Key Findings:
- Bacterial infection diagnostics, such as phenotypic methods, genotypic methods, rapid point-of-care diagnostics, and companion diagnostics, are available across a variety of U.S. healthcare facilities. No single diagnostic technology is superior to others across all healthcare settings.
- No current data source adequately tracks the availability and use of novel bacterial infection diagnostics, though evaluation through a combination of public and proprietary sources may provide evidence to enhance infection disease management. Nonetheless, gaps in data remain.
- Barriers to uptake of novel bacterial infection diagnostics include cost, reimbursement variability, turnaround time, delays in clinical guideline development and implementation, clinical practices such as outdated diagnostic workflows that providers have historically relied on, technological limitations of available diagnostics, and clinician training and expertise in diagnostic technologies.
Background:
Bacterial infection diagnostics are crucial for ensuring accurate and prompt determination of patient infection status, identifying the infection-causing pathogen, and are critical to the fight against antimicrobial resistance (AMR). When a bacterial infection is suspected, but suitable diagnostic tools are delayed or unavailable, clinicians often resort to empiric prescriptions of broad-spectrum antimicrobials, which may be less effective, unnecessary, and can contribute to AMR and poorer patient outcomes. Diagnostics are particularly important for the appropriate use of newer antimicrobial agents. Clinicians may hesitate to prescribe newer agents, even when they are highly effective, due to a lack of susceptibility information.3 Diagnostic limitations can undermine the marketability of new antimicrobial products, leading to hesitation to invest in the next generation of necessary therapeutics.
Advanced diagnostics that use molecular, genetic, or novel detection technologies provide faster, more accurate identification of bacterial infections than traditional, culture-based methods and are becoming more available. But access to these diagnostics is still limited and may vary by healthcare setting. The primary objective of this study was to survey the published literature regarding the availability and use of diagnostics for managing bacterial infections in the United States, and the barriers to deployment and uptake of diagnostic testing in various healthcare settings. Another aim of the study was to investigate available data sources that can be used to quantify the extent of use and gaps in adoption of bacterial infection diagnostics.
*This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to Cody Fisher, cody.fisher@hhs.gov. Content will be updated pending the outcome of the Section 508 review.
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