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

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

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 fr...

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Main Authors: C. Ozongwu, Y. Personne, G. Platt, C. Jeanes, S. Aydin, N. Kozato, V. Gant, J. O’Grady, V.I. Enne
Format: Article
Language:English
Published: Elsevier 2017-09-01
Series:Biomolecular Detection and Quantification
Online Access:http://www.sciencedirect.com/science/article/pii/S2214753517300062
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spelling doaj-2a8972b1e6f94f5d9d20e93354a964542020-11-25T00:40:00ZengElsevierBiomolecular Detection and Quantification2214-75352017-09-011316The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluationC. Ozongwu0Y. Personne1G. Platt2C. Jeanes3S. Aydin4N. Kozato5V. Gant6J. O’Grady7V.I. Enne8Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UKCentre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UKCentre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UKNorwich Medical School, University of East Anglia, Norwich, UKCentre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UKCentre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UKNIHR Biomedical Research Centre, UK; Department of Infection, University College London NHS Hospitals Foundation Trust, London, UKNorwich Medical School, University of East Anglia, Norwich, UKCentre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UK; NIHR Biomedical Research Centre, UK; Corresponding author at: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UK.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. Keywords: Pneumonia, PCR, Diagnostics, Antimicrobial resistance, 16S metagenomics, Rapid testinghttp://www.sciencedirect.com/science/article/pii/S2214753517300062
collection DOAJ
language English
format Article
sources DOAJ
author C. Ozongwu
Y. Personne
G. Platt
C. Jeanes
S. Aydin
N. Kozato
V. Gant
J. O’Grady
V.I. Enne
spellingShingle C. Ozongwu
Y. Personne
G. Platt
C. Jeanes
S. Aydin
N. Kozato
V. Gant
J. O’Grady
V.I. Enne
The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation
Biomolecular Detection and Quantification
author_facet C. Ozongwu
Y. Personne
G. Platt
C. Jeanes
S. Aydin
N. Kozato
V. Gant
J. O’Grady
V.I. Enne
author_sort C. Ozongwu
title The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation
title_short The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation
title_full The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation
title_fullStr The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation
title_full_unstemmed The Unyvero P55 ‘sample-in, answer-out’ pneumonia assay: A performance evaluation
title_sort unyvero p55 ‘sample-in, answer-out’ pneumonia assay: a performance evaluation
publisher Elsevier
series Biomolecular Detection and Quantification
issn 2214-7535
publishDate 2017-09-01
description 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. Keywords: Pneumonia, PCR, Diagnostics, Antimicrobial resistance, 16S metagenomics, Rapid testing
url http://www.sciencedirect.com/science/article/pii/S2214753517300062
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