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Blood Culture Metrics Are Human Metrics: The Missed Opportunity for Clinical Laboratory Quality Measures to Improve the Overall Blood Culture Process 血培养指标是人的指标:错失了改善整体血培养过程的临床实验室质量措施的机会
Q3 Medicine Pub Date : 2021-12-01 DOI: 10.1016/j.clinmicnews.2021.11.003
Raquel M. Martinez Ph.D., D(ABMM), M.B.A.

The human and organizational burdens of sepsis can be reduced by early recognition, diagnosis, therapy, and systems that support more effective management. The World Health Organization's (WHO's) 2020 Global Report on the Epidemiology and Burden of Sepsis will add importance to the clinical laboratory's role of monitoring blood culture metrics. The report details strategies for future efforts to characterize the global impact of sepsis more accurately, to improve the characterization of and differences in epidemiology, and to make estimates of disease burden more accurate. As the WHO is working toward improved global sepsis monitoring, re-assessment of the way clinical laboratories can contribute to this effort are long overdue at the local, national, and global levels.

Clinical laboratory dogma describes the importance of blood cultures (BCs) and optimization of BC processes, with documented impact on patient care. The BC is considered a first-line investigation for the microbiological diagnosis of sepsis, bacteremia, and fungemia and can detect a wide variety of microorganisms at a relatively low cost. Once microbes are detected in BC broth, subcultures yield microbial colonies for subsequent identification and antimicrobial susceptibility testing, and information is incorporated into the final BC result. However, the impact of BCs and the speed at which BCs are collected, incubated, and reported are minimized in the “surviving sepsis” literature, except for BC collection prior to the administration of antibiotics. Most hospital quality efforts focus on compliance with the 1-, 3-, and 6-h sepsis bundles with limited focus on the contribution of microbiology's role in rapid incubation, pathogen reporting, and other diagnostics that drive antimicrobial de-escalation and escalation protocols.

Clinical microbiology and laboratory medicine bear responsibility to ensure that BCs are collected properly and in a timely manner; that they are rapidly transported to the laboratory and incubated quickly; and that results are achieved and reported in a timely, reproducible, and accurate fashion. The quality metrics we discuss are not all required by inspection agencies; however, considering the initiatives to reduce the human cost of sepsis, attention to best practices is useful to optimize BC performance and BC yield. Examples of blood culture quality monitors and metrics are listed for laboratory consideration. Each laboratory may have unique situations in which one or more of the monitors may prove to be useful.

通过早期识别、诊断、治疗和支持更有效管理的系统,可以减少败血症给人类和组织带来的负担。世界卫生组织(世卫组织)《2020年全球败血症流行病学和负担报告》将进一步重视临床实验室监测血培养指标的作用。该报告详细介绍了未来努力的策略,以更准确地描述败血症的全球影响,改进流行病学的特征和差异,并更准确地估计疾病负担。世卫组织正在努力改善全球败血症监测,对临床实验室在地方、国家和全球层面为这一努力做出贡献的方式进行重新评估早就应该了。临床实验室教条描述了血液培养(BC)和优化BC流程的重要性,并记录了对患者护理的影响。BC被认为是败血症、菌血症和真菌血症微生物学诊断的一线调查,可以以相对较低的成本检测各种微生物。一旦在BC肉汤中检测到微生物,继代培养产生微生物菌落,用于后续鉴定和抗菌药敏试验,并将信息纳入最终的BC结果。然而,除了在使用抗生素之前收集BC外,在“幸存的败血症”文献中,BC的影响以及收集、孵育和报告BC的速度都被最小化。大多数医院的质量工作侧重于遵守1、3和6小时脓毒症包,而对微生物学在快速孵育、病原体报告和其他驱动抗菌药物降级和升级协议的诊断中的作用的贡献关注有限。临床微生物学和检验医学有责任确保正确和及时地收集bc;它们被迅速运送到实验室并迅速孵化;这些结果被及时地、可重复地、准确地报告。我们讨论的质量指标并不都是检验机构所要求的;然而,考虑到减少败血症的人力成本的举措,关注最佳实践对优化BC性能和BC产率是有用的。血液培养质量监测器和指标的例子列出实验室考虑。每个实验室可能有独特的情况,其中一个或多个监测器可能被证明是有用的。
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引用次数: 0
Are You a Pathogen? I Don't Know… Amoeby 你是病原体吗?我不知道…阿米比
Q3 Medicine Pub Date : 2021-12-01 DOI: 10.1016/j.clinmicnews.2021.11.004
Christopher Doern Ph.D.
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引用次数: 0
A Special Invitation to Authors 对作者的特别邀请
Q3 Medicine Pub Date : 2021-11-15 DOI: 10.1016/j.clinmicnews.2021.11.002
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引用次数: 0
Laboratory Strategies for Diagnosis and Monitoring of Hepatis C Virus Infection 诊断和监测丙型肝炎病毒感染的实验室策略
Q3 Medicine Pub Date : 2021-11-15 DOI: 10.1016/j.clinmicnews.2021.11.001
Bijal A. Parikh M.D., Ph.D.

