发布求助
文献互助 智能选刊 最新文献

Clinical Microbiology Newsletter最新文献

筛选
英文 中文
Navigating the new norm: The FDA's final rule on laboratory developed tests (LDTs) and its impact on clinical laboratory operations 驾驭新规范：美国食品和药物管理局关于实验室开发测试 (LDT) 的最终规定及其对临床实验室运作的影响
Clinical Microbiology Newsletter Pub Date : 2024-09-01 DOI: 10.1016/j.clinmicnews.2024.09.001
Rob E. Carpenter
{"title":"Navigating the new norm: The FDA's final rule on laboratory developed tests (LDTs) and its impact on clinical laboratory operations","authors":"Rob E. Carpenter","doi":"10.1016/j.clinmicnews.2024.09.001","DOIUrl":"10.1016/j.clinmicnews.2024.09.001","url":null,"abstract":"<div><div>On April 29, 2024, the U.S. Food and Drug Administration (FDA) issued a transformative final rule impacting the regulatory landscape for laboratory-developed tests (LDTs). This new regulation categorizes in vitro diagnostics (IVDs) used as LDTs under the same stringent oversight applied to other medical devices, thereby phasing out the agency's long-standing policy of enforcement discretion. This paper offers a concise historical overview and examines the FDA's revised regulatory framework scheduled for the next four years, examining its impact on laboratory operations in terms of safety, efficacy, and innovation. It explores how the new rule's increased compliance demands and economic implications impact laboratory operations, including economic stability, innovation, and patient safety. Also highlighted is how certain laboratories gain strategic advantages that could enhance their market stability and attract investors. The overall intent of this paper is not an in-depth analysis but instead it aims to inform stakeholders in health services about evolving laboratory standards. By doing so, it equips healthcare participants to strategically align with emerging regulatory demands, enhancing comprehension of how these changes influence healthcare delivery and laboratory procedures.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"48 ","pages":"Pages 1-8"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neisseria meningitidis pyelonephritis: A rare and unusual presentation of an established pathogen 脑膜炎奈瑟菌肾盂肾炎：一种既往病原体的罕见和不寻常表现形式
Clinical Microbiology Newsletter Pub Date : 2024-07-01 DOI: 10.1016/j.clinmicnews.2024.05.005
Hasan Hamze , Natasha Press , Aleksandra Stefanovic , Gordon Ritchie , Marc Romney
{"title":"Neisseria meningitidis pyelonephritis: A rare and unusual presentation of an established pathogen","authors":"Hasan Hamze ,&nbsp;Natasha Press ,&nbsp;Aleksandra Stefanovic ,&nbsp;Gordon Ritchie ,&nbsp;Marc Romney","doi":"10.1016/j.clinmicnews.2024.05.005","DOIUrl":"10.1016/j.clinmicnews.2024.05.005","url":null,"abstract":"<div><p><em>Neisseria meningitidis</em> is a gram-negative organism primarily associated with invasive meningococcal disease. This case report presents a rare occurrence of <em>Neisseria meningitidis</em> pyelonephritis in a 24-year-old male with congenital urological abnormalities. We describe the diagnostic challenges and management of this unique case. Ultimately, the patient completed IV then oral antibiotics and recovered with no complications. This case emphasizes the importance of considering atypical pathogens in urinary tract infections and contributes valuable insights to diagnostic microbiology and clinical practice.</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"47 ","pages":"Pages 9-13"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0196439924000217/pdfft?md5=445c7e573de940cb7ddb10e692379e0b&pid=1-s2.0-S0196439924000217-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141398019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The contamination monitoring toolbox: Best practices for molecular microbiology testing 污染监测工具箱：分子微生物学测试的最佳实践
Clinical Microbiology Newsletter Pub Date : 2024-07-01 DOI: 10.1016/j.clinmicnews.2024.07.001
Meghan W. Starolis
{"title":"The contamination monitoring toolbox: Best practices for molecular microbiology testing","authors":"Meghan W. Starolis","doi":"10.1016/j.clinmicnews.2024.07.001","DOIUrl":"10.1016/j.clinmicnews.2024.07.001","url":null,"abstract":"<div><p>Assays that utilize nucleic acid amplification are prone to contamination from a variety of sources, including both target organisms and amplicon. Implementing effective systems for contamination monitoring as well as laboratory best practices are essential to any quality management system for molecular microbiology testing. A comprehensive contamination monitoring toolbox will be introduced here that includes guidance for environment swabbing, positivity rate monitoring, use of process controls, and monitoring complaints. As prevention of contamination is preferable, best practices for laboratory design, workflow, and personnel training will also be discussed. Lastly, a suggested plan for managing a contamination event will be proposed. The laboratory director should carefully assess the specific risks associated with testing performed in the laboratory and create a written plan for contamination monitoring, prevention, and management of contamination events.</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"47 ","pages":"Pages 21-27"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141713688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Day in the life of a medical microbiology director: Navigating the diverse duties as a clinical conductor 医学微生物学主任的一天：作为临床指挥员，履行各种职责
