BACKGROUND
Infectious disease is the third leading cause of death and contributed to over 8.2 million fatalities in 2019.1-2 The World Economic Forum predicts that global mortality from antimicrobial resistance could reach 10 million per year by 2050.1,3 Patients with infectious illness often present with a constellation of symptoms that make it difficult to determine infection etiology.4
To address overlapping symptoms and the need for definitive diagnosis and antibiotic stewardship, molecular assays have been developed that are frequently more rapid, sensitive, and specific than conventional diagnostic methods (e.g., viral culture, microscopy, traditional sequencing).4-9 The development of multiplex molecular test panels for infectious diseases improves operational efficiencies and is often associated with decreased antibiotic use.4-9 Some panels identify pathogens that were previously difficult to detect via conventional methods.10 Many panels consolidate testing for multiple pathogens in a single sample, eliminating the need for multiple sample collections over return visits or in-hospital days, thereby improving operational efficiency and cost-effectiveness.
Discussions are ongoing regarding infectious disease diagnostics.11 Such topics include whether these tests should be frontline or secondary, limited to specific patient groups, or only utilized in certain locations.4,12 Some suggest limiting or customizing the largest multiplex panels to prevent to over-testing and unnecessary expense.4,12 The term “diagnostic stewardship” is becoming more frequently used—having first appeared in the medical literature in 2017.13 Attempts are being made to define it. The World Health Organization offers a broad definition emphasizing the importance of timely, accurate diagnostics.14 Others view it as an integral part of antimicrobial stewardship.13 Debate over the definition will no doubt be ongoing. As diagnostic technologies continue to rapidly evolve, strategies will be needed to assist clinicians in navigating this new frontier.
References
1. Omar RF, Boissinot M, Huletsky A, Bergeron M. Tackling infectious diseases with rapid molecular diagnosis and innovative prevention. Infect Dis Reports. 2024;16(2):216-227.
2. World Health Organization (WHO). Global Health Estimates: Leading Causes of Death. Cause-Specific Mortality, 2000–2019. Available online:
https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/ghe-leading-causes-of-death. Accessed June 13, 2024.
3. Jørgensen PA. Antibiotic resistance is the next great global challenge – we must act now. World Economic Forum.
https://www.weforum.org/agenda/2016/09/antimicrobial-resistance-is-the-next-global-commons-issue/. Accessed June 13, 2024.
4. Kim H, Huh HJ, Park E, Cung D, Kang M. Multiplex molecular point-of-care test for syndromic infectious diseases. BioChip J. 2021:15:14-21.
5. Lewinski MA, Alby K, Babady NE, et al. Exploring the utility of multiplex infectious disease panel testing for diagnosis of infection in different body sites: A joint report of the Association for MolecularPathology, American Society for Microbiology, Infectious Diseases Society of America, and Pan American Society for Clinical Virology. J Mol Diag. 2023;25(12):857:875.
6. Xu M, Qin X, Astion ML, et al. Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care. Am J Clin Pathol. 2013;139:118-23.
7. Rogers BB, Shankar P, Jerris RC, et al. Impact of a rapid respiratory panel test on patient outcomes. Arch Pathol Lab Med. 2015;139(5):636-41.
8. Subramony A, Zachariah P, Krones A, Whittier S, Saiman L. Impact of multiplex polymerase chain reaction testing for respiratory pathogens on healthcare resource utilization for pediatric inpatients. J Pediatr. 2016;173:196-201.
9. Brendish NJ, Malachira AK, Armstrong L, et al. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 201;5:401-411.
10. American Society for Microbiology. Guideline: Clinical utility of multiplex tests for respiratory and GI pathogens. August 23, 2019. https://asm.org/guideline/clinical-utility-of-multiplex-tests-for-respirator. Accessed June 13, 2024.
