Multicenter performance evaluation of the Unyvero IAI cartridge for detection of intra-abdominal infections
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Intra-abdominal infections (IAIs) are one of the most common type of infections in patients with sepsis and an important cause of death in intensive care units. Early detection and treatment are necessary to reduce patient complications and improve outcomes. The Unyvero IAI Application (Curetis GmbH) is the first automated assay to rapidly and simultaneously identify a large panel of bacteria, fungi, toxins, and antibiotic resistance markers directly from IAI-related samples. The assay was evaluated in four European clinical laboratories in comparison to routine microbiological practices. A total of 300 clinical samples were tested with an overall sensitivity of 89.3% and specificity of 99.5%, while time to results was reduced by an average of about 17 h compared to identification (ID) results and 41 h compared to full antibiotic susceptibility testing (AST) results. The Unyvero IAI was able to detect additional microorganisms compared with culture, in particular anaerobes, with most detections confirmed by sequencing. The most frequent resistance markers detected were mecA/mecC (n = 25), aacA4 (n = 20), and blaCTX-M (n = 17) and carbapenemase genes were identified in nine specimens. Further studies are now required to determine the clinical impact of this new rapid test which could play a role in the successful treatment of IAI.
KeywordsIntra-abdominal infections Diagnostics Antibiotic resistance Multiplex PCR
Curetis GmbH provided the panel reagents and instruments used in this study, and performed the additional PCR and sequencing for discrepant results analysis. All authors have reviewed and agreed to this version of the manuscript.
H. Ciesielczuk presented some of this data at ECCMID 2017.
All study reagents, consumables, and costs were provided by Curetis GmbH.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This article does not contain any studies with human participants performed by any of the authors.
Informed consent was not required for this study as there were no human participants.
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