Interpretive Data

The following bacteria are reported semi-quantitatively with bins representing approximately 10^4, 10^5, 10^6, or ≥10^7 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen:

LIMITATIONS:
 

1. For prescription use only.
2. The FilmArray Pneumonia Panel has not been validated for testing of specimens other than unprocessed sputum-like and BAL-like specimens.
3. Contact or treatment of specimens with decontaminating agents (bleach, MycoPrep (NaOH and NaCl) 2% NaOH and 5% Oxalic acid) can cause false negative results.
4. The performance of FilmArray Pneumonia Panel has not been established for specimens collected from individuals without signs and/or symptoms of lower respiratory infection.
5. The performance of the FilmArray Pneumonia Panel has not been established for monitoring treatment of infection.
6. The effect of antibiotic treatment on test performance including semi-quantitative bin results has not been specifically evaluated.
7. Viral and bacterial nucleic acids may persist in vivo independent of organism viability.  Detection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms.
8. The FilmArray Pneumonia Panel results for bacteria are provided as a qualitative Detected/Not Detected result with an associated semi-quantitative bin result of specimen.  An exact quantitative value is not provided.  The semi-quantitative (copies/mL) bin result does not distinguish between nucleic acid from live or dead bacteria.
9. An negative FilmArray Pneumonia Panel result does not exlucde the possibility of viral or bacterial infection.  Negative test results may occur form 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 that limit of detection for the test or below the reportable level for bacterial analytes.  Negative results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
10. Concomitant culture of specimens is required with the FilmArray Pneumonia Panel.  Culture is needed for recovery of isolates and antimicrobial susceptibility testing, as well as further specimen of genus, complex or group level results (if desired).
11. Due to genetic similarity between human rhinovirus and enterovirus, the FilmArray Pneumonia Panel cannot reliably differentiate them.  A FilmArray Pneumonia Panel Human Rhinovirus/Enterovirus Detected result should be followed-up using an alternate method (e.g. cell culture, or sequence analysis) if differentiation between the viruses is required.
12. The in silico analyses performed to predict amplification and detection of organisms and antimicrobial resistance genes were based on a comparison of target gene sequences available in GenBank to FilmArray Pneumonia Panel primer sequences.  In silico analyses were performed between January 2016 and January 2018.  Entries of new sequences added to the database after these dates have not been evaluated.  Additional limitations on reactivity may be identified as new sequence data are deposited and/or as new sequence variants emerge.
13. Based on in silico analysis, the MREJ assay (which is only reported is Staphylococcus aureus is detected and the mecA/C assay is also positive) is predicted to have impaired reactivity or to be non-reative with MREJ types ix, xv, and xviii, as well as types xix and xx (associated with methicillin-sensitive S. aureus MSSA), and MREJ sequences annotated from non-aureus Staphylococcus species and non-staphylococci such as Bacillus cerus, Bacillus thuringiensis, Macrococcus caseolyticus, Clostridium acidurici, and Rummeliibacillus stabekisii.
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 test results are more likely during periods when prevalence is moderate to low.
15. Performance characteristics for influenza A were established during the 2016-2017 influenza season.  When other novel influenza A viruses are emerging, performance characteristics may vary.  If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing.  Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
16. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for several analytes in one or both matrices were primarily established using archived and/or contrived specimens as detailed in the Clinical Performance section.