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BIOFIRE® Respiratory 2.1 plus (RP2.1plus) Panel
The new BIOFIRE® Respiratory 2.1 plus Panel enables rapid and accurate automated detection of pathogens behind respiratory infections. It tests for 19 viruses including SARS-CoV-2, and 4 bacteria that cause respiratory tract infections in 45 min.
- Simple: 2 minutes of hands-on time
- Fast: Turnaround time of 45 minutes for RP2.1 plus
- Comprehensive: 23 targets including viruses and bacteria
- Accurate: Overall 97.1% sensitivity and 99.3% specificity (prospective specimens) *1 SARS-CoV-2 98.4% PPA and 98.9% NPA*2
1: Based on the prospective portion of the clinical study for the BIOFIRE® FILMARRAY® Respiratory 2 Panel
2: Overall performance based on prospective SARS-COV-2 clinical study for the BIOFIRE® Respiratory 2.1 Panel in comparison to 3 EUA tests, Data on file, BIOFIRE Diagnostics.
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Simple, comprehensive respiratory testing
1 Test. 23 Targets. ~45 Minutes.
The BIOFIRE RP2.1 plus Panel uses a syndromic approach to accurately detect and identify the pathogens most commonly associated with respiratory infections. Fast and comprehensive, the BioFire RP2.1 Panel offers a run time of about 45 minutes, enabling high efficiency and throughput on the BIOFIRE® FILMARRAY® 2.0 and the BIOFIRE® FILMARRAY® Torch Systems. Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. Quick turnaround on a broad menu of pathogens may also help clinicians make vital decisions regarding admission, isolation, cohorting, and additional diagnostic testing.
- Simple: 2 minutes of hands-on time
- Easy: No precise measuring or pipetting required
- Fast: Turnaround time of about 45 minutes
- Comprehensive: 23 target respiratory panel
BIOFIRE® Respiratory 2.1 plus Panel is one of six FDA-cleared and/or CE-marked panels for use on the BIOFIRE® FILMARRAY® multiplex PCR system. Taken together, the six BIOFIRE® panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:
- BIOFIRE® FILMARRAY® ME panel
- BIOFIRE® FILMARRAY® BCID2 panel
- BIOFIRE® FILMARRAY® GI panel
- BIOFIRE® FILMARRAY® Pneumonia plus Panel
- BIOFIRE® Joint Infection (JI) Panel
The BIOFIRE RP 2.1 plus Panel Menu
| Viruses | Bacteria | |
|
Adenovirus Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Middle East respiratory syndrome coronavirus (MERS-CoV) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Human metapneumovirus Human rhinovirus/enterovirus Influenza A virus Influenza A virus A/H1 Influenza A virus A/H3 Influenza A virus A/H1-2009 Influenza B virus Parainfluenza virus 1 Parainfluenza virus 2 Parainfluenza virus 3 Parainfluenza virus 4 Respiratory syncytial virus |
Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae |
|
Improve Clinical Outcomes
The BIOFIRE® FILMARRAY® Respiratory Panels have has been shown to significantly reduce ICU days3 and duration of antibiotic use.4 Optimize patient management with clinically actionable results.
3. Martinez R, et al. Clinical Virology Symposium, Poster #C-368, May 2016.
4. Rogers B, et al. Arch. Path. & Lab. Med. 2015;139(5): 636-41.
Panel Specification
| Sample Handling | Performance Parameters |
|---|---|
| Sample Type: Nasopharyngeal Swab | Hands-on time: Approx. 2 minutes |
| Sample Volume: 300 μL | Run turnaround time: ~45 minutes |
Clinical Outcomes PUBLICATIONS
- Impact of Early Multiplex FilmArray Respiratory Pathogen Panel (RPP) Assay on Hospital Length of Stay in Pediatric Patients Younger Than 3 Months Admitted for Fever or Sepsis Workup
- Impact of multiplex molecular assay turn-around-time on antibiotic utilization and clinical management of hospitalized children with acute respiratory tract infections
- Clinical impact of rapid molecular detection of respiratory pathogens in patients with acute respiratory infection
- Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial
- Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogens on Healthcare Resource Utilization for Pediatric Inpatients.
