Commercially available FDA-cleared multiplex nucleic acid-based tests for infectious agents include systems from Luminex, GenMark, and BioFire (now a subsidiary of bioMérieux) (Table 1). At present, all such systems combine the sequential steps of:
Nucleic acid purification from the appropriate human sample matrix (e.g., nasal swab, blood or blood culture, stool)
cDNA synthesis (reverse transcription) to convert viral RNA to DNA, if necessary
Multiplex PCR to amplify molecules of the pathogen nucleic acid
Specific detection of the expected amplicons to confirm that the correct target nucleic acids have been identified
（Multiplex PCR for Detection and Identification of Microbial Pathogens 10 November 2018 Advanced Techniques in Diagnostic Microbiology pp 475-493）
Multiplex PCR system for the rapid diagnosis of respiratory virus infection: systematic review and meta-analysis. Clinical Microbiology and Infection Volume 24, Issue 10, October 2018, Pages 1055-1063 diagnostic accuracies of three multiplex PCR systems (mPCRs)—BioFire FilmArray RP (FilmArray), Nanosphere Verigene RV+ test (Verigene RV+) and Hologic Gen-Probe Prodesse assays—on the detection of viral respiratory infections.
Multiplex PCR for Detection and Identification of Microbial Pathogens 10 November 2018 Advanced Techniques in Diagnostic Microbiology pp 475-493
The FILMARRAY is an FDA-cleared multiplex PCR system that integrates sample preparation, amplification, detection and analysis. It requires just a few minutes of hands-on-time and its turnaround time is just about an hour, giving you faster results which may lead to better patient care. (biomerieux-usa.com)
The Clinical Impact of the BioFire® FilmArray® System 2020/01/17 BioFire Diagnostics
Stop waiting. Start living. The BioFire® FilmArray® System. 2013/10/30 BioFire Diagnostics
BioFire® FilmArray® System Demo 2013/04/06 BioFire Diagnostics
診療科に合わせて検出したい病原体のパネルが用意されているようです。
バイオファイアのフィルムアレイ特許
SALT LAKE CITY, Utah,(March13, 2013) –BioFire Diagnostics,Inc.,today announced that the United States Patent and Trademark Office has issued U.S.Patent No. 8,394,608 covering the company’s FilmArray system. FilmArray’s proprietary technology represents a significant advancement in user-friendliness and multiplex infectious disease testing capability for hospital clinical labs. This is the first U.S. patent issued to cover the FilmArray system, and BioFire has exclusive rights to the patented technology. Specifically, the patent covers methods for sample preparation and two-step multiplex polymerase chain reaction (PCR) in a sealed container. (BioFire Diagnostics)
The FilmArray Blood Culture Identification (BCID) panel, which is able to identify 24 different microorganisms and the resistance genes Klebsiella pneumoniae carbapenemase (KPC), mecA and vanA/B, has the potential to facilitate point-of-care testing and provides results in 1 hour. (Application of BioFire FilmArray Blood Culture Identification panel for rapid identification of the causative agents of ventilator-associated pneumonia. Clinical Microbiology and Infection Volume 24, Issue 11, November 2018, Pages 1213.e1-1213.e4)
BioFire FilmArray Meningitis/Encephalitis panel
The BioFire FA ME addresses such diagnostic underutilization by providing a comprehensive panel testing for 15 CNS pathogens simultaneously using a minimal amount of CSF with rapid turn-around time (1 h). Shown to be an effective alternative for other infections such as gastroenteritis [3], and bacteremia [5–8] BioFire’s FA ME was approved by the Federal Drug Administration on October 8, 2015 with promising results both in the US [9] and internationally [10, 11]. (Enhancing pathogen identification in patients with meningitis and a negative Gram stain using the BioFire FilmArray® Meningitis/Encephalitis panel. Annals of Clinical Microbiology and Antimicrobials volume 15, Article number: 26 (2016))
