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The Unyvero P55 'sample-in, answer-out' pneumonia assay: A performance evaluation
C Ozongwu1, Y Personne1, G Platt1
1Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UK.
Biomolecular Detection and Quantification
|October 13, 2017
Summary
The Unyvero P55 rapidly detects more pathogens in respiratory infections than standard methods. While promising for antimicrobial stewardship, its clinical impact on prescribing and patient outcomes requires further investigation.
Area of Science:
- Clinical microbiology
- Infectious disease diagnostics
- Antimicrobial resistance
Background:
- Antimicrobial resistance necessitates improved diagnostic approaches.
- High-income countries are encouraged to mandate rapid diagnostic evidence for antimicrobial prescribing.
- Current diagnostic methods may not fully capture the microbial landscape of severe infections.
Purpose of the Study:
- To evaluate the Unyvero P55, a rapid multiplex diagnostic test, for lower respiratory specimens.
- To compare the Unyvero P55's performance against routine microbiology for pathogen and antimicrobial resistance marker detection.
Main Methods:
- Comparison of Unyvero P55 results with routine microbiology for 95 respiratory specimens.
- Detection of 20 pathogens and 19 antimicrobial resistance markers by Unyvero P55.
- Supplementary molecular testing, comprehensive culture, and 16S rRNA sequencing for verification.
Main Results:
- Unyvero P55 achieved 67% concordance with routine laboratory results.
- The test identified significantly more potential pathogens per specimen (1.34 vs. 0.47).
- Sensitivity and specificity for organism detection were 88.8% and 94.9%, respectively, with some resistance markers missed.
Conclusions:
- Unyvero P55 is a rapid diagnostic tool for lower respiratory tract infections, identifying more pathogens than conventional methods.
- The clinical relevance of additional detected organisms needs further evaluation.
- Additional research is necessary to ascertain the test's impact on antimicrobial prescribing and patient outcomes.
