1 Hour Direct-From-Blood Test Detects 95% Of Pathogens Associated with Bloodstream Infections
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By LabMedica International staff writers Posted on 11 Dec 2024 |
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Early detection is crucial for treating a variety of infections, particularly sepsis. Sepsis is responsible for one in three hospital deaths in the U.S., and septic shock has a global mortality rate of 30-40%. However, early diagnosis remains difficult due to the non-specific and often subtle symptoms. Currently, the standard method for diagnosing sepsis involves complex blood culture tests, which can take several days to provide results. This method, over 40 years old, is limited to identifying 'viable' organisms, often overlooking a wide array of microbial markers present in the blood. Now, a groundbreaking one-hour test can detect 95% of pathogens linked to bloodstream infections (BSIs) that could lead to sepsis, along with specific genetic markers for antimicrobial resistance (AMR).
deepull’s (Barcelona, Spain) UllCORE BSI Test and UllCore system offer 50 reportable results, identifying pathogens and antibiotic resistance markers directly from blood within about one hour. This real-time multiplex PCR system extracts microbial DNA from 8 mL of whole blood, bypassing the slow blood culture process. The assay covers a broad range of bacterial targets, fungi, and genetic determinants of antibiotic resistance. UllCORE’s rapid results and high sensitivity empower clinicians to make better-informed decisions, minimizing the risks of over- and under-treatment with antibiotics and contributing to efforts to combat antimicrobial resistance in hospitals. While focused on sepsis, deepull envisions its system as useful for diagnosing various other acute infections. The company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the UllCORE BSI Test.
“We are thrilled to receive breakthrough designation from the FDA,” said Jordi Carrera, Chief Executive Officer and Co-Founder of deepull. “Providing life-saving results for patients suspected of serious infection in one hour represents a significant advantage over current standard of care blood culture. Faster pathogen identification and AMR testing will provide clinicians with a powerful tool to more quickly and accurately tailor antimicrobial therapy, which could lead to faster patient recovery, shorter length of stay, and reduced morbidity and mortality.”
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