The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation

Ozongwu, C., Personne, Y., Platt, G., Jeanes, C., Aydin, S., Kozato, N., Gant, V., O'Grady, J. and Enne, V.I. (2017) The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation. Biomolecular Detection and Quantification, 13. pp. 1-6. ISSN 2214-7535

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Background: O’Neill’s recent Review on Antimicrobial Resistance expressed the view that by 2020 high-income countries should make it mandatory to support antimicrobial prescribing with rapid diagnostic evidence whenever possible. Methods: Routine microbiology diagnosis of 95 respiratory specimens from patients with severe infection were compared with those generated by the Unyvero P55 test, which detects 20 pathogens and 19 antimicrobial resistance markers. Supplementary molecular testing for antimicrobial resistance genes, comprehensive culture methodology and 16S rRNA sequencing were performed. Results: Unyvero P55 produced 85 valid results, 67% of which were concordant with those from the routine laboratory. Unyvero P55 identified more potential pathogens per specimen than routine culture (1.34 vs. 0.47 per specimen). Independent verification using 16S rRNA sequencing and culture (n = 10) corroborated 58% of additional detections compared to routine microbiology. Overall the average sensitivity for organism detection by Unyvero P55 was 88.8% and specificity was 94.9%. While Unyvero P55 detected more antimicrobial resistance markers than routine culture, some instances of phenotypic resistance were missed. Conclusions: The Unyvero P55 is a rapid pathogen detection test for lower respiratory specimens, which identifies a larger number of pathogens than routine microbiology. The clinical significance of these additional organisms is yet to be determined. Further studies are required to determine the effect of the test in practise on antimicrobial prescribing and patient outcomes.

Item Type: Article
Uncontrolled Keywords: pneumonia,pcr,diagnostics,antimicrobial resistance,16s metagenomics,rapid testing
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Medical Microbiology (former - to 2018)
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Depositing User: Pure Connector
Date Deposited: 06 Jul 2017 05:06
Last Modified: 22 Oct 2022 02:52
DOI: 10.1016/j.bdq.2017.06.001


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