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      Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

      research-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , for the Infectious Diseases Society of America (IDSA)
      Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
      Oxford University Press
      diagnostics, rapid diagnostics, point-of-care testing, molecular diagnostics, clinical microbiology, infectious diseases

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          Abstract

          In this IDSA policy paper, we review the current diagnostic landscape, including unmet needs and emerging technologies, and assess the challenges to the development and clinical integration of improved tests. To fulfill the promise of emerging diagnostics, IDSA presents recommendations that address a host of identified barriers. Achieving these goals will require the engagement and coordination of a number of stakeholders, including Congress, funding and regulatory bodies, public health agencies, the diagnostics industry, healthcare systems, professional societies, and individual clinicians.

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          Most cited references71

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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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            Tracking a hospital outbreak of carbapenem-resistant Klebsiella pneumoniae with whole-genome sequencing.

            The Gram-negative bacteria Klebsiella pneumoniae is a major cause of nosocomial infections, primarily among immunocompromised patients. The emergence of strains resistant to carbapenems has left few treatment options, making infection containment critical. In 2011, the U.S. National Institutes of Health Clinical Center experienced an outbreak of carbapenem-resistant K. pneumoniae that affected 18 patients, 11 of whom died. Whole-genome sequencing was performed on K. pneumoniae isolates to gain insight into why the outbreak progressed despite early implementation of infection control procedures. Integrated genomic and epidemiological analysis traced the outbreak to three independent transmissions from a single patient who was discharged 3 weeks before the next case became clinically apparent. Additional genomic comparisons provided evidence for unexpected transmission routes, with subsequent mining of epidemiological data pointing to possible explanations for these transmissions. Our analysis demonstrates that integration of genomic and epidemiological data can yield actionable insights and facilitate the control of nosocomial transmission.
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              Etiology of Community-Acquired Pneumonia: Increased Microbiological Yield with New Diagnostic Methods

              Abstract Background The microbial etiology of community-acquired pneumonia (CAP) is still not well characterized. During the past few years, polymerase chain reaction (PCR)-based methods have been developed for many pathogens causing respiratory tract infections. The aim of this study was to determine the etiology of CAP among adults—especially the occurrence of mixed infections among patients with CAP—by implementing a new diagnostic PCR platform combined with conventional methods. Methods Adults admitted to Karolinska University Hospital were studied prospectively during a 12-month period. Microbiological testing methods included culture from blood, sputum, and nasopharyngeal secretion samples; sputum samples analyzed by real-time quantitative PCR for Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis; nasopharyngeal specimens analyzed by use of PCR; serological testing for Mycoplasma pneumoniae, Chlamydophila pneumoniae, and viruses common in the respiratory tract; and urine antigen assays for detection of pneumococcal and Legionella pneumophila antigens. Results A microbial etiology could be identified for 67% of the patients (n = 124). For patients with complete sampling, a microbiological agent was identified for 89% of the cases. The most frequently detected pathogens were S. pneumoniae (70 patients [38]) and respiratory virus (53 patients [29]). Two or more pathogens were present in 43 (35%) of 124 cases with a determined etiology. Conclusions By supplementing traditional diagnostic methods with new PCR-based methods, a high microbial yield was achieved. This was especially evident for patients with complete sampling. Mixed infections were frequent (most commonly S. pneumoniae together with a respiratory virus).
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                Author and article information

                Journal
                Clin Infect Dis
                Clin. Infect. Dis
                cid
                cid
                Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
                Oxford University Press
                1058-4838
                1537-6591
                1 December 2013
                1 December 2013
                1 December 2013
                : 57
                : Suppl 3 , Better Tests, Better Care: Improved Diagnostics for Infectious Diseases
                : S139-S170
                Affiliations
                [1 ] Department of Medicine, Alpert Medical School of Brown University , Providence, Rhode Island
                [2 ] Division of Infectious Diseases, Providence Portland Medical Center
                [3 ] Department of Medicine, Oregon Health & Science University , Portland, Oregon
                [4 ] Division of Infectious Disease Diagnostics, North Shore–LIJ Laboratories , Lake Success
                [5 ] Departments of Pathology and Laboratory Medicine
                [6 ] Molecular Medicine, Hofstra North Shore–LIJ School of Medicine , Hempstead, New York
                [7 ] Departments of Medicine
                [8 ] Pathology, University of Utah , Salt Lake City
                [9 ] Department of Emergency Medicine, George Washington University , Washington, District of Columbia
                [10 ] Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda
                [11 ] Department of Medicine, Johns Hopkins School of Medicine , Baltimore, Maryland
                [12 ] Cepheid , Sunnyvale, California
                [13 ] Center for Emerging Pathogens, Department of Medicine, Rutgers–New Jersey Medical School, Rutgers University , Newark
                [14 ] Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Utah School of Medicine , Salt Lake City
                [15 ] Research Service, Louis Stokes Cleveland Department of Veterans Affairs Medical Center
                [16 ] Departments of Medicine
                [17 ] Pharmacology
                [18 ] Molecular Biology and Microbiology, Case Western Reserve University School of Medicine , Cleveland, Ohio
                [19 ] Department of Pathology, Division of Medical Microbiology
                [20 ] Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine , Baltimore, Maryland
                [21 ] Departments of Pathology
                [22 ] Medicine, Harvard Medical School and Massachusetts General Hospital
                [23 ] Department of Global Health and Social Medicine, Harvard Medical School
                [24 ] JSI Research and Training Institute , Boston, Massachusetts
                [25 ] Siemens Clinical Laboratory , Berkeley
                [26 ] Genomic Health , Redwood City
                [27 ] XDx Laboratory , San Francisco
                [28 ] Tethys Bioscience , Emeryville, California
                [29 ] Becton, Dickinson and Company , Sparks, Maryland
                [30 ] Infectious Diseases, Private Practice , Miami
                [31 ] Department of Internal Medicine , Nova Southeastern University , Fort Lauderdale, Florida
                [32 ] Departments of Medicine
                [33 ] Pathology, Duke University School of Medicine , Durham, North Carolina
                [34 ] Infectious Diseases Society of America , Arlington, Virginia
                Author notes

                The Infectious Diseases Society of America (IDSA) is a national medical society representing infectious diseases physicians, scientists, and other healthcare professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has >10 000 members, was founded in 1963 and is based in Arlington, Virginia. (For more information, visit www.idsociety.org.) This policy paper was developed for and approved by the IDSA Board of Directors on 20 August 2013.

                Correspondence: Audrey F. Jackson, PhD, Infectious Diseases Society of America, 1300 Wilson Blvd, Ste 300, Arlington, VA 22209 ( ajackson@ 123456idsociety.org ).
                Article
                cit578
                10.1093/cid/cit578
                3820169
                24200831
                56a21d0a-c33e-4d8f-86c1-2b72b603ae3a
                © The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@ 123456oup.com .

                This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

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                Categories
                Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

                Infectious disease & Microbiology
                diagnostics,rapid diagnostics,point-of-care testing,molecular diagnostics,clinical microbiology,infectious diseases

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