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1

Toxopeus, Corike, Brian Jones, Jessica Brown, Mark Gurling, Cynthia Andjelic, and Cynthia L. Phillips. "422. Performance Evaluation of a Rapid and Easy-to-Use COVID-19 Test." Open Forum Infectious Diseases 7, Supplement_1 (2020): S278. http://dx.doi.org/10.1093/ofid/ofaa439.616.

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Abstract Background The BioFire® COVID-19 Test is a qualitative test for use on the FilmArray® 2.0 and Torch systems for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs (NPS) in transport media. This test received Emergency Use Authorization from the FDA. A closed, disposable pouch contains all the necessary reagents for sample preparation, nucleic acid extraction, reverse transcription, polymerase chain reaction (PCR), and amplified nucleic acid detection to identify RNA from SARS-CoV-2 virus in an NPS specimen. Internal controls monitor all stages of the test process. Once an NPS sam
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Helm, Jared R., Brian Jones, Corike Toxopeus, et al. "1221. Evaluation of the FilmArray® Global Fever Panel." Open Forum Infectious Diseases 7, Supplement_1 (2020): S631—S632. http://dx.doi.org/10.1093/ofid/ofaa439.1406.

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Abstract Background Acute Febrile Illness (AFI) is caused by a diverse set of pathogens. The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex nested PCR system to evaluate whole blood samples for multiple pathogens simultaneously in under an hour. Methods BioFire Defense conducted analytical performance studies to show sensitivity (LoD), inclusivity, and specificity (exclusivity), and a prospective clinical study to evaluate the positive percent agreement (PPA) and negative percent agree
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Green, Jeremy, Caitlin Carter, Craig Chandler, Angela Clark, and Stephanie Thatcher. "1015. Enhanced Detection of Bloodstream Pathogens From Positive Blood Culture Specimens With an Improved Multiplex PCR Molecular Diagnostic System." Open Forum Infectious Diseases 5, suppl_1 (2018): S302. http://dx.doi.org/10.1093/ofid/ofy210.852.

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Abstract Background Timely bloodstream infection (BSI) pathogen identification requires robust sample purification and testing methods that can accommodate the wide variety of blood culture media used for growing positive blood culture (PBC) specimens. Sensitive molecular methods are needed for identification of all organisms present in PBD, especially polymicrobial cultures which can be difficult to identify with standard methods. Multiple types of BD and BioMérieux blood culture media commonly used in hospital laboratories were used to evaluate the performance of a prototype BioFire® FilmArr
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Oberhettinger, Philipp, Jan Zieger, Ingo Autenrieth, Matthias Marschal, and Silke Peter. "Evaluation of two rapid molecular test systems to establish an algorithm for fast identification of bacterial pathogens from positive blood cultures." European Journal of Clinical Microbiology & Infectious Diseases 39, no. 6 (2020): 1147–57. http://dx.doi.org/10.1007/s10096-020-03828-5.

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Abstract Fast identification of pathogens directly from positive blood cultures is of highest importance to supply an adequate therapy of bloodstream infections (BSI). There are several platforms providing molecular-based identification, detection of antimicrobial resistance genes, or even a full antimicrobial susceptibility testing (AST). Two of such test systems allowing rapid diagnostics were assessed in this study: The Biofire FilmArray® and the Genmark ePlex®, both fully automated test system with a minimum of hands-on time. Overall 137 BSI episodes were included in our study and compared
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Liesman, Rachael M., Angela P. Strasburg, Angela K. Heitman, Elitza S. Theel, Robin Patel, and Matthew J. Binnicker. "Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis." Journal of Clinical Microbiology 56, no. 4 (2018): e01927-17. http://dx.doi.org/10.1128/jcm.01927-17.

