Consensus Publication Supports Magnolia Medical's Sepsis Testing Standard of Care Initiative

Multi-discipline thought leaders call for a new national benchmark blood culture contamination rate of less than 1%

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Jan 23, 2020, 09:00 ET

SEATTLE, Jan. 23, 2020 /PRNewswire/ -- A peer-reviewed multi-disciplinary consensus manuscript published in the January edition of Clinical Microbiology Reviews (CMR) concluded that the national benchmark for blood culture contamination should be reduced from the current 3% 'acceptable' threshold for false positive diagnostic results for sepsis testing to less than 1.0%.

Widespread sustained performance at this rate was previously thought unachievable prior to the demonstrated clinical performance of the Steripath^® Initial Specimen Diversion Device^®¹ designed for blood culture collection and contamination reduction.

This comprehensive review of the clinical, antibiotic stewardship and economic impacts of blood culture contamination examined the scope and magnitude of the problem with a systematic discussion of evidence-based methods and technology solutions to address contamination and false-positive sepsis test results.

The authors, consisting of physicians from leading institutions including Johns Hopkins University, Duke University, Rutgers RWJ University Hospital, University of Houston, University of Nebraska and University of Iowa noted, "overall institutional contamination rates <1.0% are now achievable, and therefore, consideration should be given to the establishment of a new universal threshold value of <1.0%."

The authors further noted that, "when contamination rates rise above 1%, objective, step-wise quality improvement programs designed to improve patient care and reduce unnecessary costs should be implemented."

"Initial specimen diversion devices represent a major advance in managing the important problem of blood culture contamination," said Gary V. Doern, Ph.D., lead author of the publication and Professor Emeritus, Department of Pathology, University of Iowa Carver College of Medicine and Former Editor in Chief, Journal of Clinical Microbiology.

"The experience accumulated with the Steripath device both in objective, systematic investigations published in the peer-reviewed literature as well as in routine practice in over a hundred healthcare settings throughout the United States is compelling. Clearly, the Steripath device represents a safe, convenient and cost-effective means for reducing blood culture contamination rates to levels of <1.0%," added Doern.

Each year, tens of millions of patients in the U.S. require a blood culture test for diagnosis of sepsis and other bloodstream infections. On average, 3% of these tests are false-positive due to contamination.¹ These false-positive results place over 1.2 million patients at risk of a misdiagnosis for sepsis.⁸ These patients are often treated with unnecessary antibiotics and spend, on average, two additional days in the hospital, increasing their risk of antibiotic-resistant infections, C. difficile and other antibiotic-related complications.^5,6

According to a 2019 Centers for Disease Control (CDC) report, there are over three million antibiotic-resistant and C. difficile infections each year in the US leading to an estimated 48,000 deaths. This represents a 50% increase in infections and doubling of deaths annually since the 2013 CDC report.

The Steripath Gen2 ISDD^® diverts and sequesters the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants⁷, delivering up to a 92% reduction in blood culture contamination with sustained rates as low as 0.2% in the emergency department.³ Steripath is the only technology of its kind demonstrated in leading national peer-reviewed medical journals to deliver sustained results below this new recommended 1.0% threshold.^2,3,4,5,6

"At Magnolia, we are committed to dramatically improving sepsis testing accuracy. We believe the current 3% national threshold for contaminated results, which represents up to 50% of positive sepsis tests in many hospitals throughout the country, is unacceptable. We strongly support the consensus recommendation of a reset national standard of care benchmark to less than 1.0%," said Greg Bullington, CEO of Magnolia.

"Adoption of Steripath as a new standard of care for sepsis testing accuracy continues to accelerate at hospitals nationwide based on the irrefutable clinical and cost-effectiveness data supporting its performance. We are proud to have developed a proven solution to this significant hidden problem in healthcare which not only addresses patient safety and hospital costs, but also supports antibiotic stewardship to help stave off the growing threat of antibiotic-resistance," concluded Bullington.

Magnolia Medical Technologies develops, manufactures and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical laboratory tests. Magnolia Medical invented and patented the initial specimen diversion technique (ISDT^™) and device (ISDD^®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio including more than 70 issued method, apparatus and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.