![]() ![]() 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. BioFire COVID-19 Test v1.Lower respiratory tract infections, including hospital-acquired and ventilator-associated pneumonia, are common in hospitalized patient populations.BioFire COVID-19 Test Pouch Module Installation InstructionsīioFire COVID-19 Test v1.1 ERM Software Download Form (Released September 2022).IFU Updated: May 2022 Quick Guide Updated: June 2021ĭownload the BioFire COVID-19 Test v1.1 Information SheetīioFire COVID-19 Software Pouch Module for v1.1 (Updated May 2022) Quick Guide BIOFIRE SHIELD Control Kit for the BioFire COVID-19 Test v1.1 (PDF, 3 MB).BIOFIRE SHIELD Control Kit Instructions for use for the BioFire COVID-19 Test v1.1 (PDF, 1 MB).Instructions for Use and Quick Guides are found in the table aboveīIOFIRE ® SHIELD ™ Control Kit for the BioFire COVID-19 Test v1.1 (6 control vials) Quick Guide for BioFire COVID-19 Test v1.1 for Lower Respiratory Testing.Quick Guide for BioFire COVID-19 Test v1.1 for Upper Respiratory or Saliva Testing.BioFire COVID-19 Test v1.1 Instructions for Use (IFU).Healthcare Provider Fact Sheet (PDF, 327 KB)ĭeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19).The EUA (Emergency Use Authorization) for the BioFire COVID-19 Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for SARS-CoV-2 in-house, providing results in approximately one hour. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 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. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens and 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
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