Film Array multiplex Polymerase Chain Reaction (PCR)
Detection of respiratory viruses SARS-CoV-2, Adenovirus, Coronavirus 229E, 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, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.
1. The use of this assay as an in vitro diagnostic under the UD FDA Emergency Use Authorization (EUA) is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderately complexity tests.
2. The performance of this test has not been established for patients without signs and symptoms of respiratory infection.
3. The performance of this test has not been established for immunocompromised individuals.
4. The performance of the RP2.1 has not been established for monitoring treatment of any infection with any of the panel organisms.
5. There is a risk of false positive or false negative values resulting from improperly collected, transported, or handled specimens.
6. Negative results should not be used as the sole basis for diagnosis, treatment, or other management decisions.
7. 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.
8. BioFire RP2.1 should not be used if B. pertussis infection is specifically suspected; Bordetella pertussis / parapertussis PCR, Nasopharynx (PCRBP) should be ordered instead.
9. 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).
10. 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.
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.
SWAB: Use flocked swab, dacron, or rayon swab to obtain specimen and place into approved transport medium. Refrigerate. BAL FLUID: Place in sterile cup and refrigerate. PBS or UTM transport media is also acceptable. Deliver all specimen types to the laboratory as soon as possible. The possibility for virus isolation decreases as the length of storage time increases. Many viral agents will survive at room temperature for several hours; however, for optimum recovery of viruses, please refrigerate; do not freeze.
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.
Additional laboratory testing including viral and bacterial culture, immunofluorescence and radiography may be necessary to evaluate respiratory tract infections.
Factsheet for healthcare providers:
Factsheet for patients: