Clinical Consequences of Very Major Errors with Semi-Automated Testing Systems for Antimicrobial Susceptibility of Carbapenem-Resistant Enterobacterales

Clinical Consequences of Very Major Errors with Semi-Automated Testing Systems for Antimicrobial Susceptibility of Carbapenem-Resistant Enterobacterales. Bartoletti, M., Antonelli, A., Bussini, L., Corcione, S., Giacobbe, D. R., Marconi, L., Pascale, R., Dettori, S., Shbaklo, N., Ambretti, S., Gaibani, P., Giani, T., Coppi, M., Bassetti, M., De Rosa, F. G., Marchese, A., Cavallo, R., Lewis, R., Rossolini, G. M., Viale, P., & Giannella, M. Clinical Microbiology and Infection, March, 2022. Cited By :1 \par Cited By :1 \par Export Date: 20 November 2022 \par Export Date: 20 November 2022
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Objectives In this study we investigated the rate of susceptibility testing discrepancies between semi-automated and reference systems with carbapenem-resistant Enterobacterales (CRE) and the impact of alleged errors by semi-automated systems on guiding targeted therapy for CRE bloodstream infection (BSI). Methods This was a multicentre, retrospective study enrolling patients with monomicrobial BSI caused by CRE from January 2013 to December 2016. Nonduplicate isolates from index blood cultures tested locally with semi-automated systems were centralized at a referral laboratory and retested with a reference broth microdilution or agar dilution method. Results We enrolled 366 patients with CRE-BSI; 220 (60%) were male, and the median age was 67 years (interquartile range, 54–76 years). When compared with the results of the reference methods, those of the semi-automated systems exhibited variable rates of very major errors (VMEs; i.e. false susceptibilities) and major errors (MEs; i.e. false resistances). The highest rates of VMEs were observed with fosfomycin (14%) and colistin (13.9%), and the highest rates of MEs were observed with gentamicin (21%), fosfomycin (7.7%), and tigecycline (34%). Overall, VMEs and MEs led clinicians to prescribe or confirm ineffective therapy in 25 of 341 patients (7%). Receipt of ineffective therapy supported by a misleading susceptibility test was associated with higher 30-day mortality rates by Kaplan–Meier survival curves rates compared with receipt of active therapy (56% vs. 26%; p = 0.002), and the difference was confirmed after adjustment for confounders in a Cox regression model (adjusted hazard ratio: 2.91; 95% CI, 1.62–5.22; p $< $0.001). Discussion MEs and VMEs were relatively common with semi-automated susceptibility testing systems. VMEs were associated with inappropriate use of antibiotics and poorer outcomes.

@article{bartoletti.etal_2022,
  title = {Clinical Consequences of Very Major Errors with Semi-Automated Testing Systems for Antimicrobial Susceptibility of Carbapenem-Resistant {{Enterobacterales}}},
  author = {Bartoletti, Michele and Antonelli, Alberto and Bussini, Linda and Corcione, Silvia and Giacobbe, Daniele Roberto and Marconi, Lorenzo and Pascale, Renato and Dettori, Silvia and Shbaklo, Nour and Ambretti, Simone and Gaibani, Paolo and Giani, Tommaso and Coppi, Marco and Bassetti, Matteo and De Rosa, Francesco Giuseppe and Marchese, Anna and Cavallo, Rossana and Lewis, Russell and Rossolini, Gian Maria and Viale, Pierluigi and Giannella, Maddalena},
  year = {2022},
  month = mar,
  journal = {Clinical Microbiology and Infection},
  issn = {1198-743X},
  doi = {10.1016/j.cmi.2022.03.013},
  urldate = {2022-04-30},
  abstract = {Objectives In this study we investigated the rate of susceptibility testing discrepancies between semi-automated and reference systems with carbapenem-resistant Enterobacterales (CRE) and the impact of alleged errors by semi-automated systems on guiding targeted therapy for CRE bloodstream infection (BSI). Methods This was a multicentre, retrospective study enrolling patients with monomicrobial BSI caused by CRE from January 2013 to December 2016. Nonduplicate isolates from index blood cultures tested locally with semi-automated systems were centralized at a referral laboratory and retested with a reference broth microdilution or agar dilution method. Results We enrolled 366 patients with CRE-BSI; 220 (60\%) were male, and the median age was 67~years (interquartile range, 54--76~years). When compared with the results of the reference methods, those of the semi-automated systems exhibited variable rates of very major errors (VMEs; i.e. false susceptibilities) and major errors (MEs; i.e. false resistances). The highest rates of VMEs were observed with fosfomycin (14\%) and colistin (13.9\%), and the highest rates of MEs were observed with gentamicin (21\%), fosfomycin (7.7\%), and tigecycline (34\%). Overall, VMEs and MEs led clinicians to prescribe or confirm ineffective therapy in 25 of 341 patients (7\%). Receipt of ineffective therapy supported by a misleading susceptibility test was associated with higher 30-day mortality rates by Kaplan--Meier survival curves rates compared with receipt of active therapy (56\% vs. 26\%; p~=~0.002), and the difference was confirmed after adjustment for confounders in a Cox regression model (adjusted hazard ratio: 2.91; 95\% CI, 1.62--5.22; p~{$<~$}0.001). Discussion MEs and VMEs were relatively common with semi-automated susceptibility testing systems. VMEs were associated with inappropriate use of antibiotics and poorer outcomes.},
  langid = {english},
  keywords = {Category agreement,Essential agreement,Major errors,Mortality,Very major errors},
  note = {Cited By :1
\par
Cited By :1
\par
Export Date: 20 November 2022
\par
Export Date: 20 November 2022},
  file = {/Users/russelllewis/Zotero/storage/FYDKVCFJ/Bartoletti et al_2022_Clinical consequences of very major errors with semi-automated testing systems.pdf;/Users/russelllewis/Zotero/storage/EW9V8PX3/S1198743X22001525.html}
}

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