新研究表明，使用Steripath®初始样本分流装置®（ISDD®）进行中心静脉导管采血可提高血培养的准确性-动脉网

New Study Demonstrates Potential for Enhanced Accuracy of Blood Cultures with Steripath® Initial Specimen Diversion Device® (ISDD®) for Central Line Draws

CISION 等信源发布 2025-03-06 02:15

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SEATTLE

西雅图

，

March 5, 2025

2025年3月5日

/PRNewswire/ -- Magnolia Medical Technologies, Inc., the pioneer in Initial Specimen Diversion Device

/PRNewswire/ -- Magnolia Medical Technologies, Inc.，初始样本分流设备的先驱

(ISDD

（ISDD

) technology, today announced groundbreaking new findings from an in-vitro study demonstrating that the Steripath

）技术，今天宣布了一项体外研究的突破性新发现，证明了Steripath

ISDD may improve the accuracy of blood cultures drawn directly from an existing central venous catheter (CVC). Conducted by researchers at the

ISDD可能提高直接从现有的中心静脉导管（CVC）抽取的血培养的准确性。该研究由研究人员进行，

University of Nebraska Medical Center

内布拉斯加大学医学中心

(UNMC) and published in a leading peer-reviewed medical journal,

（UNMC）并发表在领先的同行评审医学期刊上，

Infection Control & Hospital Epidemiology

感染控制与医院流行病学

, the study, entitled '

，这项研究题为‘

In Vitro assessment of effect of initial specimen diversion device on detection of central venous catheter contamination or colonization

体外评估初始样本分流装置对中心静脉导管污染或定植检测的影响

,' represents the first published assessment of a closed-system, engineered diversion device for this application.

',' 代表了对此应用的封闭系统工程分流装置的首次公开发表的评估。

Blood cultures drawn with standard method vs. cultures drawn using the Steripath ISDD were compared in a simulated CVC colonization and contamination model. The study highlights a critical advancement: the use of Steripath ISDD technology resulted in the detection of 100% of colonized CVCs while decreasing false-positive cultures by 56% (36% to 16%)..

在模拟的中心静脉导管（CVC）定植和污染模型中，比较了使用标准方法抽取的血培养与使用Steripath ISDD抽取的血培养。研究表明了一项关键进展：使用Steripath ISDD技术能够检测到100%的定植CVC，同时将假阳性培养减少了56%（从36%降至16%）。

This result underscores the potential role of the Steripath ISDD family in enhancing diagnostic precision for bloodstream infection detection, particularly for critically ill patients reliant on central venous catheters.

这一结果突显了Steripath ISDD系列在提高血流感染检测诊断精确性方面的潜在作用，特别是对于依赖中心静脉导管的重症患者。

'Accurately identifying patients with sepsis/bloodstream infection is critical and differentiating true bacteremia from blood culture contamination is vitally important. This study provides promising, new evidence that the Steripath ISDD may play a role in improving the accuracy of blood cultures for patients who require a culture drawn directly from a central vascular catheter,' said Dr.

“准确识别脓毒症/血流感染患者至关重要，区分真正的菌血症和血培养污染也非常重要。这项研究提供了令人鼓舞的新证据，表明Steripath ISDD可能在提高需要直接从中心血管导管取样的患者的血培养准确性方面发挥作用，”博士表示。

。

Mark E. Rupp

马克·E·鲁普

, Professor and Interim Chair, Department of Internal Medicine at the

，教授兼内科系临时主任，

University of Nebraska Medical Center

内布拉斯加大学医学中心

. 'By ensuring that colonized catheters are accurately detected, and contamination events are mitigated, clinicians can make more informed treatment decisions, reduce unnecessary antibiotic use, and improve patient outcomes. The Steripath ISDD technology used for CVC cultures in this study improved relative specificity and based on these results, warrants further investigation in a prospective clinical trial.'.

