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Integrating an LFA Carbapenemase Detection System into the Laboratory Diagnostic Routine: Preliminary Data and
Maddalena Calvo1, Gaetano Maugeri2, Dafne Bongiorno2
1U.O.C. Laboratory Analysis Unit, A.O.U. "Policlinico-San Marco", 95123 Catania, Italy.
Diagnostics (Basel, Switzerland)
|June 13, 2025
Summary
A new lateral flow assay (LFA) accurately detects carbapenemases, including variants and dual types, in Enterobacterales. This rapid test offers a reliable, resource-efficient alternative for clinical diagnostics, crucial for combating antimicrobial resistance.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Molecular Diagnostics
Background:
- Carbapenemase production is a primary carbapenem-resistance mechanism in Enterobacterales, with KPC, VIM, NDM, IMP, and OXA-48 being prevalent in Europe.
- Southern Italy exhibits a high prevalence of carbapenemase-producing Enterobacterales in hospital settings, posing risks for patient colonization and dissemination.
- Emerging carbapenemase variants and co-production necessitate diagnostic tools with broad detection capabilities and high specificity.
Purpose of the Study:
- To evaluate the diagnostic performance of a novel lateral flow assay (LFA) for detecting carbapenemases in Enterobacterales.
- To assess the LFA's ability to identify specific carbapenemase types, including variants and double carbapenemase producers.
- To determine the LFA's reliability and efficiency compared to standard antimicrobial susceptibility testing (AST).
Main Methods:
- A retrospective study was conducted on 62 carbapenem- and/or ceftazidime/avibactam-resistant Enterobacterales isolates.
- The KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit, utilizing a lateral flow assay (LFA) method, was employed for carbapenemase detection.
- LFA results were compared against phenotypic antimicrobial susceptibility testing (AST) Minimum Inhibitory Concentration (MIC) results.
Main Results:
- The LFA demonstrated a 100% agreement rate with phenotypic AST MIC results.
- The LFA successfully detected carbapenemases in all tested Enterobacterales strains.
- The assay identified carbapenemase variants and instances of double carbapenemase production.
Conclusions:
- Lateral flow assays (LFAs) offer a reliable and accessible diagnostic alternative for carbapenemase detection.
- The tested LFA requires minimal economic and personnel resources with straightforward interpretation.
- Further investigation with larger isolate numbers and a wider spectrum of carbapenemase variants is warranted.
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