title: 'Sample-in, answer-out'? Evaluation and comprehensive analysis of the Unyvero P50 pneumonia assay.
abstract: This study aimed to evaluate the performance of the Unyvero P50 pneumonia assay, the first 'sample-in, answer-out' system for rapid identification of pathogens and antibiotic resistance markers directly from clinical specimens. Overall, Unyvero P50 displayed very good sensitivity (>95%); however, specificity was low (33%) mainly because 40% of the specimens were reported as normal flora. Specifically, one or more pathogens were identified in 28 of them. From a detailed analysis of 42 specimens selected at random, 76% of the additionally reported pathogens were confirmed present in primary specimens. Detection of selected resistance markers was compared to routine phenotypic susceptibility testing, supplemented with Checkpoints microarray system, PCR and sequencing. Concordance was mixed, primarily due to issues with panel's choice of markers and detection of some intrinsic beta-lactamases. Finally, we offer a critical analysis of the assay's microbial panel and resistance markers and provide suggestions for improvement.
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK.
authors.forename: Y
authors.initials: Y
authors.lastname: Personne
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK.
authors.forename: C
authors.initials: C
authors.lastname: Ozongwu
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK.
authors.forename: G
authors.initials: G
authors.lastname: Platt
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Basurto-Lozada
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Shamin
authors.affiliation: NIHR Biomedical Research Centre, University College London NHS Hospitals Foundation Trust, London, UK; Department of Infection, University College London NHS Hospitals Foundation Trust, London, UK.
authors.forename: V A
authors.initials: VA
authors.lastname: Gant
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Zumla
authors.affiliation: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Rowland Hill Street, London, UK. Electronic address: v.enne@ucl.ac.uk.
authors.forename: V I
authors.initials: VI
authors.lastname: Enne
mesh_terms: D000328:Adult; D057205:Automation, Laboratory / Q000379:methods*; D006801:Humans; D008172:Lung Diseases, Fungal / Q000175:diagnosis* / Q000382:microbiology; D008828:Microbiological Techniques / Q000379:methods*; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D018410:Pneumonia, Bacterial / Q000175:diagnosis* / Q000382:microbiology; D012680:Sensitivity and Specificity
keywords: Antimicrobial resistance; Beta-lactamase; PCR; Pneumonia; Rapid diagnostics