Multicenter Evaluation of the Unyvero Platform for Testing Bronchoalveolar Lavage Fluid

Klein Matthias; Bacher Johannes; Barth SandraAtrzadeh FaranakSiebenhaller KatjaFerreira InesBeisken StephanPosch Andreas E.Carroll Karen C.Wunderink Richard G.Qi ChaoWu FannHardy Dwight J.Patel RobinSims Matthew D.

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Multicenter Evaluation of the Unyvero Platform for Testing Bronchoalveolar Lavage Fluid

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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 similar to 4.5 h. 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.

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《Journal of Clinical Microbiology》 |2021年第3期|共16页
作者
Klein Matthias; Bacher Johannes; Barth SandraAtrzadeh FaranakSiebenhaller KatjaFerreira InesBeisken StephanPosch Andreas E.Carroll Karen C.Wunderink Richard G.Qi ChaoWu FannHardy Dwight J.Patel RobinSims Matthew D.;
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作者单位

Ares Genet GmbH, Vienna, Austria;

Johns Hopkins Univ, Sch Med, Baltimore, MD USA;

Northwestern Univ, Dept Med, Div Pulm & Crit Care Med, Feinberg Sch Med, Chicago, IL 60611 USANorthwestern Univ, Dept Pathol, Clin Microbiol Lab, Feinberg Sch Med, Chicago, IL 60611 USAColumbia Univ, Med Ctr, New York, NY USAUniv Rochester, Med Ctr, Rochester, NY 14642 USAMayo Clin, Div Clin Microbiol, Rochester, MN USABeaumont Hosp, Sect Infect Dis & Int Med, Royal Oak, MI 48073 USACuretis GmbH, Holzgerlingen, GermanyOpGen Inc, Gaithersburg, MD USA;

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正文语种英语
中图分类医学微生物学（病原细菌学、病原微生物学）;
关键词
BAL; molecular diagnostics; multiplex PCR; pneumonia;

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Multicenter Evaluation of the Unyvero Platform for Testing Bronchoalveolar Lavage Fluid

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