi":"10.1093/ofid/ofaf445","DOIUrl":"https://doi.org/10.1093/ofid/ofaf445","url":null,"abstract":"<p><p>Syndromic multiplex polymerase chain reaction (PCR) panels have revolutionized the diagnosis of gastrointestinal infections, allowing the rapid and simultaneous detection of multiple pathogens, including rare or difficult-to-identify organisms, with superior analytic sensitivity as compared with conventional methods. Although multiplex PCR panels are costly, their costs are offset by lower health care costs resulting from improved diagnostic accuracy and more targeted therapy. However, significant barriers to reimbursement may discourage providers from ordering PCR panels or incentivize them to use smaller panels that are less comprehensive. Addressing these challenges will require a collaborative effort, including regulators, payors, and clinicians. Key steps will include updating clinical guidelines to better define appropriate utilization of gastrointestinal panels, harmonizing reimbursement criteria to align with evidence-based practice, and modernizing diagnostic codes for acute gastroenteritis to match payors' requirements. These reforms will be essential to improve access to advanced diagnostics and ensure better patient care.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 Suppl 2","pages":"S1418-S1430"},"PeriodicalIF":3.8,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12541719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145355610","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":"Beyond Accuracy: Methodological Advances for Assessing the Clinical Impact of Infectious Disease Diagnostics.","authors":"Kimberly C Claeys, Andrea M Prinzi, Tristan T Timbrook","doi":"10.1093/ofid/ofaf489","DOIUrl":"https://doi.org/10.1093/ofid/ofaf489","url":null,"abstract":"<p><p>Evaluating the clinical impact of <i>in vitro</i> diagnostic tests (IVDs) for infectious diseases is complex given their effectiveness depends on context, implementation, and provider behavior. Traditional methodologies for therapy interventions do not adequately capture this complexity, necessitating novel analytical approaches and study designs. This review highlights methodological considerations for improving evidence generation for infectious diseases IVDs. Design and analysis challenges leading to bias and related solutions are reviewed such as the target trial framework. Moreover, novel frameworks such as Benefit-Risk Evaluation of Diagnostics: A Framework, Desirability of Outcome Ranking Management of Antimicrobial Therapy, and Desirability of Outcome Ranking and study designs such as hybrid effectiveness-implementation designs are discussed which allow for holistic ways to assess real-world outcomes. By evaluating IVDs with practical, real-world evidence, tests can better inform clinical decision making, policy, and ultimately patient outcomes.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 Suppl 2","pages":"S1391-S1403"},"PeriodicalIF":3.8,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12541908/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145355612","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":"Investigating the Molecular Epidemiology of Extended-Spectrum β-Lactamase-Producing Enterobacterales (ESBL-E) Among Patients Admitted to the Intensive Care Unit.","authors":"Sima L Sharara, Patricia J Simner, Yehudit Bergman, Emily Jacobs, Suiyini Fiawoo, Eili Y Klein, Sara E Cosgrove, Pranita D Tamma","doi":"10.1093/ofid/ofaf590","DOIUrl":"https://doi.org/10.1093/ofid/ofaf590","url":null,"abstract":"<p><p>At a United States hospital, sequencing of ICU rectal surveillance cultures indicated 5% ESBL-E colonization. Of confirmed ESBL isolates, 91% were <i>Escherichia coli</i> or <i>Klebsiella pneumoniae</i>; 6% carried non-<i>bla</i> _CTX-M genes. Only 53% of third-generation cephalosporin-resistant Enterobacterales harbored ESBL genes, underscoring the limitations of phenotypic approaches as ESBL surrogates, particularly for non-<i>E. coli/K. pneumoniae</i> species.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 10","pages":"ofaf590"},"PeriodicalIF":3.8,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12538287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145346367","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":"HCV Core Antigen Diagnostic Performance for Acute/Recent HCV Infection in People With HIV-1: A Systematic Review and Meta-Analysis.","authors":"Tsung-Yu Tsai, Guan-Jhou Chen, Hsin-Yun Sun, Chien-Ching Hung","doi":"10.1093/ofid/ofaf576","DOIUrl":"10.1093/ofid/ofaf576","url":null,"abstract":"<p><strong>Background: </strong>Hepatitis C virus (HCV) core antigen (HCVcAg) has been validated to identify HCV infection, but its efficacy in diagnosing acute HCV infection among people with HIV-1 (PWH) warrants further investigation. This systematic review and meta-analysis aimed to evaluate the diagnostic performance of HCVcAg for acute or recent HCV infection among PWH.</p><p><strong>Methods: </strong>We conducted a literature search to identify studies assessing the diagnostic performance of HCVcAg from January 2020 to May 2024. Acute or recent HCV infection was defined as the presence of negative anti-HCV antibody but positive nucleic acid amplification tests (NAATs), or anti-HCV antibody seroconversion within 1 year. Studies were included if they evaluated HCVcAg diagnostic accuracy using NAATs as the gold standard and provided sufficient data for sensitivity and specificity assessment. Studies lacking a clear definition of acute or recent infection were excluded.</p><p><strong>Results: </strong>Four out of 229 articles met our inclusion criteria, with 1015 participants providing 1796 tests. The sensitivity of HCVcAg to diagnose acute or recent HCV infection ranged from 87.1% to 100% and specificity from 95.0% to 100%. The meta-analysis yielded a pooled sensitivity of 0.92 (95% CI, 0.78-0.98) and specificity of 0.99 (95% CI, 0.97-1.00). Based on the global incidence (8.46 per 1000 person-years) of HCV viremia among PWH, the positive and negative predictive values of HCVcAg were 0.44 (95% CI, 0.18-1.00) and 1.00 (95% CI, 0.99-1.00), respectively.