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Review
. 2023 Oct 16;77(Suppl 4):S314-S320.
doi: 10.1093/cid/ciad541.

Priorities and Progress in Diagnostic Research by the Antibacterial Resistance Leadership Group

Kimberly E Hanson  1   2 , Ritu Banerjee  3 , Sarah B Doernberg  4 , Scott R Evans  5 , Lauren Komarow  6 , Michael J Satlin  7 , Nyssa Schwager  8 , Patricia J Simner  9 , L Gayani Tillekeratne  10   11 , Robin Patel  12   13 ; Antibacterial Resistance Leadership Group
Collaborators, Affiliations
Review

Priorities and Progress in Diagnostic Research by the Antibacterial Resistance Leadership Group

Kimberly E Hanson et al. Clin Infect Dis. .

Abstract

The advancement of infectious disease diagnostics, along with studies devoted to infections caused by gram-negative and gram-positive bacteria, is a top scientific priority of the Antibacterial Resistance Leadership Group (ARLG). Diagnostic tests for infectious diseases are rapidly evolving and improving. However, the availability of rapid tests designed to determine antibacterial resistance or susceptibility directly in clinical specimens remains limited, especially for gram-negative organisms. Additionally, the clinical impact of many new tests, including an understanding of how best to use them to inform optimal antibiotic prescribing, remains to be defined. This review summarizes the recent work of the ARLG toward addressing these unmet needs in the diagnostics field and describes future directions for clinical research aimed at curbing the threat of antibiotic-resistant bacterial infections.

Keywords: antibacterial resistance; bacterial infections; diagnostics.

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Conflict of interest statement

Potential conflicts of interest. All authors report funding support from the ARLG of the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID; UM1AI104681). K. E. H. reports holding leadership roles with ARLG as the Diagnostics Committee Chair and Study Principal Investigator (PI), the Clinical and Laboratory Standards Institute (CLSI) as an advisor, Journal of Clinical Microbiology (JCM) as a Mycology Section Editor, and Clinical Infectious Diseases as a Deputy Editor. S. B. D. reports grants or contracts from Gilead, Pfizer, F2G, Regeneron, Chan Zuckerberg Biohub, and NIAID/NIH; consulting fees from Genentech and Janssen/J+J; support from the Infectious Diseases Society of America (IDSA) for travel to speak at IDWeek; patent US20100143379A1 for Mif agonists and antagonist and therapeutic uses thereof; leadership on the IDSA Antibacterial Resistance Committee, Healthcare-Associated Infection Advisory Committee for the California Department of Public Health, Antibacterial Resistance Leadership Group (ARLG) Innovations Group, ARLG Laboratory Center, ARLG Mentorship Committee, ARLG Gram-positive Committee, and ARLG Immunosuppressed Host Group; and payment to her institution from Shinogi, Basilea, and the Duke Clinical Research Institute for clinical events committee/adjudication committee participation. S. R. E. reports grants from the NIAID/NIH, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), Centers for Disease Control and Prevention (CDC), and Degruter (Editor-in-Chief for Statistical Communications in Infectious Diseases); royalties from Taylor & Francis; consulting fees from Genentech, AstraZeneca, Takeda, Microbiotix, Johnson & Johnson, Endologix, ChemoCentryx, Becton Dickinson, Atricure, Roviant, Neovasc, Nobel Pharma, Horizon, International Drug Development Institute, Medtronic, Regeneron, Wake Forest University, Recor, Janssen, and SVB Leerink; payments from Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION); meeting support from the US Food and Drug Administration, Deming Conference on Applied Statistics, Clinical Trial Transformation Initiative, Council for International Organizations of Medical Sciences, International Chinese Statistical Association Applied Statistics Symposium, and Antimicrobial Resistance and Stewardship Conference; and board member participation for the NIH, Breast International Group, University of Pennsylvania, Washington University, Duke University, Roche, Pfizer, Takeda, Akouos, Apellis, Teva, Vir, DayOneBio, Alexion, Tracon, Rakuten, Abbvie, GSK, Eli Lilly, Nuvelution, Clover, FHI Clinical, Lung Biotech, SAB Biopharm, Advantagene, Candel, Novartis, American Statistical Association, Society for Clinical Trials, and Frontier Science Foundation. M. J. S. reports grants and contracts from Merck, Biomerieux, SNIPRBiome, and Selux Diagnostics; consulting fees from Shionogi; and participation on a Data and Safety Monitoring Board or Advisory Board for AbbVie. P. J. S. reports grants or contracts from BD Diagnostics, T2 Diagnostics, OpGen, Inc, Affinity Biosensors, and Qiagen Sciences, Inc; consulting fees from OpGen, Inc, Entasis, BD Diagnostics, Merck, Qiagen Sciences, Inc, and Shionogi; payment or honoraria from GenMark Dx, OpGen, Inc, and BD Diagnostics; leadership on the ARLG Diagnostics Committee, Clinical and Laboratory Standards Institute Antimicrobial Susceptibility Testing Subcommittee, and College of American Pathologists Microbiology Committee; and stock in GeneCapture. R. P. reports grants or contracts from ContraFect, TenNor Therapeutics Limited, BIOFIRE, and Adaptive Phage Therapeutics; a royalty-bearing know-how agreement and equity in Adaptive Phage Therapeutics through the Mayo Clinic; consulting fees from PhAST, Torus Biosystems, Day Zero Diagnostics, Mammoth Biosciences, HealthTrackRx, Netflix, Abbott Laboratories, Trellis Bioscience, Inc, Oxford Nanopore Technologies, and CARB-X; honoraria from the National Board of Medical Examiners (NBME), Up-to-Date, and the Infectious Diseases Board Review Course; a patent on Bordetella pertussis/parapertussis polymerase chain reaction (PCR) issued, a patent on a device/method for sonication with royalties paid by Samsung to Mayo Clinic, and a patent on an anti-biofilm substance issued; and a financial relationship with Pathogenomix through the Mayo Clinic. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
ARLG diagnostic studies focused on the detection of bloodstream, sexually transmitted, and respiratory tract infections. Abbreviations: ARI, acute respiratory illness; ARLG, Antibacterial Resistance Leadership Group; BSI, bloodstream infection; FAST, Fast Antibiotic Susceptibility Testing for Gram-negative Bacteremia; MASTERMIND-BSI, Master Protocol for Evaluating Multiple Infection Diagnostics for Rapid Detection of Bloodstream Infection; MASTERMIND-GC, Master Protocol for Evaluating Multiple Infection Diagnostics–Gonorrhoeae and Chlamydia Testing of Extragenital Specimens; MASTERMIND-RING, Master Protocol for Evaluating Multiple Infection Diagnostics–Resistant Neisseria gonorrhoeae; RADICAL, Rapid Diagnostics in Categorizing Acute Lung Infections; RAPIDS-GN, Rapid Identification and Phenotypic Susceptibility Testing for Gram-negative Bacteremia; STI, sexually transmitted infection; TRAP-LRTI, Targeted Reduction of Antibiotics using Procalcitonin in Lower Respiratory Tract Infection.
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References

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