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Updated: Feb 7, 2026

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
Multicenter assessment of the rapid Unyvero Blood Culture molecular assay
Sandra Christina Burrack-Lange1, Yoann Personne1, Monika Huber2
11Curetis GmbH, Max-Eyth-Straße 42, 71088, Holzgerlingen, Germany.
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.
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