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      Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial

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          Abstract

          Sepsis is a major cause of morbidity, mortality, and increased medical expense. Rapid diagnosis improves outcomes and reduces costs. The FilmArray blood culture identification panel (BioFire Diagnostics LLC, Salt Lake City, UT), a highly multiplexed PCR assay, can identify 24 etiologic agents of sepsis (8 Gram-positive, 11 Gram-negative, and 5 yeast species) and three antimicrobial resistance genes ( mecA, vanA/ B, and bla KPC) from positive blood culture bottles. It provides results in about 1 h with 2 min for assay setup. We present the results of an eight-center trial comparing the sensitivity and specificity of the panel with those of the laboratories' standard phenotypic identification techniques, as well as with molecular methods used to distinguish Acinetobacter baumannii from other members of the A. calcoaceticus- A. baumannii complex and to detect antimicrobial resistance genes. Testing included 2,207 positive aerobic blood culture samples, 1,568 clinical and 639 seeded. Samples were tested fresh or were frozen for later testing within 8 h after the bottles were flagged as positive by an automated blood culture system. At least one organism was detected by the panel in 1,382 (88.1%) of the positive clinical specimens. The others contained primarily off-panel organisms. The panel reported multiple organisms in 81 (5.86%) positive clinical specimens. The unresolved blood culture identification sensitivity for all target detections exceeded 96%, except for Klebsiella oxytoca (92.2%), which achieved 98.3% sensitivity after resolution of an unavoidable phenotypic error. The sensitivity and specificity for vanA/ B and bla KPC were 100%; those for mecA were 98.4 and 98.3%, respectively.

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          THE USE OF CONFIDENCE OR FIDUCIAL LIMITS ILLUSTRATED IN THE CASE OF THE BINOMIAL

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            The epidemic of antibiotic-resistant infections: a call to action for the medical community from the Infectious Diseases Society of America.

            The ongoing explosion of antibiotic-resistant infections continues to plague global and US health care. Meanwhile, an equally alarming decline has occurred in the research and development of new antibiotics to deal with the threat. In response to this microbial "perfect storm," in 2001, the federal Interagency Task Force on Antimicrobial Resistance released the "Action Plan to Combat Antimicrobial Resistance; Part 1: Domestic" to strengthen the response in the United States. The Infectious Diseases Society of America (IDSA) followed in 2004 with its own report, "Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates, A Public Health Crisis Brews," which proposed incentives to reinvigorate pharmaceutical investment in antibiotic research and development. The IDSA's subsequent lobbying efforts led to the introduction of promising legislation in the 109 th US Congress (January 2005-December 2006). Unfortunately, the legislation was not enacted. During the 110 th Congress, the IDSA has continued to work with congressional leaders on promising legislation to address antibiotic-resistant infection. Nevertheless, despite intensive public relations and lobbying efforts, it remains unclear whether sufficiently robust legislation will be enacted. In the meantime, microbes continue to become more resistant, the antibiotic pipeline continues to diminish, and the majority of the public remains unaware of this critical situation. The result of insufficient federal funding; insufficient surveillance, prevention, and control; insufficient research and development activities; misguided regulation of antibiotics in agriculture and, in particular, for food animals; and insufficient overall coordination of US (and international) efforts could mean a literal return to the preantibiotic era for many types of infections. If we are to address the antimicrobial resistance crisis, a concerted, grassroots effort led by the medical community will be required.
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              Initiation of inappropriate antimicrobial therapy results in a fivefold reduction of survival in human septic shock.

