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PN Panel Quick Guide
PN Panel Quick Guide
For use with FilmArray , FilmArray® 2.0, and FilmArray® Torch systems
®
RFIT-ASY-0144
To avoid contamination, always wear clean gloves and work RFIT-ASY-0145
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Pneumonia Panel Quick Guide
For use with FilmArray®, FilmArray® 2.0, and FilmArray® Torch systems
Run
Run Information
Run Information — Displays information about the sample, Information
Sample ID
ID Example Report
Report Run Date
Date 12 Jul
Jul 2016
2016 12:00
12:00 AM
AM
Sample Example Run 12
protocol (sample type), pouch, instrument, run status, and Protocol
Protocol Sputum
Sputum v3.3
v3.3 Serial
Serial No.
No. 01234567
01234567
Pouch Type Pneumo v2.0 Lot
Lot No. 012345
operator. Shown on both pages of the report. 1 Pouch Type
Controls
Pneumo v2.0
Passed
No.
Operator
012345
Anonymous
Controls Passed Operator Anonymous
Run Status
Status Completed Instrument FA0000
1. Controls: 2 Run Completed Instrument FA0000
Detection
Detection Summary
• If 'Passed', results are valid Bacteria
Summary
Bacteria
• If ' ! Failed’ or ' ! Invalid', RETEST SAMPLE Bin
Bin
Bin (copies/mL)
(copies/mL)
Bin 10^4 10^5 10^6
10^6 ≥10^7
≥10^7
(copies/mL) 10^4 10^5
2. Run Status (copies/mL)
Detected:
Detected: 3a ≥10^7
≥10^7 Klebsiella pneumoniae group
Klebsiella pneumoniae group 3b
• If ‘Completed’, run is complete 10^6
10^6 Streptococcus
Streptococcus pyogenes
pyogenes
10^4
10^4 Haemophilus influenzae
Haemophilus influenzae
• If 'Incomplete', 'Aborted', or any other error message,
Note: Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent
RETEST SAMPLE Note: DetectionSemi-quantitative
of pneumonia. of bacterial nucleic
Binacid may be indicative
(copies/mL) of colonizing
results generated or FilmArray
by the normal respiratory
PneumoniafloraPanel
and may notequivalent
are not indicate the
to causative
CFU/mL and
of pneumonia. Semi-quantitative Bin (copies/mL) results generated by the FilmArray Pneumonia Panel are not equivalent to CFU/mL and do
not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the
agent
do
not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the
relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL).
relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL).
Detection Summary — Displays a short summary of test FilmArray
Clinical correlation is advised to determine significance of semi-quantitative Bin (copies/mL) for clinical management.
Clinical correlation is advised to determine significance of semi-quantitative Bin (copies/mL) for clinical management.
second page of report. Note: Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent
of pneumonia. Semi-quantitative Bin (copies/mL) results generated by the FilmArray Pneumonia Panel are not equivalent to CFU/mL and do
not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the
6. If ' Detected', organism or antimicrobial resistance relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL).
Clinical correlation is advised to determine significance of semi-quantitative Bin (copies/mL) for clinical management.
gene was detected Antimicrobial Resistance Genes
Detected CTX-M
• Bin (copies/mL) – See explanation under Detection Not Detected IMP
Not Detected KPC
Summary above. 8 N/A mecA/C and MREJ
Not Detected NDM
7. If ‘Not Detected’, organism or antimicrobial resistance Not Detected OXA-48-like
gene was not detected Not Detected VIM
Note: Antimicrobial resistance can occur via multiple mechanisms. A Not Detected result for a genetic marker of antimicrobial resistance does not
8. If ‘Ø N/A’, antimicrobial resistance gene was not reported indicate susceptibility to associated antimicrobial drugs or drug classes. A Detected result for a genetic marker of antimicrobial resistance cannot be
definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing and FilmArray
Pneumonia Panel results should be used in conjunction with culture results for the determination of susceptibility or resistance.
because an organism associated with the gene was not Atypical Bacteria
Not Detected Chlamydia pneumoniae
detected Not Detected Legionella pneumophila
9. If ‘ ! Invalid’, RETEST SAMPLE Not Detected Mycoplasma pneumoniae
Viruses
Not Detected Adenovirus
Not Detected Coronavirus
NOTE: If repeated ‘Error’ messages are obtained, Not Detected Human Metapneumovirus
Not Detected Human Rhinovirus/Enterovirus
contact BioFire Diagnostics, the local bioMérieux sales Detected Influenza A
representative, or an authorized distributor. Not Detected
Not Detected
Influenza B
Parainfluenza Virus
Not Detected Respiratory Syncytial Virus
RFIT-PRT-0368-01
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