11. Pandolfo AM, Horne R, Jani Y, et al. Intensivists’ beliefs about rapid multiplex molecular diagnostic testing and its potential role in improving prescribing decisions and antimicrobial stewardship: a qualitative study. Antimicrob Resist Infect Control. 2021;10:95.
12. Messacar K, Parker SK, Todd JK, Dominguez SR. Implementation of rapid molecular infectious disease diagnostics: the role of diagnostic and antimicrobial stewardship. J Clin Microbiol. 2017;55:715–723.
13. Shorten, R, Pickering, K, Goolden, C, et al. Diagnostic stewardship in infectious diseases: a scoping review. J Med Microbiol. 2024;73(5): 001831.
14. World Health Organization. Diagnostic stewardship: A guide to implementation in antimicrobial resistance surveillance sites. https://iris.who.int/bitstream/handle/10665/251553/WHO-DGO-AMR-2016.3-eng.pdf. Accessed June 13, 2024.
1. Omar RF, Boissinot M, Huletsky A, Bergeron M. Tackling infectious diseases with rapid molecular diagnosis and innovative prevention. Infect Dis Reports. 2024;16(2):216-227.
2. World Health Organization (WHO). Global Health Estimates: Leading Causes of Death. Cause-Specific Mortality, 2000–2019. Available online:
https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/ghe-leading-causes-of-death. Accessed June 13, 2024.
3. Jørgensen PA. Antibiotic resistance is the next great global challenge – we must act now. World Economic Forum.
https://www.weforum.org/agenda/2016/09/antimicrobial-resistance-is-the-next-global-commons-issue/. Accessed June 13, 2024.
4. Kim H, Huh HJ, Park E, Cung D, Kang M. Multiplex molecular point-of-care test for syndromic infectious diseases. BioChip J. 2021:15:14-21.
5. Lewinski MA, Alby K, Babady NE, et al. Exploring the utility of multiplex infectious disease panel testing for diagnosis of infection in different body sites: A joint report of the Association for MolecularPathology, American Society for Microbiology, Infectious Diseases Society of America, and Pan American Society for Clinical Virology. J Mol Diag. 2023;25(12):857:875.
6. Xu M, Qin X, Astion ML, et al. Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care. Am J Clin Pathol. 2013;139:118-23.
7. Rogers BB, Shankar P, Jerris RC, et al. Impact of a rapid respiratory panel test on patient outcomes. Arch Pathol Lab Med. 2015;139(5):636-41.
8. Subramony A, Zachariah P, Krones A, Whittier S, Saiman L. Impact of multiplex polymerase chain reaction testing for respiratory pathogens on healthcare resource utilization for pediatric inpatients. J Pediatr. 2016;173:196-201.
9. Brendish NJ, Malachira AK, Armstrong L, et al. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 201;5:401-411.
10. American Society for Microbiology. Guideline: Clinical utility of multiplex tests for respiratory and GI pathogens. August 23, 2019. https://asm.org/guideline/clinical-utility-of-multiplex-tests-for-respirator. Accessed June 13, 2024.
11. Pandolfo AM, Horne R, Jani Y, et al. Intensivists’ beliefs about rapid multiplex molecular diagnostic testing and its potential role in improving prescribing decisions and antimicrobial stewardship: a qualitative study. Antimicrob Resist Infect Control. 2021;10:95.
12. Messacar K, Parker SK, Todd JK, Dominguez SR. Implementation of rapid molecular infectious disease diagnostics: the role of diagnostic and antimicrobial stewardship. J Clin Microbiol. 2017;55:715–723.
13. Shorten, R, Pickering, K, Goolden, C, et al. Diagnostic stewardship in infectious diseases: a scoping review. J Med Microbiol. 2024;73(5): 001831.
14. World Health Organization. Diagnostic stewardship: A guide to implementation in antimicrobial resistance surveillance sites. https://iris.who.int/bitstream/handle/10665/251553/WHO-DGO-AMR-2016.3-eng.pdf. Accessed June 13, 2024.