In the fight to eradicate hepatitis C virus (HCV), recent advances have provided both challenges and opportunities in our current laboratory approach for screening, diagnosis, and therapeutic response monitoring. Highly sensitive molecular assays have replaced serological confirmatory assays, while direct-acting antivirals have replaced interferon-based approaches, providing new weapons in the battle against chronic HCV infection. Aligned with these developments, the Centers for Disease Control and Prevention, U.S. Preventive Services Task Force, and American Association for the Study of Liver Diseases have recently updated guidance on the populations that should be offered testing and the methods and strategies to effectively do so. This review describes the details of these opportunities and the impacts of new guidance on laboratory evaluation in both routine and unique populations at risk for or infected with HCV.

在根除丙型肝炎病毒(HCV)的斗争中,最近的进展为我们目前的实验室筛查、诊断和治疗反应监测方法提供了挑战和机遇。高度敏感的分子测定法取代了血清学确证测定法,而直接作用的抗病毒药物取代了基于干扰素的方法,为抗击慢性丙型肝炎病毒感染提供了新的武器。与这些发展相一致,疾病控制和预防中心、美国预防服务工作组和美国肝病研究协会最近更新了应该提供检测的人群以及有效检测的方法和策略的指南。本综述详细介绍了这些机会,以及新的实验室评估指南对HCV常规人群和特殊高危人群或感染人群的影响。
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引用次数: 0
A Special Invitation to Authors 对作者的特别邀请
Q3 Medicine Pub Date : 2021-11-01 DOI: 10.1016/j.clinmicnews.2021.10.002
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引用次数: 0
A Side-by-Side Comparison of Clinical versus Current Good Manufacturing Practices (cGMP) Microbiology Laboratory Requirements for Sterility Testing of Cellular and Gene Therapy Products 细胞和基因治疗产品无菌检测的临床与现行良好生产规范(cGMP)微生物学实验室要求的比较
Q3 Medicine Pub Date : 2021-11-01 DOI: 10.1016/j.clinmicnews.2021.10.001
James E.T. Gebo B.S., M.P.A., Amanda D. East M(ASCP), Anna F. Lau Ph.D., D(ABMM)

Over the last few years, there have been numerous discussions on the American Society for Microbiology’s clinical listservs (DivC, and ClinMicroNet) regarding sterility testing of cell and gene therapy products and environmental monitoring and gloved fingertip testing for hospital pharmacies. Clinical microbiology laboratories have often been asked to assist with testing due to the on-site proximity of laboratory equipment and microbiological expertise within the hospital environment. The role of the clinical microbiology laboratory in this setting, however, is questionable due to major differences in test requirements and regulatory oversight. Here, we provide a side-by-side comparison of clinical versus current good manufacturing practices microbiology laboratories to provide guidance to those that are currently assisting with or have been asked to assist with sterility testing of manufactured biopharmaceutical products that have become common frontline treatments in modern medicine.

在过去的几年里,在美国微生物学会的临床列表服务(DivC和ClinMicroNet)上,关于细胞和基因治疗产品的无菌测试、环境监测和医院药房的手套指尖测试,已经有了许多讨论。临床微生物实验室经常被要求协助进行测试,因为现场靠近实验室设备和医院环境中的微生物专业知识。然而,临床微生物实验室在这种情况下的作用是值得怀疑的,因为在测试要求和监管监督方面存在重大差异。在这里,我们提供了临床与当前良好生产规范微生物实验室的并排比较,为那些目前正在协助或已被要求协助已成为现代医学常见一线治疗的人造生物制药产品的无菌检测的人员提供指导。
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引用次数: 3
A Special Invitation to Authors 对作者的特别邀请
Q3 Medicine Pub Date : 2021-10-15 DOI: 10.1016/j.clinmicnews.2021.09.003
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引用次数: 0
Leptospiral Infections in Humans 人类钩端螺旋体感染
Q3 Medicine Pub Date : 2021-10-15 DOI: 10.1016/j.clinmicnews.2021.09.002
David A. Haake M.D., Renee L. Galloway B.S., M.Ph.