“通过确保准确检测被污染的导管并减少污染事件，临床医生可以做出更明智的治疗决策，减少不必要的抗生素使用，并改善患者的预后。本研究中用于中心静脉导管培养的Steripath ISDD技术提高了相对特异性，基于这些结果，值得在前瞻性临床试验中进一步研究。”

This latest research builds on the extensive clinical evidence already supporting the clinical impact of Steripath ISDD device families in preventing false-positive blood cultures for peripheral venipunctures and peripheral IV starts.

这项最新的研究建立在已经支持 Steripath ISDD 设备系列在防止外周静脉穿刺和外周静脉注射启动时产生假阳性血培养物的广泛临床证据之上。

2-7

A separate, landmark study conducted at

一项单独的、具有里程碑意义的研究

Stanford University

斯坦福大学

Medical Center demonstrated that the use of Steripath reduced blood culture contamination to 0% in over 11,200 blood cultures drawn, while also significantly decreasing false-positive central line-associated bloodstream infections (CLABSIs).

医疗中心的数据显示，在超过 11,200 例抽取的血培养中，使用 Steripath 将血培养污染率降低至 0%，同时显著减少了假阳性的中心静脉导管相关血流感染 (CLABSIs)。

The reduction in false-positive CLABSIs has profound implications for hospital quality metrics, antibiotic stewardship programs, and reimbursement under CMS' Value-Based Purchasing (VBP) Program.

减少假阳性的中心静脉导管相关血流感染（CLABSIs）对医院质量指标、抗生素管理计划以及根据CMS的价值基础采购（VBP）计划的报销都有深远的影响。

A Paradigm Shift for Blood Cultures

血培养的范式转变

For decades, clinicians have faced the challenge of differentiating true bloodstream infections that may progress to sepsis from contamination events, particularly when blood cultures are drawn from a central line, which are highly prone to contamination. The findings from the UNMC study provide evidence that Steripath ISDD technology could play a role in improving the diagnostic reliability of this critical microbiology test..

数十年来，临床医生一直面临着区分可能发展为败血症的真性血流感染和污染事件的挑战，特别是当从中心静脉导管采集血培养时，这种情况极易发生污染。UNMC研究的发现提供了证据，表明Steripath ISDD技术可能在提高这项关键微生物学检测的诊断可靠性方面发挥作用。

'With the large body of evidence available in peer-reviewed studies and in best practice guidelines from CLSI and CDC, we are driving change to national standards for blood culture contamination rates,' added

“有了大量经同行评议研究和CLSI及CDC最佳实践指南提供的证据，我们正在推动改变国家血培养污染率的标准，”他补充道。

Greg Bullington

格雷格·布林顿

, CEO and Co-Founder of Magnolia Medical. 'Hospitals can combine evidence-based best practice techniques with Steripath ISDD technology to improve the accurate detection of bloodstream infections that can progress to sepsis. This is not only better for patients but could also save the healthcare system billions of dollars annually.'.

Magnolia Medical的首席执行官兼联合创始人表示：“医院可以将基于证据的最佳实践技术与Steripath ISDD技术相结合，以提高对可能发展为败血症的血流感染的准确检测。这不仅对患者更好，而且每年还可以为医疗系统节省数十亿美元。”

Magnolia Medical remains committed to revolutionizing blood culture collection with scientifically validated, clinically proven innovations. The company continues to partner with leading healthcare institutions to further research and expand access to Steripath ISDD technology nationwide.

木兰医疗仍致力于通过科学验证、临床证实的创新技术彻底改变血液培养采集。公司继续与领先的医疗机构合作，进一步研究并在全国范围内扩大Steripath ISDD技术的使用范围。

About Steripath

关于Steripath

The Steripath

无菌路径

Initial Specimen Diversion Device

初始样本分流装置

platform offers the only family of FDA 510(k)-cleared, all-in-one engineered devices referenced to reduce blood culture contamination in the ENA, CLSI, CDC, INS, SHEA, ASM, IDSA, and AHRQ evidence-based best practice guidelines and strategy recommendations. These guidelines reference high-quality, technology-specific evidence generated with Steripath ISDD..

