Test Overview
Film Array multiplex Polymerase Chain Reaction (PCR)
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. Respiratory pathogens cause acute local and systemic disease, with the most severe cases occurring in children, the elderly, and immunocompromised individuals. Respiratory symptoms can include coughing, nasal discharge, congestion, fever, wheezing, shortness of breath, headache, and myalgia. Due to the similarity of diseases caused by many viruses and bacteria, diagnosis based on clinical symptoms alone is difficult. Identification of potential causative agents provides data to aid the physician in determining appropriate patient treatment and public health response for disease containment.
The following organism types and subtypes are identified using the BIOFIRE RP2.1: SARS-CoV-2(COVID-19), Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus (RSV), Bordetella pertussis, Bordetella parapertussis Chlamydia pneumoniae, and Mycoplasma pneumoniae.
Not detected
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
If four or more organisms are detected in a specimen, retesting is recommended to confirm the polymicrobial result.
The performance of this test has not been established for patients without signs and symptoms of respiratory infection.
The performance of the RP2.1 has not been established for monitoring treatment of any infection with any of the panel organisms.
There is a risk of false positive or false negative values resulting from improperly collected, transported, or handled specimens.
Negative results should not be used as the sole basis for diagnosis, treatment, or other management decisions.
Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely during peak activity when prevalence of disease is high. False positive test results are more likely during periods when prevalence is moderate to low.
BioFire RP2.1 should not be used if B. pertussis infection is specifically suspected; Bordetella pertussis / parapertussis PCR, Nasopharynx (PCRBP) should be ordered instead.
The BioFire RP2.1 Bordetella pertussis (ptxP) assay can also amplify pertussis toxin pseudogene sequences when present in B. bronchiseptica and B parapertussis. Cross-reactivity was observed only at high concentration (e.g. > 1.2E+09 CFU/mL).
The FilmArray RP2.1 Human Rhinovirus/Enterovirus assay may amplify off-target sequences found in strains of B. pertussis, B. bronchiseptica and B. parapertussis. Cross-reactivity with B. pertussis was observed at a concentration of 4.5E+7 CFU/mL.
Test Details
1 day (6 hours for UM inpatients and ED).
Testing is performed 24/7 throughout the day with turnaround time dependent on staffing and the current load on the instrument.
Non- Nasopharyngeal specimens - 12 hour turn around time
- Metapneumovirus
- Adenovirus
- Respiratory Syncytial Virus
- Parainfluenza
- Influenza
- Mycoplasma pneumoniae
- Bordetella pertussis
- Bordetella parapertussis
Specimen Requirements
SWAB: Use flocked swab, dacron, or rayon swab to obtain specimen and place into UTM / VTM. Refrigerate.
BAL FLUID: Place in sterile cup and refrigerate.
Deliver all specimen types to the laboratory as soon as possible. The possibility for virus isolation decreases as the length of storage time increases. Specimens should be stored and transported refrigerated for up to 3 days (preferred) but can be held at room temperature for up to 4 hours or frozen for up to 30 days.
Special Handling:
For patients seen in the ER (CES or ESA) please order test code ERPNC instead of RPANC. Test code ERPNC will receive priority testing and is only approved for use by clinicians in the ED and inpatient population.
1 nasopharyngeal swab in UTM / VTM; M2 mL BAL; 2 mL tracheal aspirate or suction; 2 mL nasal aspirate