Interpretive Data

LIMITATIONS:

1. Results from this test must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
2. This test is not validated for use with specimens other than nasopharyngeal swabs.
3. The performance of this assay has not been established for specimens collected from patients without signs and symptoms of respiratory infection.
4. The performance of this assay has not been specifically evaluated for NPS specimens from immunocompromised patients.
5. The effect of antibiotic treatment on test performance has not been evauated.
6. The performance of this test has not been established with potentially interfering medications for the treatment of influenza or cold viruses. The effect of interfering substances has only been evaluated for those listed in the Interference section of the package insert. Interference from unevauated substances could lead to erroneous results.
7. The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.
8. The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any step can lead to incorrect results. There is a risk of a false positive or negative result resulting from improperly collected, transported or handled specimens.
9. A negative result does not exclude the possibility of viral or bacterial infection. Negative test results may occur from the presence of sequence variants in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up or an infection caused by an organism not detected by the panel. Test results may also be affected by concurrent antiviral/antibacterial therapy or levels of organism in the specimen that are below the limit of detection for the test. Negative results should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a NPS.
10. There is a risk of false positive results due to cross-contamination by target organisms, their nucleic acids or amplified product.
11. There is a risk of false positive results due to non-specific amplification and cross-reactivity with organisms found in the respiratory tract. Observed and predicted cross-reactivity may be found in the current package insert. Erroneous results due to cross-reactivity with organisms that were not evaluated or new variant sequences that emerge is also possible.
12. If four or more organisms are detected in the specimen, it is recommended that a second specimen be collected and tested to confirm the polymicrobial result.
13. Viral and bacterial nucleic acids may persist in vivo independent of organism viability. Detection of target(s) does not imply that the corresponding organisms are infectious or are the causitive agents for clinical symptoms.
14. 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 results are more likely during periods when prevalence is moderate to low.
15. Clinical performance was established when Influenza A H1-2009 was the predominant Influenza A virus in circulation. When other Influenza A viruses are emerging, performane may vary.
16. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordatella pertussis, Bordatella parapertussis, Chlamydia pneumoniae, Coronavirus 229E, Influenza A H1, Influenza A H3, Influenza B, Parainfluenza Virus 1, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. Performance characteristics for Influenza A H1 was established primarily using contrived clinical samples.
17. The RP2 influenza A subtyping assays target the influenza A hemagglutinin (H) gene only. The FilmArray  RP2 does not detect or differentiate between influenza A neuraminidase (N) subtypes.
18. This assay may not be able to distinguish between existing viral strains and new variants as they emerge. If variant viral infection is suspected, clinicians should request testing by the state health department.
19. Due to the genetic similarity between Human Rhinovirus and Enterovirus, this assay cannot reliably differentiate them.
20. This assay detects a single copy Pertussis Toxin promoter target (ptxP, present at one copy per cell) in B. pertussis. Other PCR tests for this organism target the multi-copy IS481 insertion sequence and are therefore capable of detecting lower levels of B. pertussis (more sensitive).
    1. This assay should not be used if B. pertussis infection is specifically suspected.
    2. Due to lower sensitivity, this assay is less susceptible than IS481 assays to the detection of very low levels of contaminating B. pertussis vaccine material. However, care must always be taken to avoid contamination of specimens with vaccine material as higher levels may still lead to false positive results with this assay.
    3. The IS481 sequence is also present in B. holmesii and to a lesser extent in B. bronchiseptica, whereas this assay was designed to be specific for B. pertussis. However this assay can also amplify pertussis toxin pseudogene sequences when present in B. bronchiseptica and B. parapertussis. Cross-reactivity was observed at high concentrations.
21. Some stains of B. bronchiseptica (rarely isolated from humans) do carry IS1001 insertion sequences identical to those carried by most strains of B. parapertussis. These sequences will be amplified by the IS001 assay and reported as positive on the RP2 as B. parapertussis.
22. One of the RP2 Human Rhinovirus/Enterovirus assays may amplify off-target sequences found in strains of B. pertussis, B. bronchiseptica, and B. parapertussis. Cross-reactivity with B. pertusssis was observed.
23. Recent administration of nasal infuenza vaccine prior to NPS collection could lead to accurate virus detection by this assay but would not represent infection.