Resources Regulatory Publications: Draft Guidance for Industry and Food and Drug Administration (FDA) Staff - Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). 2011. Linked on February 7, 2011 from www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm237235.htm Summary: Draft FDA guidelines for molecular MRSA testing released in January 2011 state that to gain FDA approval, MRSA screening tests should be able to routinely distinguish between MRSA and other Staphylococcus aureus (SA) variants, including MSSA. The Detect-Ready MRSA Panel is the only screening test on the market or in late-stage development with the proven ability to routinely distinguish between these pathogens. Detect-Ready® in Journal Articles: Tzubery T. Next Generation MRSA Screening: an interview with Molecular Detection Inc. APUA (Alliance for the Prudent Use of Antibiotics) Newsletter. 2011 Sept;29(2). http://www.tufts.edu/med/apua/news/newsletter_2011-6.shtml. Summary: Tzvi Tzubery, Ph.D., Director of Research and Development at MDI is interviewed by the APUA Newsletter. Dr. Tzubery discusses the current state of MRSA screening in healthcare facilities and the potential for new tests like MDI’s Detect-Ready® to improve outcomes for patients and healthcare facilities. Journal Articles: Anderson D.J., Arduino J.M., Reed S.D., Sexton D.J., Kaye K.S., Grussemeyer C.A., Peter S.A., Hardy C., Choi Y.I., Friedman J.Y., Fowler V.G. Jr. Variation in the Type and Frequency of Postoperative Invasive Staphylococcus aureus Infections According to Type of Surgical Procedure. Infect Control Hosp Epidemiol. 2010 Jul;31(7):701-9. www.journals.uchicago.edu/doi/abs/10.1086/653205. Summary: Researchers call for increased preventative interventions to limit invasive S. aureus infections, which were found to occur at high rates in patients undergoing certain surgeries, such as cardiothoracic procedures. Anderson D.J., Kaye K.S., Chen L.F., Schmader K.E., Choi Y., Sloane R., Sexton D.J. Clinical and Financial Outcomes Due to Methicillin Resistant Staphylococcus aureus Surgical Site Infection: A Multi-Center Matched Outcomes Study. PLoS One. 2009 Dec 15;4(12):e8305. www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008305. Engemann J.J., Carmeli Y., Cosgrove S.E., Fowler V.G. Jr., Bronstein M.Z., Trivette S.L., Briggs J.P., Sexton D.J. Adverse Clinical and Economic Outcomes Attributable to Methicillin Resistance among Patients with Staphylococcus aureus Surgical Site Infection. Clin Infect Dis. 2003 Mar 1;36(5):592-8. www.carefusiondev.com/pdf/Engemann_ClinInfDis_030103.pdf. Flayhart D., Hindler J.F., Bruckner D.A., Hall G., Shrestha R.K., Vogel, S.A. et al. Multicenter evaluation of BBL CHROMagar MRSA medium for direct detection of methicillin-resistant Staphylococcus aureus from surveillance cultures of the anterior nares. J Clin Microbiol. 2005 Nov;43(11):5536-40. Jernigan J.A., Pullen A.L., Flowers L., Bell M., Jarvis W.R. Prevalence of and risk factors for colonization with methicillin-resistant Staphylococcus aureus at the time of hospital admission. Infect Control Hosp Epidemiol. 2003 June;24(6):392-6. Keshtgar M.R.S., Khalili A., Coen P.G., Carder C., Macrae B., Jeanes A. et al. Impact of rapid molecular screening for methsicillin-resistant Staphylococcus aureus in surgical wards. Br J Surg. 2008 Mar;95(3):381-6. Klevens R.M., Morrison M.A. , Nadle J., Petit S., Gershman K., Ray S. et al. Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States. JAMA. 2007 Oct;298(15):1763-71. Muto C.A., Jernigan J.A., Ostrowosky B.E., Richet H.M., Jarvis W.R., Boyce J.M., et al. SHEA guideline for preventing nosocomial transmission of multidrug-resistant strains of Staphylococcus aureus and Enterococcus. Infect Control Hosp Epidemiol. 2003 May;24(5):362-86. Nyman J.A., Lees C.H., Bockstedt L.A., Filice G.A., Lexau C., Lesher L.J., Como-Sabetti K., Lynfield R. Am J Infect Control. 2011 Feb;39(1):27-34. Access at www.ajicjournal.org/article/S0196-6553(10)00946-6/abstract. Summary: This study concluded that the high cost of caring for MRSA patients in the hospital means that interventions that reduce the spread of MRSA infections are likely to pay for themselves—screening ICU patients for MRSA upon admission could result in savings of almost $500 per patient. The researchers estimated that early detection of MRSA via screening of all ICU patients would also reduce rates of MRSA infection and transmission within the hospital overall. Robicsek A. Beaumont J.L., Paule S.M., Hacek, D.M., Thomson R.B., Kaul K.L., King P., Peterson L.R. Universal Surveillance for Methicillin-Resistant Staphylococcus aureus in 3 Affiliated Hospitals. Ann Intern Med. 2008 Mar 18;148(6):409-18. www.annals.org/cgi/reprint/148/6/409.pdf. Safdar N., Bradley E.A. The risk of infection after nasal colonization with Staphylococcus aureus. Am J Med. 2008 Apr;121(4):310-5. Styers D., Sheehan D.J., Hogan P., Sahm D.F. Laboratory-based surveillance of current antimicrobial resistance patterns and trends among Staphylococcus aureus: 2005 status in the United States. Ann Clin Microb and Antimicrob 2006; 5:2. ann-clinmicrob.com/content/5/1/2. Additional Resources: Centers for Disease Control and Prevention. Laboratory Detection of: Oxacillin/Methicillin-resistant Staphylococcus aureus. Retrieved August 10, 2009 from www.cdc.gov/mrsa/lab/lab-detection.html. Centers for Disease Control and Prevention. Prevention of MRSA Infections in Healthcare Settings. 2010. Retrieved Jan. 11, 2011 from www.cdc.gov/mrsa/prevent/healthcare.html. Herchline T. Staphylococcal Infections, 2008. Retrieved Jan. 29, 2009 from emedicine.medscape.com/article/228816-overview. Siegel J.D., Rhinehart E., Jackson M., Chiarello L. Management of Multidrug-Resistant Organisms In Healthcare Settings. Centers for Disease Control and Prevention 2006. www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline2006.pdf. Todar K. The Normal Bacterial Flora of Humans. In Todar, K. Todars' Online Textbook of Bacteriology. 2008. Published online at www.textbookofbacteriology.net/normalflora.html. Tolan R.J., Baorto E.P. Staphylococcus aureus Infection. 2009 Retrieved Jan. 29, 2009 from emedicine.medscape.com/article/971358-overview.