Laboratory identification of a specific infectious etiology in patients with pneumonia has been associated with a statistically significant reduction in mortality, presumably because it enables targeted effective therapy ( 6). An emphasis of the current American Thoracic Society (ATS) and Infectious Disease Society of America (IDSA) guidelines for management of patients with HAP or VAP is to reduce exposure to broad-spectrum and unnecessary antibiotics by targeting therapy to treat the most likely pathogens based on patient risk factors and laboratory results ( 3). As a result, it is estimated that up to 50% of antibiotics used in hospital intensive care units (ICUs) are prescribed to treat these infections ( 3, 8). Based on these findings, broad-spectrum empirical antibiotic therapy consisting of 2 or 3 agents is recommended for patients with symptoms consistent with HAP or VAP until definitive laboratory results are available to inform targeted and specific therapy ( 3, 7). Selected studies have identified a significant decrease in mortality for patients who receive prompt and effective antibiotic therapy to treat pneumonia ( 3, 4, 6). This includes carbapenemase-producing organisms, which have been independently associated with higher mortality rates following infection ( 5). Bacterial pathogens associated with HAP and VAP, including Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, and other members of the Enterobacteriaceae, are often multidrug resistant ( 2). These infections can be caused by bacterial, viral, or fungal agents, depending on patient exposure and clinical risk factors. Lower respiratory tract infections, including community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP), are linked to significant morbidity and mortality ( 1, – 4). A review of patient medical records, including clinically prescribed antibiotics, revealed the potential for antibiotic adjustment in 70.7% of patients based on the PN panel result, including discontinuation or de-escalation in 48.2% of patients, resulting in an average savings of 6.2 antibiotic days/patient. Viral targets were identified by the PN panel in 17.7% of specimens tested, of which 39.1% were detected in conjunction with a bacterial target. Semiquantitative values reported by the PN panel were frequently higher than values reported by culture, resulting in semiquantitative agreement (within the same log 10 value) of 43.6% between the PN panel and culture however, all bacterial targets reported as >10 5 CFU/ml in culture were reported as ≥10 5 genomic copies/ml by the PN panel. The PN panel demonstrated a combined 96.2% positive percent agreement (PPA) and 98.1% negative percent agreement (NPA) for the qualitative identification of 15 bacterial targets compared to routine bacterial culture. We examined the impact of the multiplexed, semiquantitative BioFire FilmArray Pneumonia panel (PN panel) test on laboratory reporting for 259 adult inpatients submitting bronchoalveolar lavage (BAL) specimens for laboratory analysis. The potential severity of these infections combined with a failure to clearly identify the causative pathogen results in administration of empirical antibiotic agents based on clinical presentation and other risk factors. Standard methods frequently fail to identify the infectious etiology due to the polymicrobial nature of respiratory specimens and the necessity of ordering specific tests to identify viral agents. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.Lower respiratory tract infections, including hospital-acquired and ventilator-associated pneumonia, are common in hospitalized patient populations. *This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
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