Test Overview
Test Methodology

Film Array multiplex Polymerase Chain Reaction (PCR)

Test Usage

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.

Reference Range *

Negative

Test Limitations

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.

Test Details
Days Set Up
Daily
Analytic Time

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.

Soft Order Code
RPANC
MiChart Code
Respiratory Virus Panel + SARS-CoV2; PCR
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection

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.

Special Handling

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.

Rejection Criteria
specimens collected with a calcium alginate swab or wooden handled swab.
Normal Volume
1 nasopharyngeal or oropharynx swab; 2 mL BAL; 2 mL tracheal aspirate or suction; 2 mL nasal aspirate
Storage Temperature
Specimens in VTM should be processed and tested as soon as possible. If storage is required, specimens in VTM can be held at room temperature (15°-25°C) for up to 4 hours, at refrigerator temperature (2°-8° C) for up to 3 days, or at freezer temperature (<-15° C or greater than or equal to -70 C°) for up to 30 days.
Additional Information

Additional laboratory testing including viral and bacterial culture, immunofluorescence and radiography may be necessary to evaluate respiratory tract infections.
Factsheet for healthcare providers:
https://www.fda.gov/media/137581/download

Factsheet for patients:
https://www.fda.gov/media/137582/download

Billing
CPT Code
0202U
Fee Code
LA027
LOINC
82159-5
NY State Approved
No