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ABSTRACT Rapid and accurate laboratory tests are important for the timely diagnosis and treatment of central nervous system infections. The FilmArray meningitis/encephalitis (ME) panel (BioFire Diagnostics, Salt Lake City, UT) is an FDA-cleared, multiplex molecular panel that allows the detection of 14 pathogens (bacterial [n = 6], viral [n = 7], and fungal [n = 1] pathogens) from cerebrospinal fluid (CSF). In this study, we evaluated the performance characteristics of the FilmArray ME panel using clinical, residual CSF samples (n = 291) that tested positive by a routine method(s) (e.g., bacte
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Ruzante, Juliana M., Katherine Olin, Breda Munoz, Jeff Nawrocki, Rangaraj Selvarangan, and Lindsay Meyers. "Real-time gastrointestinal infection surveillance through a cloud-based network of clinical laboratories." PLOS ONE 16, no. 4 (2021): e0250767. http://dx.doi.org/10.1371/journal.pone.0250767.

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Acute gastrointestinal infection (AGI) represents a significant public health concern. To control and treat AGI, it is critical to quickly and accurately identify its causes. The use of novel multiplex molecular assays for pathogen detection and identification provides a unique opportunity to improve pathogen detection, and better understand risk factors and burden associated with AGI in the community. In this study, de-identified results from BioFire® FilmArray® Gastrointestinal (GI) Panel were obtained from January 01, 2016 to October 31, 2018 through BioFire® Syndromic Trends (Trend), a clo
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Nguyen, Kiet, Lacie McKamey, and Sarah Green. "196. Impact of BioFire FilmArray® Blood Culture Identification on the Management of Staphylococcus aureus Bacteremia." Open Forum Infectious Diseases 6, Supplement_2 (2019): S117. http://dx.doi.org/10.1093/ofid/ofz360.271.

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Abstract Background Staphylococcus aureus bacteremia (SAB) is associated with 30-day mortality rates that are as high as 20 to 40%. In order to reduce mortality and treatment failures, SAB management should include prompt infectious diseases (ID) consult, repeat blood cultures, source control, intravenous antibiotics for the entirety of treatment, and optimal treatment duration. The objective of this study was to determine the impact of BioFire FilmArray® Blood Culture Identification (BCID) on the implementation of these standard of care measures in the management of SAB across a large health
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Maves, Ryan, Derek Larson, Michael Dempsey, et al. "Feasibility and Validation of Viral Respiratory Disease Surveillance in a Combat Theater Using the Filmarray Respiratory Panel." Open Forum Infectious Diseases 4, suppl_1 (2017): S360. http://dx.doi.org/10.1093/ofid/ofx163.874.

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Abstract Background Viral respiratory infections are a significant threat to deployed military units. Pathogen-based surveillance may be hampered by limitations in trained personnel in theater, difficulty with specimen shipment, and technical issues with equipment maintenance. In this project, we evaluated the performance of the FilmArray respiratory panel at military clinics in Afghanistan and compare results to testing performed in the United States. Methods Participants were recruited after presenting at military clinics at Bagram Airfield (BAF), Afghanistan, in 2013–2014 with fever (≥38° C
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Chen, Lynette, Matthew Pettengill, Bryan Hess, and Joseph DeSimone. "866. Increased Diagnosis of Varicella-Zoster Virus Infection of the Central Nervous System With the BioFire FilmArray Meningitis/Encephalitis Panel." Open Forum Infectious Diseases 5, suppl_1 (2018): S22—S23. http://dx.doi.org/10.1093/ofid/ofy209.051.

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Abstract Background Varicella-zoster virus (VZV) infection of the central nervous system (CNS) is relatively uncommon. Diagnostic tests historically utilized culture, serologies, and targeted PCR methods. In April 2016, our institution began using the BioFire FilmArray meningitis/encephalitis (BFME) panel for cerebrospinal fluid (CSF) specimen analysis. We hypothesized that the diagnosis of VZV CNS infection increased at our institution with the implementation of this diagnostic panel. Methods We conducted chart reviews of patients from 2 time periods. In the first period, April 2013–March 201
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Salimnia, Hossein, Marilynn R. Fairfax, Paul R. Lephart, et al. "Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial." Journal of Clinical Microbiology 54, no. 3 (2016): 687–98. http://dx.doi.org/10.1128/jcm.01679-15.

