1. Multicenter Evaluation of the Xpert MRSA NxG Assay for Detection of Methicillin-Resistant Staphylococcus aureus in Nasal Swabs
- Author
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Yarbrough, Melanie L, Warren, David K, Allen, Karen, Burkholder, Dennis, Daum, Robert, Donskey, Curtis, Knaack, Dennis, LaMarca, Anthony, May, Larissa, Miller, Loren G, Parenti, David M, Peterson, Lance, Tan, Thean Yen, Widen, Raymond, Hernandez, Diana R, Wolk, Donna M, and Burnham, Carey-Ann D
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Vaccine Related ,Prevention ,Emerging Infectious Diseases ,Clinical Research ,Antimicrobial Resistance ,Infectious Diseases ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Bacteriological Techniques ,Child ,Child ,Preschool ,DNA ,Bacterial ,Female ,Humans ,Male ,Methicillin-Resistant Staphylococcus aureus ,Middle Aged ,Nasal Cavity ,Polymerase Chain Reaction ,Reagent Kits ,Diagnostic ,Sensitivity and Specificity ,Staphylococcal Infections ,Young Adult ,methicillin-resistant Staphylococcus aureus ,bacterial colonization ,nasal swab ,Biological Sciences ,Agricultural and Veterinary Sciences ,Medical and Health Sciences ,Microbiology ,Clinical sciences ,Medical microbiology - Abstract
Health care-associated methicillin-resistant Staphylococcus aureus (MRSA) infections are a burden on the health care system. Clinical laboratories play a key role in reducing this burden, as the timely identification of MRSA colonization or infection facilitates infection control practices that are effective at limiting invasive MRSA infections. The Xpert MRSA NxG assay recently received FDA clearance for the direct detection of MRSA from nasal swabs. This multicenter study evaluated the clinical performance characteristics of the Xpert MRSA NxG assay with prospectively collected rayon nasal swabs (n = 1,103) and flocked swab (ESwab) nasal specimens (n = 846). Culture-based identification methods and antimicrobial susceptibility testing were used as the reference standards for comparison. According to the reference method, the positivity rates for MRSA in the population evaluated were 11.1% (122/1,103) for rayon swabs and 11.6% (98/846) for flocked swabs. The overall sensitivity and specificity of the rayon swabs were 91.0% (95% confidence interval [CI], 84.6 to 94.9%) and 96.9% (95% CI, 95.7 to 97.8%), respectively, across eight testing sites. The flocked swab specimens were 92.9% sensitive (95% CI, 86.0 to 96.5%) and 97.6% specific (95% CI, 96.2 to 98.5%) for MRSA detection across six testing sites. The sensitivity and specificity of the combined flocked and rayon swab data were 91.8% (95% CI, 87.4 to 94.8%) and 97.2% (95% CI, 96.3 to 97.9%), respectively. The positive predictive value (PPV) for rayon swabs was 78.7%, versus 83.5% for ESwabs. The negative predictive values (NPVs) for rayon swabs and ESwab specimens were 98.9% and 99.1%, respectively. In conclusion, the Xpert MRSA NxG assay is a sensitive and specific assay for the direct detection of MRSA from nasal swab specimens.
- Published
- 2018