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      Noninvasive Testing and Surrogate Markers in Invasive Fungal Diseases

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          Abstract

          Invasive fungal infections continue to increase as at-risk populations expand. The high associated morbidity and mortality with fungal diseases mandate the continued investigation of novel antifungal agents and diagnostic strategies that include surrogate biomarkers. Biologic markers of disease are useful prognostic indicators during clinical care, and their use in place of traditional survival end points may allow for more rapid conduct of clinical trials requiring fewer participants, decreased trial expense, and limited need for long-term follow-up. A number of fungal biomarkers have been developed and extensively evaluated in prospective clinical trials and small series. We examine the evidence for these surrogate biomarkers in this review and provide recommendations for clinicians and regulatory authorities.

          Abstract

          The morbidity and mortality of invasive fungal diseases has fostered interest in surrogate biomarkers. These are used for diagnosis and may convey prognostic information. We review current evidence for the use of biomarkers for invasive fungal infections.

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          Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium

          J. Peter Donnelly, Sharon C-J Chen, Carol A Kauffman … (2020)
          Abstract Background Invasive fungal diseases (IFDs) remain important causes of morbidity and mortality. The consensus definitions of the Infectious Diseases Group of the European Organization for Research and Treatment of Cancer and the Mycoses Study Group have been of immense value to researchers who conduct clinical trials of antifungals, assess diagnostic tests, and undertake epidemiologic studies. However, their utility has not extended beyond patients with cancer or recipients of stem cell or solid organ transplants. With newer diagnostic techniques available, it was clear that an update of these definitions was essential. Methods To achieve this, 10 working groups looked closely at imaging, laboratory diagnosis, and special populations at risk of IFD. A final version of the manuscript was agreed upon after the groups’ findings were presented at a scientific symposium and after a 3-month period for public comment. There were several rounds of discussion before a final version of the manuscript was approved. Results There is no change in the classifications of “proven,” “probable,” and “possible” IFD, although the definition of “probable” has been expanded and the scope of the category “possible” has been diminished. The category of proven IFD can apply to any patient, regardless of whether the patient is immunocompromised. The probable and possible categories are proposed for immunocompromised patients only, except for endemic mycoses. Conclusions These updated definitions of IFDs should prove applicable in clinical, diagnostic, and epidemiologic research of a broader range of patients at high-risk.
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            Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America.

            Thomas Patterson, George Thompson, David W. Denning … (2016)
            It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.
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              Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care.

              Cornelius J Clancy, M Hong Nguyen (2013)
              Blood cultures are limited for diagnosing invasive candidiasis by poor sensitivity and slow turn-around time. New diagnostics are needed to complement cultures, in particular to identify the "missing 50%" of patients who are blood culture-negative. Mannan/anti-mannan immunoglobulin G, β-D-glucan (BDG) and polymerase chain reaction (PCR) assays can diagnose candidemia before blood cultures and show promising sensitivity/specificity, but they are not widely investigated in blood culture-negative, deep-seated candidiasis. In a recent study, BDG and PCR were superior to blood cultures in deep-seated candidiasis, suggesting they may identify currently undiagnosed patients and expand our understanding of disease spectrum. Positive predictive values of nonculture tests are limited by the low prevalence of invasive candidiasis, which mandates that results be interpreted judiciously. When used as biomarkers that assess a patient's risk of having invasive candidiasis, tests will facilitate preemptive antifungal strategies. Because negative predictive values are excellent, tests will also be useful for ruling out invasive candidiasis and discontinuing unnecessary antifungal therapy.
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                Author and article information

