Multicenter assessment of the rapid Unyvero Blood Culture molecular assay

J Med Microbiol. 2018 Sep;67(9):1294-1301. doi: 10.1099/jmm.0.000804. Epub 2018 Jul 27.

Abstract

Purpose: Bloodstream infections remain an important cause of morbidity and mortality. Rapid diagnosis can reduce the time from empiric antimicrobial therapy to targeted therapy and improve patient outcomes.

Methodology: The fully automated Unyvero Blood Culture (BCU) Application (Curetis GmbH) can identify a broad panel of pathogens (36 analytes covering over 50 pathogens) and 16 antibiotic resistance gene markers simultaneously in about 5 h. The assay was evaluated in three clinical laboratories in comparison to routine microbiological procedures.

Results: A total of 207 blood cultures were included in the study, and 90.5 % of the species identified by culture were covered by the Unyvero BCU panel with an overall sensitivity of 96.8 % and specificity of 99.8 %. The time to result was reduced on average by about 34 h. The assay accurately identified 95 % of the species, including 158/164 monomicrobial and 7/9 polymicrobial cultures. The Unyvero BCU Cartridge detected a large number of resistance markers including mecA (n=57), aac(6')aph(2'') (n=40), one vanB resistance gene, and six instances of blaCTX-M.

Conclusion: The Unyvero BCU Application provided fast, reliable results, while significantly improving turnaround time in blood culture diagnostics.

Keywords: Bloodstream infection; antibiotic resistance; blood culture; diagnostics; multiplex PCR; sepsis.

Publication types

  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Anti-Bacterial Agents / pharmacology
  • Bacteremia / diagnosis
  • Bacteremia / microbiology*
  • Bacteria / classification
  • Bacteria / drug effects
  • Bacteria / genetics
  • Bacteria / isolation & purification*
  • Bacterial Proteins / genetics
  • Bacterial Proteins / metabolism
  • Blood Culture / methods*
  • Humans
  • Multiplex Polymerase Chain Reaction / methods*
  • Polymerase Chain Reaction / methods*
  • Sensitivity and Specificity

Substances

  • Anti-Bacterial Agents
  • Bacterial Proteins