Product Specifications.pdf

The BioFire® Respiratory

2.1 (RP2.1) Panel 1 Test. 22 Targets. ~45 Minutes.

The BioFire RP2.1 Panel Targets

VIRUSES

Adenovirus Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Human Metapneumovirus Human Rhinovirus/Enterovirus Influenza A

Influenza A/H1 Influenza A/H3 Influenza A/H1-2009 Influenza B Parainfluenza Virus 1 Parainfluenza Virus 2 Parainfluenza Virus 3 Parainfluenza Virus 4 Respiratory Syncytial Virus

BACTERIA

Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae

COVID-19 and the Value of the Syndromic Approach

Study results suggest higher rates of co-infection between SARS-CoV-2 and other respiratory pathogens than previously reported. In some cases, as many as 20% of COVID-19 patients have co-infections with another respiratory virus.1 Because respiratory symptoms are similar and overlapping, a syndromic panel can provide fast, comprehensive answers and take the guesswork out of choosing which pathogens to test for.

Co-infection for SARS-CoV-2 Positive Patients1

Only Infected with SARS-CoV-2

Co-infection with Another Respiratory Virus

79.3%

20.7%

BFR0001-3107-01

Part Number

BioFire RP2.1 Reagent Kit (30 Pouches): 423742

Sample Type: Nasopharyngeal swab in transport media or saline Sample Volume: 0.3 mL

Hands-On Time: approximately 2 minutes Storage Conditions: All kit components stored at room temperature (15-25 ˚C)

Overall Performance: 97.1% sensitivity, 99.3% specificity7 SARS-CoV-2 Performance: 98.4% PPA, 98.9% NPA8

Panel Specifications

The BioFire RP Panel resulted in avoidance of antibiotics in 30% of pediatric patients tested.6

Help Guide Antimicrobial Stewardship Programs

The US CDC estimates that 50% of outpatient prescriptions for acute respiratory conditions are unnecessary, contributing to increased levels of antibiotic resistance.5 Use of the BioFire RP Panel has been shown to reduce antibiotic use by identifying respiratory viruses in a clinically actionable timeframe.6

Knowing the Pathogen Matters

Reduce Length of Stay The hospital length of stay was nearly 5 days less for febrile infants with a positive BioFire RP Panel result compared to those with a negative result.4

Reduce Unnecessary Testing Use of the BioFire RP Panel was shown to reduce chest radiographs in children by 19%.3

Inform Clinical Decisions Respiratory infections can be characterized by similar symptoms, making diagnosis difficult.

The BioFire® FilmArray® Respiratory (RP) Panel was shown to increase diagnostic yield by 30%, compared to traditional testing methods.2

45%

15%

BioFire RP Panel

Traditional Testing

References

1. Kim, D et al. (2020) JAMA doi:10.1001/jama.2020.6266

2. Brendish et al. (2017) Lancet Respiratory Medicine. 5(5):401.

3. Subramony A, Zachariah P, Krones A, Whittier S, Saiman L. J Pediatr. 2016; doi: 10.1016/j.jpeds.2016.02.050016.02.050.

4. McFall, et al., Pediatrics. 2017 Feb;:000992281774066.

5. CDC. Antibiotic Use in the United States, 2017: Progress and Opportunities. Atlanta, GA: US Department of Health and Human Services, CDC; 2017.

6. Sutton C, Walton P, Williams M, Bastian T, Wright M, Spires S. Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogen Detection in Pediatric Patients, ID Week 2017, poster 1607.

7. Overall performance based on prospective clinical study for the BioFire® FilmArray® Respiratory 2 Panel, Data on file, BioFire Diagnostics.

8. 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.

Contact Us

Phone: +1-801-736-6354 x 2

Email: sales@biofiredx.com biofiredx.com

FDA-Cleared