Assessment of the multiplex PCR-based assay Unyvero pneumonia application for detection of bacterial pathogens and antibiotic resistance genes in children and neonates
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Pneumonia is a major healthcare problem. Rapid pathogen identification is critical, but often delayed due to the duration of culturing. Early, broad antibacterial therapy might lead to false-negative culture findings and eventually to the development of antibiotic resistances. We aimed to assess the accuracy of the new application Unyvero P50 based on multiplex PCR to detect bacterial pathogens in respiratory specimens from children and neonates.
In this prospective study, bronchoalveolar lavage fluids, tracheal aspirates, or pleural fluids from neonates and children were analyzed by both traditional culture methods and Unyvero multiplex PCR.
We analyzed specimens from 79 patients with a median age of 1.8 (range 0.01–20.1). Overall, Unyvero yielded a sensitivity of 73.1% and a specificity of 97.9% compared to culture methods. Best results were observed for non-fermenting bacteria, for which sensitivity of Unyvero was 90% and specificity 97.3%, while rates were lower for Gram-positive bacteria (46.2 and 93.9%, respectively). For resistance genes, we observed a concordance with antibiogram of 75% for those specimens in which there was a cultural correlate.
Unyvero is a fast and easy-to-use tool that might provide additional information for clinical decision making, especially in neonates and in the setting of nosocomial pneumonia. Sensitivity of the PCR for Gram-positive bacteria and important resistance genes must be improved before this application can be widely recommended.
KeywordsChildren Neonates Bacterial pneumonia Bronchoalveolar lavage Multiplex PCR
Antimicrobial susceptibility testing
Multi-resistant Gram-negative bacteria
Methicillin-resistant Staphylococcus aureus
Neonatal intensive care unit
Polymerase chain reaction
We would like to thank Hannelore Zeilhofer, Petra Aydin, Petra Kappel, and Birgit Hanings for excellent technical assistance. Curetis GmbH (Holzgerlingen, Germany) provided the Unyvero system, cartridges, and technical support.
CP designed the study, analyzed and interpreted the data, performed literature search, and drafted the initial manuscript; MMB and GL both analyzed data and revised the manuscript; TN and MG performed bronchoscopy, obtained BAL fluids, and revised the manuscript; JH designed the study, interpreted the data, and revised the manuscript; all authors read and approved the final manuscript.
Compliance with ethical standards
Ethics approval and consent to participate
This observational study was reviewed and approved by the ethic committee of the Ludwig-Maximilians-Universität München (UE Nr. 012-14). The committee declared the study unobjectionable and waived the need for informed consent, since no additional patient samples were obtained.
Availability of data and material
All data generated or analyzed during this study are included in this published article [and its supplementary information files].
The authors declare that they have no competing interests.
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