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

SEATTLE, March 5, 2025 /PRNewswire/ -- Magnolia Medical Technologies, Inc., the pioneer in Initial Specimen Diversion Device^® (ISDD^®) technology, today announced groundbreaking new findings from an in-vitro study demonstrating that the Steripath^® ISDD may improve the accuracy of blood cultures drawn directly from an existing central venous catheter (CVC). Conducted by researchers at the University of Nebraska Medical Center (UNMC) and published in a leading peer-reviewed medical journal, Infection Control & Hospital Epidemiology, the study, entitled "In Vitro assessment of effect of initial specimen diversion device on detection of central venous catheter contamination or colonization," represents the first published assessment of a closed-system, engineered diversion device for this application.

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%).¹ 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.

"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. Mark E. Rupp, Professor and Interim Chair, Department of Internal Medicine at the University of Nebraska Medical Center. "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."

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.^2-7 A separate, landmark study conducted at Stanford University 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).³ 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.

A Paradigm Shift for Blood Cultures

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.

"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 Greg Bullington, 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 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.

About Steripath

The Steripath^® Initial Specimen Diversion Device^® 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.^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.¹⁷

Steripath and Steripath Micro 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.

About Magnolia Medical Technologies

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^® (ISDT^®) and Initial Specimen Diversion Device^® (ISDD^®) to prevent blood culture contamination.

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 www.magnolia-medical.com.

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2. 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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8. Vanhoy MA, Horigan A, Kaiser J, et al. Emergency Nurses Association (ENA). Clinical practice guideline: prevention of blood culture contamination. 2020.
9. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. 2022.
10. CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 2022.
11. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute. 2022.
12. Nickel B, Gorski LA, Kleidon, T, et al. Infusion therapy standards of practice, 9th edition. J Infus Nurs. 2024.
13. Ku TSN, Al Mohajer M, Newton JA, et al. Improving antimicrobial use through better diagnosis: The relationship between diagnostic stewardship and antimicrobial stewardship. Infect Control Hosp Epidemiol. 2023;44(12):1901-1908. doi: 10.1017/ice.2023.156.
14. Sautter RL, Parrott JS, Nachamkin I, et al. American Society for Microbiology evidence-based laboratory medicine practice guidelines to reduce blood culture contamination rates: a systematic review and meta-analysis. Clin Microbiol Rev, 2024; 37:e00087-24. https://doi.org/10.1128/cmr.00087-24.
15. Miller JM, Binnicker MJ, Campbell S, et al. Guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2024 update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM). Clinical Infectious Diseases. 2024; ciae104. doi.org/10.1093/cid/ciae104.
16. Agency for Healthcare Research and Quality (AHRQ). Strategies to prevent blood culture contamination. 2024. Retrieved on February 10, 2025 at https://www.ahrq.gov/hai/tools/mrsa-prevention/toolkit/blood-culture.html
17. Data on file.

SOURCE Magnolia Medical Technologies