Leptospirosis is a globally widespread spirochetal infection spread from animals to humans. Infections are common in settings of endemicity, primarily in tropical regions of the world. Leptospirosis is typically a self-limited febrile illness but may progress to potentially fatal multiorgan system failure. Patients often present with a nonspecific acute febrile illness that is clinically difficult to distinguish from other similarly presenting infections endemic to tropical regions, including dengue fever, influenza, and malaria. A high index of suspicion is essential to early identification of patients who may benefit from antimicrobial therapy. Diagnostic testing is key to both recognition of early infection and outbreak investigation, typically in the setting of water exposure after heavy rainfall and flooding. This review focuses on the epidemiology, clinical manifestations, and laboratory diagnosis of leptospirosis, including nucleic acid amplification tests, culture, direct detection, and serological approaches.

钩端螺旋体病是一种全球广泛传播的从动物传播给人类的螺旋体感染。感染在流行环境中很常见,主要是在世界热带地区。钩端螺旋体病通常是一种自限性发热性疾病,但也可能发展为潜在致命的多器官系统衰竭。患者通常表现为非特异性急性发热性疾病,这种疾病在临床上很难与其他表现类似的热带地区地方性感染(包括登革热、流感和疟疾)区分开来。高怀疑指数对于早期识别可能受益于抗菌药物治疗的患者至关重要。诊断检测是识别早期感染和调查疫情的关键,特别是在暴雨和洪水后接触水的情况下。本文综述了钩端螺旋体病的流行病学、临床表现和实验室诊断,包括核酸扩增试验、培养、直接检测和血清学方法。
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引用次数: 0
Routine, Molecular, and Sequence-Based Antimicrobial Susceptibility Testing: Progression from Research Databases to Future Predictive Models 常规,分子和基于序列的抗菌药物敏感性测试:从研究数据库到未来预测模型的进展
Q3 Medicine Pub Date : 2021-10-01 DOI: 10.1016/j.clinmicnews.2021.09.001
G. Terrance Walker Ph.D.

Automated antimicrobial susceptibility testing (AST) is the standard clinical diagnostic for antibiotic resistance. The polymerase chain reaction and genome sequencing offer alternative molecular AST approaches. This review compares practical advantages, disadvantages, and advances across the three AST methods for clinical diagnosis of antibiotic resistance with an eye toward coordinated hybrid approaches leveraging adaptive artificial intelligence that responds to patient demographics, vital signs, and diagnostic test results against a backdrop of evolving epidemiology and local outbreaks monitored through coordinated public health surveillance.

自动抗菌药物敏感性试验(AST)是抗生素耐药性的标准临床诊断。聚合酶链反应和基因组测序提供了替代的分子AST方法。本综述比较了用于抗生素耐药性临床诊断的三种AST方法的实际优点、缺点和进展,并着眼于协调混合方法,利用自适应人工智能对患者人口统计学、生命体征和诊断测试结果做出反应,以应对不断演变的流行病学背景和通过协调公共卫生监测监测的当地疫情。
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引用次数: 0
Diagnosis and Monitoring of Viral Infections in the Transplant Population 移植人群中病毒感染的诊断和监测
Q3 Medicine Pub Date : 2021-09-15 DOI: 10.1016/j.clinmicnews.2021.08.003
Anisha Misra Ph.D., Matthew J. Binnicker Ph.D.

Viral infections are a major cause of morbidity and mortality in patients undergoing solid organ or hematopoietic stem cell transplantation. Due to their immunocompromised status, transplant recipients are at a higher risk for community-acquired and reactivated viral infections. Serologic screening prior to transplantation can assist with risk stratification of patients and guide decisions regarding the use of pre-emptive antiviral therapy. Following transplantation, molecular testing has become the most common method to detect viral infections, with histopathology of infected tissue often being required to confirm a diagnosis. Quantitative nucleic acid amplification tests have been the standard to detect and monitor viral infections in transplant patients; however, important challenges remain, including lack of standardization across many testing laboratories, limited availability of FDA-approved viral load assays, and the absence of universal viral load thresholds that can be used to diagnose disease and guide management decisions.

病毒感染是实体器官或造血干细胞移植患者发病和死亡的主要原因。由于其免疫功能低下的状态,移植受者社区获得性和再激活病毒感染的风险较高。移植前的血清学筛查有助于患者的风险分层,并指导决定是否使用先发制人的抗病毒治疗。移植后,分子检测已成为检测病毒感染最常用的方法,通常需要对感染组织进行组织病理学检查才能确诊。定量核酸扩增试验已成为检测和监测移植患者病毒感染的标准;然而,重要的挑战仍然存在,包括许多检测实验室缺乏标准化,fda批准的病毒载量测定方法的可用性有限,以及缺乏可用于诊断疾病和指导管理决策的通用病毒载量阈值。
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引用次数: 0
期刊
Clinical Microbiology Newsletter
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