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Sepsis is a major cause of morbidity, mortality, and increased medical expense. Rapid diagnosis improves outcomes and reduces costs. The FilmArray blood culture identification panel (BioFire Diagnostics LLC, Salt Lake City, UT), a highly multiplexed PCR assay, can identify 24 etiologic agents of sepsis (8 Gram-positive, 11 Gram-negative, and 5 yeast species) and three antimicrobial resistance genes (mecA,vanA/B, andblaKPC) from positive blood culture bottles. It provides results in about 1 h with 2 min for assay setup. We present the results of an eight-center trial comparing the sensitivity a
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Kirera, Ronald, Erick Kipkirui, Margaret Koech, et al. "Identification of selected primary bloodstream infection pathogens in patients attending Kisii level five and Homa Bay county hospitals." F1000Research 9 (October 12, 2020): 1228. http://dx.doi.org/10.12688/f1000research.26300.1.

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Background: Bloodstream infection (BSI) contributes to a substantial proportion of mortality in sub-Saharan Africa and is marked by the presence of bacterial and/or fungal microorganisms in the blood. Because BSI can be life threatening, it requires a timely, reliable and accurate diagnosis. This study retrospectively analyzed data of identified BSI pathogens and compared the performance of the different diagnostic technologies used in terms of accuracy, sensitivity, turnaround time (TAT) and cost. Methods: Currently, culture followed by analytical profile index biochemical strips (API), (BioM
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12

O’Neal, Melissa, Hanna Murray, Sangita Dash, Majdi N. Al-Hasan, Julie Ann Justo, and P. Brandon Bookstaver. "Evaluating appropriateness and diagnostic stewardship opportunities of multiplex polymerase chain reaction gastrointestinal testing within a hospital system." Therapeutic Advances in Infectious Disease 7 (January 2020): 204993612095956. http://dx.doi.org/10.1177/2049936120959561.

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Objective: This single-center, retrospective, observational cohort study evaluates the appropriateness of the BioFire® FilmArray® Gastrointestinal (GI) multiplex PCR panel testing at a community-teaching hospital. Methods: All adult, hospitalized patients at Prisma Health Richland Hospital with a documented GI multiplex PCR panel from 1 April 2015 through 28 February 2018 were included in the analysis. Inappropriate use of the GI panel was defined as a test obtained without documented diarrhea, greater than 2 days of hospitalization, redundant use with other diagnostic tests (e.g. Clostridioid
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Moffa, Matthew A., Derek N. Bremmer, Dustin Carr, et al. "Impact of a Multiplex Polymerase Chain Reaction Assay on the Clinical Management of Adults Undergoing a Lumbar Puncture for Suspected Community-Onset Central Nervous System Infections." Antibiotics 9, no. 6 (2020): 282. http://dx.doi.org/10.3390/antibiotics9060282.

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Patients admitted from the community with a suspected central nervous system (CNS) infection require prompt diagnostic evaluation and correct antimicrobial treatment. A retrospective, multicenter, pre/post intervention study was performed to evaluate the impact that the BioFire® FilmArray® meningitis/encephalitis (ME) panel run in-house had on the clinical management of adult patients admitted from the community with a lumbar puncture (LP) performed for a suspected CNS infection. The primary outcome was the effect that this intervention had on herpes simplex virus (HSV) polymerase chain reacti
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Posnakoglou, Lamprini, Vasiliki Syriopoulou, Tania Siahanidou, Eleni Atmatzidou, Triantafyllos Syriopoulos, and Athanasios Michos. "1399. A Prospective Cohort Study Regarding the Impact of Biofire® FilmArray® Meningitis/Encephalitis (FA) Panel in Children with Suspected Central Nervous System Infection." Open Forum Infectious Diseases 6, Supplement_2 (2019): S509. http://dx.doi.org/10.1093/ofid/ofz360.1263.