Clinical Microbiology Newsletter Pub Date : 2024-07-01 DOI: 10.1016/j.clinmicnews.2024.06.001
Karissa Culbreath , Peera Hemarajata , Richard B. Thomson Jr. , Rebecca Yee
{"title":"A Day in the life of a medical microbiology director: Navigating the diverse duties as a clinical conductor","authors":"Karissa Culbreath ,&nbsp;Peera Hemarajata ,&nbsp;Richard B. Thomson Jr. ,&nbsp;Rebecca Yee","doi":"10.1016/j.clinmicnews.2024.06.001","DOIUrl":"10.1016/j.clinmicnews.2024.06.001","url":null,"abstract":"<div><p>Clinical microbiology laboratories support a range of services such as infectious disease diagnosis, infection prevention, and antimicrobial stewardship. The role of the clinical microbiology laboratory is more pivotal than ever as we face emerging pathogens, increases in healthcare-associated infections, antibiotic-resistant organisms, and rapidly advancing technologies. In the wake of these challenges, it is crucial for a clinical microbiology laboratory to be directed by medical microbiologists (i.e. laboratory directors) as they can provide accurate laboratory oversight and professional competence. Medical microbiologists can be found pursuing leadership roles in academic medical centers, diagnostic reference laboratories, public health institutions, and commercial entities such as diagnostic and pharmaceutical companies. Given the diverse career trajectories that medical microbiologists can have, the perspectives of these laboratory directors may be different even though they all strive to meet the common goal of providing diagnosis and management of infectious diseases.</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"47 ","pages":"Pages 14-20"},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141623984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Update on common Bartonella infections 常见巴顿氏菌感染的最新情况
Clinical Microbiology Newsletter Pub Date : 2024-05-26 DOI: 10.1016/j.clinmicnews.2024.05.002
Portia Mira, Elitza S. Theel
{"title":"Update on common Bartonella infections","authors":"Portia Mira,&nbsp;Elitza S. Theel","doi":"10.1016/j.clinmicnews.2024.05.002","DOIUrl":"https://doi.org/10.1016/j.clinmicnews.2024.05.002","url":null,"abstract":"<div><p>This comprehensive review provides updates on the epidemiology, clinical presentations, and diagnostic methods for the most common <em>Bartonella</em> species causing human disease, including <em>B. henselae, B. quintana,</em> and <em>B. bacilliformis.</em> We highlight the distinctive transmission dynamics and clinical manifestations associated with each species, such as cat-scratch disease, trench fever, and Carrion's disease. The review also evaluates the advantages and limitations of serological and molecular diagnostic techniques, emphasizing the importance of integrating clinical evaluation with laboratory testing for accurate diagnosis and effective management of <em>Bartonella</em> infections.</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"47 ","pages":"Pages 1-8"},"PeriodicalIF":0.0,"publicationDate":"2024-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141429522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Aminoglycoside antibiotics: Trying to find a place in this world 氨基糖苷类抗生素：试图在这个世界上找到一席之地
Clinical Microbiology Newsletter Pub Date : 2024-04-01 DOI: 10.1016/j.clinmicnews.2024.03.002
Erin N. Deja
{"title":"Aminoglycoside antibiotics: Trying to find a place in this world","authors":"Erin N. Deja","doi":"10.1016/j.clinmicnews.2024.03.002","DOIUrl":"https://doi.org/10.1016/j.clinmicnews.2024.03.002","url":null,"abstract":"<div><p>Aminoglycoside antibiotics were historically a cornerstone of antimicrobial therapy for many bacterial infections but as the threat of antimicrobial resistance continues to rise, the once broad-spectrum activity of these agents grows smaller. They are also plagued with the potential for severe adverse events such as nephrotoxicity and ototoxicity, and emerging evidence suggests that these risks may outweigh their benefit in many cases. With the recent introduction of newer and likely safer broad-spectrum antibiotics, do aminoglycosides still have a place in therapy in modern medicine?</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"46 ","pages":"Pages 4-10"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0196439924000126/pdfft?md5=84be899ff85f0c15b13019ab54bad65b&pid=1-s2.0-S0196439924000126-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141539857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enter the Matrix: An Update on MALDI-ToF MS Advancements through 2024 进入矩阵：到 2024 年 MALDI-ToF MS 的最新进展
