Staphylococcal Bloodstream Pathogens Identified in Ninety Minutes

Staphylococcal pathogens are identified directly from positive blood cultures in 90 minutes. The fast results help clinicians improve antibiotic selection and outcomes for patients with true staphylococcal infections while avoiding unnecessary therapy due to blood culture contamination.

Staphylococcus species are the most frequent causes of bloodstream infections (BSI) as well as blood culture contamination. True infections caused by S. aureus present considerable clinical challenges associated with increased mortality rates, prolonged hospital stays, and significant hospital costs.

Blood culture contamination with coagulase-negative Staphylococci (CNS) account for up to 30% of all positive blood cultures. This often results in a false diagnosis of a true staphylococcal bloodstream infection and therefore leads to unnecessary use of broad-spectrum antibiotics, longer hospital stays, and unnecessary extra costs.

AdvanDx (Woburn, MA, USA) received U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) 510(k) clearance for the fast, 90 minutes protocol for its S. aureus peptide nucleic acid fluorescence in situ hybridization (PNA FISH) and S. aureus/ CNS PNA FISH tests. The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes.

Clinical validation studies performed at hospitals in the United States demonstrated excellent equivalence between the 90 minutes protocol and the original PNA FISH protocol, ensuring the faster protocol maintains the high sensitivity and specificity required versus slower, conventional methods.

AdvanDx provides advanced molecular diagnostic products for the diagnosis and treatment of life-threatening, bloodstream infections. The easy-to-use products provide fast and accurate results that enable improvements in patient care and help to save lives and reduce hospital costs.

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AdvanDx
US Food and Drug Administration