All-in-One Device Reduces False-Positive Diagnostic Test Results for Bloodstream Infections

By LabMedica International staff writers
Posted on 26 Jan 2023

Image: Steripath improves the diagnostic accuracy and timeliness of sepsis test results (Photo courtesy of Magnolia)

Blood cultures are considered the gold standard diagnostic test for the detection of blood stream infections, such as sepsis. However, positive blood culture results can be frequently wrong, and about 40% of positive results return a false-positive result owing to contamination. Such false-positive results can cause misdiagnosis of sepsis and expose the patient to unnecessary, prolonged, and harmful broad-spectrum antibiotic treatment and extended length of in-patient hospital stay. This may put the patent at a higher risk for acute kidney injury, Clostridioides difficile infection (CDI), Multidrug-Resistant Organism (MDRO) infections, other hospital-acquired infections (HAI), and significantly high hospital costs. Preventing false-positive results and sepsis misdiagnosis has to begin with reducing blood culture contaminations. Now, a new technology can help reduce blood culture contamination and false-positive test results, thereby preventing the patient from being harmed, and reducing unnecessary and prolonged usage of antibiotics, duration of stay, and hospital expenses.

Magnolia Medical Technologies’ (Seattle, WA, USA) Steripath is the only FDA 510(k)-cleared device that is specifically indicated to reduce blood culture contamination with an FDA-cleared labeling claim for an 83% and 88% reduction in contamination rates. Optimally designed for blood culture contamination prevention, Steripath comes pre-assembled and sterile to actively divert and sequester the initial 1.5-2.0mL of blood, the volume that is known to contain contaminants. Blood cultures are collected through an independent, second flow path, creating a closed vein-to-bottle collection system meant to avoid bypassing diversion.

Magnolia is entering into partnerships with hospitals and healthcare providers in the U.S. to prevent sepsis misdiagnosis by improving the accuracy of blood culture results using Steripath. A recent peer-reviewed study published in a leading medical journal constituted the largest controlled clinical dataset ever documented with zero blood culture contamination events. Importantly, the study demonstrated that it was possible to eliminate blood culture contamination and “get to zero” with the use of Steripath. Another large-scale, peer-reviewed study quantified multiple devastating patient harms associated with blood culture contamination and most significantly, a 74% higher risk of in-hospital patient mortality.

“This study includes one of the largest data sets to date examining and directly quantifying the preventable consequences of blood culture contamination on patient safety and clinical outcomes,” said Greg Bullington, CEO and Co-Founder of Magnolia Medical. “This definitive data adds to the substantial body of evidence that already exists demonstrating that contaminated blood culture results drive avoidable, severely negative outcomes for patients and the healthcare system, including increased costs, inappropriate antibiotic usage that contributes to the rise of multidrug-resistant organisms, increased length of stay, and other preventable adverse events.”

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Magnolia Medical Technologies