                Contributors
                George R Thompson III
                David R Boulware:
                ORCID: https://orcid.org/0000-0002-4715-0060
                Nathan C Bahr
                Cornelius J Clancy
                Thomas S Harrison
                Carol A Kauffman
                Thuy Le:
                ORCID: https://orcid.org/0000-0002-3393-6580
                Marisa H Miceli
                Eleftherios Mylonakis
                M Hong Nguyen
                Luis Ostrosky-Zeichner:
                ORCID: https://orcid.org/0000-0002-4784-7589
                Thomas F Patterson
                John R Perfect
                Andrej Spec:
                ORCID: https://orcid.org/0000-0001-7612-4710
                Dimitrios P Kontoyiannis
                Peter G Pappas
                Journal
                Journal ID (nlm-ta): Open Forum Infect Dis
                Journal ID (iso-abbrev): Open Forum Infect Dis
                Journal ID (publisher-id): ofid
                Title: Open Forum Infectious Diseases
                Publisher: Oxford University Press (US )
                ISSN (Electronic): 2328-8957
                Publication date Collection: June 2022
                Publication date (Electronic): 04 March 2022
                Publication date PMC-release: 04 March 2022
                Volume: 9
                Issue: 6
                Electronic Location Identifier: ofac112
                Affiliations
                Division of Infectious Diseases, Department of Internal Medicine, University of California-Davis Medical Center , Sacramento California, USA
                Department of Medical Microbiology and Immunology, University of California-Davis , Davis, California, USA
                Division of Infectious Diseases, Department of Internal Medicine, University of Minnesota , Minneapolis, Minnesota, USA
                Division of Infectious Diseases, Department of Medicine, University of Kansas , Kansas City, Kansas, USA
                Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania, USA
                VA Pittsburgh Healthcare System , Pittsburgh, Pennsylvania, USA
                Centre for Global Health, Institute of Infection and Immunity, St George’s University of London , London, United Kingdom
                Clinical Academic Group in Infection, St George’s Hospital NHS Trust , London, United Kingdom
                MRC Centre for Medical Mycology, University of Exeter , Exeter, United Kingdom
                VA Ann Arbor Healthcare System and University of Michigan , Ann Arbor, Michigan, USA
                Division of Infectious Diseases and International Health, Duke University School of Medicine , Durham, North Carolina, USA
                Oxford University Clinical Research Unit , Ho Chi Minh City, Vietnam
                University of Michigan , Ann Arbor, Michigan, USA
                Division of Infectious Diseases, Warren Alpert Medical School, Brown University , Providence, Rhode Island, USA
                Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania, USA
                University of Pittsburgh Medical Center , Pittsburgh, Pennsylvania, USA
                Division of Infectious Diseases, McGovern Medical School , Houston, Texas, USA
                Division of Infectious Diseases, Department of Medicine, The University of Texas Health Science Center , San Antonio, Texas, USA
                Division of Infectious Diseases and International Health, Duke University School of Medicine , Durham, North Carolina, USA
                Division of Infectious Diseases, Department of Molecular Genetics and Microbiology, Duke University , Durham, North Carolina, USA
                Division of Infectious Diseases, Department of Medicine, Washington University in St. Louis, School of Medicine , St. Louis, Missouri, USA
                Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center , Houston, Texas, USA
                Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham , Birmingham, Alabama, USA
                Author notes
                Correspondence: George R. Thompson, MD, FIDSA, Department of Medicine, 4150 V Street, Suite G500, UC-Davis Medical Center, Sacramento, CA 95817 ( grthompson@ 123456ucdavis.edu ).
                Author information
                https://orcid.org/0000-0002-4715-0060
                https://orcid.org/0000-0002-3393-6580
                https://orcid.org/0000-0002-4784-7589
                https://orcid.org/0000-0001-7612-4710
                Article
                Publisher ID: ofac112
                DOI: 10.1093/ofid/ofac112
                PMC ID: 9124589
                PubMed ID: 35611348
                SO-VID: 6653061f-f82e-4e62-b712-1f3a07f503c2
                Copyright © © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Date received : 07 December 2021
                Date accepted : 02 March 2022
                Date: 23 February 2022
                Date: 22 May 2022
                Page count
                Pages: 19
                Categories
                Subject: Invited Article
                Subject: AcademicSubjects/MED00290
                Subject: Editor's Choice

                Keywords: diagnosis,fungal infections,mycology
                Data availability:
                Keywords: diagnosis, fungal infections, mycology

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