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. The CDC did not immediately respond to a request for comment on the new test.Lower respiratory tract infections, including hospital-acquired and ventilator-associated pneumonia, are common in hospitalized patient populations. Problems quickly arose with the test, however, when some labs reported problems with the reagents and could not implement the test. Also, an RT-PCR-based respiratory panel from Qiagen that includes SARS-CoV-2 and 20 other viral and bacterial pathogens, including influenza A and B types, obtained FDA EUA in March.Īn assay from CDC was the first test to be granted EUA from the FDA for SARS-CoV-2. For example, a PCR-based respiratory panel from BioMérieux's BioFire Diagnostics business that can detect the coronavirus and 20 other viral and bacterial respiratory pathogens, including various influenza A subtypes, received FDA EUA in early May. In preparation for such a scenario, the CDC is seeking EUA from the FDA for a new assay that can simultaneously detect SARS-CoV-2 and influenza, as "determining if influenza or SARS-CoV-2 is causing the infection is also important to clinical treatment, infection control, and community mitigation efforts," Redfield said.Īs of Thursday afternoon, there were almost 1.9 million cases of COVID-19 confirmed in the US and nearly 109,000 deaths from the disease.Ī couple of diagnostic panels that test for COVID-19 and influenza already exist in the US. Many predict that a second wave of coronavirus cases could hit in the fall during the start of the flu season. In prepared remarks for a hearing before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Redfield said that it is unclear how long the COVID-19 pandemic will last but that "COVID-19 activity will continue for some time." Similarly, the impact the pandemic will have on the upcoming flu season is unclear, but "if there is substantial COVID-19 and seasonal influenza activity at the same time, this could place a tremendous burden on the healthcare system and result in many illnesses, hospitalizations, and deaths." NEW YORK – The US Centers for Disease Control and Prevention has designed a new assay that can simultaneously detect the SARS-CoV-2 coronavirus and the influenza virus, and is seeking Emergency Use Authorization for it from the US Food and Drug Administration, CDC Director Robert Redfield told a congressional subcommittee on Thursday. Advances in Clinical Genomics Profiling.
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