A bloodstream infection with Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA), is a serious condition that carries a high mortality rate and is also associated with significant hospital costs. The rapid and accurate identification and differentiation of methicillin-susceptible S. aureus (MSSA) and MRSA directly from positive blood cultures has demonstrated benefits in both patient outcome and cost-of-care metrics. We compare the next-generation Xpert MRSA/SA BC (Xpert) assay to the GeneOhm StaphSR (GeneOhm) assay for the identification and detection of S. aureus and methicillin resistance in prospectively collected blood culture broths containing Gram-positive cocci. All results were compared to routine bacterial culture as the gold standard. Across 8 collection and test sites, the Xpert assay demonstrated a sensitivity of 99.6% (range, 96.4% to 100%) and a specificity of 99.5% (range, 98.0% to 100%) for identifying S. aureus, as well as a sensitivity of 98.1% (range, 87.5% to 100%) and a specificity of 99.6% (range, 98.3% to 100%) for identifying MRSA. In comparison, the GeneOhm assay demonstrated a sensitivity of 99.2% (range, 95.2% to 100%) and a specificity of 96.5% (range, 89.2% to 100%) for identifying S. aureus, as well as a sensitivity of 94.3% (range, 87.5% to 100%) and a specificity of 97.8% (range, 96.1% to 100%) for identifying MRSA. Five of six cultures falsely reported as negative for MRSA by the GeneOhm assay were correctly identified as positive by the Xpert assay, while one culture falsely reported as negative for MRSA by the Xpert assay was correctly reported as positive by the GeneOhm assay.
Bloodstream infection (BSI) is a serious condition, resulting in Ͼ500,000 hospitalizations per year in the United States, accounting for up to 11% of intensive care unit admissions (1, 2). Mortality associated with BSI can range from 25% to 80%, depending on underlying illnesses, and it is higher in nosocomial versus community-acquired infections (3-5). Bloodstream infections also carry a high monetary burden, ranging from $36,000 to $40,000 in additional expenses per patient as a result of prolonged hospitalization (4-6). The leading causes of community-and hospital-acquired BSI are Staphylococcus aureus, Staphylococcus epidermidis, and various other coagulase-negative Staphylococcus (CoNS) species (5, 7). Within this group of organisms, infection with methicillin-resistant S. aureus (MRSA) is most critical and has been associated with a mortality rate 1.70 to 1.93 times higher than that of methicillin-susceptible S. aureus (MSSA) strains (8, 9). The outcome of these infections can be positively impacted by early diagnosis and effective antimicrobial therapy (10-12). Rapid diagnostic methods, such as peptide nucleic acid fluorescence in situ hybridization (PNA FISH), matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS), and nucleic acid amplification and detection have been successfully applied to directly analyze positive blood culture broths ...