              Our goal was to determine the impact of the initiation of inappropriate antimicrobial therapy on survival to hospital discharge of patients with septic shock. The appropriateness of initial antimicrobial therapy, the clinical infection site, and relevant pathogens were retrospectively determined for 5,715 patients with septic shock in three countries. Therapy with appropriate antimicrobial agents was initiated in 80.1% of cases. Overall, the survival rate was 43.7%. There were marked differences in the distribution of comorbidities, clinical infections, and pathogens in patients who received appropriate and inappropriate initial antimicrobial therapy (p < 0.0001 for each). The survival rates after appropriate and inappropriate initial therapy were 52.0% and 10.3%, respectively (odds ratio [OR], 9.45; 95% CI, 7.74 to 11.54; p < 0.0001). Similar differences in survival were seen in all major epidemiologic, clinical, and organism subgroups. The decrease in survival with inappropriate initial therapy ranged from 2.3-fold for pneumococcal infection to 17.6-fold with primary bacteremia. After adjustment for acute physiology and chronic health evaluation II score, comorbidities, hospital site, and other potential risk factors, the inappropriateness of initial antimicrobial therapy remained most highly associated with risk of death (OR, 8.99; 95% CI, 6.60 to 12.23). Inappropriate initial antimicrobial therapy for septic shock occurs in about 20% of patients and is associated with a fivefold reduction in survival. Efforts to increase the frequency of the appropriateness of initial antimicrobial therapy must be central to efforts to reduce the mortality of patients with septic shock.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                J Clin Microbiol
                J. Clin. Microbiol
                jcm
                jcm
                JCM
                Journal of Clinical Microbiology
                American Society for Microbiology (1752 N St., N.W., Washington, DC )
                0095-1137
                1098-660X
                6 January 2016
                25 February 2016
                March 2016
                25 February 2016
                : 54
                : 3
                : 687-698
                Affiliations
                [a ]Department of Pathology, Wayne State University School of Medicine, Detroit, Michigan, USA
                [b ]DMC University Laboratories, Detroit, Michigan, USA
                [c ]Loyola University Medical Center, Chicago, Illinois, USA
                [d ]Department of Pathology, University of Maryland, Baltimore, Maryland, USA
                [e ]Division of Medical Microbiology, Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
                [f ]Cedars-Sinai Medical Center, Los Angeles, California, USA
                [g ]Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA
                [h ]New York-Presbyterian Hospital, Weill-Cornell Medical Center, New York, New York, USA
                [i ]Department of Pathology, University of Utah, and Primary Children's Medical Center, Salt Lake City, Utah, USA
                [j ]BioFire Diagnostics LLC, Salt Lake City, Utah, USA
                Author notes
                Address correspondence to Marilynn R. Fairfax, mfairfax@ 123456dmc.org .
                [*]

                Present address: Frances Valencia-Shelton, Clinical Microbiology Laboratories, Strong Memorial Hospital, University of Rochester Medical Center, Rochester, New York, USA.

                Citation Salimnia H, Fairfax MR, Lephart PR, Schreckenberger P, Desjarlais SM, Johnson JK, Robinson G, Carroll KC, Greer A, Morgan M, Chan R, Loeffelholz M, Valencia-Shelton F, Jenkins S, Schuetz AN, Daly JA, Barney T, Hemmert A, Kanack KJ. 2016. Evaluation of the FilmArray blood culture identification panel: results of a multicenter controlled trial. J Clin Microbiol 54:687–698. doi: 10.1128/JCM.01679-15.

                Article
                01679-15
                10.1128/JCM.01679-15
                4767991
                26739158
                a31d9ece-097c-46bf-9795-c1fb7c6ce694
                Copyright © 2016 Salimnia et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-ShareAlike 3.0 Unported license, which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 23 June 2015
                : 21 July 2015
                : 28 December 2015
                Page count
                Figures: 0, Tables: 6, Equations: 0, References: 32, Pages: 12, Words: 12053
                Funding
                Funded by: BioFire Diagnostics LLC
                Award Recipient : Hossein Salimnia Award Recipient : Paul C. Schreckenberger Award Recipient : J. Kristie Johnson Award Recipient : Gwen L. Robinson Award Recipient : Karen C. Carroll Award Recipient : Margie Morgan Award Recipient : Michael J. Loeffelholz Award Recipient : Stephen G. Jenkins Award Recipient : Judy Daly
                Categories
                Bacteriology

                Microbiology & Virology
                Microbiology & Virology

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