BioFire FilmArray Pneumonia Panel
The BioFire FilmArray pneumonia panel (BFPP) was recently FDA cleared (November 2018) for detection and identification of multiple respiratory viral and bacterial pathogens in addition to selected antimicrobial resistance genes from sputum or bronchial alveolar lavage (BAL)-like specimens from individuals with suspected lower respiratory tract (LRT) infections. This assay includes targets for 18 bacteria and 8 viruses that commonly cause pneumonia as well as 7 antibiotic resistance genes. (Evaluation of the BioFire FilmArray Pneumonia Panel for Detection of Viral and Bacterial Pathogens in Lower Respiratory Tract Specimens in the Setting of a Tertiary Care Academic Medical Center. Journal of Clinical Microbiology)
The BioFire FilmArray Pneumonia Panel (FA-Pneumo; BioFire Diagnostics, Salt Lake City, UT, USA) was recently cleared by the US Food and Drug Administration (US FDA, Washington, DC, USA). FA-Pneumo is a fully automated multiplex PCR assay for identifying a number of typical and atypical bacterial pathogens, respiratory viruses, and several classes of antimicrobial susceptibility-associated genes directly from sputum, endotracheal aspirate (ETA), and bronchoalveolar lavage-like specimens in approximately 1 h (Table 1). The assay provides semi-quantitative results for 15 typical respiratory bacterial pathogens.
Table 1. FilmArray Pneumonia Panel plus targets.
Typical bacteria
Acinetobacter calcoaceticus–baumannii complex
Enterobacter cloacae complex
Escherichia coli
Haemophilus influenzae
Klebsiella aerogenes
Klebsiella oxytoca
Klebsiella pneumoniae group
Moraxella catarrhalis
Proteus spp
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes
Atypical bacteria
Chlamydia pneumoniae
Legionella pneumophila
Mycoplasma pneumoniae
Viruses
Adenovirus
Human metapneumovirus
Human rhinovirus/enterovirus
Influenza A
Influenza B
Parainfluenza virus
Respiratory syncytial virus
Antimicrobial resistance genes
Methicillin resistance
mecA/C and MREJ
Extended-spectrum β-lactamase
CTX-M
Carbapenemases
NDM, IMP, OXA-48-like, KPC, and VIM
(Evaluation of the BioFire FilmArray Pneumonia Panel for rapid detection of respiratory bacterial pathogens and antibiotic resistance genes in sputum and endotracheal aspirate specimens. International Journal of Infectious Diseases Volume 95, June 2020, Pages 326-331)
The BioFire® FilmArray® Gastrointestinal (GI) Panel The FDA-cleared BioFire GI Panel tests for 22 of the most common pathogens associated with gastroenteritis—all from one patient sample and one easy to use reagent, with results available in about one hour.
Impact of the BioFire FilmArray gastrointestinal panel on patient care and infection control. February 6, 2020 PLOS ONE Routine PCR detected one or more pathogens in 52 (28.6%) patients compared to 72 (39.6%) using the FilmArray. Turnaround time (including transport) decreased from median 53 hours for the routine PCR to 16 hours for the FilmArray.
Evaluation of the BioFire FilmArray Gastrointestinal Panel and Real-Time Polymerase Chain Reaction Assays for the Detection of Major Diarrheagenic Pathogens by a Multicenter Diarrheal Disease Surveillance Program in China Foodborne Pathogens and Disease Vol. 16, No. 11
Contribution of the FilmArray® Gastrointestinal Panel in the laboratory diagnosis of gastroenteritis in a cohort of children: a two-year prospective study International Journal of Medical Microbiology Volume 308, Issue 5, July 2018, Pages 514-521
FilmArray™ GI panel performance for the diagnosis of acute gastroenteritis or hemorragic diarrhea 12 May 2017 BMC Microbiology volume 17, Article number: 111 (2017)
Multicenter Evaluation of the BioFire FilmArray Gastrointestinal Panel for Etiologic Diagnosis of Infectious Gastroenteritis. 19 February 2015Journal of Clinical Microbiology Vol. 53, No. 3
