Diagnostic accuracy of rapid molecular tests for detecting antimicrobial resistance in bloodstream infections: a systematic review
DOI:
https://doi.org/10.65759/9dmxec61Keywords:
bloodstream infections, antimicrobial resistance, Rapid molecular tests, diagnostic accuracy, blood cultureAbstract
Background: Rapid molecular tests (RMTs) accelerate antimicrobial resistance detection in bloodstream infections, and accuracy differs by target. This systematic review evaluated diagnostic performance. Methods: We searched PubMed, Scopus, Web of Science, and Embase for original studies assessing RMTs for resistance detection in bloodstream infections (BSIs) using positive blood cultures or whole blood. Eligible studies compared assays with conventional microbiology, phenotypic susceptibility testing, molecular methods, or combined standards. We extract data on assay characteristics, resistance targets, diagnostic outcomes, turnaround time, and clinical impact. Results: We include nine studies involving 2,439 samples. Platforms included FilmArray/BCID, Verigene BC-GP/BC-GN, BIOFIRE BCID2, T2Resistance, and the Molecular Mouse System. Performance was high for covered organisms and resistance markers. BCID2 showed 98.9% sensitivity and 99.6% specificity for organism targets, with 97.9% positive percent agreement and 99.9% negative percent agreement for resistance determinants. T2Resistance showed 100% sensitivity for several genes and shorter time to detection than conventional methods. Lower performance was reported in polymicrobial cultures and when resistance mechanisms were outside assay panels. Conclusion: RMTs are adjuncts for early resistance detection in BSIs and shorten time to results. They should complement conventional culture and susceptibility testing because limited target coverage, off-panel organisms, and imperfect genotype-phenotype correlation is important constraints.
References
[1] Banerjee R, Humphries R. Rapid Antimicrobial Susceptibility Testing Methods for Blood Cultures and Their Clinical Impact. Front Med (Lausanne) 2021;8. https://doi.org/10.3389/fmed.2021.635831.
[2] Liborio MP, Harris PNA, Ravi C, Irwin AD. Getting Up to Speed: Rapid Pathogen and AMR Diagnostics in Sepsis. Microorganisms 2024;12. https://doi.org/10.3390/microorganisms12091824.
[3] Peri AM, Ling W, Furuya-Kanamori L, Harris PNA, Paterson DL. Performance of BioFire Blood Culture Identification 2 Panel (BCID2) for the detection of bloodstream pathogens and their associated resistance markers: a systematic review and meta-analysis of diagnostic test accuracy studies. BMC Infect Dis 2022;22. https://doi.org/10.1186/s12879-022-07772-x.
[4] Walsh TJ, Mencacci A, Paggi R, Douka E, Vrettou C, Smith R, et al. Prospective observational pilot study of the T2Resistance panel in the T2Dx system for detection of resistance genes in bacterial BSIs. J Clin Microbiol 2024;62. https://doi.org/10.1128/jcm.01296-23.
[5] De Angelis G, Grossi A, Menchinelli G, Boccia S, Sanguinetti M, Posteraro B. RMTs for detection of AMR determinants in Gram-negative organisms from positive blood cultures: a systematic review and meta-analysis. Clinical Microbiology and Infection 2020;26:271–80. https://doi.org/10.1016/j.cmi.2019.11.009.
[6] Giacobbe DR, Giani T, Bassetti M, Marchese A, Viscoli C, Rossolini GM. Rapid microbiological tests for BSIs due to multidrug resistant Gram-negative bacteria: therapeutic implications. Clinical Microbiology and Infection 2020;26:713–22. https://doi.org/10.1016/j.cmi.2019.09.023.
[7] Tićac M, Grubić Kezele T, Abram M, Bubonja-Šonje M. Evaluation of the Microbiological Performance and Potential Clinical Impact of New RMTs for the Diagnosis of BSIs. Microorganisms 2025;13. https://doi.org/10.3390/microorganisms13030616.
[8] Timbrook TT, Morton JB, Mcconeghy KW, Caffrey AR, Mylonakis E, LaPlante KL. The effect of molecular rapid diagnostic testing on clinical outcomes in BSIs: A systematic review and meta-analysis. Clinical Infectious Diseases 2017;64:15–23. https://doi.org/10.1093/cid/ciw649.
[9] She RC, Bender JM. Advances in Rapid Molecular Blood Culture Diagnostics: Healthcare Impact, Laboratory Implications, and Multiplex Technologies. Journal of Applied Laboratory Medicine 2019;3:617–30. https://doi.org/10.1373/jalm.2018.027409.
[10] Blaschke AJ, Heyrend C, Byington CL, Fisher MA, Barker E, Garrone NF, et al. Rapid identification of pathogens from positive blood cultures by multiplex polymerase chain reaction using the FilmArray system. Diagn Microbiol Infect Dis 2012;74:349–55. https://doi.org/10.1016/j.diagmicrobio.2012.08.013.
[11] Altun O, Almuhayawi M, Ullberg M, Ozenci V. Clinical evaluation of the Filmarray blood culture identification panel in identification of bacteria and yeasts from positive blood culture bottles. J Clin Microbiol 2013;51:4130–6. https://doi.org/10.1128/JCM.01835-13.
[12] Wojewoda CM, Sercia L, Navas M, Tuohy M, Wilson D, Hall GS, et al. Evaluation of the verigene gram-positive blood culture nucleic acid test for rapid detection of bacteria and resistance determinants. J Clin Microbiol 2013;51:2072–6. https://doi.org/10.1128/JCM.00831-13.
[13] Mestas J, Polanco CM, Felsenstein S, Bard JD. Performance of the verigene gram-positive blood culture assay for direct detection of gram-positive organisms and resistance markers in a pediatric hospital. J Clin Microbiol 2014;52:283–7. https://doi.org/10.1128/JCM.02322-13.
[14] Hill JT, Tran KDT, Barton KL, Labreche MJ, Sharp SE. Evaluation of the Nanosphere Verigene BC-GN assay for direct identification of gram-negative bacilli and antibiotic resistance markers from positive blood cultures and potential impact for more-rapid antibiotic interventions. J Clin Microbiol 2014;52:3805–7. https://doi.org/10.1128/JCM.01537-14.
[15] Siu GKH, Chen JHK, Ng TK, Lee RA, Fung KSC, To SWC, et al. Performance evaluation of the verigene gram-positive and gram-negative blood culture test for direct identification of bacteria and their resistance determinants from positive blood cultures in Hong Kong. PLoS One 2015;10. https://doi.org/10.1371/journal.pone.0139728.
[16] Rhoads DD, Pournaras S, Leber A, Balada-Llasat JM, Harrington A, Sambri V, et al. Multicenter Evaluation of the BIOFIRE Blood Culture Identification 2 Panel for Detection of Bacteria, Yeasts, and AMR Genes in Positive Blood Culture Samples. J Clin Microbiol 2023;61:e0189122. https://doi.org/10.1128/jcm.01891-22.
[17] Peri AM, Chatfield MD, Ling W, Furuya-Kanamori L, Harris PNA, Paterson DL. Rapid Diagnostic Tests and Antimicrobial Stewardship Programs for the Management of BSI: What Is Their Relative Contribution to Improving Clinical Outcomes? A Systematic Review and Network Meta-analysis. Clinical Infectious Diseases 2024;79:502–15. https://doi.org/10.1093/cid/ciae234.


