Multicenter evaluation of the unyvero platform for testing bronchoalveolar lavage fluid

Matthias Klein, Johannes Bacher, Sandra Barth, Faranak Atrzadeh, Katja Siebenhaller, Inês Ferreira, Stephan Beisken, Andreas E. Posch, Karen C. Carroll, Richard G. Wunderink, Chao Qi, Fann Wu, Dwight J. Hardy, Robin Patel, Matthew D. Sims

Research output: Contribution to journalArticlepeer-review

Abstract

Bronchoalveolar lavage (BAL) culture is a standard, though time-consuming, approach for identifying microorganisms in patients with severe lower respiratory tract (LRT) infections. The sensitivity of BAL culture is relatively low, and prior antimicrobial therapy decreases the sensitivity further, leading to overuse of empirical antibiotics. The Unyvero LRT BAL Application (Curetis GmbH, Germany) is a multiplex molecular panel that detects 19 bacteria, 10 antibiotic resistance markers, and a fungus, Pneumocystis jirovecii, in BAL fluid in;4.5h. Its performance was evaluated using 1,016 prospectively collected and 392 archived specimens from 11 clinical trial sites in the United States. Overall positive and negative percent agreements with culture results for identification of bacteria that grow in routine cultures were 93.4% and 98.3%, respectively, with additional potential pathogens identified by Unyvero in 21.7% of prospectively collected specimens. For detection of P. jirovecii, the positive percent agreement with standard testing was 87.5%. Antibiotic resistance marker results were compared to standard antibiotic susceptibility test results to determine positive predictive values (PPVs). PPVs ranged from 80 to 100%, based on the microorganism and specific resistance marker(s). The Unyvero LRT BAL Application provides accurate detection of common agents of bacterial pneumonia and of P. jirovecii. The sensitivity and rapidity of this panel suggest significant clinical value for choosing appropriate antibiotics and for antibiotic stewardship.

Original languageEnglish (US)
Article numbere02497-20
JournalJournal of clinical microbiology
Volume59
Issue number3
DOIs
StatePublished - Mar 2021

Keywords

  • BAL
  • Molecular diagnostics
  • Multiplex PCR
  • Pneumonia

ASJC Scopus subject areas

  • Microbiology (medical)

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