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Abstract Background Rapid detection of pathogens involved in central nervous system (CNS) infections could be important for the optimal patient management and overall hospitalization cost. The aim of the study was to evaluate the possible benefits with the use of BioFire® FilmArray® meningitis/encephalitis (FA) panel in children with suspected CNS infection. Methods A prospective cohort study, was performed on children admitted to a tertiary pediatric hospital, over a period of 1 year (April 2018–April 2019), with possible CNS infection and cerebrospinal fluid (CSF) pleocytosis (>15 cells/m
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Lu, Yang, Joseph Hatch, Kristen Holmberg, et al. "651. Multi-Center Evaluation of the BioFire® FilmArray® Blood Culture Identification 2 Panel for the Detection of Microorganisms and Resistance Markers in Positive Blood Cultures." Open Forum Infectious Diseases 6, Supplement_2 (2019): S299—S300. http://dx.doi.org/10.1093/ofid/ofz360.719.

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Abstract Background The BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel is a diagnostic test that provides results for 26 bacterial, 7 fungal pathogens and 10 antimicrobial resistance (AMR) genes from positive blood culture (PBC) specimens in about an hour. The BCID2 Panel builds upon the existing BCID Panel with several additional assays that include Candida auris and an expanded AMR gene menu that provides methicillin-resistant Staphylococcus aureus (MRSA) results plus detection for mcr-1, carbapenem resistance, and ESBL. Here, we summarize studies conducted to establish cli
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Sieling, William, Matthew Oberhardt, Philip Zachariah, et al. "2220. Comparative Incidence and Burden of Respiratory Viruses Associated with Hospitalization in Adults." Open Forum Infectious Diseases 6, Supplement_2 (2019): S757—S758. http://dx.doi.org/10.1093/ofid/ofz360.1898.

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Abstract Background The population-based incidence and burden of community-onset non-influenza respiratory viruses associated with hospitalization in adults has not been systematically assessed. Methods On admission, patients with respiratory symptoms are tested for respiratory viruses by multiplex polymerase chain reaction (BioFire FilmArray Respiratory Panel) as per standard of care at our university teaching hospital (1160 beds). A retrospective study was performed to identify adults who had influenza, parainfluenza virus (PIV), respiratory syncytial virus (RSV), human metapneumovirus (hMPV
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Dave, Gipshu, Phoebe Katzenbach, Johanna Sandlund, et al. "645. Singulex Clarity Norovirus Assay (In Development) Provides Ultrasensitive Detection of Norovirus Genogroups I and II." Open Forum Infectious Diseases 6, Supplement_2 (2019): S297—S298. http://dx.doi.org/10.1093/ofid/ofz360.713.

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Abstract Background Commercially available enzyme immunoassays (EIAs) for detection of norovirus antigen have poor sensitivity and are limited to use in investigations of a gastroenteritis outbreak. Hence, there remains a need for a standalone high-sensitivity assay that enables rapid and accurate detection of norovirus antigen. Methods The Singulex Clarity norovirus assay is currently in development for use on the Singulex Clarity® system (Singulex Inc., Alameda, CA, USA), a fully-automated platform powered by Single Molecule Counting technology (registered with the FDA and CE marked). The as
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Claeys, Kimberly C., Kathryn Schlaffer, Zegbeh Kpadeh-Rogers, et al. "151. Comparing the Clinical Utility of Rapid Diagnostic Tests for Gram-Negative Bloodstream Infection Using a Desirability of Outcomes Ranking." Open Forum Infectious Diseases 6, Supplement_2 (2019): S102. http://dx.doi.org/10.1093/ofid/ofz360.226.