平台提供唯一一家获FDA 510(k)批准的全合一工程设备系列，在ENA、CLSI、CDC、INS、SHEA、ASM、IDSA和AHRQ基于证据的最佳实践指南和战略建议中提到，该设备可减少血培养污染。这些指南引用了通过Steripath ISDD生成的高质量、特定技术的证据。

8-16

To date, over 20 clinical studies, including nine peer-reviewed publications in leading clinical journals, have been completed supporting the clinical and cost effectiveness of Steripath.

迄今为止，已有20多项临床研究完成，其中包括在领先临床期刊上发表的九篇同行评审出版物，支持了Steripath的临床和成本效益。

Steripath

无菌路径

and

和

Steripath Micro

Steripath 微型

have been adopted by over 500 U.S. hospitals and healthcare systems to address the problem of blood culture contamination, which can lead to sepsis misdiagnosis resulting in unnecessary, prolonged, and harmful antibiotic treatment, extended length of hospital stay, false-positive CLABSIs, and wasted healthcare resources..

已被美国500多家医院和医疗系统采用，以解决血培养污染问题，该问题可能导致败血症误诊，从而引发不必要、延长且有害的抗生素治疗、住院时间延长、假阳性的中心静脉导管相关血流感染（CLABSIs）以及医疗资源的浪费。

About Magnolia Medical Technologies

关于木兰医疗技术

Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to improve the accuracy, consistency, and predictability of critical laboratory tests. The company invented and patented the Initial Specimen Diversion Technique

麦格纳医疗技术公司开发、制造和销售创新的血液和体液收集装置，以提高关键实验室测试的准确性、一致性和可预测性。该公司发明并获得了初始样本分流技术的专利。

(ISDT

) and Initial Specimen Diversion Device

）和初始样本分流装置

(ISDD

) to prevent blood culture contamination.

）以防止血液培养污染。

Magnolia Medical has built a robust intellectual property portfolio with nearly 200 issued patents and over 50 additional patent applications pending encompassing hundreds of devices and integrated diagnostic concepts and embodiments. For more information, visit

麦格纳医疗建立了强大的知识产权组合，拥有近200项已颁发的专利和50多项正在审批中的额外专利申请，涵盖数百种设备以及集成诊断概念和实施例。欲了解更多信息，请访问

www.magnolia-medical.com

。

Rupp ME, Fey PD, Lyden E, Handke L. In vitro assessment of effect of initial specimen diversion device on detection of central venous catheter contamination or colonization. Infect Control Hosp Epidemiol. 2024;46(2):1-4. doi: 10.1017/ice.2024.220. Epub ahead of print. PMID: 39696936; PMCID: PMC11790329. .

Rupp ME, Fey PD, Lyden E, Handke L. 体外评估初始样本分流装置对中心静脉导管污染或定植检测的影响。《感染控制与医院流行病学》。2024；46（2）：1-4。doi: 10.1017/ice.2024.220。提前在线发表。PMID：39696936；PMCID：PMC11790329。

Nielsen LE, Nguyen K, Wahl CK, et al. Initial Specimen Diversion Device® reduces blood culture contamination and vancomycin use in academic medical centre. J Hosp Infect. 2022;120:127-133. doi: 10.1016/j.jhin.2021.10.017. Epub 2021 Nov 13. PMID: 34780808.

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Tompkins LS, Tien V, Madison AN. Getting to zero: impact of a device to reduce blood culture contamination and false-positive central line-associated blood stream infections. Infect Control Hosp Epidemiol. 2022;1-5. doi:10.1017/ice.2022.284.

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July 2022

2022年7月

。

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February 10, 2025

2025年2月10日

在

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Data on file.

数据存档。

SOURCE Magnolia Medical Technologies

来源：木兰医疗技术公司

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