2002. Evaluation of the BioFire® Pneumonia Panel in ICU Patients With Suspected Ventilator-Associated Pneumonia

Abstract

BackgroundVentilator-associated pneumonia (VAP) is one of the most commonly encountered hospital-acquired infections worldwide, and one of the major contributors to an over mortality in critically ill patients. Initial empirical antimicrobial therapy is often broad-spectrum. Fast identification and quantification of microorganisms is of great importance to enable early effective targeted antimicrobial treatment. This trial compares the performance of the new BioFire® Pneumonia Panel (BPP) with quantitative conventional culture (CC) and an independent real-time quantitative molecular-based method (MM), in Intensive Care Unit (ICU) patients with VAP suspicion.MethodsBronchoalveolar lavage (BAL) specimens from 120 patients with suspected VAP, enrolled at four different French ICUs, during January to November 2013, were analysed by CC, following microbiological standard procedures, by BPP and MM. A total of 15 bacterial targets, commonly detected by the three methods, were analysed for concordance above an agreed threshold for positivity. While every step is fully integrated, from specimen-to-results (BPP), bacterial DNA was extracted from each sample on the NucliSENS easyMAG® Platform, and real-time polymerase chain reactions were run in an ABI 7500 Dx thermocycler (MM).ResultsA total of 117 different BAL specimens were processed. Positive culture was obtained for 65.8% of BAL, while positive detections were observed in 79.4% with BPP and 75.4% with independent MM. Fourteen different species were detected by the three methods, with majority of the bacteria being S. aureus, P. aeruginosa, and H. influenzae. Overall concordance performance between BPP and CC was 89.0% (83.1%–94.9%) positive percentage agreement (PPA) and 95.9% (95.0%–96.9%) negative percentage agreement (NPA). Overall concordance between BPP and MM was 97.1% (93.8%–100.3%) PPA and 96.6% (95.6%–97.6%) NPA. Following discrepancy analyses overall performance increased to 95.3% (91.2–99.3%) PPA when comparing BPP to CC.ConclusionThe new BioFire® Pneumonia Panel provides reliable quantitative microbiological data in BAL specimens, in only 65 minutes, which can lead to more appropriate management of VAP suspected patients in the ICU.RUO products used in this study have not been evaluated by the FDA or other regulatory agencies for In Vitro Diagnostic use.Disclosures A. Iannello, bioMérieux: Employee, Salary. C. Dubost, bioMérieux: Employee, Salary. C. Weber, bioMérieux: Employee, Salary. C. Alberti-Segui, bioMérieux: Employee, Salary. C. Mousset, bioMérieux: Employee, Salary. C. Ginocchio, bioMérieux: Employee, Salary. M. Rogatcheva, BioFire: Employee, Salary. V. Moucadel, bioMérieux: Employee, Salary. J. Yugueros-Marcos, bioMérieux: Employee, Salary.

Impact of Nested Multiplex Polymerase Chain Reaction Assay in the management of pediatric patients with acute respiratory tract infections: a single center experience

“…The overall percent agreement between the Fil-mArray panels and conventional bacterial culture in our study was 100%, with 100% PPA and 29.9% NPA. This was concordant with Iannello et al who reported 89.0% PPA and 95.9% NPA with bacterial culture [24]. Edin and his team demonstrated 100% PPA and 73.2% NPA [25].…”

Multicenter Evaluation of the BioFire FilmArray Pneumonia/Pneumonia Plus Panel for Detection and Quantification of Agents of Lower Respiratory Tract Infection

“…The PN panel expands on these existing technologies to provide an easy-to-use, rapid sample-to-answer platform that can detect viral entities and atypical bacteria known to cause pneumonia, in addition to providing a semiquantitative result for 15 commonly encountered bacterial analytes. An earlier study using an RUO version of the PN panel on BAL from patients suspected of having ventilator-associated pneumonia concluded that the panel would provide data that could guide appropriate management in this patient population (36).…”

Multinational evaluation of the BioFire® FilmArray® Pneumonia plus Panel as compared to standard of care testing

“…Edin demonstrated for on-panel pathogens a PPA of 100% and an NPA of 73.2% [ 25 ], and Gastli demonstrated a PPA of 94.4% and an NPA of 96.0% as compared to culture [ 26 ]. Similarly, a VAP study using a research use only version of BioFire PN plus Panel demonstrated for bacteria an 89.0% PPA and 95.9% NPA with SOC [ 27 ]. BioFire PN plus Panel reflects high performance compared to SOC, yielding additional clinically actionable results that may be missed by SOC.…”