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Abstract Background Rapid diagnostic testing (RDT) technology in bloodstream infections (BSI) has outpaced provider understanding of how to effectively use it. To optimize the use of RDT platforms and antibiotic therapy, decision makers must determine which RDTs to implement at their institutions. A thorough understanding of which platform to choose extends beyond simple analytic measures of sensitivities and specificities and should include a robust analysis of how these RDTs could impact clinical decisions. Methods Retrospective study of adult patients with Gram-negative (GN) BSI from at Uni
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Abu Sitta, Emad, Nicole Hubbard, and Geehan Suleyman. "643. Comparison of Multiplex Polymerase Chain Reaction (PCR) and Routine Culture for the Detection of Respiratory Pathogens in Pneumonia Patients." Open Forum Infectious Diseases 6, Supplement_2 (2019): S297. http://dx.doi.org/10.1093/ofid/ofz360.711.

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Abstract Background The identification of causative pathogens in pneumonia can be challenging, and conventional culture methods can take up to 72 hours. However, rapid microbiologic tests identify organisms within hours. The Biofire®Filmarray ((bioMérieux, North Carolina) Pneumonia Panel was recently approved by the FDA. The multiplex PCR system identifies 33 targets from sputum and bronchoalveolar (BAL) samples, which include 18 bacteria, 8 viruses, and 7 antibiotic resistance genes. The purpose is to compare the panel to routine culture methods for the detection of respiratory pathogens in p
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Chiasson, Jordan, James B. Cutrell, James B. Cutrell, Jodlowski Tomasz, Winter Smith, and Marcus Kouma. "2001. Assessment of Real-world Effectiveness of a Rapid Blood Culture Diagnostic Panel at a Veterans Affairs Medical Center." Open Forum Infectious Diseases 6, Supplement_2 (2019): S671. http://dx.doi.org/10.1093/ofid/ofz360.1681.

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Abstract Background Rapid blood culture diagnostics can improve patient outcomes, particularly when paired with robust interventions such as 24/7 stewardship coverage. We sought to determine the clinical impact of a rapid blood culture identification (BCID) panel (BioFire® FilmArray Multiplex PCR) in an established antimicrobial stewardship program (ASP). In addition to clinician education, BCID results were reviewed by the ASP team during weekday business hours, for an average of 2 hours daily based on availability. Methods Data on demographics, blood cultures, antimicrobial use, length of st
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Montgomery, Jesse, Neil Draper, Andrew Hemmert, and Robert Crisp. "Rapid Detection and Genotyping of Antimicrobial Resistance Determinants with the BioFire FilmArray® System." Open Forum Infectious Diseases 3, suppl_1 (2016). http://dx.doi.org/10.1093/ofid/ofw172.1547.

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Fhooblall, Mokshanand, Fikile Nkwanyana, and Koleka P. Mlisana. "Evaluation of the BioFire® FilmArray® Blood Culture Identification Panel on positive blood cultures in a regional hospital laboratory in KwaZulu-Natal." African Journal of Laboratory Medicine 5, no. 1 (2016). http://dx.doi.org/10.4102/ajlm.v5i1.411.

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Background: There are presently many non-culture-based methods commercially available to identify organisms and antimicrobial susceptibility from blood culture bottles. Each platform has its benefits and limitations. However, there is a need for an improved system with minimal hands-on requirements and short run times.Objectives: In this study, the performance characteristics of the FilmArray® BCID Panel kit were evaluated to assess the efficiency of the kit against an existing system used for identification and antimicrobial susceptibility of organisms from blood cultures.Methods: Positive bl
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Holma, Tanja, Jukka Torvikoski, Nathalie Friberg, et al. "Rapid molecular detection of pathogenic microorganisms and antimicrobial resistance markers in blood cultures: evaluation and utility of the next-generation FilmArray Blood Culture Identification 2 panel." European Journal of Clinical Microbiology & Infectious Diseases, August 5, 2021. http://dx.doi.org/10.1007/s10096-021-04314-2.