</p><p><strong>Conclusions: </strong>HCVcAg has good diagnostic performance in identifying PWH with acute or recent HCV infection, supporting its integration into HCV screening protocols for PWH.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 10","pages":"ofaf576"},"PeriodicalIF":3.8,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12531625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145329642","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":"Human-bat Competition on Cultivated Fruit Resources Promotes Bat-borne Pathogens Spillover to Humans and Domestic Animals in Bangladesh: An Exploratory Qualitative Study.","authors":"A K M Dawlat Khan, Md Arif Khan, Pronesh Dutta, Monjurul Islam, Nabila Nujhat Chowdhury, Shusmita Dutta Choudhury, Tahmina Shirin, Ariful Islam","doi":"10.1093/ofid/ofaf595","DOIUrl":"10.1093/ofid/ofaf595","url":null,"abstract":"<p><strong>Background: </strong>Nipah virus (NiV) outbreaks have recurred nearly annually in Bangladesh since 2001, with a fatality >70%. These outbreaks are primarily linked to the consumption of raw date palm sap (RDPS), which is contaminated by Indian flying fox bats. Due to the rapidly changing ecology, bats increasingly depend on cultivated fruits. To address this, we observed how humans and domestic animals compete and interact with bats for cultivated fruits facilitate pathogen transmission to humans and animals.</p><p><strong>Methods: </strong>We conducted an exploratory qualitative study in 4 NiV outbreak districts of Bangladesh spanning both the summer (April-June) and winter (December-February) of 2021 and 2022, including 60 ethnographic interviews and 24 observations with fruit orchard owners and RDPS harvesters.</p><p><strong>Results: </strong>Almost all participants reported frequent visits of fruit bats to cultivated fruit orchards and RDPS trees. They noted wild fruit trees are scarce in their localities due to deforestation, resulting in bats turning to feed on cultivated fruits and RDPS. Participants also reported consuming bat-bitten dropped fruits and RDPS, occasionally feeding them to domestic animals, which also consume these fruits while grazing in the orchards. Orchard owners often use nets to protect their fruits from bats, and are exposed to bats during removal from the nets. Even some local ethnic people collect the trapped bats for consumption. Although RDPS harvesters use protective measures, bats scratch them to access and consume sap.</p><p><strong>Conclusions: </strong>The study's findings highlight the significance of increasing human-bat and domestic animal-bat food competition on cultivated fruits. We recommend future studies on ecological and behavioral interventions to prevent bat-borne pathogen spillover to humans and animals.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 10","pages":"ofaf595"},"PeriodicalIF":3.8,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12531628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145329698","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":"Turning the Tide Against Carbapenem-resistant <i>Acinetobacter baumannii</i>: Advancing Care With Sulbactam-Durlobactam.","authors":"Michael Satlin, Ryan K Shields, Antoni Torres, Glenn Tillotson","doi":"10.1093/ofid/ofaf618","DOIUrl":"10.1093/ofid/ofaf618","url":null,"abstract":"","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 10","pages":"ofaf618"},"PeriodicalIF":3.8,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12530933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145329662","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":"Carbapenem-Resistant Organisms in Companion Animals in New York City, 2019-2022.","authors":"Caroline A Habrun, William G Greendyke, Donald Szlosek, Andy Plum, Molly M Kratz, Elise Mantell, Karen A Alroy","doi":"10.1093/ofid/ofaf613","DOIUrl":"10.1093/ofid/ofaf613","url":null,"abstract":"<p><p>Carbapenem-resistant organisms (CROs) are a type of antibiotic-resistant bacteria that threaten human health. They can infect or colonize dogs and cats, with potential for zoonotic transmission to humans, but their prevalence in pet populations is not well described. To characterize CRO prevalence among gram-negative cultured isolates from New York City dogs and cats, we analyzed antimicrobial susceptibility data from a commercial veterinary diagnostic laboratory serving New York City veterinarians during 2019-2022. Among 16 115 gram-negative isolates, 256 (1.6%) were CROs cultured from 241 dogs and cats. CRO detections and the percentage positivity fluctuated during 2019-2022 and differed across the city's 5 boroughs. Data sharing between public health and veterinary diagnostic laboratories can identify CROs in pets and create opportunities to improve veterinary outreach and control of CROs in companion animals.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 10","pages":"ofaf613"},"PeriodicalIF":3.8,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12534726/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145329729","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":"Do Aminopenicillins Have a Role in Treating Ampicillin-Resistant <i>Enterococcus</i> UTIs?","authors":"Armani M Hawes, Pranita D Tamma, Navaneeth Narayanan","doi":"10.1093/ofid/ofaf619","DOIUrl":"10.1093/ofid/ofaf619","url":null,"abstract":"<p><p>Urinary tract infections caused by <i>Enterococcus</i> species are a frequent clinical challenge. The rising prevalence of ampicillin resistance often seemingly precludes the use of aminopenicillins. However, evidence suggests that aminopenicillins may retain clinical efficacy, even when susceptibility testing indicates resistance. Integrating available pharmacokinetics/pharmacodynamics and clinical data and risk-benefit considerations, we seek to address the question: Can aminopenicillins still be a viable treatment option in the management of ampicillin-resistant <i>Enterococcus</i> infections?</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 10","pages":"ofaf619"},"PeriodicalIF":3.8,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12531624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145329674","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}