- Impact of a rapid respiratory panel test on patient outcomes.
- Rapid respiratory panel testing influences patient management and clinical outcomes.
- Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care.
- Comparison of turnaround time and time to oseltamivir discontinuation between two respiratory viral panel testing methodologies.
- Seasonality and prevalence of respiratory pathogens detected by multiplex PCR at a tertiary care medical center.
POSTERS
- Clinical Outcomes Among Febrile Infants Before and After Implementation of BioFire® FilmArray® Panels
- Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogen Detection in Pediatric Patients
- Comparison of Turnaround Time (TAT) and Time to Oseltamivir Discontinuation between Two Respiratory Viral Panel Testing (RVP) Methodologies
- Utilization and Impact of Rapid Respiratory Virus Panel Testing on Evaluation and Managment of Children Seen in a Pediatric Emergency Department
Economic Outcomes PUBLICATIONS
- Clinical impact of rapid molecular detection of respiratory pathogens in patients with acute respiratory infection
- Impact of a rapid respiratory panel test on patient outcomes.
- Rapid respiratory panel testing influences patient management and clinical outcomes.
- Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care.
- Comparison of turnaround time and time to oseltamivir discontinuation between two respiratory viral panel testing methodologies.
POSTERS
Performance PUBLICATIONS
- Multicenter Evaluation of the BioFire FilmArray Respiratory Panel 2 for the Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples.
- Point-Counterpoint: Large multiplex PCR panels should be first line tests for detection of respiratory and intestinal pathogens
- Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogens on Healthcare Resource Utilization for Pediatric Inpatients
- Impact of a rapid respiratory panel test on patient outcomes.
- Rapid respiratory panel testing influences patient management and clinical outcomes.
- FilmArray, an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection.
- Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care.
- Comparison of turnaround time and time to oseltamivir discontinuation between two respiratory viral panel testing methodologies.
- Seasonality and prevalence of respiratory pathogens detected by multiplex PCR at a tertiary care medical center.
- For respiratory virus detection, a golden age.
POSTERS
- Real-Time Monitoring of Respiratory Illness During Flu Season
- Analytical Studies for FilmArray®: A Rapid and Easy-to-Use Platform for Molecular Detection of Respiratory, Blood, and Gastrointestinal Pathogens.
Fast facts on Respiratory Pathogens
What are Respiratory Pathogens?
The vast majority of respiratory illnesses are caused by viruses and bacteria. In both children and adults, acute respiratory infections (ARI) are most frequently due to infections with Influenza A and B viruses, Parainfluenza viruses 1, 2 and 3, Respiratory Syncytial Virus (RSV A and B), Adenoviruses and Rhinoviruses. Others pathogens such as Coronaviruses, Bocaviruses, Enteroviruses, Parainfluenza 4, Human Metapneumovirus, Mycoplasma pneumonia and Chlamydophila pneumoniae also infect the respiratory tract and can cause various diseases from mild self-limiting upper respiratory infections to potentially threatening pneumonia.
Who is most at risk?
Anyone can become infected and ill with these respiratory pathogens. However, young children, the elderly, immunocompromised or weakened individuals (including those with chronic disease, cancer, or in intensive care) are most likely to suffer serious and potentially life-threatening pneumopathies.
What are the benefits of Respiratory pathogens molecular testing?
Clinical symptoms for different respiratory illnesses are similar so in vitro diagnostic molecular methods are necessary to determine the causative agents. Early, rapid and specific detection of the virus or bacteria involved using real-time PCR methods is essential to provide patient-tailored therapy for better outcomes. An accurate diagnosis may also help to control outbreaks, reduce potential antibiotic resistance and facilitate a more rapid patient recovery.
Technical Notes and Advisory Notes:
- Guidelines for Laboratory Verification of Performance of the BIOFIRE® FILMARRAY® Respiratory Panel (RP)
- Contamination Prevention & Decontamination
- Bordetella pertussis Advisory Notice
Instructions for Use and Manuals:
- BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel (RP2.1plus) Instruction Booklet, FAIV
Product Support Documents:
- BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel Quick Guide
EC Declarations of conformity:
Please consult your local bioMérieux representative for product availability in your country
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