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AbstractRapid detection of pathogens causing bloodstream infections (BSI) directly from positive blood cultures is of highest importance in order to enable an adequate and timely antimicrobial therapy. In this study, the utility and performance of a recently launched next-generation fully automated test system, the Biofire FilmArray® Blood Culture Identification 2 (BCID2) panel, was evaluated using a set of 103 well-characterized microbial isolates including 29 antimicrobial resistance genes and 80 signal-positive and 23 signal-negative clinical blood culture samples. The results were compared
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DiDiodato, Giulio, and Nellie Bradbury. "Cerebrospinal Fluid Analysis With the BioFire FilmArray Meningitis/Encephalitis Molecular Panel Reduces Length of Hospital Stay in Patients With Suspected Central Nervous System Infections." Open Forum Infectious Diseases 6, no. 4 (2019). http://dx.doi.org/10.1093/ofid/ofz119.

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Waldrop, Greer, Jason Zucker, Alexandra Boubour, Sara Radmard, Daniel A. Green, and Kiran T. Thakur. "Clinical Significance of Positive Results of the BioFire Cerebrospinal Fluid FilmArray Meningitis/Encephalitis Panel at a Tertiary Medical Center in the United States." Archives of Pathology & Laboratory Medicine, June 4, 2021. http://dx.doi.org/10.5858/arpa.2020-0380-oa.

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Context.— The FilmArray Meningitis/Encephalitis (ME) panel is the first US Food and Drug Administration–cleared multiplex polymerase chain reaction panel for the detection of central nervous system infections. While the assay's performance characteristics have been described, the real-world significance of positive results has not been fully characterized. Objective.— To evaluate the clinical significance of positive ME panel results in a tertiary care medical center in New York, New York. Design.— Four physicians independently performed retrospective clinical assessments of all positive ME pa
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Dien Bard, Jennifer, and Kevin Alby. "Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory." Journal of Clinical Microbiology 56, no. 4 (2018). http://dx.doi.org/10.1128/jcm.00018-18.

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INTRODUCTION Syndromic panels were first FDA cleared for detection of respiratory pathogens in 2008. Since then, other panels have been approved by the FDA, and most recently, the FilmArray meningitis/encephalitis panel (BioFire, Salt Lake City, UT) has become available. This assay detects 14 targets within 1 h and includes pathogens that typically cause different manifestations of infection, although they infect the same organ system. Several studies have reported both false-positive and false-negative results with this test, and all agree that the cost is significant. As with other panels, h
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Aldriweesh, Mohammed A., Edi A. Shafaay, Saud M. Alwatban, et al. "Viruses Causing Aseptic Meningitis: A Tertiary Medical Center Experience With a Multiplex PCR Assay." Frontiers in Neurology 11 (December 7, 2020). http://dx.doi.org/10.3389/fneur.2020.602267.

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Background: Central nervous system (CNS) infection is associated with high rates of morbidity and mortality, and despite advancements in molecular testing, aseptic meningitis remains challenging to diagnose. Aseptic meningitis cases are often underreported worldwide, which impacts the quality of patient care. Therefore, we aimed to assess the results of BioFire® FilmArray® meningitis/encephalitis (ME) PCR panel, clinical characteristics, and etiologies of aseptic meningitis patients.Methods: From January 2018 to January 2020, all pediatric and adult patients in a large tertiary medical center
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Keske, Şiran, Burak Zabun, Kahraman Aksoy, Füsun Can, Erhan Palaoğlu, and Önder Ergönül. "Rapid Molecular Detection of Gastrointestinal Pathogens and Its Role in Antimicrobial Stewardship." Journal of Clinical Microbiology 56, no. 5 (2018). http://dx.doi.org/10.1128/jcm.00148-18.

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ABSTRACT We aimed to detect the etiological agents of acute diarrhea by a molecular gastrointestinal pathogen test (MGPT) and to assess the impact of MGPT on antimicrobial stewardship programs (ASP). This is a prospective observational study and was conducted between 1 January 2015 and 30 June 2017. We included consequent patients who had acute diarrhea. At the end of 2015, we implemented ASP in acute diarrhea cases and compared the outcomes in the pre-ASP and post-ASP periods. An FDA-cleared multiplexed gastrointestinal PCR panel system, the BioFire FilmArray (Idaho Technology, Salt Lake City
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