Clinical Microbiology Newsletter Pub Date : 2024-04-01 DOI: 10.1016/j.clinmicnews.2024.05.001
John A. Fissel
{"title":"Enter the Matrix: An Update on MALDI-ToF MS Advancements through 2024","authors":"John A. Fissel","doi":"10.1016/j.clinmicnews.2024.05.001","DOIUrl":"10.1016/j.clinmicnews.2024.05.001","url":null,"abstract":"<div><p>MALDI-ToF MS has become a cornerstone of the clinical microbiology laboratory. The reliability and ease-of-use of these instruments make them a popular choice of study to expand their applications and increase efficiency. The use of artificial intelligence has rapidly expanded in recent years and efforts are underway to integrate this technology into the clinical microbiology laboratory to expand the applications of MALDI-ToF MS and advance beyond current limitations in the identification of clinical isolates. At the same time as the rise of AI, clinical laboratories are facing pressure to increase efficiency due to the critical shortage of qualified laboratory personnel. Studies examining the performance of simplified testing workflows seek to help laboratorians do more with less. The improvement and creation of additional databases is also improving the rate of successful identifications. This review seeks to provide an update on recent developments around these topics.</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"46 ","pages":"Pages 22-26"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0196439924000163/pdfft?md5=c6740b41df7c838c2077718e4a4d970f&pid=1-s2.0-S0196439924000163-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141023677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Erratum regarding previously published articles 关于以前发表的文章的勘误
Clinical Microbiology Newsletter Pub Date : 2024-04-01 DOI: 10.1016/j.clinmicnews.2024.05.003
{"title":"Erratum regarding previously published articles","authors":"","doi":"10.1016/j.clinmicnews.2024.05.003","DOIUrl":"https://doi.org/10.1016/j.clinmicnews.2024.05.003","url":null,"abstract":"","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"46 ","pages":"Pages 1-2"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0196439924000187/pdfft?md5=a107e4f6fe580ee570d1637830d3bd08&pid=1-s2.0-S0196439924000187-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141303393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Erratum regarding previously published articles. 对之前已发表文章的勘误。
Clinical Microbiology Newsletter Pub Date : 2024-04-01 DOI: 10.1016/j.clinmicnews.2024.05.004
{"title":"Erratum regarding previously published articles.","authors":"","doi":"10.1016/j.clinmicnews.2024.05.004","DOIUrl":"https://doi.org/10.1016/j.clinmicnews.2024.05.004","url":null,"abstract":"","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"46 ","pages":"Page 3"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0196439924000199/pdfft?md5=498d68de1ca3508174c747acde5d4673&pid=1-s2.0-S0196439924000199-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141303394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diagnosing ocular infections in the clinical microbiology laboratory 在临床微生物学实验室诊断眼部感染
Clinical Microbiology Newsletter Pub Date : 2024-04-01 DOI: 10.1016/j.clinmicnews.2024.03.004
Ashleigh N. Riegler, Sixto M. Leal Jr
{"title":"Diagnosing ocular infections in the clinical microbiology laboratory","authors":"Ashleigh N. Riegler,&nbsp;Sixto M. Leal Jr","doi":"10.1016/j.clinmicnews.2024.03.004","DOIUrl":"https://doi.org/10.1016/j.clinmicnews.2024.03.004","url":null,"abstract":"<div><p>The accurate diagnosis of ocular infections hinges on precise specimen collection, handling, communication, and strategic prioritization of testing methods. This review highlights the intricate eye anatomy clinical microbiologists should know to understand ocular collection techniques and diagnostic strategies. It explores limitations regarding specimen volume, offers insight into optimal ocular sample collection and processing, recommends optimal diagnostic strategies for a wide breadth of ocular pathogens, explores the utility of antimicrobial susceptibility testing, and emphasizes the necessity of robust collaboration between laboratory specialists and ocular healthcare providers to ensure superior ophthalmic care.</p></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"46 ","pages":"Pages 11-21"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0196439924000114/pdfft?md5=c133c869d9dec6f76d3e8d82b088290a&pid=1-s2.0-S0196439924000114-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141539856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
首页 上一页 下一页 尾页
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整，为了账户安全，请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们：info@booksci.cn Book学术提供免费学术资源搜索服务，方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号：604180095
Book学术官方微信